Archive for July, 2020

The Canadian navy has found a very creative way to keep its second-hand submarines afloat until the late 2030s and early 2040s a plan that emphasizesmaintenance over age in predicting how long the vessels can remain seaworthy.

The plan according to a newly-releasedbriefing note prepared in the run-up to the release of the Liberal government's marquee defence policy would not see HMCS Victoria decommissioned until the end of 2042, giving the warship over 45 years service in Canada.

That estimate does not include the time the boat served with Britain's Royal Navy, which would add at least a decade to its working life.

The retirements of the other submarines HMCS Chicoutimi, HMCS Windsor and HMCS Corner Brook would be staggered throughout the 2030s, with Windsor being the first to go in 2033.

"The [Victoria Class Submarines] are a well-designed and solidly constructed class of modern conventional submarines that have had an unusual life since entering service with the [Royal Navy] in the early 1990s," said the August 2016 briefinganalysis, recently obtained by Conservative Party researchers. "'While chronologically 20 years older, they have not been operated extensively during that time."

The boats were first constructed for the Royal Navy in the 1980s, but Britain decided to sell them when the government of the day made the policy decision to operate only nuclear-powered submarines.

One aspect of the Liberal defence policy, released in June 2017, that has puzzled military experts and oppositioncritics alike was its assumption that the submarines which have had a tortured technical history that includesone fatal fire will remain in serviceuntil at least the 2040s.

The briefing notespells out in detail and for the first time publicly how the navy intends to squeeze more life out ofboats it wassupposed to start retiring in four years.

It was originally envisioned, the briefing said,that the Victoria-Class submarines would retire one at a time, beginning in 2024.

The report argues it is possible to operate the submarines beyond their expected working lives if the militaryassesses the"material state" of each boat rather than following"a simplistic calendar driven" evaluation of their operational condition.

In others words, the report argues that what matters most is not how oldthe submarines are, butrather how hard have they been driven and how well have they been maintained.

The submarines operate on what's called a "6-2 schedule" six years of service at sea followed by two years of deep maintenance before returning to duty.

The briefing note proposesthat the boats do nine years of service and then go into a longer refurbishment of up to three years.The submarines would need a full life-extension overhaulin addition to the extendedmaintenance plan.

As evidence to support the plan, the briefing note to senior defence officials pointed to a 2013 study of the Victoria-Class submarines which said that "although there are numerous technical and supportability challenges, there was no single obstacle precluding a life extension of up to 12 years."

The briefing offers one note of caution, however:"It is reasonable to assume that operational availability will decrease as the submarine ages."

The briefing note predicted higher maintenance and sustainment costs as the boats get older. To save money, it said,the navy might have to lower expectations of what the boats can do.

The existing plan "assumed that there would be no relaxation of operational performance requirements, although in fact some discretion by the Operational Requirements Authority in this regard may be feasible as a cost saving measure," said the note.

Conservative defence critic James Bezansaid he was astounded by the plan to stretch out the operational life of the subs. He said he doesn't blame thenaval planners who drew up the document but he does hold the Liberal government accountable, arguing itmust have ordered the Department of National Defence to give it some justification for putting off the purchase of new submarines.

"It is ridiculous," Bezan said. "There was potential for some political direction on how this was written."

In an interview with CBC News at the end of last year, the commander of the navy, Vice-Admiral Art McDonald, defended the plan to extend the life of the boats, saying he had full confidence in the "pretty resourceful and capable"submarine engineering community.

The defence policy, he said, "directed us to operate and modernize" the submarine fleet and he's confident it can be done safely.

"We know there is still excellent life in the Victoria-class submarine," McDonald told CBC News. "I've seen that personally as an outsider who has come into the program and taken a look at it."

The focus of the subs' modernization project which was in the early stages of being developed when the pandemic hit back in latewinter will be on survivability and making the submarines more livable forcrewmembers.

"We're going to be able to operate those boats into the 2030s, but to do that we have to continue with the routine investments we've made and modernize, as was directed" by the defence policy,McDonald said.

A series of assessments was conducted between 2008 and 2014. The defence department's naval board, which is charged with planning the future shape of the fleet, met in November 2014 to study the life expectancy of the second-hand boats.

"While it is considered unrealistic to predict the material state of 40-year-old platforms, 20 years into the future, certain items such as the pressure hull and main motor will require additional monitoring and maintenance above the current regime, since unpredicted degradation in such areas may not be cost effective to repair and mitigate," said the 2016 briefing note.

And that's the problem with the life-extension plan, saidBezan: somekey partsof a submarine such as the pressure hull and the engines can't be upgraded.He also pointed to how the submarine fleet had "zero days at sea" in 2019 because all of the vessels were tied up for maintenance.

The analysis, Bezan said, shows thatthe Liberal government should immediately begin looking for a replacement for the submarines something the previous Conservative government was in the process of doing when it was defeated in 2015.

The options that werediscussed before the election, he said, included partnering with the Australians who were in the process of acquiring their own submarine replacements or buying an off-the-shelf design for inclusion in the federal shipbuilding strategy.None of those ideas got very far before the election, he added.

Read more:
It's the mileage, not the years: Military says it plans to keep subs afloat past retirement dates - CBC.ca

The Czech government on 28 July signed agreements with power utility CEZ for the planned expansion of the Dukovany NPP. Deputy Prime Minister and Minister of Industry and Trade Karel Havlcek and CEZ CEO Daniel Bene signed a contract in addition to the umbrella agreement, which defines the zoning permit for the location of the building and the selection of the contractor by 2024. The agreements cover the general structure of the project and its inception phase, including the holding of a tender, which will result in CEZ receiving a preferred list of suppliers of reactor technology by 2022. The contract with the supplier is expected to be signed in 2024. Construction of the new unit may begin in 2029, for commissioning in 2036.

The Czech government, which owns 70% of the CEZ shares earlier in July approved plans to provide an interest-free loan for the new unit.

The government also approved a model for buying electricity from the new unit at a specific price, with consumers paying the difference if this price is higher than the wholesale market prices. These plans will still need to be approved by the European Commission to verify that they comply with EU state aid rules.

The Czech state has long been negotiating with CEZ to expand its nuclear fleet, but costs and funding were the main obstacles. Benes had said earlier that the company would prepare a tender by June 2020, with five bidders expected in 2021. He added that market valuations for the new unit range from $5.9 billion to $6.9 billion, but the final price will be announced at auction.

Among other things, the implementation contract states that the contract with the supplier should be negotiated and ready for signing by 31 December 2022 and no later than 30 June 2024. CEZ's subsidiary CEZ Dukovany II (EDU II), which is responsible for the project, however, is expected to try to negotiate and prepare the contract for signature earlier. The budget for the preparation of the construction of the unit and the operation of EDU II for the first phase of the project until the middle of 2024 amounts to CZK3.4 billion ($153m) according to the contract.

A spokesman for CEZ confirmed that the company had consulted with potential tenderers, and they all confirmed their interest. These include China's CGN, France's EDF, South Korea's KEPCO, Russia's Rosatom and US-based Westinghouse.

Bene said that it is not in CEZ's interest to exclude some applicants from the competition for the Dukovan construction before the tender. The possible participation of Chinese and Russian companies had been criticised by opposition politicians. "It is in CEZ's interest to have as many candidates as possible in the competition, who will compete against each other, and thus force each other to improve their offers, because we need to get the best possible offer. For this reason, it is not in CEZ's interest to exclude anyone, " he said.

"On the other hand, the agreement between the state and CEZ, which we signed, describes the basic security interests of the state and ways to enforce them, and it says that the state can say during or at the end of the competition that it prefers one of the bidders for security reasons," said Bene. He added that Havlcek and Prime Minister Andrej Babi have similar views on the matter and favour keeping as many candidates in the competition as possible for as long as possible.

The Czech Republic operates six commercial nuclear power units four Soviet-built VVER-440s at the the Dukovany NPP and two Russian VVER-1000 units at the Temelin NPP, which together provided about 35% of total electricity production. The current units at Dukovany, which were commissioned in 1985-1987, will be decommissioned no later than 2045-2047, which means that the original units and the new unit will work together for up to 10 years. The government plans long-term operation of the Dukovany units for up to 60 years. CEZ recently announced an investment of about 2 billion in a life extension project, which means annual investments in the modernisation and reconstruction of the units will increase from 56 million to 93 million by 2028.In 2014, CEZ cancelled a tender for the construction of two new units of the Temelin NPP after the company did not receive government guarantees for the project.

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EZ and Czech government agree on Dukovany expansion - Nuclear Engineering

WASHINGTON Congress is establishing increased oversight of the Missile Defense Agencys plans for its homeland missile defense system designed to protect against possible intercontinental ballistic missile threats from North Korea and Iran through provisions in the House and Senate passed versions of the fiscal 2021 National Defense Authorization Act.

Displeased with the abrupt cancellation of the agencys major upgrade to interceptors in the ground at Fort Greely, Alaska, and Vandenberg Air Force Base, California, lawmakers are demanding the agency show its work on its plan to build an entirely new interceptor for the Ground-based Midcourse Defense System (GMD). It also wants more details on the agency plan to develop an underlay of additional regional missile defense systems to bolster GMD.

MDA announced in May 2019 that it would pause its plans to develop and field a Redesigned Kill Vehicle (RKV) essentially the warhead of the GMD systems interceptors due to technical issues. Then the Pentagons under-secretary of defense for research and engineering subsequently scrapped the program in August 2019 in favor of designing a brand new interceptor.

Ending the program was the responsible thing to do, Mike Griffin said at the time. He resigned from his post at the Pentagon earlier this month.

Griffins decision to abruptly cancel the RKV program without congressional notification ahead of time created a serious rift with lawmakers. And the House Armed Services Committee even recommended moving the MDA outside of Griffins control.

The agency also unveiled plans in its FY21 budget request in February to create a more layered homeland defense system that would include regional missile defense capability already resident with the Navy and Army to bolster homeland defense against ICBMs.

The plan would include establishing layers of defensive capability relying on the Aegis Weapon System, particularly the SM-3 Block IIA missiles used in the system, and a possible Aegis Ashore system in Hawaii. The underlay also would include the Terminal High Altitude Area Defense (THAAD) system. The Army is already operating a THAAD battery in South Korea and Guam.

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Lawmakers were less than thrilled with the sudden cancellation of the RKV program and were dissatisfied with Griffins projections that a new interceptor wouldnt be ready until the 2030s. The MDA director has since said its possible to field the next generation interceptor by 2028.

The Senate Armed Services Committees version of the bill includes a provision requiring the agency to develop an interim Ground-based Interceptor (GBI) for the GMD system.

The interim interceptor would meet current proposed capabilities of the RKV and use existing technologies for the kill vehicle and the booster. It also requires 20 of the interim interceptors be delivered by 2026 after rigorous flight testing, according to the legislation.

The SASC language includes waivers to get out of development effort. These include if the technology isnt feasible, if the capability is not in the national security interest of the United States and if the NGI can be fielded faster. To seek a waiver, the defense secretary must issue a report to the relevant congressional committees explaining why the waiver is needed along with an updated schedule.

In the House version of the defense policy bill, lawmakers arent asking for an interim interceptor, but they are requiring that MDA notify congressional defense committees within a week if any changes are made to the requirements for the NGI.

The agency would also be required to brief congress within two weeks of awarding a contract for the interceptor.

House lawmakers also want a report within three months of the passage of the bill that seeks an explanation of how existing contracts for GMD could be used to improve and sustain the current kill vehicle and boosters, a plan for a service life extension program, how much it would cost and a schedule to produce boosters for 20 additional interceptors by 2026 as well as an analysis of policy implications.

The bill also requires the Cost Assessment and Program Evaluation (CAPE) office to conduct an independent cost assessment of the NGI program and have it validated by the Office of the Undersecretary of Defense for Acquisition and Sustainment, which has been mulled as a future home for the MDA.

Two successful flight tests of NGI are also mandated as part of the House version of the bill and a briefing of the test results to congressional defense committees, including a rundown of how operationally realistic the tests were, should be delivered before any initial production decision for the interceptor.

The agencys FY21 budget did not lay out a clear plan for what an underlay for ballistic missile defense for the homeland might look like, so the SASC is also limiting half of the appropriated funding for the underlay until a report is submitted on a strategy to build such an architecture. The report should include analysis of requirements and capabilities and an assessment of basing and sites for the assets within the underlay.

On the House side, lawmakers want an analysis of alternatives on using THAAD and Aegis for homeland ballistic missile defense. That analysis should cover sensors that would be used, an assessment of locations to provide similar coverage to the GMD system, acquisition objectives for interceptors and what command-and-control aspects need to be improved.

The report should also include manning, training and sustainment, a schedule for establishing the underlay, lifecycle cost estimates and a comparison of capabilities with additional GMD sites.

The provision includes a requirement for another report by the Defense Intelligence Agency on reactions from adversaries and potential responses to those reactions.

Together, these half dozen legislative provisions mark a bipartisan and bicameral vote of no confidence in one persons ability to assemble and communicate a short, medium, and long-term plan for the future of homeland missile defense, Tom Karako, a missile defense analyst at the Center for Strategic and International Studies, told Defense News. But circumstances have recently changed, and the dust is settling.

More here:
Congressional oversight of homeland missile defense plans increase in FY21 defense policy bills - DefenseNews.com

You might be able to do your seven-step skincare routine in your sleep, but have you given any TLC to the rest of the skin on your body lately? Your face may be glowing and nearly pore-less, but the dry, cracked skin on your elbows might be screaming out for help. Treat your parched and scaly skin to one of the best sugar body scrubs. You might hesitate when you hear the word scrub, especially if you have sensitive skin, but dont worry. Unlike other exfoliating scrubs, this one wont totally dry out your skin and leave it worse off than before. The sugar, which is much gentler than salt, is combined with oil to slough off dead dull skin cells and moisturize your healthy skin underneath at the same time.

Its basically a 2-in-1 skincare product that you bring into the shower with you. You accomplish two tasks at once. You just gently massage it into your skin when you shower and rinse it off. Its that easy. These body scrubs are must-haves. Theyll make your after-shower moisturizing that much more effective. We rounded up the top sugar body scrubs for you. You can even use a few of them on your face and lipstalk about a versatile product.

Our mission at STYLECASTER is to bring style to the people, and we only feature products we think youll love as much as we do. Please note that if you purchase something by clicking on a link within this story, we may receive a small commission of the sale and the retailer may receive certain auditable data for accounting purposes.

Made out of shea butter and a mix of seed and fruit oils, this is definitely a popular sugar scrub. You rub it on your skin as you shower and it both softens and moisturizes your skin, while hitting you with a beautiful aroma. Its a great exfoliator and removes dead skin. There are four different varieties of sugar scrub, including Tropical Mango, Pear & Chia, Mocha & Coffee Bean and Amazon Pequi.

Courtesy of Tree Hut.

The exfoliating scrub will remove any dead skin and moisturize the healthy, elastic skin underneath. Designed for sensitive skin, the scrub gives you a gentle treatment that wont leave your skin feeling dried out. This scrub isnt just for your body either. You can also use it on your face and feet. It can even be a lip scrub in a pinch. Youll feel like you just stepped out of a spa treatment.

Courtesy of Brooklyn Botany.

This brown sugar scrub has a few extra secret weapons baked incollagen and stem cells. This antioxidant rich scrub gives you healthier, more elastic skin while also getting rid of toxins. Your skin will look younger and more supple after a good scrub, because its moisturizing. In addition to getting rid of blackheads, the face and body scrub can also reduce the size of your pores.

Courtesy of M3 Naturals.

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The Best Sugar Body Scrubs That You Can Buy on Amazon - STYLECASTER

The Regenerative Medicine Market report 2020 covers all the significant developments which are recently being adopted across the global market. The prime objective of the Regenerative Medicine market report is to provides an in-depth analysis of all market dynamics including drivers and restraints, and trends, and opportunities. The Regenerative Medicine market report covers both the demand and supply aspects of the market. The report also highlighted the future trends in the Regenerative Medicine market that will impact the demand during the forecast period.

Scope of the Report:

As per the , regenerative medicines are used to repair, replace, and regenerate the tissues and organs affected by injury, disease, or the natural aging process. These medicines restore the functionality of cells and tissues and are used in several degenerative disorders, such as dermatology, neurodegenerative diseases, cardiovascular, and orthopedic applications.

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Market Overview:

Some of the Top Key Players of Regenerative Medicine Market Report Are:

Report Highlights:

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Key Market Trends:

Dermatology is the Segment by Application that is Expected to be the Largest During the Forecast Period

Dermatology is estimated to have the largest share in revenue generation, and this high contribution is attributive to the presence of easy grafting techniques for dermatological wounds and diseases. Skin, being an organ with great cell replication characteristics, provides various types of stem cells from its different layers. Therefore, there are a broad range of products present, from patches to cure small injuries to matrix and grafts for chronic wounds and burns. Thus, the segment is expected to continue to dominate the market through to the forecast period.

The increasing number of accidents and bone defects is also expected to drive the regenerative medicine market. There are also several research studies that are being conducted on tissue engineering for the development of bone graft substitutes, with the help of regenerative medicine. So, with the new advances in bone graft, the market is expected to grow over the forecast period.

North America Holds the Largest Share and is Expected to Follow the Same Trend Over the Forecast Period

North America is estimated to have the largest share, in terms of revenue, owing to the presence of major players and rapid advances in technology, along with high investments in stem cell and oncology research. There is also an increasing prevalence of diseases, such as cancer and diabetes, which can now be cured by various stem cell therapies. Additionally, the awareness regarding the available stem cell procedures and therapies among people is rising, which in turn, is increasing the demand for the overall market.

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Detailed TOC of Regenerative Medicine Market Report 2020-2024:

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Increasing Adoption of Stem Cell Technology4.2.2 Technological Advancements in Regenerative Medicine4.3 Market Restraints4.3.1 Regulatory and Ethical Issues4.3.2 High Cost of Treatments4.4 Porters Five Forces Analysis4.4.1 Threat of New Entrants4.4.2 Bargaining Power of Buyers/Consumers4.4.3 Bargaining Power of Suppliers4.4.4 Threat of Substitute Products4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION5.1 By Type of Technology5.1.1 Stem Cell Therapy5.1.2 Biomaterial5.1.3 Tissue Engineering5.1.4 Other Types of Technologies5.2 By Application5.2.1 Bone Graft Substitutes5.2.2 Osteoarticular Diseases5.2.3 Dermatology5.2.4 Cardiovascular5.2.5 Central Nervous System5.2.6 Other Applications5.3 Geography5.3.1 North America5.3.1.1 United States5.3.1.2 Canada5.3.1.3 Mexico5.3.2 Europe5.3.2.1 Germany5.3.2.2 United Kingdom5.3.2.3 France5.3.2.4 Italy5.3.2.5 Spain5.3.2.6 Rest of Europe5.3.3 Asia-Pacific5.3.3.1 China5.3.3.2 Japan5.3.3.3 India5.3.3.4 Australia5.3.3.5 South Korea5.3.3.6 Rest of Asia-Pacific5.3.4 Middle East & Africa5.3.4.1 GCC5.3.4.2 South Africa5.3.4.3 Rest of Middle East & Africa5.3.5 South America5.3.5.1 Brazil5.3.5.2 Argentina5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Allergan6.1.2 Osiris Therapeutics6.1.3 Integra Lifesciences6.1.4 Cook Biotech Incorporated6.1.5 Organogenesis Inc.6.1.6 Baxter6.1.7 Medtronic6.1.8 Thermo Fisher Scientific6.1.9 Sigma-Aldrich Co.6.1.10 Becton Dickinson and Company

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Regenerative Medicine Market 2020 | Research Objectives and Methodology, Growth Analysis, Top Manufacturers Sales, and Cost Structures Forecast 2024 -...

Consumers behind face masks pay more attention to skin problems around eyes such as eye bags, crows feet, and dark circles.

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With a lot of care in mind, BEAUTYFLUFF has infused this product withL.O.V.E. (Lifting Optimal and Vitality Express) formula of peptides, stem cells, plantextracts, antioxidants, and more star ingredients like Instensyl Px, Eyeliss,Cobio-phytonic and Squalane, to help increase blood circulation and reduce puffiness,to improve the appearance of fine lines and wrinkles and to give the skin a plumper lookwhile providing the moisturizing and soothing properties as the basic necessities for thelong term benefits. It can also be used as an eye and lip mask at night.

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BEAUTYFLUFF, a rising skin care line, has launched a new eye and lip product in the midst of a pandemic. - Your Digital Wall

For in-depth understanding of market and competitive landscape, this Exosome Therapeutic Market research report provides a lot of parameters and detailed data about Healthcare industry. The report offers persistent knowledge and information of revolutionizing market landscape, what already exists in the market, future trends or what the market expects, the competitive environment, and strategies to plan to outshine the competitors. Various market related parameters considered in this Exosome Therapeutic Market research report helps businesses for better decision making.

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Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in theExosome Therapeutic Marketreport areevox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global.Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

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Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

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Exosome Therapeutic Market 2020 : Industry Size & Share, Business Strategies, Growth Analysis By EXOCOBIO, Exopharm, AEGLE Therapeutics, United...

Pune, Maharashtra, India, July 31 2020 (Wiredrelease) Prudour Pvt. Ltd : Market.us Anti-Ageing Drugs Market research report provides a comprehensive, 360-degree analysis of the targeted market which helps stakeholders to identify the opportunities as well as challenges during COVID-19 pandemic across the globe.

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Anti-Ageing Drugs Market reports provide in-depth analysis of Top Players, Geography, End users, Applications, Competitor analysis, Revenue, Financial Analysis, Market Share, COVID-19 Analysis, Trends, and Forecast 2020-2029. It incorporates market evolution study, involving the current scenario, growth rate, and capacity inflation prospects, based on Porters Five Forces and DROT analyses.

The Anti-Ageing Drugs Market report includes analysis in terms of both quantitative and qualitative data, taking into factors such as Product pricing, Product penetration, Country GDP, movement of parent market & child markets, End application industries, etc. The report is defined by bifurcating various parts of the market into segments that provide an understanding of different aspects of the market.

The overall report is divided into the following primary sections: segments, market outlook, competitive landscape, and company profiles. The segments cover various aspects of the market, from the trends that are affecting the market to major market players, in turn providing a well-rounded assessment of the market. In terms of the market outlook section, the report provides a study of the major market dynamics that are playing a substantial role in the market. The market outlook section is further categorized into sections; drivers, restraints, opportunities, and challenges. The drivers and restraints cover the internal factors of the market whereas opportunities and challenges are the external factors that are affecting the market. The market outlook section also comprises Porters Five Forces analysis (which explains buyers bargaining power, suppliers bargaining power, the threat of new entrants, threat of substitutes, and degree of competition in the anti-ageing drugs) in addition to the market dynamics.

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To justifiably share in-depth info regarding the decisive elements impacting the increase of industry (growth capacity, chances, drivers and industry-specific challenge and risks) To know the Anti-Ageing Drugs Market by pinpointing its many sub-segments To profile the important players and analyze their growth plans To endeavor the amount and value of the Anti-Ageing Drugs Market sub-markets, depending on key regions (various vital states) To analyze the Global Anti-Ageing Drugs Market concerning growth trends, prospects and also their participation in the entire sector To inspect and study the Global Anti-Ageing Drugs Market size form the company, essential regions/countries, products and applications, background information and also predictions to 2029 Primary worldwide Anti-Ageing Drugs Market manufacturing companies, to specify, clarify and analyze the product sales amount, value and market share, market rivalry landscape, SWOT analysis and development plans for the next coming years To examine competitive progress such as expansions, arrangements, new product launches and acquisitions on the market

Leading Anti-Ageing Drugs manufacturers/companies operating at both regional and global levels:

Nu SkinBIOTIMEElysium HealthLa Roche-PosayDermaFix

Anti-Ageing Drugs Market segment by type can be split into:

Hormonal TherapyAntioxidantsEnzymesStem Cells

Anti-Ageing Drugs Market segment by the application can be split into:

SkinHair

Foremost Areas Covering Anti-Ageing Drugs Market:

Asia-Pacific Market (China, Southeast Asia, Japan, Korea, India, and Western Asia) The Middle East & Africa Market ( South Africa, GCC, and North Africa) North America Market ( Mexico, Canada, and the United States) Europe Market (Germany, Russia, France, Netherlands, Turkey, the UK, Italy, Spain, and Switzerland) South America Market ( Peru, Brazil, Argentina, Columbia, and Chile)

The report provides industry analysis, important insights, and a competitive and useful advantage to the pursuers. The report analyzes different segments and offers the current and prospects of each segment. Furthermore, this research report contains an in-depth analysis of the top players with data such as product specification, company profiles and product picture, sales area, and base of manufacturing in the global anti-ageing drugs market. The impact on the supply and demand of the raw materials, due to the COVID-19 is also analyzed in the global anti-ageing drugs market.

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An overview of the market Comprehensive analysis of the market Analyses of recent developments in the market Events in the market scenario in the past few years Emerging market segments and regional markets Segmentations up to the second and/or third level Historical, current, and estimated market size in terms of value and volume Competitive analysis, with company overview, products, revenue, and strategies. An impartial assessment of the market Strategic recommendations to help companies increase their market presence

Anti-Ageing Drugs Market Research Report 2020-2029

Chapter 1: Industry Overview

Chapter 2: Anti-Ageing Drugs Market International and China Market Analysis

Chapter 3: Environment Analysis of Market.

Chapter 4: Anti-Ageing Drugs Analysis of Revenue by Classifications

Chapter 5: Analysis of Revenue by Regions and Applications

Chapter 6: Analysis of Anti-Ageing Drugs Market Revenue Market Status.

Chapter 7: Anti-Ageing Drugs Analysis of Industry Key Manufacturers

Chapter 8: Sales Price and Gross Margin Analysis of Market.

Chapter 9: ..Continue to TOC

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The objective of androgen deprivation therapy (ADT) in men with prostate cancer is to maintain very low levels of testosterone so that the hormone does not promote tumor growth. But a new analysis found that drugs commonly used to achieve this are administered later than the recommended 28-day regimen, and this late dosing was associated with ineffective suppression of testosterone.

"Evidence suggests achieving and sustaining T levels <20 mg/dL with ADT is desirable and correlates with improved disease-specific survival in patients with advanced prostate cancer," lead author David Crawford, MD, professor of urology, University of California, San Diego, and colleagues point out.

They looked at administration schedules for luteinizing hormone-releasing hormone (LHRH) agonists and found that they were frequently (84%) administered later than the recommended schedule of every 28 days. Nearly half of the late testosterone values for the extended month were greater than 20 ng/dl, and mean testosterone was almost double the castration level, they report.

"Considering the presumed clinical benefits of maintaining effective T suppression throughout the course of ADT, clinicians should administer treatments within approved dosing instructions, monitor T levels, and consider prescribing treatments with proven efficacy through the dosing interval to maintain T below castration levels," they emphasize.

The analysis was published in the Journal of Urology and was presented during the virtual American Urological Association 2020 annual meeting.

The study was done before the current pandemic, which canceled the in-person gathering of AUA 2020. Now, in the COVID-19 era, the interval between when men are scheduled for their next injection and when they actually get it may well be growing longer. Crawford says he recently saw one patient who waited 3 months before getting his next "monthly" injection.

For the review, Crawford and colleagues examined electronic health records (EHRs) and associated insurance claims for a total of 85,030 injections to evaluate the frequency of late dosing.

When the pivotal registration trials for LHRH agonist were done, a 1-month injection of an LHRH formulation was defined as every 28 days, and not 30 or 31 days as per calendar months.

The current analyses were done using 2 definitions of a month: a 28-day month with late dosing defined as injections given after day 28, and an "extended" month with late dosing defined as injections given after day 32, for products that are dosed once-monthly. The analyses also looked at products that are dosed once every 3-months, once every 4 months, and once every 6 months.

The team also evaluated how often testosterone exceeded the castration level of 20 ng/dL, as well as mean T levels and frequency of T tests and prostate specific antigen (PSA) tests taken by physicians prior to administering the injection.

Results showed that 84% of the 28-day dosing interval and 27% of the extended-month dosing administrations were late.

Furthermore, "when LHRH agonist dosing was late, both the proportion of T tests with T >20 ng/dL and mean T were higher compared to when the dosing was early or on-time," Crawford and colleagues point out.

For example, 43% of T values exceeded 20 ng/dL when injections were late compared to only 21% of T values when injections were given early or on time.

Furthermore, mean T values were 21 ng/dL when injections were given early or on time, but they rose to a mean of 79 ng/dL when injections were late.

Physicians were also far less likely to measure T levels at the time of administering the injections when compared to measuring PSA levels, the team found. T levels were assessed only 13% of the time, whereas PSA levels were assessed 83% of the time while administering LHRH injections.

"All of the package inserts say clinicians should measure T periodically when men are on these drugs, yet urologists don't do it most of the time. They are more interested in PSA because that is what the patient wants to know," Crawford commented in an interview with Medscape Medical News.

The thinking is that "so as long as the PSA is fine, everything else is fine too," he added.

That, however, is not necessarily the case.

As Crawford and his colleagues explain, rising PSA levels can reflect disease progression to castrate-resistant prostate cancer but they may also simply reflect late ADT dosing or other technical issues such as inappropriate dosing for a patient's body weight.

With a number of new therapies now available for castrate-resistant prostate cancer, it's important that physicians ensure that T levels remain below castration levels in order to not wrongly diagnose a man with castrate resistance disease as subsequent changes in management could be entirely inappropriate.

More of an issue, Crawford suggests, is that every time a patient receives an injection of an LHRH agonist, not only do his T levels flare, but so does his PSA.

Crawford suspects that levels of follicle-stimulating hormone (FSH) are also going up in response to LHRH agonist injections.

"We know that hormone therapy is associated with a lot of side effects but the big one for us right now is cardiovascular, so you may be doing the patient a significant disservice by allowing these 'mini-flares' to occur with late injections," Crawford said.

As to why men are receiving their injections beyond recommended intervals, Crawford feels that many urologists are not taking the timing of dosing as seriously as they should.

"There may also be scheduling issues and patient compliance issues as well," he acknowledged.

Disturbingly, however, if a man does show up in a timely way for his next injection, "insurance companies may refuse to reimburse him unless he comes back on days 30 or 31," Crawford observed.

For men who are concerned about COVID-19 and reluctant to attend the clinic for the next injection, there are ways to deliver healthcare that can facilitate timely dosing.

For example, some big urology clinics are having men drive up to their parking lots and receive their next injection in the car, by appointment only of course. Some centers are trying out at home administration.

The other solution to the late dosing problem is to prescribe longer-acting depot formulations so men need less frequent infections.

"It is simply not acceptable to be giving drugs out of their indication and time frame for which they were approved, so people need to take this more seriously," Crawford said.

"We need to administer these drugs on time," he emphasized.

"We need to monitor T levels because some patients will still experience escapes even if they are getting the drug on time," Crawford explained, "and we now have evidence that when patients do have these T failures, this is reflected in rising PSA levels and that may be an indication of disease progression, which we clearly don't want to happen."

The study was funded by Tolmar. Crawford reports receiving fees from Tolmar and Ferring. The other study authors have disclosed no relevant financial relationships.

The American Urologist Association (AUA) 2020 Annual Meeting: Abstract MP37-18.

J Urol. Published online April 1, 2020. Abstract

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ADT for Prostate Cancer: Concern That Injections Often Given Late - Medscape

Audrey Fenske has always been a night owl. But even by her standards, the past few months have wreaked havoc on her sleep patterns.

Since March, when the COVID-19 pandemic upended most daily routines, Fenske, a program assistant with the Duke Career Center, has up woken up on many nights around 3 a.m., unable to fall back asleep.

Im a chronic over-thinker and over-worrier, Fenske said. So in the past when Ive woken up in the night, my thoughts tend to go to things Im worried bout. Id probably exaggerate things in my mind. But now there are so many serious things going on in the world, its much more stressful.

For many, the stress and anxiety brought on by the COVID-19 pandemic has made it harder to get a good nights sleep. While some data shows that Americans may be gettingslightly more sleep, likely due to the lack of a morning commute, other studies show that these uncertain times have increased insomnia in some populations byaround 20 percent.

Duke Clinical Psychologist Meg Danforth, who leads theDuke Behavioral Sleep MedicineClinic, said shes seen a spike in people seeking treatment for chronic insomnia, which is defined as an inability to fall, or stay, asleep, since the pandemic began.

It is a basic survival mechanism to not sleep well when were in danger, thats evolution, said Danforth, who pointed out the brain often unconsciously equates nighttime with danger. In a very real way, with COVID-19, were all in danger. So its really natural to not be sleeping well.

The Centers for Disease Control and Prevention recommends that adults getaround seven hoursof sleep per night. In addition to leaving you fatigued, irritable and unable to focus during the day, chronic insomnia can leave you at greater risk for developing depression and anxiety.

So if youre having trouble with sleep, here are a few things to consider.

For people facing sleep problems, Danforth recommends embracing three slight behavioral changes.

Avoid what she calls social jetlag, which is the effect irregular schedules can have on your internal clock.

Social jetlag happens when you keep different schedules on different days, especially on work days and days off, Danforth said. That creates a physical state thats really similar to jetlag, because your body clock is trying to tell time but it cant.

You can help your body establish a defined internal rhythm by keeping bedtimes, wake-up times, meals and exercise on a somewhat consistent schedule. Danforth pointed out that each of these activities sends signals to the brain, which regulates the bodys internal clock and can cue the release of melatonin, a hormone that can relax the body and help you get to sleep.

Secondly, Danforth said its important to protect the connection between your bed and sleep. By spending too much time watching television, staring at your phone or doing work in bed, you can send mixed signals to your body about the purpose of being in bed.

You want to make sure that your bed and bedroom creates a consistent cue for sleep, Danforth said. That means dont go to bed unless you feel like you can fall asleep quickly. If you go to bed before youre sleepy, youre just setting yourself up for failure.

Finally, try to install a buffer zone of at least 30 minutes before bedtime, during which you avoid things like bright or excessive light, worrying about work or watching intense television shows. If you can use the time to calm your mind and body, it can create better conditions for sleep.

Between pandemic worries, work stress and angst about the latest news headlines, theres no shortage of sources for negative emotions. And when youre trying to go to sleep, these factors stand in the way.

Thats why its important to begin the bedtime routine by finding a way to fill your mind with positive thoughts.

Positive emotions undo the stress response, said Carrie Adair, assistant director for theDuke Center for Healthcare Safety and Quality.If youre lying in bed and thinking about all the stressors you have coming at you tomorrow, your heart rate goes up, your respiration increases. But when we experience positive emotions, it actually relaxes all of those processes.

Adair and her colleagues study the science of stress and provideresources, includingone toolto improve sleep,for increasing resilience and reducing the risk of burnout. She said trouble sleeping is one of the first things brought up by people who are struggling with stress. Likewise, improved sleep is often the first sign that peoples ability to deal with stress is improving.

A tool thats proven useful for people looking reach a more positive mental space at the end of the day is 3 Good Things.

Developed as part of a study and now available to anyone over the age of 18, the3 Good Thingsprogram spans 15 days and asks participants to list three pleasant experiences from that day. With text message reminders and a short questionnaire, the requirements to take part are low. But Adair said the effect of spending mental energy dwelling on happy moments can be great.

Asking you to reflect on events that you might not have taken much notice of during the day can help reduce the effect of stress, Adair said. If you do it within two hours of sleep onset, that actually gives you better likelihood of better sleep and longer sleep.

According Danforth, most sleep problems only last a short time and often disappear when the stressful situation that brought them on clears up. But chronic insomnia occurs when someone has frequent trouble falling asleep or staying asleep for a period of longer than three months.

Why that matters is that once chronic insomnia takes root, it often lasts longer than the external stressors that may have caused it.

With COVID-19, were now four-plus months into this, Danforth said. So if people started sleeping poorly back in March, and theyre still sleeping poorly in July, all of a sudden, they become at more risk for having that sleep problem stick around even once, God willing, we come out on the other side of this.

When facing chronic insomnia, experts recommend seeking treatment. Duke has multiple places that treat sleep problems, including theDuke Sleep Disorders Clinic, which uses a nightlong evaluation to diagnose sleep apnea.

TheDuke Behavioral Sleep Medicine Clinic, part ofDuke Psychiatry and Behavioral Sciences, uses Cognitive Behavioral Therapy for Insomnia (CBT-i), an eight-week program - which is available via telemedicine that addresses the underlying causes of a sleep disorder.

Danforth also recommends the freeCBT-I Coach mobile app, which was developed for military veterans. Available forAppleandAndroiddevices it can help create healthy sleeping habits.

If youre having sleep problems in the short run, it will probably get better, Danforth said. But if youre having chronic sleep problems, remember that it is treatable.

Doyou have some sleep tips? Join the conversation on our Facebook story.

Is there something youd like for us to cover? Send ideas, shout-outs and photographshereor writeworking@duke.edu.

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3 Ways to Improve Your Sleep During COVID-19 - Duke Today

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Viking Therapeutics(NASDAQ:VKTX)Q22020 Earnings CallJul 29, 2020, 4:30 p.m. ET

Operator

Welcome to the Viking Therapeutics 2020 second-quarter financial results conference call. [Operator instructions] As a reminder, this conference call is being recorded today, July 29, 2020. I would now like to turn the conference over to Viking's manager of investor relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz -- Manager of Investor Relations

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's president and CEO; and Greg Zante, senior vice president of finance. Before we begin, I'd like to caution that comments made during this conference call today, July 29, 2020, will contain forward-looking statements within the meaning of the Securities Act of 1933, concerning the current beliefs of the company, which involve a number of assumptions, risks and uncertainties. Actual results could differ from these statements and the company undertakes no obligation to revise or update any statement made today.

I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments. Brian?

Brian Lian -- President and Chief Executive Officer

Thanks, Stephanie, and thanks to everyone listening on the webcast or by phone. Today, we'll provide an overview of our second-quarter 2020 financial results, as well as an update on recent progress and developments related to our pipeline programs and operations. I'll begin by reviewing the status of our ongoing Phase 2b VOYAGE study. As a reminder, this trial is evaluating our small molecule thyroid hormone beta receptor agonist VK2809, in patients with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis.

Enrollment in the trial continues. And despite the ongoing pandemic, more sites are open today for patients screening and enrollment, and fewer sites are reporting operational disruptions compared with two months ago. We currently anticipate completion of enrollment in this study in the first half of 2021. I'll provide more color on VOYAGE in a few minutes.

During the quarter, we also made great progress with our second small molecule thyroid receptor beta agonist, VK0214, which we're developing as a potential treatment for X-linked adrenoleukodystrophy. We're pleased to report that we recently filed an IND with the FDA to initiate the first-in-human studies of this important molecule. We plan to initiate these studies following clearance of the IND. I'll provide additional detail on our development activities after we review our second-quarter financial results.

With that, I'll turn the call over to Greg Zante, Viking's senior vice president of finance. Greg?

Greg Zante -- Senior Vice President of Finance

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later today for additional details. I'll now go over our financial results for the second quarter and first six months ended June 30, 2020. I'll first go over the second-quarter results.

Our research and development expenses for the three months ended June 30, 2020 were $7.8 million, compared to $7.3 million for the same period in 2019. The increase was primarily due to increased expenses related to our clinical studies, manufacturing for our drug candidates, salaries and benefits, and stock-based compensation, partially offset by decreased expenses related to preclinical studies and services provided by third party consultants. Our general and administrative expenses for the three months ended June 30, 2020 were $2.8 million, compared to $2.2 million for the same period in 2019. The increase was primarily due to increased expenses related to stock-based compensation, legal expenses, and insurance expenses, partially offset by decreased expenses related to services provided by third-party consultants and travel.

For the three months ended June 30, 2020, Viking reported a net loss of $9.6 million or $0.13 per share, compared to a net loss of $7.7 million or $0.11 per share in the corresponding period of 2019. The increase in net loss and net loss per share for the three months ended June 30, 2020, was primarily due to the increases in research and development and general and administrative expenses noted previously, as well as decreased interest income due to the decline in interest rates throughout the second quarter of 2020 as compared to prevailing interest rates during the second quarter of 2019. I'll now go over our results for the first six months of 2020. Our research and development expenses for the six months ended June 30, 2020 were $15.8 million, compared to $11.8 million for the same period in 2019.

The increase was primarily due to increased expenses related to our clinical studies, manufacturing for our drug candidates, salaries and benefits, and stock-based compensation, partially offset by decreased expenses related to services provided by third-party consultants and preclinical studies. Our general and administrative expenses for the six months ended June 30, 2020 were $5.8 million, compared to $4.5 million for the same period in 2019. The increase was primarily due to increased expenses related to stock-based compensation, legal expenses, and insurance expenses, partially offset by decreased expenses related to services provided by third-party consultants, professional fees, and travel. For the six months ended June 30, 2020, Viking reported a net loss of $19.3 million or $0.27 per share, compared to a net loss of $12.6 million or $0.18 per share in the corresponding period in 2019.

The increase in net loss and net loss per share for the six months ended June 30, 2020 was primarily due to the increases in research and development and general and administrative expenses noted previously, as well as decreased interest income due to the decline in interest rates throughout the first half of 2020 as compared to prevailing interest rates during the first half of 2019. Turning to the balance sheet. At June 30, 2020, Viking held cash, cash equivalents, and short-term investments totaling $263 million and had 72,758,342 shares of common stock outstanding. This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian -- President and Chief Executive Officer

Thanks, Greg. I'll now provide an update on our recent development activities, beginning with our lead program, VK2809, for the treatment of NASH. As a reminder, VK2809 is an orally available small molecule agonist of the thyroid homeowner receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of metabolic disorders, including NASH. As we previously discussed, in a 12-week Phase 2 trial in patients with hypercholesterolemia and nonalcoholic fatty liver disease, VK2809 produced statistically significant reductions in liver fat content, as well as improvements in LDL cholesterol, meeting the study's primary and secondary efficacy endpoints.

On exploratory efficacy measures, evaluating other plasma lipids such as triglycerides, apolipoprotein B and lipoprotein A, treatment with VK2809 also resulted in significant reductions. Importantly, the study showed VK2809 to possess an encouraging safety and tolerability profile with no serious adverse events reported among patients receiving VK2809 or placebo. The initial data from this study were highlighted at the annual meeting of the American Association for the Study of Liver Diseases, or AASLD, in 2018. Additional data, including efficacy at the low dose of 5 milligrams daily, were presented at the international liver conference, or EASL, in 2019.

As we indicated on our last quarterly call, further results from this study have been selected for oral presentation at the upcoming 2020 EASL meeting, which will be held in a virtual format from August 27 through August 29. The VK2809 presentation will occur on Friday, August 28. In our view, the data obtained thus far suggests that VK2809 possesses several differentiating characteristics relative to the current NASH development landscape. In addition to the potent reductions observed in liver fat, which we believe suggests promise for improvement in other histologic features, VK2809's broader efficacy on lipid measures suggest additional potential cardiometabolic benefits for patients with NASH.

The compound's oral route of administration, liver-targeted mode of action and encouraging safety and tolerability to date combined to place it among the most promising development programs in the NASH landscape today. Given the encouraging findings from the 12-week Phase 2 study, last year, we initiated a 52-week Phase 2b study to evaluate the safety and efficacy of VK2809 in patients with biopsy-confirmed NASH and fibrosis. This study, which we've called the VOYAGE study, is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in the setting of NASH. The study is targeting enrollment of approximately 340 patients across five treatment arms, including 1 milligram daily, 2.5 milligrams daily, 5 milligrams every other day, 10 milligrams every other day and placebo.

The target population includes patients with F2 and F3 fibrosis, as well as up to 25% with F1 fibrosis. F1 patients must possess additional risk factors to be eligible for enrollment. The primary endpoint of the study will evaluate the relative change in liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week 12, in subjects treated with VK2809 as compared to subjects receiving placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of therapy.

We are currently enrolling patients in this study in the United States, and we remain on track to open sites outside the U.S. later this quarter. As we reported in our last quarterly update, we continue to closely monitor site activities in the context of the ongoing coronavirus pandemic. To reiterate an important comment from our last update, we have never paused enrollment in this study or indicated to our sites that we plan to defer any activities required for trial execution.

Since our last update, we're encouraged that sites continue to loosen many of the restrictions put in place earlier in the pandemic. We have more sites open for in-person and virtual patient engagement today than in prior months and anticipate further expansion of site activities in the coming months. In addition, we're pleased to report that dosing in this study has now exceeded six months and we look forward to completion of the planned 52-week treatment window that will enable the evaluation of VK2809 safety and efficacy on histologic endpoints in NASH. With respect to further expansion of clinical sites, we remain on track to open sites outside the U.S.

later this year in both the third and fourth quarters and continue to target over 80 sites globally. As we've previously indicated, we continue to anticipate completion of enrollment in VOYAGE in the first half of next year. I would now like to provide an update on our VK0214 program. Like VK2809, VK0214 is an orally available small molecule thyroid hormone receptor agonist that possesses selectivity for the beta receptor subtype.

We are developing VK0214 as a potential treatment for X-linked adrenoleukodystrophy or X-ALD. X-ALD is a serious degenerative neuromuscular disease for which no pharmacologic treatment exists. The disease is caused by a defect in a peroxisome transporter called ABCD1. This defect can result in increased plasma and tissue levels of very long-chain fatty acids, which are believed to contribute to the cerebral and motor neuron toxicities that are characteristic of the disease.

The thyroid beta receptor is an important potential target for therapeutic intervention in X-ALD because is believed to play a role in very long-chain fatty acid metabolism. Data from in vivo models have demonstrated that treatment with VK0214 produces reductions in very long-chain fatty acids in both plasma and tissue. These encouraging findings suggest potential benefit in the setting of X-ALD and we're eager to move VK0214 into the clinic. To this end, we are pleased to report that we recently filed an IND for VK0214 to initiate the clinical development of this important program.

Following clearance of the IND, we plan to initiate the first in-human studies of VK0214, to be followed by initiation of a proof-of-concept study in patients with X-ALD. We will provide more details on trial design upon study initiation. As we advance both VK2809 and VK0214, we continue to carefully manage our cash resources and maintain a strong financial position. As Greg stated earlier, we ended the second quarter with approximately $263 million in cash, which we currently expect will provide sufficient runway to achieve a number of the key clinical milestones that we believe will drive value creation in the future.

In conclusion, we continue to make exciting progress with both our VK2809 and VK0214 programs. With respect to our Phase 2b VOYAGE trial, evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis, we've increased the number of sites that are open and actively enrolling and look forward to adding new sites, both within and outside the U.S. in the coming months. We're also happy to report that we passed the six-month dosing milestone and continue to treat subjects for the planned 52-week trial duration.

We currently anticipate completion of enrollment in the first half of 2021. With respect to VK0214 for the treatment of X-linked Adrenoleukodystrophy, we recently filed an IND for this program, and we expect to initiate clinical development in the third quarter. Finally, during the second quarter, we continued to carefully manage our cash to ensure that we have the resources to optimally advance our key programs through their critical milestones. This concludes our prepared comments for today.

Thanks again for joining us. And now, we'll open the call for questions. Operator?

Operator

[Operator instructions] The first question comes from John -- Joon Lee, excuse me, of SunTrust. Please go ahead.

Joon Lee -- SunTrust Robinson Humphrey -- Analyst

Hi. Good afternoon and thanks for taking my questions. Brian, did I hear correctly that in your VOYAGE study, you have passed the six-month threshold? And you are now going beyond that in treating patients?

Brian Lian -- President and Chief Executive Officer

Hi, Joon. Yes, that's correct.

Joon Lee -- SunTrust Robinson Humphrey -- Analyst

Great. So that pretty much puts the question at rest. OK. That's great to hear.

And then the other question I have is one of your peer companies, Intercept, received a disciplining CRL last month without an AdCom. And then the FDA stated that they did not believe the risk-benefit justified approval. What are your thoughts on that CRL? And how does this, if at all, change your development plans for 2809?

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Joon. It's really a complicated question. And I don't have a lot of insight on the nature of the CRL or any discussions Intercept may or may not have had with the FDA.

As far as our plans, our plans are unchanged. So we're going to complete the VOYAGE study and read those data out and then plan for a Phase 3 trial. And currently, the guidance is unchanged with the registration endpoints. So we are not altering our strategy at all.

We look forward to completing the VOYAGE study. That's the main focus right now.

Joon Lee -- SunTrust Robinson Humphrey -- Analyst

In your view, if you look -- as you look at the profile of 2809 and compare that with OCA, what can you point to as a source of conviction that this 2809 won't be as nearly as a concern when it comes to review process down the line?

Brian Lian -- President and Chief Executive Officer

Yes. Well, it's a -- they're a little bit apples to oranges. It's a different mechanism with obeticholic acid. They did a longer, larger study.

We're focused now on a Phase 2b study. We're looking at both the registration endpoints as secondary endpoints at 12 months. But it's tough to make that comparison just because they're just different molecules targeting different receptors and different mechanisms.

Joon Lee -- SunTrust Robinson Humphrey -- Analyst

Yeah. Understand. And then the last question is, when you report the additional data at EASL next month, what should we be focusing on?

Brian Lian -- President and Chief Executive Officer

Yes. We'll report data from the 16-week visit in that study. And then we'll also report data from some of the subsets of patients. Patients with higher BMI, higher baseline ALT, that sort of thing.

So I think it's an interesting data set. So we look forward to presenting it.

Joon Lee -- SunTrust Robinson Humphrey -- Analyst

Great. Looking forward to it. And congrats and thanks so much.

Brian Lian -- President and Chief Executive Officer

Thanks a lot, Joon.

Operator

The next question comes from Michael Morabito of Chardan Capital Markets. Please go ahead.

Michael Morabito -- Chardan Capital Markets -- Analyst

Hi, guys. Thanks for taking the questions. I was wondering if you could go into any more detail on the ex U.S. sites that you plan to open.

You said about 80 sites globally. Do you know, once all is said and done, how many of those will be ex U.S. versus in the U.S.? And what do you think the mix of U.S. versus non-U.S.

patients will be by the time the study is finished?

Brian Lian -- President and Chief Executive Officer

Yeah. The mix should be about three to one, at least, maybe closer to four to one, but at least three to one. And we had originally targeted around 12 ex U.S., and we'll be potentially moving that up closer to 15. But that's sort of the broad mix there, primarily U.S.

but a little tranche of ex-U.S. as well.

Michael Morabito -- Chardan Capital Markets -- Analyst

And so when you enroll patients in the ex U.S. sites, do you expect the U.S. versus ex-U.S. next to be relatively equal in all five arms of the study?

Brian Lian -- President and Chief Executive Officer

I would expect so. Well, obviously, there are more U.S. sites, so we'll have more patients from the U.S. in the study.

But yes, it should be well balanced in that regard. It's a randomized study.

Michael Morabito -- Chardan Capital Markets -- Analyst

OK. And some of your competitors have hinted that they may be able to run registrational trials at -- with an endpoint of less than 52 weeks based on some of their data. From the data that you've seen today, do you think that there's any chance that you would be able to run a trial that would be shorter than a 52-week Phase 3?

Brian Lian -- President and Chief Executive Officer

So it's a good question. We don't know. We haven't generated any data longer than 12 weeks. We have the 16-week data from the follow-up visit, but the patients only received 12 weeks of therapy.

So we'll make that determination once we have our 12-month data in hand, but it's just hard to answer right now.

Michael Morabito -- Chardan Capital Markets -- Analyst

OK. Thanks for taking the question.

Brian Lian -- President and Chief Executive Officer

Thanks, Michael.

Operator

The next question comes from Matt Luchini of BMO Capital. Please go ahead.

Matt Luchini -- BMO Capital Markets -- Analyst

Hi. Good afternoon, and thanks for taking my question. And congrats on the progress. So it sounds like from an enrollment -- VOYAGE enrollment perspective, you're pretty optimistic on how things are progressing.

And so I'm just wondering, is the gating factor in terms of your enrollment guidance more actually on the ex U.S. side? Or is it still pulling enough patients through on the U.S. side? And then secondarily, while I appreciate that it's somewhat a moot point given that we passed the six-month mark. Can you just maybe comment, did the FDA actually come back and sort of bless VOYAGE to continue dosing? Or was it more a continuation of the no-news-is-good-news commentary that we saw last quarter? Thank you.

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Matt. So on the second question, there was never any requirement that we check in with the FDA at six months. The trial that was cleared to proceed was a 52-week trial, and we were requested to submit our 12-month tox data at some time frame before any subject reach that six-month threshold.

So there wasn't any sort of a check in or OK or anything from the FDA. We didn't receive one. We didn't expect one, and there was never one outlined for us. With respect to enrollment, the modeling that we do for completion enrollment, it encompasses the time to get the U.S.

and ex-U.S. sites onboard. And then we have enrollment assumptions in each of those sites and model it out from there. So it's a combination of U.S.

and ex-U.S., and they're both going to be important contributors. But bulk of the contribution will come from U.S. patients, at least that's our expectation today.

Matt Luchini -- BMO Capital Markets -- Analyst

OK. And just given all the -- in terms of the initial PDFF data, should we be expecting that closer to, say, the tail end of the first half? Or do you think, really, it's a second-half event? Or is it still too early to say?

Brian Lian -- President and Chief Executive Officer

I think it's early to say. We'll report it as soon as we have it, but it's early to say. We have some -- a pretty broad window in there, and that reflects a lot of the uncertainty in the current clinical environment. But I don't think we're going to narrow it down today.

Matt Luchini -- BMO Capital Markets -- Analyst

Understood. Just thought I would ask. Thanks for taking the questions.

Brian Lian -- President and Chief Executive Officer

See the article here:
Viking Therapeutics (VKTX) Q2 2020 Earnings Call Transcript - Motley Fool

San Diego Jul 30, 2020 (Thomson StreetEvents) -- Edited Transcript of Viking Therapeutics Inc earnings conference call or presentation Wednesday, July 29, 2020 at 8:30:00pm GMT

Viking Therapeutics, Inc. - President, CEO & Director

* Gregory S. Zante

Viking Therapeutics, Inc. - SVP of Finance

Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst

Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst

* Matthew W. Luchini

B. Riley FBR, Inc., Research Division - Research Analyst

Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Biotechnology and Pharmaceuticals

ROTH Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research

Vida Strategic Partners Inc. - President & CEO

Welcome to the Viking Therapeutics 2020 Second Quarter Financial Results Conference Call. (Operator Instructions). As a reminder, this conference call is being recorded today, July 29, 2020.

I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz, Vida Strategic Partners Inc. - President & CEO [2]

Hello, and thank you, all, for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Senior Vice President of Finance.

Before we begin, I'd like to caution that comments made during this conference call today, July 29, 2020, will contain forward-looking statements within the meaning of the Securities Act of 1933, concerning the current beliefs of the company, which involve a number of assumptions, risks and uncertainties. Actual results could differ from these statements and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

I'll now turn the call over to Brian Lian for his initial comments. Brian?

Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [3]

Thanks, Stephanie, and thanks to everyone listening on the webcast or by phone. Today, we'll provide an overview of our second quarter 2020 financial results as well as an update on recent progress and developments related to our pipeline programs and operations. I'll begin by reviewing the status of our ongoing Phase IIb VOYAGE study. As a reminder, this trial is evaluating our small molecule thyroid hormone beta receptor agonist VK2809, in patients with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis. Enrollment in the trial continues. And despite the ongoing pandemic, more sites are open today for patients screening and enrollment, and fewer sites are reporting operational disruptions compared with 2 months ago. We currently anticipate completion of enrollment in this study in the first half of 2021. I'll provide more color on VOYAGE in a few minutes.

During the quarter, we also made great progress with our second small molecule thyroid receptor beta agonist, VK0214, which we're developing as a potential treatment for X-linked adrenoleukodystrophy. We're pleased to report that we recently filed an IND with the FDA to initiate the first-in-human studies of this important molecule. We plan to initiate these studies following clearance of the IND.

I'll provide additional detail on our development activities after we review our second quarter financial results. For that, I'll turn the call over to Greg Zante, Viking's Senior Vice President of Finance. Greg?

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Gregory S. Zante, Viking Therapeutics, Inc. - SVP of Finance [4]

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Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later today for additional details.

I'll now go over our financial results for the second quarter and first 6 months ended June 30, 2020. I'll first go over the second quarter results. Our research and development expenses for the 3 months ended June 30, 2020, were $7.8 million compared to $7.3 million for the same period in 2019. The increase was primarily due to increased expenses related to our clinical studies, manufacturing for our drug candidates, salaries and benefits and stock-based compensation, partially offset by decreased expenses related to preclinical studies and services provided by third party consultants. Our general and administrative expenses for the 3 months ended June 30, 2020, were $2.8 million compared to $2.2 million for the same period in 2019. The increase was primarily due to increased expenses related to stock-based compensation, legal expenses and insurance expenses, partially offset by decreased expenses related to services provided by third-party consultants and travel. For the 3 months ended June 30, 2020, Viking reported a net loss of $9.6 million or $0.13 per share compared to a net loss of $7.7 million or $0.11 per share in the corresponding period of 2019. The increase in net loss and net loss per share for the 3 months ended June 30, 2020, was primarily due to the increases in research and development and general and administrative expenses noted previously,as well as decreased interest income due to the decline in interest rates throughout the second quarter of 2020 as compared to prevailing interest rates during the second quarter of 2019.

I'll now go over our results for the first 6 months of 2020. Our research and development expenses for the 6 months ended June 30, 2020, were $15.8 million compared to $11.8 million for the same period in 2019. The increase was primarily due to increased expenses related to our clinical studies, manufacturing for our drug candidates, salaries and benefits and stock-based compensation, partially offset by decreased expenses related to services provided by third-party consultants and preclinical studies. Our general and administrative expenses for the 6 months ended June 30, 2020, were $5.8 million compared to $4.5 million for the same period in 2019. The increase was primarily due to increased expenses related to stock-based compensation, legal expenses and insurance expenses, partially offset by decreased expenses related to services provided by third party consultants, professional fees and travel. For the 6 months ended June 30, 2020, Viking reported a net loss of $19.3 million or $0.27 per share compared to a net loss of $12.6 million or $0.18 per share in the corresponding period in 2019. The increase in net loss and net loss per share for the 6 months ended June 30, 2020, was primarily due to the increases in research and development and general and administrative expenses noted previously as well as decreased interest income due to the decline in interest rates throughout the first half of 2020, as compared to prevailing interest rates during the first half of 2019.

Turning to the balance sheet. At June 30, 2020, Viking held cash, cash equivalents and short-term investments totaling $263 million, and had 72,758,342 shares of common stock outstanding. This concludes my financial review, and I'll now turn the call back over to Brian.

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Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [5]

--------------------------------------------------------------------------------

Thanks, Greg. I'll now provide an update on our recent development activities, beginning with our lead program, VK2809 for the treatment of NASH. As a reminder, VK2809 is an orally available small molecule agonist of the thyroid homeowner receptor that possesses selectivity for liver tissue as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of metabolic disorders, including NASH. As we previously discussed, in a 12-week Phase II trial in patients with hypercholesterolemia and nonalcoholic fatty liver disease, VK2809 produced statistically significant reductions in liver fat content as well as improvements in LDL cholesterol, meeting the study's primary and secondary efficacy endpoints. On exploratory efficacy measures, evaluating other plasma lipids such as triglycerides, apolipoprotein B and lipoprotein A, treatment with VK2809 also resulted in significant reductions. Importantly, the study showed VK2809 to possess an encouraging safety and tolerability profile with no serious adverse events reported among patients receiving VK2809 or placebo. The initial data from this study were highlighted at the annual meeting of the American Association for the Study of Liver Diseases, or AASLD, in 2018. Additional data, including efficacy at the low dose of 5 milligrams daily, were presented at the international liver conference, or EASL, in 2019. As we indicated on our last quarterly call, further results from this study have been selected for oral presentation at the upcoming 2020 EASL meeting, which will be held in a virtual format from August 27 through August 29. The VK2809 presentation will occur on Friday, August 28. In our view, the data obtained thus far suggests that VK2809 possesses several differentiating characteristics relative to the current NASH development landscape. In addition to the potent reductions observed in liver fat, which we believe suggests promise for improvement in other histologic features, VK2809's broader efficacy on lipid measures suggest additional potential cardiometabolic benefits for patients with NASH. The compound's oral route of administration, liver-targeted mode of action and encouraging safety and tolerability to date combined to place it among the most promising development programs in the NASH landscape today.

Given the encouraging findings from the 12-week Phase II study, last year, we initiated a 52-week Phase IIb study to evaluate the safety and efficacy of VK2809 in patients with biopsy-confirmed NASH and fibrosis. This study, which we've called the VOYAGE study, is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in the setting of NASH. The study is targeting enrollment of approximately 340 patients across 5 treatment arms, including 1 milligram daily, 2.5 milligrams daily, 5 milligrams every other day, 10 milligrams every other day and placebo. The target population includes patients with F2 and F3 fibrosis as well as up to 25% with F1 fibrosis. F1 patients must possess additional risk factors to be eligible for enrollment. The primary endpoint of the study will evaluate the relative change in liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week 12, in subjects treated with VK2809 as compared to subjects receiving placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of therapy.

We are currently enrolling patients in this study in the United States, and we remain on track to open sites outside the U.S. later this quarter. As we reported in our last quarterly update, we continue to closely monitor site activities in the context of the ongoing coronavirus pandemic. To reiterate an important comment from our last update, we have never paused enrollment in this study or indicated to our sites that we plan to defer any activities required for trial execution. Since our last update, we're encouraged that sites continue to loosen many of the restrictions put in place earlier in the pandemic. We have more sites open for in-person and virtual patient engagement today than in prior months and anticipate further expansion of site activities in the coming months. In addition, we're pleased to report that dosing in this study has now exceeded 6 months and we look forward to completion of the planned 52-week treatment window that will enable the evaluation of VK2809 safety and efficacy on histologic endpoints in NASH. With respect to further expansion of clinical sites, we remain on track to open sites outside the U.S. later this year in both the third and fourth quarters, and continue to target over 80 sites globally. As we've previously indicated, we continue to anticipate completion of enrollment in VOYAGE in the first half of next year.

I would now like to provide an update on our VK0214 program. Like VK2809, VK0214 is an orally available small molecule thyroid hormone receptor agonist that possesses selectivity for the beta receptor subtype. We are developing VK0214 as a potential treatment for X-linked adrenoleukodystrophy, or X-ALD. X-ALD is a serious degenerative neuromuscular disease for which no pharmacologic treatment exists. The disease is caused by a defect in a peroxisome transporter called ABCD1. This defect can result in increased plasma and tissue levels of very long-chain fatty acids, which are believed to contribute to the cerebral and motor neuron toxicities that are characteristic of the disease. The thyroid beta receptor is an important potential target for therapeutic intervention in X-ALD because is believed to play a role in very long-chain fatty acid metabolism. Data from in vivo models have demonstrated that treatment with VK0214 produces reductions in very long-chain fatty acids in both plasma and tissue. These encouraging findings suggest potential benefit in the setting of X-ALD and we're eager to move VK0214 into the clinic. To this end, we are pleased to report that we recently filed an IND for VK0214 to initiate the clinical development of this important program. Following clearance of the IND, we plan to initiate the first in-human studies of VK0214, to be followed by initiation of a proof-of-concept study in patients with X-ALD. We will provide more details on trial design upon study initiation.

As we advance both VK2809 and VK0214, we continue to carefully manage our cash resources and maintain a strong financial position. As Greg stated earlier, we ended the second quarter with approximately $263 million in cash, which we currently expect will provide sufficient runway to achieve a number of the key clinical milestones that we believe will drive value creation in the future.

In conclusion, we continue to make exciting progress with both our VK2809 and VK0214 programs. With respect to our Phase IIb VOYAGE trial, evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis, we've increased the number of sites that are open and actively enrolling and look forward to adding new sites, both within and outside the U.S. in the coming months. We're also happy to report that we passed the 6-month dosing milestone and continue to treat subjects for the planned 52-week trial duration. We currently anticipate completion of enrollment in the first half of 2021. With respect to VK0214 for the treatment of X-linked Adrenoleukodystrophy, we recently filed an IND for this program, and we expect to initiate clinical development in the third quarter. Finally, during the second quarter, we continued to carefully manage our cash to ensure that we have the resources to optimally advance our key programs through their critical milestones.

This concludes our prepared comments for today. Thanks again for joining us. And now we'll open the call for questions. Operator?

================================================================================

Questions and Answers

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Operator [1]

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(Operator Instructions) The first question comes from Joon Lee of SunTrust.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [2]

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Brian, did I hear correctly that in your VOYAGE study, you have passed the 6-month threshold? And you are now going beyond that in treating patients?

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Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [3]

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Joon, yes, that's correct.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [4]

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Great. So that pretty much puts the question at rest. Okay. That's great to hear. And then the other question I have is one of your peer companies, Intercept, received a disciplining CRL last month without an AdCom. And then the FDA stated that they did not believe the risk-benefit justified approval, what are your thoughts on that CRL? And how does this, if at all, change your development plans for 2809?

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Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [5]

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Yes. Thanks, Joon, it's really a complicated question. And I don't have a lot of insight on the nature of the CRL or any discussions Intercept may or may not have had with the FDA. As far as our plans, our plans are unchanged. So we're going to complete the VOYAGE study and read those data out and then plan for a Phase III trial. And currently, the guidance is unchanged with the registration endpoints. So we are not altering our strategy at all. We look forward to completing the VOYAGE study. That's the main focus right now.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [6]

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In your view, if you look -- as you look at the profile of 2809 and compare that with OCA, what can you point to as a source of conviction that this 2809 won't be as nearly as a concern when it comes to review process down the line?

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Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [7]

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Yes. Well, it's -- they're a little bit apples to oranges. It's a different mechanism with obeticholic acid. They did a longer, larger study. We're focused now on a Phase IIb study. We're looking at both the registration endpoints as secondary endpoints at 12 months. But it's tough to make that comparison just because they're just different molecules targeting different receptors and different mechanisms.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [8]

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Yes. Understand. And then the last question is, when you report the additional data at EASL next month, what should we be focusing on?

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Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [9]

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Yes. We'll report data from the 16-week visit in that study. And then we'll also report data from some of the subsets of patients. Patients with higher BMI, higher baseline ALT, that sort of thing. So I think it's an interesting data set. So it's -- we look forward to presenting it.

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Operator [10]

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The next question comes from Michael Morabito of Chardan Capital Markets.

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Michael Vincent Morabito, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Biotechnology and Pharmaceuticals [11]

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I was wondering if you could go into any more detail on the ex U.S. sites that you plan to open. You said about 80 sites globally. Do you know, once all is said and done, how many of those will be ex U.S. versus in the U.S.? And what do you think the mix of U.S. versus non-U. S. patients will be by the time the study is finished?

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Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [12]

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Yes. The mix should be about 3:1 at least, maybe closer to 4:1, but at least 3:1. And we had originally targeted around 12 ex U.S., and we'll be potentially moving that up to -- closer to 15, but that's sort of the broad mix there. Primarily U.S., but a little tranche of ex U.S. as well.

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Michael Vincent Morabito, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Biotechnology and Pharmaceuticals [13]

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And so when you enroll patients in the ex U.S. sites, do you expect the U.S. versus ex U.S. next to be relatively equal in all 5 arms of the study?

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Brian Lian, Viking Therapeutics, Inc. - President, CEO & Director [14]

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I would expect so. Well, the -- obviously, there are more U.S. sites so we'll have more patients from the U.S. in the study. But yes, it should be well balanced in that regard. It's a randomized study.

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Michael Vincent Morabito, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Biotechnology and Pharmaceuticals [15]

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Okay. And some of your competitors have hinted that they may be able to run registrational trials at -- with an endpoint of less than 52 weeks based on some of their data. From the data that you've seen today, do you think that there's any chance that you would be able to run a trial that would be shorter than a 52-week Phase III?

Excerpt from:
Edited Transcript of VKTX.OQ earnings conference call or presentation 29-Jul-20 8:30pm GMT - Yahoo Finance

References

1. Ahmed A. Am J Cardiol 2007;99:54953.

2. Taylor JC et al, 2016. Australian Family Physician; 45 (11): 823-827.

3. Calvert MJ et al. Eur J Heart Fail 2005;7:24351.

4. Moser DK et al. Heart Lung 2010;39:37885.

5. Cowie MR et al. ESC Heart Failure 2014;1:11045.

6. Chandra A et al. JAMA Cardiol. 2018 Jun; 3(6): 498505.

7. Desai AS et al. Eur Heart J 2015; 36: 1990-1997.

8. Okumura N et al. Circulation 2016; 133: 22542262

9. McMurray JJ et al. N Eng J Med 2014; 371(11): 993-1004.

10. ENTRESTO New Zealand Data Sheet.

11. Pharmaceutical Schedule Pharmac http://www.pharmac.govt.nz.

Abbreviations

ACEi Angiotensin Converting Enzyme inhibitor, NYHA New York Heart Association, ARB Angiotensin Receptor Blocker, HF Heart Failure, LVEF Left Ventricular Ejection Fraction, ECHO - Echocardiogram, HFrEF Heart Failure with reduced Ejection Fraction, BNP - B-type natriuretic peptide, NT-proBNP - N-terminal (NT)-pro hormone BNP, eGFR - estimated Glomerular Filtration Rate

Minimum Prescribing Information

PRESCRIPTION MEDICINE. Entresto 24mg/26mg, 49mg/51mg, 97mg/103mg (sacubitril/valsartan) film coated tablets. Consult full Data Sheet before prescribing, available from http://www.medsafe.govt.nz. Entresto is fully funded under Special Authority Criteria, please refer to http://www.pharmac.health.nz.

Indication: Treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction. Contraindications: Hypersensitivity to sacubitril, valsartan, or excipients. ACE inhibitors (ACEi). Do not administer within 36 hours of switching from or to an ACEi. Angioedema related to previous ACEi or ARB therapy. Use with aliskiren in Type 2 diabetes (T2D). Severe hepatic impairment, biliary cirrhosis and cholestasis. Pregnancy. Precautions: Caution switching from ACEi or while co-administering with aliskiren in T2D (see Contraindications). Should not be co-administered with an ARB. May cause symptomatic hypotension, especially in those 75 years old, renal disease and systolic BP <112 mmHg or patients with an activated RAAS. Initiation not recommended in systolic BP <100 mmHg. Monitor BP when initiating therapy or during dose titration. If hypotension occurs, dose adjustment of diuretics, antihypertensives, and consider treatment of other causes of hypotension. If hypotension persists, consider dose reduction or temporary interruption. Correct sodium and/or volume depletion before starting treatment. May be associated with decreased renal function; assess renal function before initiation and during treatment. Monitor serum creatinine, and down-titrate or interrupt if a clinically significant decrease in renal function develops. May increase urea and creatinine levels in patients with renal artery stenosis. Not recommended with end-stage renal disease. Should not be initiated and consider discontinuation if the serum potassium level is >5.4 mmol/L. Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors, dosage reduction or interruption may be required. Caution with medications known to raise potassium levels. If clinically significant hyperkalaemia occurs, consider adjusting the dose of concomitant medications. If angioedema occurs, immediately discontinue, and provide appropriate therapy and monitoring until complete and sustained resolution; black patients or patients with a prior history of angioedema may be at higher risk. Caution in NYHA Class IV or in moderate hepatic impairment or with AST/ALT >2X ULN. Use in lactation not recommended. Use contraception during treatment and for 1 week after last dose. Interactions: Aliskiren in T2D, ACEi/ARB. Caution with statins, sildenafil, lithium, potassium-sparing diuretics including mineralocorticoid antagonists, potassium supplements, or salt substitutes containing potassium, NSAIDs including selective COX-2 Inhibitors, frusemide, inhibitors of OATP1B1/B3, OAT3 or MPR2 and metformin. Dosage: Target dose one tablet of 97 mg/103 mg twice daily. Starting dose one tablet of 49 mg/51 mg twice daily. Starting dose one tablet of 24 mg/26 mg taken twice daily recommended for ACEi/ARB naive patients, those with severe renal impairment, moderate hepatic impairment, and in those 75 years old. Double every 2-4 weeks to the target dose. Adverse effects: Very common ( 10%): Hyperkalaemia, hypotension, renal impairment. Common (1 to 10%): Cough, dizziness, renal failure, diarrhoea, hypokalaemia, fatigue, headache, syncope, nausea, asthenia, orthostatic hypotension, vertigo. Uncommon (0.1 to 1%): Angioedema, dizziness postural. Unknown: Hypersensitivity (including rash, pruritus, and anaphylaxis).

Novartis New Zealand Limited, Auckland. Ph 0800 652 422 Registered Trademark

NZ-00758 June 2020, TAPS NA12043, BGA200605

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Why urgency is needed when managing stable heart failure patients such as Bernard - New Zealand Doctor Online

BUFFALO, N.Y. The findings from a recent study by a University at Buffalo researcher and others could prove to be a game-changer for men with Type 2 diabetes.

The single-site study, conducted over 11 years in Bremerhaven, Germany, found that testosterone therapy reversed Type 2 diabetes in a one-third of the study participants.

The occurrence of this syndrome is common and with appropriate testosterone replacement, obesity insulin resistance and diabetes may be reversible, said Paresh Dandona, MD, PhD, SUNY Distinguished Professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. He co-authored the study, titled Remission of type 2 diabetes following long-term treatment with injectable testosterone undecanoate in patients with hypogonadism and type 2 diabetes: 11-year data from a real-world registry study.

The prospective, registry-based study was published in the online journal Diabetes, Obesity and Metabolism in June. Dandona also presented the data to the Annual Mohan Diabetes Foundation Symposium in Chennai, India, on July 25, where he was given the organizations Lifetime Achievement Award.

Type 2 diabetes, also known as Type 2 diabetes mellitus, results from a combination of insulin resistance and insufficient production of insulin, causing high blood sugar. The condition is common, with more than 3 million new cases per year in the United States. Reduced testosterone concentrations are found in 33% of men with Type 2 diabetes.

The discovery of this syndrome of hypogonadism in Type 2 diabetes was made by Dandonas group at UB in 2004. This group then extended the prevalence of this syndrome to include 25% of non-diabetic obese men in 2010. Thus, diabetes and obesity became the main cause of male hypogonadism. The group went on to demonstrate that such patients have additional insulin resistance that reverses with testosterone treatment in 2016.

Testosterone deficiency, which is also called male hypogonadism, contributes to reduced response of insulin to glucose, increased insulin resistance and eventually the onset of Type 2 diabetes.

The objective of the researchers study was to determine if men with Type 2 diabetes who also exhibit hypogonadism, when treated with testosterone in addition to their regular diabetes treatment, would demonstrate improved glycemic control and insulin sensitivity and possibly eventually experience remission of Type 2 diabetes.

The investigators observed 356 men in a single urology practice clinic over 11 years. All patients received standard diabetes treatment, which included mandatory educational courses and materials. In addition, 178 men with a mean age of 62 years, received 1,000 milligrams of subcutaneously injected, slow-release testosterone every 12 weeks after an initial six-week interval. The 178 subjects, mean age 64 years, who opted out of the testosterone therapy served as the control group.

The researchers took numerous measurements, including height, weight, waist circumference, blood pressure, hemoglobin, fasting glucose, HbA1c (the average amount of glucose in blood over a 6 or 12 week period), insulin, heart rate, lipids, highly sensitive C-reactive protein and total testosterone among others. They also assessed quality of life using the Aging Males Symptoms scale. Erectile function was also assessed, using the International Index of Erectile Function. Assessment of these clinical metrics was performed at least twice a year, and data over 11 years were analyzed.

The results showed that the men treated with testosterone had significant progressive and sustained reductions in their body weight, fasting glucose, HbA1c and fasting insulin over the treatment period, the authors wrote. In the control group, fasting glucose, HbA1c and fasting insulin increased.

One-third (34.3%) of men treated with testosterone saw remission of their diabetes; almost half (46.6%) achieved normal glucose regulation with antidiabetic treatment and a vast majority (83.1%) reached their target level of HbA1c.

Patients in the control group saw no remission of diabetes or reduction in glucose or HbA1c levels were noted.

In addition, there were fewer deaths, myocardial infarctions, strokes, and diabetic complications in the group treated with testosterone.

The research indicates that long-term treatment with testosterone is potentially a novel additional therapy for men with Type 2 diabetes and hypogonadism, the authors wrote.

The clinical significance of these results is further enhanced by the fact that one-third of men with Type 2 diabetes have hypogonadism. Hence, physicians encounter men with hypogonadism and diabetes very frequently. It is remarkable that while Type 2 diabetes mellitus leads to hypogonadism, treatment of hypogonadism results in remission of diabetes itself, the authors wrote.

Going forward, prospective randomized controlled trials are needed to confirm the data. One such trial is currently in progress.

Dandona is one of the worlds leading experts in the treatment of diabetes and vascular disease. He is also the ex-chief of endocrinology at UB and the founder of the Diabetes and Endocrinology Center of Western New York, which is sponsored by the Jacobs School and Kaleida Heath. He sees patients at UBMD Internal Medicine.

Dandonas co-authors on the study include Karim Sultan Haider, MD, and Ahmad Haider, MD, urologists in Bremerhaven, Germany; Farid Saad, PhD, a consultant to Medical Affairs Andrology at Bayer AG in Berlin; Gheorghe Doros,, PhD, from the Department of Epidemiology and Biostatistics at the Boston University School of Public Health; Markolf Hanefeld, MD, from GWT-TU Dresden GmbH and Medizinische Klinik, Universittsklinikum Carl Gustav Carus, in Dresden; Sandeep Dhindsa, MD, from the Division of Endocrinology, Diabetes and Metabolism at Saint Louis University; and Abdulmaged Traish, PhD, from the Department of Urology at the Boston University School of Medicine.

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UB diabetes expert's research shows testosterone therapy can lead to remission in men with Type 2 diabetes - UB News Center

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A latest survey on Global Male Hypogonadism Market is conducted covering various organizations of the industry from different geographies to come up with 200+ page report. The study is a perfect mix of qualitative and quantitative information highlighting key market developments, challenges that industry and competition is facing along with gap analysis and new opportunity available and may trend in Male Hypogonadism market. The report bridges the historical data from 2014 to 2019 and forecasted till 2027, product outline, the organizations required raw materials, and others growth factors .

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Male Hypogonadism Market Report provides an overview of the market based on key parameters such as market size, sales, sales analysis and key drivers. The market size of the market is expected to grow on a large scale during the forecast period (2019-2026). This report covers the impact of the latest COVID-19 on the market. The coronavirus epidemic (COVID-19) has affected all aspects of life around the world. This has changed some of the market situation. The main purpose of the research report is to provide users with a broad view of the market. Initial and future assessments of rapidly.

Male Hypogonadism MarketCompetitive Analysis:

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Dr. Amauri Wellness Centre, based in Toronto, Ontario, Canada, recently published a blog post written by Arv Buttar, NP, regarding potential testosterone therapy mental health benefits in men. In the article, Arv Buttar, NP points out that placebo-controlled trials and clinical research on testosterone therapy indicate potential improvements in mood and overall mental health in men. The article focuses on what is know so far about the potential psychological benefits offered by testosterone therapy or testosterone replacement therapy (TRT).

Arv Buttar, NP, says, Did you know that our testosterone levels decline as we age? Several mental health issues may arise with this decline, such as mood changes, an increased risk of developing a major depressive disorder, and increased anxiety.

She continues, Research is uncovering the pros and cons of testosterone therapy on mens psychological health, which must be noted since testosterone levels decline as we age. To see if testosterone replacement therapy is right for you, please contact our clinic to learn more.

It is quite common for men who are more than 40 years old to have symptoms of low testosterone levels. However, there may be some men as young as 25 years old who suffer from a deficiency in testosterone. There are a number of symptoms or indicators of low testosterone levels or hypogonadism. These include prostate issues/PSA health; low sex drive; weak or absent erections; decreased muscle mass; premature ejaculation; inability to have an orgasm; frequent urination; enlarged prostate; depression; fatigue and anxiety; sleep issues; cognitive issues; weight gain, increased fat, especially abdominal; reduced mental clarity; mood swings; and lack of motivation and drive.

TRT may be able to help in increasing muscle mass; improving sleep, mood and energy; and restoring sexual function. The mens health program offered at Dr. Amauri Wellness Centre, includes TRT, disease prevention and optimum health, which may help in improving vitality, energy levels, health and wellness, libido and cognitive health.

Their TRT program includes: full hormone assessment (with a complete evaluation and detailed medical history); comprehensive hormone, adrenal and thyroid lab tests (some may be covered by OHIP); monitoring of symptoms for optimum care; progress consultations throughout the treatment; individualized hormone and testosterone replacement consultation; prescription management with multiple treatment options (topical compound creams, gels, pills, troches, capsules and/or injectable therapy by Arv Buttar, NP); patient-specific custom treatment; and follow-up appointments during the year.

Dr. Amauri Caversan, ND, has partnered with Arv Buttar, NP, to provide a functional and fully integrative TRT for men program for patients to help men balance testosterone and put it back to optimum levels, which may come with minimal side effects. Testosterone therapy may be used to help relieve the symptoms of low testosterone levels by: boosting energy, intensifying libido, building stronger bones and muscles, increasing lean body mass, improving workouts and cardiovascular endurance, sharpening memory, and elevating mood.

TRT is part of the wellness services offered at Dr. Amauri Wellness Centre. Other services include naturopathic medicine; functional medicine; detoxification and weight loss; addiction and neurological support treatments; bio-identical hormone replacement therapy; lab testing services; and thyroid support.

They also provide paint treatment services. It should be noted that pain is most often not the disease but a symptom of imbalance in one or more areas of the body. Pain treatment services include acupuncture, natural anti-inflammatory and pain meds, naturopathic manipulation, shockwave therapy, and cold laser therapy.

They also offer nutritional IV vitamin therapy, which is designed to provide the nutritional needs of the bodys cells. IV therapy has the advantage of bypassing the digestive tract and being able to deliver a large concentration of nutrients to the cells, which the cells require to support their function. When combined with their wellness program, IV therapy may be able to help in reducing inflammation, decreasing fatigue, boosting the immune system, and more.

Those who are interested in learning more about the services provided by a Toronto naturopath and the potential benefits may want to check out the Dr. Amauri Wellness Centre website, or contact them on the telephone, or through email.

###

For more information about Dr. Amauri Wellness Centre, contact the company here:

Dr. Amauri Wellness CentreDr. Amauri Caversan, ND(416) 922-4114info@dramauriwellnesscentre.comDr. Amauri Wellness Center1200 Bay Street #1102Toronto, Ontario M5R 2A5

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Testosterone Replacement Therapy and Its Potential Mental Health Benefits to Men - Press Release - Digital Journal

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200 mg/mL100 mg/mL

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Primary hypogonadismHypogonadotropic hypogonadismLate-onset hypogonadism

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Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience , Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com:https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - BioSpace

Victoria Gray, a 34-year-old mother of four in Forest, Miss., had been going to the hospital seven times a year for transfusions to help with the severe pain brought on by her sickle cell disease. In July 2019, she volunteered for a radical new technology known as gene editing. She has been free of the pain and suffering since.

I chose to participate in this trial because of hopehope that it would change my life, Gray tells Barrons. And it has already in so many ways.

Her successful treatment gives hope to the 100,000 other Americans who suffer from sickle cell. It also illuminates the enormous potential for the companies that are pioneering genetic medicine to cure diseases with a one-time treatment.

Sickle cell is among their first targets. The companies include the sponsors of Victoria Grays clinical trial Crispr Therapeutics (ticker: CRSP) and Vertex Pharmaceuticals (VRTX)as well as biotechs like bluebird bio (BLUE), whose gene therapy for sickle cell is further along in testing and could be introduced by 2022.

For these companies, genetic therapies for sickle cell could fetch annual revenue of several billion dollars apiece. A recent Bank of America Securities report predicts that new treatments for sickle cell will surpass $6 billion in sales by 2028. That is meaningful for a company of any size, but particularly so for these biotechs. Crispr doesnt yet have sales. Bluebirds revenue last year was $45 million, and Vertexs, $4 billion.

More important, the sickle cell therapies will demonstrate how such genetic technology could open the door to curing dozens of other diseases.

Investors seem persuaded. They have lifted Crispr stock threefold since March to a recent high of $97, which values the development-stage company above $6 billion. Hitting a record high of $306, Vertexs value has topped $75 billion, while bluebirdwhose investors have waited nearly a decade for their paydaytrades at a more modest market cap of $4.2 billion. Biotech valuations may be hard to rationalize these days, but that reflects the radical changes that new technologies are bringing to the health-care business. One need look only at this years fourfold rise of the messenger RNA vaccine leader Moderna (MRNA).

The focus on sickle cell is a turnaround for the pharmaceutical industry, which had long ignored the inherited disorder. Sickle cell mainly afflicts Black Americans and residents of poor African nations. It is the most commonly diagnosed genetic disorder among newborn Americans. Yet it has not had as much funding as some less-common inherited conditions. Cystic fibrosis, for example, affects one-third as many Americans, but researchers at Duke University have shown that it has historically received more than seven times the federal and foundation research funding per patient.

This year, two new sickle cell drugs came on the market. And sometime next year, bluebird will ask the U.S. Food and Drug Administration to approve its sickle cell gene therapy. Crispr and Vertex hope that they will not be not far behind.

The starting prices of the new sickle cell treatments are expected to range from $100,000 to over $1 million. It will be a challenge to make them accessible to the millions of people in poor countries who have sickle cell.

The disease is caused by a single variation in a gene for hemoglobin, the protein that carries oxygen in our red blood cells. The genetic trait is prevalent among those whose descent traces to sub-Saharan Africa, because a single copy of the sickle cell gene protects you from developing malaria. Inherit a copy from each parent, however, and you become one of 300,000 babies born in the world each year with sickle cell disease. It causes hemoglobin molecules to form long chains that warp red blood cells into sickle shapes that get stuck in blood vessels and block the flow to vital organs.

The result is terrible pain, organ damage, infections, andwhen left untreateddeath before age 5, on average. In the U.S., where the disease occurs in one of every 365 Black babies, available treatments still leave many with a life of pain, disability, and death before age 50.

The first sickle cell treatment approved by the U.S. Food and Drug Administration was hydroxyurea, in 1998. For the half of sickle cell patients with moderate disease, treatment with hydroxyurea, antibiotics, and transfusions can allow productive lives. Hydroxyurea is off-patent and costs less than a dollar a day. But even that price is beyond reach of those who live in resource-poor countries, says Russell Ware, a pediatric hematology professor at the University of Cincinnati College of Medicine. Ware is working with medical colleagues in Uganda to get more children there on hydroxyurea.

Data as of 7/22/20

Bloomberg; company filings

The beauty is that its off-patent, says Ware, but its also a curse, because no one can make money off it.

Novartis (NVS) is supporting hydroxyurea availability in collaboration with the government of Ghana. The Swiss drug giant is also planning clinical trials in Ghana and Kenya for Adakveo, a monoclonal antibody approved by the FDA last November as one of the first novel treatments in decades for sickle cell disease. Adakveo dampens the inflammatory process that makes sickle cells clog blood vessels in cases that send some 50,000 Americans to the emergency room every year.

The intravenous drugs initial sales in the years first half were $36 million, but analysts hope that by the middle of this decade, Adakveos annual sales could reach $1 billion to $2 billion in the U.S. and Europe.

Just days after approving the Novartis drug, the FDA approved another sickle cell drug called Oxbryta, from Global Blood Therapeutics (GBT). Oxbryta is a pill that prevents defective hemoglobin from forming chains within red blood cells. The product is GBTs first, and it produced $14 million in sales for the March quarter, with a loss of $73 million.

But analysts like Yatin Suneja of Guggenheim Securities say that Oxbryta can hit sales of $1.7 billion in a few years, yielding some $13 a share in earnings for GBT. That makes Suneja think that GBT stock can rise from its current level of $72 to $115.

Successful sickle cell treatments could lift a number of biotech companies.

GBT CEO Ted Love says that Oxbrytas benign safety profile gives the company confidence that it will win approval to market the product for children, and in higher doses for adults. If other sickle cell treatments in the companys pipeline pan out, he imagines that sickle cell might one day become as well managed a disease as HIV.

Love is aware of the potentially curative gene therapies being tested by others, but he thinks that patients with milder cases of sickle cell might say, Just give me a pill.

For several decades, it has been possible to cure sickle cell with a bone-marrow transplant from a related donor. But the scarcity of matched donors and the risk of serious immune reactions have limited the number of such procedures to about 1,000. Recent breakthroughs in genetic technology promise to overcome those limitations by extracting a patients own cells, manipulating the cells genetic code, and then replacing the patients marrow with the amended cells.

The Cambridge, Mass.based bluebird bio is already in Phase 3 clinical trials of its beti-cel gene therapy for another inherited disorder of red blood cells called beta-thalassemia. Less common than sickle cell, thalassemia leaves patients with so few red blood cells that they can need more than a dozen transfusions a year. At a recent online gathering of hematologists, bluebird said that 60 children and adults with thalassemia had gone through its beti-cel procedure. About 90% had gone a year without needing a single transfusion.

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With a similar treatment for sickle cell, which bluebird calls LentiGlobin, more than two dozen patients have been infused with their own modified cells. Among the 14 patients who were six months past their treatment, there has been a 99.5% decrease in the blood vessel jam-ups that the patients previously suffered.

That is fundamentally transformative, says bluebird CEO Nick Leschly, and far exceeds any and all expectations weve ever had, any of our investigators have ever had, or the patients that have been treated.

These potentially curative cell therapies are complex procedures that are expected to be priced at about $1 million a patient. The thalassemia treatment is already approved in Europe. After the patients in bluebirds U.S. trials for thalassemia and sickle cell have been followed up for 18 months, the company will seek FDA approvalhopefully next year.

RBC Capital Markets believes that the companys sickle cell treatment could reach sales of $2 billion a year and help lift bluebird stock from its recent price of $66 to $100.

It took bluebird a decade to get to this point, and its shares have sunk as low as $17 and soared as high as $236, as investors reacted to the companys dramatic successes against refractory cancers. With Buy recommendations all along Wall Street, bluebird will get the capital it needs to cross the finish line.

Hard on the heels of bluebird are companies that believe they have better genetic treatments. One of them is Crispr Therapeutics. The company takes its name from CRISPR, shorthand for a Nobel Prizewinning technology that homes in on a targeted stretch of DNA and snips the double-stranded molecular code with a kind of chemical scissors.

The way I describe it to my patients, says patient Grays doctor Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville, is that you have a book with 500 pages of thousands of words, and we are finding one word and correcting it.

Crispr Therapeutics CEO Sam Kulkarni says that CRISPR technology should provide more durable and uniform results than earlier generation treatments like bluebirds. When Crispr reported Grays healthy progress last month, it said that a second patient with sickle cell has also been treated, as well as five patients with thalassemia. Kulkarni hopes to reach the market with his treatments not too far behind bluebird.

This years surge in Crispr Therapeutics stock allowed it to raise about $450 million in a June stock offering. Jefferies analyst Maury Raycroft has estimated that a successful sickle cell treatment could contribute a third of the $5 billion in annual revenue he projects for Crispr by 2030, with earnings above $30 a share. The stock has blasted through his last price target of $82.

Behind Crispr are still other gene-editing companies working on treatments for thalassemia and sickle cell, including Sangamo Therapeutics (SGMO), Editas Medicine (EDIT), and Intellia Therapeutics (NTLA).

One of this years most successful initial public offerings was the February debut of Beam Therapeutics (BEAM), which is in preclinical testing of sickle and thalassemia treatments that would use a next-generation editing technology that CEO John Evans believes will be even more effective than CRISPR.

If these other companies sickle cell treatments pan out, they may be scrapping for market share after bluebird and Crispr have established products. Still, as the pharmaceutical giants shop for gene-editing know-how, there may be buyouts.

Sickle cell has been a long-neglected illness, but many companies are now competing with treatments that each hopes will be best-in-class. This should be a dogfight, says bluebird CEO Leschly, because thats in the interest of patients.

Write to Bill Alpert at william.alpert@barrons.com

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These Companies Are Seeking a Cure for Sickle Cell. And Its Just the Beginning for Some Gene Therapy Stocks. - Barron's

Officials with the FDA have approved atezolizumab (Tecentriq, Genentech) plus cobimetinib (Cotellic, Genentech and Exelixis) and vemurafenib (Zelboraf, Genentech and Daiichi Sankyo) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma. The safety profile observed in the atezolizumab combination was consistent with the known safety profiles of the individual medicines, according to Genentech.

Atezolizumab is a prescription monoclonal antibody designed to bind with a protein, PD-L1, expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. The therapy is currently utilized for treatment of patients with certain types of cancer, including urothelial carcinoma, non-small cell lung cancer, triple-negative breast cancer, and hepatocellular carcinoma.

The approval of the atezolizumab combination for BRAF V600 mutation-positive advanced melanoma is based on results from the Phase III IMspire150 study, a multi-center, double-blind, placebo-controlled randomized study in individuals with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study results showed the addition of atezolizumab to cobimetinib and vemurafenib helped individuals live longer without their disease worsening or death (progression-free survival, PFS), compared to placebo plus cobimetinib and vemurafenib (median PFS 15.1 months versus 10.6 months respectively; hazard ratio, HR=0.78; confidence interval: 0.63-0.97; P=0.025).

The most common adverse reactions (rate 20%) in patients who received atezolizumab with cobimetinib and vemurafenib were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).

The supplemental Biologics License Application or atezolizumab was granted under Priority Review. The review was also conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.

According to Genentech, the company has an extensive development program for atezolizumab, including multiple ongoing and planned phase 3 studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating atezolizumab both alone and in combination with other medicines.

For those who qualify, Genentech will offer patient assistance programs for patients prescribed atezolizumab with cobimetinib and vemurafenib by their doctor through Genentech Access Solutions.

REFERENCE

FDA Approves Genentechs Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma [news release]. South San Francisco, CA; July 30, 2020: Genentech website. https://www.gene.com/media/press-releases/14868/2020-07-30/fda-approves-genentechs-tecentriq-plus-c Accessed July 30, 2020.

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FDA Approves Combination Therapy for Treating Advanced Melanoma - Pharmacy Times

As the COVID-19 pandemic continues unfolding, technology solutions and government initiatives are multiplying to help monitor and control the viruss journey. Their aid includes reducing the load on the health system and reinforcing the efforts of overworking and burned-out healthcare workers.

While smart technologies cannot replace or compensate public institution measures, they do play a crucial role in emergency responses. Lets take a look at the promising use cases of how technology can help fight the novel coronavirus outbreak.

People tend to think of technology as a heartless machine, which is true, but only until its used for good. Just look at all the wonderful things weve managed to do with its help.

Telemedicine is gaining traction by offering remote patient monitoring and interactive remote doctors visits. At the same time, 3D printing and open-source solutions are facilitating the production of more affordable face masks, ventilators, and breathing filters as well as optimizing the supply of the medical equipment. Even more, the pandemic has driven scientists to desperate measures. They are now experimenting with gene editing, synthetic biology, and nanotechnology to develop and test vaccines faster than ever in the history of humanity.

Smart technologies like the Internet of things (IoT), big data, and artificial intelligence (AI) are being massively adopted to help track the disease spread and contagion, manage insurance payments, uphold medical supply chains, and enforce restrictive measures. Lets go step by step to see how IoT, AI, big data, and mobile solutions are actually enhancing medical care.

IoT has already found its use among healthcare providers. Today, connected patient imaging, health devices or applications, worker solutions, and ambulance programs are being adopted globally. But COVID-19 made the technology take on new applications to help the world combat the epidemic. Tracking quarantine, pre-screening and diagnosing, cleaning and disinfecting, innovative usage of drones, reducing in-home infections, are all new normals thanks to IoT.

For example, an American health technology companyKinsacreates smart thermometers that screen and aggregate peoples temperature and symptoms data in real-time. Having gathered data from over one million connected thermometers, Kinsa rolled out itsUS HealthWeather Map.

The map is updated daily, highlighting how severely the population is being affected by influenza-like illness (ILI). This real-time information helps health authorities see an increase. In fevers as early indicators of the community spread of COVID-19 to streamline the allocation of health resources. These areas are marked in the Atypical mode of the map.

To slow down the spread of COVID-19, a team of Seattle engineers createdImmutouch, a smart wristband vibrating every time a person wearing it tries to touch their face.

Smart speakers, lights, and security systems are being used to open doors and switch on lights to reduce in-home infections. These gadgets allow people to avoid touching the surfaces of doorknobs, switches, mail, packages, or anything that could easily spread germs.

Tapping into big data is a must to develop real-time forecasts and arm healthcare professionals with a profound database to help with decision-making.

IBMClinical Development system is an advanced Electronic Data Capture (EDC) platform that allows an accelerated delivery of medications to market and reduces the time and cost of clinical trials thanks to cognitive computing, patient data assets, and IoT. Additionally, the U.S. government had been in active talks with Facebook, Google, and others to determine how to use location data to glean insights for combating the COVID-19 pandemic.

The COVID-19 pandemic has become a game-changer for the healthcare continuum. Todays mobile apps are on guard to help patients receive online therapy, at-home testing, conclude self-checks, and improve mental well-being. Thanks to smartphone apps, it is now possible to trace the viruss journey and help limit its spread.

Apple COVID-19, for instance, was created in partnership with the Centers for Disease Control and Prevention (CDC), the White House, and the Federal Emergency Management Agency (FEMA). The application contains vital and relevant information from trusted sources on the coronavirus pandemic: hand hygiene practices, social distancing FAQs, quarantine guidelines, self-checking tutorials, tips on cleaning, and disinfecting surfaces. On top of that, it has a screening tool that advises people on what to do when a person has COVID-19 symptoms, has just returned from abroad, or has come in close contact with someone who might be infected with the disease.

Meanwhile, health authorities in Abu Dhabi have created theTraceCovidapp for Bluetooth-enabled smartphones to minimize the spread of the disease. The service allows tracing individuals who have come into proximity with a person tested positive for COVID-19. Thanks to it, medical professionals an react faster and render the necessary healthcare. Germany, in turn, is going to roll outa smartphone app, which will use Bluetooth to alert people if they are close to someone with the confirmed viral infection.

Telemedicine has also proved to be an efficient tool for flattening the curve.The Sheba Medical Centre, the largest Israeli hospital, launched a telehealth program for remote patient-monitoring to control the pandemic spread. Doctolib, a Franco-German company, Qare (France), Livi (Sweden), Push Doctor (the UK), Compugroup Medical (Germany) are offeringvirtual doctorstoo.

Artificial intelligence-powered by natural language processing (NLP) and location monitoring is crucial for identifying, tracking, and scanning outbreaks, predicting hotspots and helping make better decisions.

For example, Microsoft collaborated with the U.S. Centers for Disease Control and Prevention (CDC) to create an AI-basedCOVID-19 Assessment botto treat patients more effectively and allocate limited resources. The bot, nicknamed Clara, can evaluate symptoms, advice on the next steps to take and track users who need urgent care the most.

The Canadian startup BlueDot has applied AI to spot and track the spread of COVID-19 and predict outbreaks, and the Japanese company Bespoke rolled outBebot, an AI-powered chatbot that was developed specifically for travelers. This mobile app informs and assists them with coronavirus-related questions as they move about.

Theres no doubt that the coronavirus pandemic has become a real-life test for everyone. It has caused tremendous damage, but at the same time, it has forced tech innovators to roll out advanced solutions, and it seems that they dont plan on slowing down anytime soon.

Healthcare providers across the globe are continually switching to smart technologies. So if you are in the smart technology niche, consider the current trends to steer your business in the right direction.

Link:
How Can Technology Help Fight the COVID-19 Pandemic? - IoT For All

In a biopic about the mating rituals of anglerfish, its unclear what would earn the film its R-rating: the sex or the violence.

Born into an inky deep sea world, the males of certain anglerfish species exist solely to sniff out their mates. Upon locating his lady (who might be up to 60 times his size), the male will nip at her belly. His mouth then dissolves in a sludge of chemicals that physically fuse him to his bioluminescent bride, forever commingling his blood and tissues with hers.

This grotesque ritual, called sexual parasitism, looks just as bizarre as it sounds. To an immunologist, though, the aesthetics of this macabre form of unholy matrimony arent actually the weirdest part.

Two genetically distinct animals, no matter how much in love, shouldnt be able to merge their flesh without serious consequences, said Dr. Thomas Boehm of the Max Planck Institute of Immunobiology and Epigenetics. Its the same reason that transplanted organs often get rejected by a recipients body: Vertebrate immune systems are built to wage war on any foreign matter.

And yet, some male anglerfish are full-time grafts the ultimate live-in boyfriends. It really is a mysterious phenomenon, Dr. Boehm said.

With the help of modern genetic sequencing, Dr. Boehm and his colleagues may have solved this deep sea dilemma. Anglerfish have largely jettisoned a branch of the immune system thats been a fixture of vertebrate bodies for the last 500 million years, they report in a study published Thursday in Science. The adaptation may help the clingiest of couples stick together.

Its a substantial sacrifice to make, even for sex: Similar changes would be lethal for humans and no other animals have yet been documented doing the same.

This is some of the cooler science Ive read in a while, said Jesyka Melndez Rosa, an evolutionary biologist and expert in the genetics of the immune system at the University of Puerto Rico who wasnt involved in the study. It just goes to show, nothing is sacred.

Anglerfish have good reason to resort to extreme evolution. Thousands of feet below the surface of the sea, where the suns rays dont shine, both food and friends are scarce. Many males never actually manage to find a female. So if they do meet up, what better thing to do than to bite and hold and stay that way? said Theodore Pietsch, an evolutionary biologist at the University of Washington and an author on the study.

Thats probably why sexual parasitism has supposedly evolved multiple times across the anglerfish family tree. In some cases, the attachments are temporary the boys hop on and off as they please. In others, though, the males become permanent fixtures on the females.

These longer-lasting hookups come with a price. After males glom onto their girls, their innards rapidly atrophy until little more is left than a bulbous pair of testes, fringed with gills, protruding from the females flank like a sperm-filled saddlebag. Theres basically no integrity at this point, Dr. Pietsch said.

In the most extreme version of this trait, females of some species will host up to eight male consorts at a time.

To figure out how the fish tissues tolerate each other, the researchers sequenced the genes of 10 types of anglerfishes. They found that two of the most decorated species, where females sported entourages of males, had lost their ability to produce functional antibodies and T cells two types of immune system sentinels that greatly underpin the bodys ability to distinguish its own cells from unfamiliar ones, and annihilate inbound threats.

That strategy comes in handy when animals must contend with germs or cancerous cells, said Zuri Sullivan, an immunologist at Yale University who wasnt involved in the study. The so-called adaptive immune system, to which antibodies and T cells belong, also helps the body remember past encounters with pathogens so they can be vanquished again. It provides this huge benefit, Ms. Sullivan said. Its a big thing to lose.

Similar genetic changes were present in anglerfish that melded monogamously, though to a lesser degree. These more faithful fish still had genes that allowed them to manufacture a limited selection of disease-fighting antibodies, for instance.

Least altered of all were the ephemeral attachers, who seem to have retained the genes for T cells and a blunted antibody response. In general, the less durable the bond, the more intact the immune system, Dr. Boehm said. That pattern makes sense: Short-lived flings between partners can withstand some tissue rejection, but the stakes are far higher when a relationship is for keeps.

Dr. Boehm said the data so far point to the possibility that deterioration of anglerfish immunity preceded the rise of sexual parasitism. But figuring out the order of these events is really a chicken or egg situation, Dr. Melndez Rosa said.

The researchers also dont yet know how anglerfish manage to ward off infections. But theres more to the immune system than antibodies and T cells; perhaps other members of this complex cavalry have risen in the ranks to compensate, Ms. Sullivan said. Clearly, these animals are doing fine, she said.

Finding these answers will likely require finding more rare deep sea anglerfish. It took several years to amass 31 specimens with enough DNA to analyze, Dr. Boehm said. But the researchers are up for the challenge.

We are not quite sure what lessons the anglerfish will teach us, Dr. Boehm said. But we know they have done something really incredible.

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The Male Anglerfishs Evolutionary Solution to Female Rejection - The New York Times

US animal scientists at the University of California, Davis, have successfully produced a bull calf that was genome-edited as an embryo to produce more male than female offspring.

Cosmo, a bull calf was born in April at UC Davis. Scientists successfully genome-edited him as an embryo to produce more male offspring. (Pic: Alison Van Eenennaam/UC Davis)

The research was presented in a poster session at the American Society of Animal Science meeting last week.

Using the genome-editing technology CRISPR, researchers can make targeted cuts to the genome or insert useful genes, which is termed a gene knock-in.

In this case, scientists successfully inserted or knocked-in the cattle SRY gene, the gene that is responsible for initiating male development, into a bovine embryo. It is the first demonstration of a targeted gene knock-in for large sequences of DNA via embryo-mediated genome editing in cattle.

We anticipate the calfs offspring that inherit this SRY gene will grow and look like males, regardless of whether they inherit a Y chromosome, said Alison Van Eenennaam, animal geneticist with the UC Davis Department of Animal Science.

Dr Van Eenennaam said part of the motivation to produce more male calves than female was that male cattle are about 15 percent more efficient at converting feed into weightgain. They are more fuel-efficient than females. Additionally, they tend to be processed at a heavier weight.

It could also be a win for the environment, with fewer cattle needed to produce the same amount of beef.

Ranchers could produce some females as replacements and direct a higher proportion of male cattle for market, said Joey Owen, a postdoctoral researcher in animal science who is leading the project with Dr Van Eenennaam.

Alison Van Eenennaam

The SRY gene was inserted into bovine chromosome 17, which is a genomic safe harbor site. That ensures the genetic elements function predictably and dont disrupt the expression or regulation of adjacent genes.

Chromosome 17 was chosen after unsuccessful attempts to knock-in the gene on the X chromosome, which would have resulted in a bull that produced only male offspring. The bull calf, nicknamed Cosmo, is expected to produce 75 percent male offspring the normal 50 percent XY animals, and another 25 percent XX animals that inherit the SRY gene.

It took two and a half years to develop the method to insert a gene into the developing embryo and another two years to successfully establish a pregnancy, said Dr Owen. But in April of 2020, a healthy 50kg male calf was born.

This has been a real labour of love, Dr Van Eenennaam said.

She said this was just the beginning for CRISPR research. Cosmo will reach sexual maturity in a year, and he will be bred to study if inheriting the SRY gene on chromosome 17 is sufficient to trigger the male developmental pathway in XX embryos, and result in offspring that will grow and look like males.

As the Food and Drug Administration regulates gene-editing of animals as if they were drugs, Cosmo and his offspring will not enter the food supply.

Other researchers on the team include James Murray, Pablo Ross, Sadie Hennig and Jason Lin from the UC Davis Department of Animal Science, and Bret McNabb and Tamer Mansour of the UC Davis School of Veterinary Medicine.

This project was supported by Biotechnology Risk Assessment Grant Program from the US Department of Agriculture, the California Agricultural Experiment Station at UC Davis and the USDA NIFA National Needs Graduate and Postgraduate Fellowship.

Source: UC Davis

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Genetically-edited bull calf is programmed to produce more male offspring - Beef Central

And without an obvious medical benefit, Eliot thinks this type of research will simply reinforce the idea that men and women are fundamentally different, or even justify misogynyalthough the authors may not intend such an outcome. This research is far from having medical value, she says. Instead, it can validate the fixed, hardwired, God-givenhowever you want to put itdifferences between the sexes, so that we can get over this idea of real equality.

Concerns like these are one reason why sex difference research in neuroscience has attracted so much controversy. But worries about consistency have also plagued the discipline. Studies that report sex differences in the sizes of brain regions, or in how strongly some regions are connected to others, often disagree about just where those differences lie. The longer people have been at it, the muddier its gotten, Eliot says.

This inconsistency might arise from a bias among scientists in favor of reporting studies that demonstrate sex differences rather than similarities. In 2018, a group of researchers from the Meta-Research Innovation Center at Stanford found evidence that scientists are more likely to publish studies that uncover potential sex differences than those that find none. Because studies that only examine a small number of subjects are prone to false positives, the authors warn, a bias in favor of publishing those positives makes it hard to know how much that research can be trusted.

Raznahan and his team were well aware of these shortcomings, so they worked to ensure that any differences they found would reflect real patterns in brain anatomy, not the random quirks of the people in the data set. Observations that hold across a substantial number of subjects are more likely to apply to the population as a whole, which is why they relied on the Human Connectome Projects large data set. After analyzing this data and correcting for total brain volume (just like mens bodies are, on average, larger than womens bodies, so too are their brains), they discovered a number of apparent differences.

Among them was a relative size advantage for men in parts of the occipital lobe (which is associated with vision) and in the amygdala and hippocampus (regions that play important roles in emotion and memory). Women, on the other hand, had more gray matter in parts of the prefrontal cortex (which is associated with decisionmaking and self-control) and the insula (which has been connected with numerous functions, including emotion and the sense of taste). These results might seem to suggest that women have an edge over men in decisionmaking and that men have better memories, but its impossible to extrapolate such broad conclusions from Raznahans results. It could be that there's absolutely no behavioral relevance for what we're finding, he says.

To begin with, its not clear what gray matter volume really means for brain function. The brain contains two major types of tissue: gray matter, which holds neuron cell bodies, and white matter, which connects gray matter in tracts and allows neurons to send signals to distant areas. They depend on each other to carry out their functions, and its not obvious whether having a larger volume of either one is advantageous.

In no way is more gray matter a good thing, necessarily, says Margaret McCarthy, a professor of pharmacology at the University of Maryland School of Medicine. It's just a measure that there's a difference in the way the neurons are, how many synapses they're making, how many there are, possibly, and stuff like that.

Yet its easy for people to jump to the conclusion that size matters, and there is some evidence in favor of that notion. Two decades ago, researchers at University College London made a particularly big splash when they published a study showing that London cab drivers, who must learn how to navigate a large, disorganized city by memory alone, have much larger hippocampuses than most other people. Since the hippocampus is linked to spatial memory, this study seemed to show that the size of a brain region correlates with a particular skill. But showing that learning a skill is associated with the growth of a specific brain region does not imply that the regions size is correlated with that ability in general. So the study doesn't imply that simply being born with a big hippocampus means a person will have an excellent memory.

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A Study Finds Sex Differences in the Brain. Does It Matter? - WIRED