Roche obtains the exclusive right to launch and commercialize SRP-9001 outside the United States

At closing, Sarepta will receive an upfront payment of $1.15 billion, comprising $750 million in cash and $400 million in Sarepta stock, priced at $158.59 per share of common stock

Additionally, Sarepta is eligible to receive up to $1.7 billion in regulatory and sales milestones, plus royalties on net sales

Sarepta will continue to be responsible for clinical development and manufacturing of SRP-9001 with global clinical development costs shared equally with Roche

Sarepta will host a conference call on Monday, Dec. 23 at 08:30 a.m. ET

CAMBRIDGE, Mass., Dec. 23, 2019 (GLOBE NEWSWIRE) Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that Sarepta and Roche have entered into a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sareptas investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the United States. Under the agreement, Sarepta will receive $1.15 billion in an upfront payment and an equity investment; up to $1.7 billion in regulatory and sales milestones; and royalties on net sales, anticipated to be in the mid-teens. In addition, Roche and Sarepta will equally share global development expenses. Sarepta retains all rights to SRP-9001 in the United States.

The collaboration combines Sareptas leading gene therapy candidate for DMD with Roches global reach, commercial presence and regulatory expertise to accelerate access to SRP-9001 for patients outside the United States. DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. SRP-9001, currently in clinical development for DMD, is designed to deliver the micro-dystrophin-encoding gene directly to the muscle tissue for the targeted production of the micro-dystrophin protein.

As a mission-driven organization, we are inspired to partner with Roche with the goal of bringing SRP-9001 to patients outside the United States. This collaboration will not only increase the speed with which SRP-9001 could benefit DMD patients outside the United States, but will also greatly expand the scope of territories within which we could potentially launch SRP-9001 and improve and save lives, said Doug Ingram, president and chief executive officer, Sarepta. In addition to the validation that comes from joining forces with Roche, this licensing agreement one of the most significant ex-U.S. licensing transactions in biopharma will provide Sarepta with the resources and focus to accelerate our gene therapy engine and, if successful, bring SRP-9001 to patients as quickly as possible, potentially transforming the lives of countless DMD patients across the globe.

Said James Sabry, Head of Roche Pharma Partnering, We are excited to enter this licensing agreement with Sarepta. By working together to provide SRP-9001 to patients, we hope to fundamentally transform the lives of patients and families living with this devastating disorder for which there are currently only limited treatment options.

As part of the agreement, Sarepta will continue to be responsible for the global development plan and manufacturing build out for SRP-9001. Through its leading hybrid manufacturing platform, Sarepta will remain responsible for manufacturing of clinical and commercial supplies. Sarepta has also granted Roche an option to acquire ex-U.S. rights to certain future DMD-specific programs, in exchange for separate milestone and royalty considerations, and cost sharing.

The closing of the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions. The parties anticipate that the agreement will close in the first quarter of 2020.

Goldman Sachs & Co. LLC is acting as the lead financial advisor to Sarepta. Morgan Stanley & Co. LLC is also serving as a financial advisor and Ropes & Gray LLP is serving as legal advisor to Sarepta.

Conference Call InformationThe conference call may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 2077714. Please specify to the operator that you would like to join the Sarepta Therapeutics Conference Call. The conference call will be webcast live under the investor relations section of Sareptas website at http://www.sarepta.com and will be archived there following the call for 90 days. Please connect to Sareptas website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

AboutSarepta TherapeuticsSarepta is at the forefront of precision genetic medicine, having built an impressive and competitive position in Duchenne muscular dystrophy (DMD) and more recently in gene therapies for limb-girdle muscular dystrophy diseases (LGMD), Charcot-Marie-Tooth (CMT), MPS IIIA and other CNS-related disorders, totaling over 20 therapies in various stages of development. The Companys programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. Sarepta is fueled by an audacious but important mission: to profoundly improve and extend the lives of patients with rare genetic-based diseases. For more information, please visit http://www.sarepta.com.

Sarepta Forward-Looking StatementThis press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as believes, anticipates, plans, expects, will, intends, potential, possible and similar expressions are intended to identify forward-looking statements. These forward-looking statements include but are not limited to statements regarding the closing of the transaction; Sareptas right to receive any upfront payment or equity investment from Roche pursuant to the agreement; Sareptas right to receive regulatory and sales milestones, and royalty payments from Roche pursuant to the agreement; Roches obligation to share global development expenses pursuant to the agreement; the continued development and manufacturing of SRP-9001; SRP-9001 expected delivery of micro-dystrophin-encoding gene directly to the muscle tissue and the expected production of the micro-dystrophin protein; the expected increased speed with which SRP-9001 could benefit patients outside the United States and expansion of territories within which Sarepta could launch SRP-9001; the expectation that the licensing agreement will provide Sarepta with the resources and focus to accelerate its gene therapy engine and potentially bringing SRP-9001 to patients as quickly as possible and transforming the lives of countless DMD patients across the globe; potential regulatory approvals of SRP-9001; and the potential launch and commercialization of SRP-9001.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sareptas control. Known risk factors include, among others, market conditions, the expected benefits and opportunities related to the licensing agreement may not be realized or may take longer to realize than expected due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in product research and development and manufacturing limitations; success in preclinical testing and early clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; our data for SRP-9001 may not be sufficient for obtaining regulatory approval; Sarepta may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing SRP-9001 to market, for various reasons, some of which may be outside of Sareptas control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions; and those risks identified under the heading Risk Factors in Sareptas most recent Annual Report on Form 10-K for the year ended December 31, 2018 and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Companys business, results of operations and the trading price of Sareptas common stock. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Internet Posting of Information

We routinely post information that may be important to investors in the For Investors section of our website atwww.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Source: Sarepta Therapeutics, Inc.

Sarepta Therapeutics, Inc.

Investors:Ian Estepan, 617-274-4052iestepan@sarepta.com

Media:Tracy Sorrentino, 617-301-8566tsorrentino@sarepta.com

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Sarepta Therapeutics Announces Partnership with Roche in Territories Outside the United States for its Investigational Micro-dystrophin Gene Therapy...

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MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 ALSEN / PEA-PME eligible) a pioneering clinical-stage biotech company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces that the French government has awarded the PATRIOT consortium a Structuring Research and Development Project for Competitiveness (Projet de recherche et dveloppement Structurant pour la Comptitivit - PSPC) non-dilutive funding. This grant will be used to finance the development of SENS-401 in SSNHL, including work by Institut Pasteur to identify response biomarkers. This project fits with the spirit of the strategic collaboration established between Sensorion and Institut Pasteur and announced on the 27th of May 2019. The financing is conditioned upon the execution of a financing agreement with Bpifrance within three months.

The PATRIOT consortium consists of Sensorion, the French Army Biomedical Research Center (IRBA), Institut Pasteur and Electronique du Mazet1, a French MedTech company focusing on hearing assessment and diagnostics. This project structures collaborative research and development to respond to a high unmet medical need and contributes to the development of SENS-401 as a treatment option, up to regulatory approval.

The commitment and active involvement of the French ministry of Armed Forces to this project emphasizes on a clear unmet medical need and on the necessity to have efficient diagnostics and therapeutic solutions. Auditory deficit is an invisible injury causing disabilities and potential social isolation. An epidemiological surveillance report from the French armed forces epidemiology and public health center revealed that 62% of military personnel suffered from hearing loss following an acute noise trauma over the 2014-2016 period.2

The participation of the French Army in the Phase 2 study represents the largest military trial ever conducted in France. It will be carried out in multiple military sites where patients will be recruited according to the protocol approved by an ethics committee.

We are extremely pleased to have the support of the French ministry of Armed Forces and the involvement of military personnel in our ongoing Phase 2 study. We believe their involvement significantly de-risks the overall study and increases the quality of the data we can collect. The project will receive 10.8m non-dilutive funding, staged over five years. Sensorion will receive 5.6m over the duration of the project, says Nawal Ouzren, CEO of Sensorion.

About SENS-401

SENS-401 (Arazasetron), is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment. A small molecule that can be taken orally or via an injection, SENS-401 has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population. It has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).

About SENS-401 Phase 2 trial

The AUDIBLE-S Phase 2 is a multi-center, randomized, double-blind, placebo-controlled study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss (SSNHL). Included patients will receive twice a day for 4 weeks one of the following: a 43,5mg dose of SENS-401, a 29mg dose of SENS-401 or a placebo. The primary endpoint is change in pure tone audiometry PTA (dB) in the affected ear from baseline to the end of treatment visit (day 28).

About Sensorion

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL). Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates. The Company has also identified biomarkers to improve diagnosis and treatment of these underserved illnesses. Sensorion has launched in the second half of 2019 two preclinical gene therapy programs aiming at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin. The Company is uniquely placed through its platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet medical need.

http://www.sensorion-pharma.com

Label: SENSORION ISIN: FR0012596468 Ticker symbol: ALSEN

Disclaimer

This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the "Document de reference" registration document filed with the "Autorit des Marchs Financiers" (AMF French Financial Market Authority) on September 7th, 2017 under nR.17-062 and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements.

This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

1 Through its subsidiary named ECHODIA2 Traumatismes sonores aigus dans les armes - Rsultats de la surveillance pidmiologique 2014-2016 Centre dpidmiologie et de sant des armes July 12, 2018

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Sensorion Announces 5.6m Non-Dilutive Funding to Support SENS-401 Phase 2 Study in Sudden Sensorineural Hearing Loss; French Ministry of Armed Forces...

Recommendation and review posted by Bethany Smith

Charles River Labs is stumping up $380 million in cash to buy out cell therapy biomaterials producer HemaCare.

This will boost Charles Rivers work in cell therapy by adding HemaCares ability to produce human-derived cellular products for this growing market.

It supplies biomaterials, including human primary cell types, and cell processing services to support the discovery, development and manufacture of cell therapies, including allogeneic (donor-derived cells) and autologous (patient-derived cells) programs.

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

This builds on the hope and hype around cell therapies like CAR-T and their capacity to hit back at certain oncology targets, namely blood cancers.

The CRO said that the deal will create a unique, comprehensive solution for cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization.

James Foster, chairman, president and CEO Charles River, said: Cell and gene therapies are important new modalities, with an estimated 10 to 20 new product approvals per year within five years. In order to continue to enhance our ability to support our clients research efforts, particularly in biologics discovery and development, we are expanding our scientific capabilities in this emerging, high-growth market with the acquisition of HemaCare.

The addition of HemaCares innovative cell therapy products and services to our integrated, early-stage solutions will create a unique, go-to partner for clients to work with Charles River across a comprehensive cell therapy portfolio from idea to novel therapeutic.

RELATED: Charles River swoops on early-stage CRO Citoxlab

Pete van der Wal, president and CEO of HemaCare, added: We are very pleased to be joining the Charles River team, which is widely recognized as the industry-leading, early-stage contract research organization. Partnering with Charles River will strengthen the value proposition for our clients, enabling them to work seamlessly with one scientific partner to enhance the speed and efficiency with which they can advance their cell therapies. The transaction will offer compelling value to our shareholders. This is an exciting day that will usher in a new era for HemaCare and my talented colleagues.

Cell therapy is becoming a focus for biopharma, but the relatively new area requires cutting-edge tech to help nurture new research like CAR-T into an established market.

Charles River says its work in the area is currently making around $100 million a year, but it sees the addressable market for HemaCares products is expected to increase from approximately $200 million today to nearly $2 billion in 10 years and wants to be a part of that.

While spending nearly $400 million in cash (the company had a market cap of $257 million at the end of play last week, with Charles River paying a 33% premium), HemaCare is expected to immediately drive profitable revenue growth, with estimated revenue growth of at least 30% annually over the next five years, the CRO estimated.

Original post:
Charles River Labs snaps up HemaCare, eyeing the growing cell therapy market - FierceBiotech

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The world awoke to the need to combat global heating

Was 2019 the year people finally started to listen to climate scientists on global heating? The previous year, the Intergovernmental Panel on Climate Change (IPCC) had laid out the monumental challenge of limiting warming to 1.5C. Global CO2 emissions would need to halve within 12 years, and reach zero around 2050. But emissions are still rising, while UN summits make tiny steps towards agreeing how to reduce them. The emissions gap between target and reality grows ever wider and becomes ever harder to close.

This struck a chord with vast numbers of people, especially the young, who are thinking ahead to what their world could look like. Greta Thunberg kickstarted a global movement of school strikers, demanding that governments listen to the science and act as if the house is on fire. Although some countries have ramped up their own emissions cuts targets the UK now officially aims for net zero emissions by 2050 public concern and frustration has kept growing. More and more members of the public have taken extreme steps to call for urgent action on climate, with Extinction Rebellion protesters being arrested en masse and controversially keeping the issue in the news.

What if we dont turn things around quickly? Major impacts are already baked in, with glaciers melting worldwide, Greenland losing ice rapidly, and heatwaves and fires happening more often and more severely. Heavy rainfall is increasing, as is drought in some places. We already need to live with a different climate. Although some campaigners rhetoric is not scientific (we dont seriously expect 6 billion deaths), unchecked warming would still expose tens or even hundreds of millions to extreme heat stress conditions and flooding from the sea. The worst can still be avoided, but the longer we keep heating the planet, the harder it gets. Prof Richard Betts, climate scientist, University of Exeter and Met Office Hadley Centre

Right now, on top of the world, a ship is frozen into the Arctic sea ice at the north pole. The RV Polarstern is pirouetting on the spot in the dark, with no prospect of sunlight for months to come. This region of Earth, the Arctic Ocean, is still one of the most remote and inaccessible places on our planet. We know very little about what happens here during the polar night, when temperatures can easily drop to -30C, and thick sea ice crunches and bends in the darkness. But this region is critical to Earths climate, and its essential to understand more.

The Polarstern is here on a once-in-for-ever opportunity to fill that data gap. Its the centrepiece of the Mosaic expedition, probably the biggest polar expedition that will ever be launched. Twenty years from now, it may not be possible to do this: to freeze into the sea ice for an entire year and to drift inside this vast cold environment to watch and learn from the inside. Its taken 20 years to organise, and over the year of the expedition (September 2019 to September 2020), 600 scientists will rotate on and off the ship, supported by many more in research institutes around the world. There is no question that the data being gathered now will drive a revolution in our understanding of the north pole and our climate, and every one of us will be affected by what they find. Helen Czerski, physicist and oceanographer

The laws of physics can be expressed in a handful of compact equations, but their reach is simply breathtaking. A stunning demonstration of this came with our first picture of a black hole, captured by the Event Horizon Telescope.

The black hole is situated at the centre of the Messier 87 galaxy, 54m light years away. The glowing ring of radiation, emitted by tortured matter spinning through warped space-time, is already iconic. The matter is plunging towards an event horizon as big as the solar system, containing the mass of 6.5bn suns.

Remarkable aspects of the image abound. The theory of general relativity, published by Einstein a hundred years ago, predicted the existence and features of this beast remarkably well. The cataclysmic whirlpool may be beyond our imagination, but it is not beyond our mathematics.

The singularity predicted at the heart of a black hole is a different story though. That is where quantum mechanics and relativity conflict and break down. We would love to know what answers lie there, and we will be scouring the image for any clues.

Finally, the global collaboration necessary to capture the image shows we can work together on a worldwide scale to a common goal something that our science tells us we need to do more of, if we want to survive as a species and continue our exploration of the amazing universe in which we find ourselves. Jon Butterworth, professor of physics, University College London

Ebola in 2019 highlights both the achievements of scientific progress and the persistent deep-rooted challenges of improving health in the most difficult settings. The 2014 Ebola outbreak in west Africa killed more than 11,000 people and alerted the world to its dangers. It highlighted the rich worlds neglect of research and development for infectious diseases that only rarely present a global risk.

At the end of 2019 we have a licensed Ebola vaccine, another hopefully soon to be licensed, and two effective therapeutic drugs. We can now treat those infected as well as prevent spread of the disease, allowing us to move from reactive containment to primary prevention, as a result of large and innovative collaborations that demonstrate how to help develop new and effective technologies, now and in the future.

But the current outbreak in eastern Democratic Republic of Congo has lasted more than 15 months and killed more than 2,000 people. Treatment and control continues to be hugely difficult in a setting characterised by political, economic and social fragility. Effective vaccines and drugs are part of what is needed for epidemic prevention, but we must continue to strive to address the fundamental causes of ill health in these settings. Anne Mills, professor of health economics and policy, London School of Hygiene & Tropical Medicine

Remember that time when we were young, and we had those nice neat family trees about human evolution? Lucy, Homo erectus, skip a few, Neanderthals and finally us? That whole scheme has been thoroughly binned in the last decade, with more fossil discoveries and the addition of ancient DNA to the armoury. We now have less confidence in the relationships between many more members of the human family, apart from the ones whose legacy we can see in our own DNA our Neanderthal and Denisovan ancestors. Others will be found soon enough.

We remain an African species. Homo sapiens evolved in multiple places in Africa, and a few thousand left some 70,000 years ago to populate the rest of the world. But now we know that there were earlier diasporas from the motherland. This year, we discovered that we had made it all the way to Greece. Embedded in the roof of a cave in the southern Peloponnese, two crushed skulls were found by Katerina Harvati and her team, one a sprightly 170,000-year-old Neanderthal, but the other is us, Homo sapiens, and is more than 210,000 years old. This is far older and much farther afield than we had previously found. The revolution in the story of how we got here shows no signs of calming down. Dr Adam Rutherford is a geneticist and author. His book How to Argue With a Racist is out in February (W&N, 12.99)

Although announced in November 2018, the shock waves from the announcement by the Chinese scientist He Jiankui that two girls had been born from embryos that were genetically modified using genome editing have been reverberating throughout 2019, and will no doubt continue to do so for years to come. This was a misguided and badly conducted attempt to make children resistant to infection by HIV, the virus that causes Aids, by mutating the CCR5 gene, which encodes a protein expressed on the surface of white blood cells that the virus uses to gain entry. He showed disregard for normal scientific and clinical practice, ignored risks to the children born and potentially to subsequent generations.

But the work made the prospect of altering our genetic makeup more immediate rather than theoretical. It also raised concerns about where to draw the line with the possibility of not just avoiding genetic and perhaps infectious disease, but ultimately carrying out forms of enhancement. However, it had the positive benefit of stimulating debate worldwide and it has led to the launch of international efforts, notably a science academies panel to judge the science, clinical need, and the conditions that would have to be met for germline (potentially heritable) genome editing to be carried out; and a WHO-appointed committee to develop a framework of governance that can be adopted to control the use of the genome editing methods in treating or avoiding disease. Both of these efforts will report next year.

Meanwhile, the science of genome editing and its application in both the field and clinic are progressing rapidly. A novel and ingenious new method termed prime editing, published by David Liu and colleagues, can efficiently make precise, small changes in DNA, without the problems associated with earlier methods, such as those used by He Jiankui. Given that about 85% of disease-causing mutations in humans could, in theory, be corrected by prime editing, it clearly offers great promise. Ways to make animals and plants resistant to disease and to allow plants to cope with climate change have been developed using genome editing, and this year we have seen a huge jump in the number of clinical trials using the methods to treat patients with genetic diseases (somatic or non-heritable gene therapy), including cancers, blindness and sickle cell disease. Robin Lovell-Badge, group leader, the Francis Crick Institute, London

The rechargeable lithium-ion battery has helped power the global revolution in portable electronics, and, indeed, many of you will be reading this article on a mobile phone, laptop or tablet computer. In October this year, the three pioneers of the lithium-ion battery, John Goodenough from the University of Texas at Austin, Stan Whittingham from Binghamton University, New York, and Akira Yoshino from Japans Meijo University, were awarded the Nobel prize in chemistry.

For me, this award was long overdue and finally recognised an exciting area of materials chemistry. There are lots of reasons to welcome this news. For the sheer beauty of literally holding the result of their fundamental research in our hands. For the celebration of John Goodenough, who at 97 is the oldest person ever awarded any Nobel prize. For the fact that new materials lie at the heart of developing green technologies that can change the way we live and work. For spurring further development of better batteries for electric vehicles and for storing energy from wind and solar.

Perhaps most of all because it helps to shine a light on one of the most urgent challenges of our time: a low-carbon future to deal with climate change. Saiful Islam, professor of materials chemistry at the University of Bath

Menabe, a dry forest in western Madagascar, is on fire. The only habitat of the worlds smallest primate (Berthes mouse lemur) is going up in flames as hungry people, many escaping droughts in the south, clear land for agriculture (despite the area being officially protected). Worryingly, we learned in October that this is far from an isolated problem and protected areas are less effective than previously thought.

Using a global data set of population density, night-time light and agriculture, researchers compared the changes in human pressures over time in more than 12,000 protected areas with similar unprotected areas. On average, pressures have increased faster inside than outside protected areas and those in poorer countries are particularly likely to suffer higher pressures. A decade ago, governments agreed a target to increase the proportion of the globe under conservation by 2020. Next year they gather to review progress and, potentially, commit to new targets.

The evidence is clear; when it comes to protecting sites for conservation, quality matters. Designating protected areas without effective management (including support for local communities) wont stop the fires, hold back the expansions of farms, or, ultimately, protect species from extinction. Julia Jones, professor in conservation science, Bangor University

Games of hide-and-seek are among my favourite childhood memories, and I still case novel environments for good hiding places. Researchers in Germany studied how rats can learn to play hide-and-seek with humans. All the rats learned to look for the hiding experimenter and all but one learned to hide from her. The only reward the rats received was the experimenter tickling and playing with them.

The data suggests that the rats were enthusiastically engaging in the game, looking frantically for the experimenter, squeaking and executing Freudensprnge (joy jumps) when they found her. They seemed to understand what it means to hide, preferring opaque boxes rather than clear boxes, and remaining silent (no squeals) until found. Frequently when they were found, they would tease the experimenter by running away and hiding again.

Its worth bearing in mind how complex this hide-and-seek is involving changes in role (hider or seeker) and theory of mind, and its almost alarming how well these rats learned to do this, all in the absence of classic psychological rewards like food. The experimenters conclude that the rats learn to play this game for the sheer joy of playing the game, and this is disconcertingly similar to the way human children play. Sophie Scott, professor of cognitive neuroscience, University College London

Once, during an ill-judged holiday in Borneo, I tried to climb a small mountain. While I crawled, panted and coughed on the slopes, my Malaysian guide, Miki, shuffled around politely, hands in his pockets, playing football with small rocks to slow his pace enough to match mine. Unacclimatised to altitude, it took me a day and a half to get to the summit. When I asked Miki how long it would normally take him to do the same he told me that, unencumbered by tourists like me, he could run up and down the mountain in just over three hours.

The molecular mechanisms that underpin Mikis apparently superhuman adaptation to high-altitude life revolve around a family of proteins known as hypoxia-inducible factors (HIFs). These substances trigger alterations in a host of genes, which together help regulate oxygen levels in the human body. Their discovery helped explain how oxygen levels could be sensed and gave scientists insight into the mechanisms that allow the body to adapt and survive when demand for oxygen greatly outstrips supply.

This year Sir Peter Ratcliffe, Gregg Semenza and William Kaelin shared a Nobel prize for their part in unpicking that mystery.

Their work informs more than ill-advised summit attempts. HIFs and the regulation of oxygen levels are together central to almost all aspects of human life, whether in health or disease. The work has already been applied to develop drugs to treat anaemia and may one day lead to new treatments for stroke, spinal cord injury, chronic inflammation and even cancer. Prof Kevin Fong is a consultant anaesthetist at University College London Hospital

My choice is a venture that failed but was a heroic failure: the Israeli effort to land a small robotic vehicle on the moon. This project, named Beresheet (Hebrew for in the beginning), was supported by private and philanthropic funding. It attracted wide interest among the young, and showed what can be achieved with hi-tech ingenuity. To minimise the weight of fuel, it didnt follow a direct track but was boosted into successively higher orbits around the Earth until it was captured by the moons gravity. It was launched on 22 February and was planned to soft-land on 10 April. But a gyroscope malfunctioned; the retro-jets didnt ignite soon enough, and it crash-landed. I highlight Beresheet because its a precursor of a new style of space ventures small scale, privately funded, and genuinely involving the public. (Indeed, Beresheet carried, as a school project, hundreds of tardigrades, microscopic water bears, which may have survived the impact.) Were moving beyond an era when all space projects must involve national agencies or large commercial conglomerates.

Groups from many nations will be able to launch follow-ups similar in concept to Beresheet. Sophisticated, privately funded miniaturised probes will gather data about the moon as well as the Earth. Some may go deeper into space, using advanced robotics, and the sophisticated electronics developed for smartphones. There will still be scope for big projects maybe even some carrying humans. But space will become an arena for independent experimenters even hobbyists. Martin Rees, Astronomer Royal

There have been so many significant science stories in 2019 that I have been spoilt for choice. I could have gone with the climate crisis (David Attenboroughs speech at Davos or Greta Thunbergs at the UN); or maybe the announcement of the first image of a black hole by scientists on the Event Horizon Telescope project, which seems to have already achieved iconic status. Or I could have chosen Googles recent announcement that they had achieved quantum supremacy with their new quantum computer. But instead, Ive gone with quirky rather than significant. In May, it was announced that the international SI units of measurement had been redefined. For example, the kilogram will no longer be compared with a cylinder of metal sitting under a bell jar outside Paris. Instead check this out it can be fixed just by knowing the frequency of vibration of an atom of caesium. That frequency defines the length of a second, which together with the speed of light defines the length of a metre, which in turn, together with knowing Plancks constant of quantum theory, allows us to calculate what a kilogram is. It is so utterly cool, but probably only fascinating to geeky physicists like me. Still, I make no apology. Jim Al-Khalili, professor of physics and public engagement in science at the University of Surrey and presenter of The Life Scientific (BBC Radio 4)

See the article here:
The science stories that shaped 2019 - The Guardian

Recommendation and review posted by Bethany Smith

Shares of Axovant Gene Therapies Ltd (NASDAQ:AXGT) have received a consensus rating of Buy from the eleven research firms that are currently covering the firm, Marketbeat Ratings reports. Two equities research analysts have rated the stock with a hold recommendation, eight have assigned a buy recommendation and one has issued a strong buy recommendation on the company. The average 1 year target price among analysts that have issued ratings on the stock in the last year is $24.72.

A number of equities analysts have issued reports on the company. Zacks Investment Research upgraded Axovant Gene Therapies from a hold rating to a strong-buy rating and set a $6.00 price target on the stock in a research report on Wednesday, November 13th. Chardan Capital raised their price objective on Axovant Gene Therapies from $10.00 to $15.00 and gave the company a buy rating in a report on Monday, October 28th.

Several hedge funds have recently added to or reduced their stakes in AXGT. BlackRock Inc. acquired a new stake in shares of Axovant Gene Therapies in the second quarter worth approximately $1,482,000. Tower Research Capital LLC TRC lifted its holdings in Axovant Gene Therapies by 955.3% in the 2nd quarter. Tower Research Capital LLC TRC now owns 4,221 shares of the companys stock valued at $27,000 after purchasing an additional 3,821 shares in the last quarter. Jane Street Group LLC lifted its holdings in Axovant Gene Therapies by 28.8% in the 2nd quarter. Jane Street Group LLC now owns 46,455 shares of the companys stock valued at $289,000 after purchasing an additional 10,375 shares in the last quarter. Finally, Barclays PLC acquired a new stake in Axovant Gene Therapies during the 3rd quarter worth $65,000. 14.80% of the stock is owned by institutional investors and hedge funds.

Shares of Axovant Gene Therapies stock traded up $0.05 during trading hours on Tuesday, reaching $5.26. The stock had a trading volume of 610,255 shares, compared to its average volume of 197,557. The stocks 50 day moving average is $5.42 and its 200 day moving average is $6.21. The company has a current ratio of 1.41, a quick ratio of 1.41 and a debt-to-equity ratio of 0.69. Axovant Gene Therapies has a twelve month low of $3.81 and a twelve month high of $19.60.

Axovant Gene Therapies (NASDAQ:AXGT) last posted its earnings results on Friday, November 8th. The company reported ($0.61) EPS for the quarter, beating the Zacks consensus estimate of ($1.15) by $0.54. As a group, equities analysts predict that Axovant Gene Therapies will post -3.56 earnings per share for the current fiscal year.

Axovant Gene Therapies Company Profile

Axovant Gene Therapies Ltd., a clinical-stage gene therapy company, focuses on developing a pipeline of product candidates for debilitating neurological and neuromuscular diseases. The company's current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis, Parkinson's disease, oculopharyngeal muscular dystrophy, amyotrophic lateral sclerosis, and frontotemporal dementia.

Further Reading: How to build a Fibonacci channel

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Axovant Gene Therapies Ltd (NASDAQ:AXGT) Given Consensus Recommendation of Buy by Brokerages - Riverton Roll

Recommendation and review posted by Bethany Smith

Until recently, he and his mate who was also his daughter and half-sister on his twisted family tree were the last two island-born wolves to call it home. But when the National Park Service last year began an effort to relocate new wolves to Isle Royale to restore predator packs in the face of a fast-rising moose population, some scientists knew those wolves' days could be numbered.

They were right. The park service announced Friday that two more wolves were found dead on the island this fall killed by other wolves in what researchers are calling territorial aggression.

The remains of M183 were found in October by park staff, just before the island closed to visitors for the winter season. A month earlier, researchers monitoring the new wolves GPS trackers saw a female wolfs collar was transmitting a mortality signal. They pinpointed the location and found her remains. They belonged to a wolf known as W004F, a 3-year-old that had been one of the first wolves captured for this relocation project. She had been captured near Grand Portage in October 2018, and released near Isle Royales Siskiwit Bay.

Necropsies of both animals determined the same thing: Their wounds showed they had been killed by another wolf or wolves.

These events are not uncommon, as wolves defend and establish their territories and social hierarchy. With many wolves on the island sorting out their relationships with one another, the dynamic nature of wolf social organization, territoriality, and wolf-on-wolf aggression during group and pack formation is not unexpected," the park service said.

With the death of the island-born male, travel patterns of the remaining wolves are likely to change significantly, and probably dependent on whether or not the island-born female is still alive, whether she is territorial and how she gets along with the newcomers, both males and females," said Rolf Peterson, a research professor at Michigan Technological University and longtime wolf and moose investigator on Isle Royale. "She is the final native wolf, never radio-collared, and searching for her will be a priority during the upcoming winter study.

Last winter, research data showed there was one spot on the island the new wolves were not venturing: the territory staked out by the island-born pair.

In all, six wolves have died and one has used an ice bridge to head back to the mainland in the 15 months since the park service began its multi-year effort to bring predator packs back to Isle Royale. Of those who died, one captured wolf died of anesthesia-related stress before she could be brought to the island, and another wolf that had been on Isle Royale for weeks died of pneumonia, park officials have said. One wolf caught in the U.P. this fall died within days of his release on the island.

These last two deaths bring the islands wolf population down to 15: seven females and eight males. These include the last native-born female and 14 new wolves that hail from Minnesota, Michigans Upper Peninsula, mainland Ontario, Canada, and Michipicoten Island in northeastern Lake Superior, Ontario, Canada.

Some see M183u2032s death as a chance for a new angle on the plethora of data researchers are collecting. Tracking collars on the new wolves are allowing scientists to map where they are traveling on the island archipelago, which sits about 60 miles northwest of Michigans U.P. mainland. What they are killing and eating is also being studied. Researchers are looking at everything from bones at kill sites to piles of wolf scat.

We have a unique opportunity to look simultaneously at the past and future of Isle Royale wolves genetic health. With the death of M183, we can now more fully understand how genetic isolation and inbreeding impacted the historic wolf population and use that to better monitor the new founders," said Dr. Kristin Brzeski, a wildlife geneticist at Michigan Tech, whom the park service has partnered with to sequence the Isle Royale wolf genome for long-term monitoring of the populations genetic health.

"This is an exciting time and we will be using cutting-edge genetic tools to track reproduction, inbreeding, and genetic change through time, hopefully providing a piece of the puzzle for maintaining a thriving Isle Royale wolf population, she said.

In addition to the decadeslong wolf/moose study ongoing on the island by Michigan Tech, other research teams from the State University of New York College of Environmental Science and Forestry Multiple are using the wolves GPS data to study if and how wolves are traveling in groups, and to identify any packs that eventually form.

We are using everything we can in our toolbox to track how this population interacts with each other, prey and the landscape. Well continue to learn as much as we can moving forward to help with the decision to add wolves as needed to meet project objectives and document ecosystem effects," said Mark Romanski, NPS project coordinator and Division Chief of Natural Resources at Isle Royale.

The wolf relocation effort began in the fall of 2018. Its a three-to-five year plan to bring up to 30 new wolves onto the island, where more than 2,000 moose are chewing their way through its forests. The concern is that a huge moose population will deforest this island wilderness, which in the warmer months draws hikers, backpackers and paddlers to enjoy its trails and bays.

Years ago, there were up to 50 wolves in different packs on Isle Royale. But a combination of inbreeding, accidents and disease caused their numbers to dwindle to just two island-born wolves.

The goal of creating strong, healthy wolf packs on this remote island means the NPS is trying to establish a good genetic stew, demonstrated by how they are trapping wolves from various points around the Great Lakes and bringing them together on Isle Royale. The hope is that with these new arrivals, the genetic problems that doomed the islands past wolves wont be replayed.

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Isle Royale's last native male wolf among 2 killed by new wolves - Duluth News Tribune

Recommendation and review posted by Bethany Smith

Wolves brought to Isle Royale National Park to bolster predators on the island have killed one, if not both, of the resident wolves/NPS file

Wolves moved to Isle Royale National Park to help balance the burgeoning moose population there have killed a male wolf that was one of the last two island-born wolves in the park, and it's possible they also killed the other, a female.

In October, just prior to island closing to the public for winter, park staff came across the remains of a male wolf, M183, one of the two remaining uncollared resident wolves inhabiting Isle Royale prior to wolf recovery efforts. A necropsy revealed that M183 had been killed by another wolf or wolves.

These events are not uncommon as wolves defend and establish their territories and social hierarchy, park staff said. With many wolves on the island sorting out their relationships with one another, the dynamic nature of wolf social organization, territoriality, and wolf-on-wolf aggression during group and pack formation is not unexpected.

"With the death of the island-born male, travel patterns of the remaining wolves are likely to change significantly, and probably dependent on whether or not the island-born female is still alive, whether she is territorial and how she gets along with the newcomers, both males and females," said Rolf Peterson, a research professor at Michigan Technological University and long-time wolf and moose investigator on Isle Royale. "She is the final native wolf, never radio-collared, and searching for her will be a priority during the upcoming winter study."

Researchers monitoring the relocated wolves' GPS collar signals identified a second wolf mortality event this fall. In September, researchers and park staff recovered the remains of female W004F. Field evidence and subsequent necropsy at the U.S. Geological Survey National Wildlife Health Center in Madison, Wisconsin, determined she died from wounds caused by another wolf or wolves.

Meanwhile,National Park Service biologists andresearch partners from the State University of New York College of Environmental Science and Forestry have been following the GPS data to monitor associations between individuals and identify possible pack formation. As researchers and park staff anticipated, new wolves immediately began interacting with each other. Researchers confirmed introduced wolves were feeding, traveling, sleeping in proximity to each other, and forming groups.

A wolf group is characterized by two or more wolves traveling and feeding together. Wolf groups are further defined as a pack if groups of two or more wolves are traveling together and/or defending a territory, and if a breeding pair reproduces. Individual preferences for mating and group or pack formation can be quite variable for a social animal like the wolf. Mate selection and pair bond formation can occur at any time, a park release said, but wolves only breed and produce pups once per year. Consequently, pack formation can take time. Based on these definitions, there are currently no wolf packs on Isle Royale.

GPS collar data shows three wolves, a female and two males, have been traveling, feeding, and bedding together since March 2019 (W001F, W007M, and W013M). This is the first wolf group to form and remain associated since introduction efforts began. Additionally, two male wolves shared bed sites and carcasses over the summer with several different female wolves, but their associations lack consistency and are currently not defined as wolf groups. Two female wolves shared bed site areas in July, but are also not considered a group. Loose associations are common when smaller prey items like moose calves, beaver and snowshoe hare are abundant on the landscape. These animals are easy prey for a single wolf.

Dr. Jerry Belant, Campfire Conservation Fund Professor at SUNY-ESF and project collaborator, said, Wolves are a highly social species and we continue to monitor their movements to document groups, and ultimately pack formations as demonstrated by reproduction.We developed a public online tool,https://belantlab.shinyapps.io/wolf-networks/based on these analyses to understand potential associations among these wolves and the areas they occupy.

Summer wolf location cluster investigations documented 122 instances of two or more wolves with overlapping space use. Twenty-nine cases (23.8 percent) of space use overlap were associated with prey remains and feeding behavior, 68 percent were associated with bed sites, and wolf use for the remaining 7.4 percent of sites was unknown or could not be determined.

Researchers continue to monitor location data weekly for evidence the three newest wolves, released on the island in September, are adjusting to their new homes, interacting and forming associations. These wolves are interacting with each other (W017M and W018F were traveling together in late November) and with the wolves released last spring (W018F and W016M traveled together in early November).

National Park Service staff and their collaborators will continue to monitor the interactions, group formation, and genetic diversity of new wolves over winter and spring to document breeding (January/February) and denning (April/May) activity in Isle Royales wolf population. Closely monitoring social organization will provide insights into the genetic health of the population. The NPS has partnered with Dr. Kristin Brzeski, wildlife geneticist at MTU, to sequence the Isle Royale wolf genome for long-term monitoring of genetic health of the population.

We have a unique opportunity to look simultaneously at the past and future of Isle Royale wolves genetic health. With the death of M183, we can now more fully understand how genetic isolation and inbreeding impacted the historic wolf population and use that to better monitor the new founders. This is an exciting time and we will be using cutting-edge genetic tools to track reproduction, inbreeding, and genetic change through time, hopefully providing a piece of the puzzle for maintaining a thriving Isle Royale wolf population, said Dr. Brzeski.

Multiple lines of investigations regarding this population will help the NPS evaluate the success of the project over the next few years.

We are using everything we can in our toolbox to track how this population interacts with each other, prey and the landscape. Well continue to learn as much as we can moving forward to help with the decision to add wolves as needed to meet project objectives and document ecosystem effects, said Mark Romanski, the NPS project coordinator and division chief of natural resources at Isle Royale.

The current wolf population in the park includes seven females and eight males. All introduced wolves are from the Great Lakes Region, translocated from northeastern Minnesota (W001F), the Upper Peninsula of Michigan (W017M, W018F, W019M), mainland Ontario, Canada (W005F, W016M), and Michipicoten Island in northeastern Lake Superior, Ontario, Canada (W007M, W009M, W010M, W011F, W012M, W013M, W014F and W015F).

Excerpt from:
Wolves Relocated To Isle Royale National Park Kill Resident Wolf - National Parks Traveler

Recommendation and review posted by Bethany Smith

On December 22, 1997, the FDA approved Propecia, a once-a-day pill for combating the genetic condition known as male pattern baldness.

The supposed link between hair and virility dates back to at least the Biblical story of Samson. Advertisements touting supposed baldness cure-alls flourished during the 19th century, and absolutely blossomed during the TV age.

As for Propecia, a prescription-only pill, it CAN slow hair loss, or even promote limited hair growth among some men, but in a bitter irony it can adversely affect virility in some who take it as well.

Definitely ask your doctor, would be our best advice.

Far from camouflaging their hair loss, some bald but bold men have always embraced it. Way back in 1985, our late colleague Bob Simon paid a visit to a Bald-Headed Men of America convention. "If you don't have it, flaunt it!" said one participant.

And in 2004 our John Blackstone dropped in for lunch at a bald-friendly restaurant in Lodi, California. There's even a bald guy's menu the less hair, the bigger the discount!

Treat it, hide it, or flaunt it ... more than enough options for any bald man to try to wrap his head around.

Story produced by Robert Marston.

2019 CBS Interactive Inc. All Rights Reserved.

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Almanac: On December 22, 1997, the FDA approved Propecia, a once-a-day pill for combating the genetic condition known as male pattern baldness - CBS...

Recommendation and review posted by Bethany Smith

In the forest of the Democratic Republic of the Congo, scientists noticed something odd happening among wild bonobos. Females were behaving like males during competition over other females aggressively getting in the way of some copulations.

When the scientists analyzed the bonobos genes, the results, reported in May 2019, led to even more questions: The fussing female bonobos turned out to be the adult males mothers.

This is #11 on Inverses 20 most incredible stories about our planet from 2019.

Martin Surbeck, study author and research group leader at the Max Planck Institute for Evolutionary Anthropology, explained to Inverse at the time that further observations revealed that the mothers were actually helping out their sons in active and passive ways.

Aside from the fighting, the moms sometimes physically pulled their sons into close spatial proximity with females in heat, taking helicopter parenting to a whole new level. In a more subtle move, those bonobo moms with high social rankings lent their clout to their sons, allowing them better mating opportunities. Bonobos live in matriarchal societies, so an endorsement from mom can mean a lot.

The meddling appears to pay off. Male bonobos who lived in close proximity to their moms were approximately 3 times more likely to sire offspring than males who did not. Moms may want to make sure their sons get out there in order to ensure that their genetic line continues, the researchers theorize.

But what works for bonobos doesnt work for all primates. While the effectiveness of human mother matchmakers is still up for debate, the team also evaluated how helpful chimpanzee moms were at getting their sons laid. They found that though chimp moms did want to meddle just as much as the bonobo moms, they should probably stay out of romance: The sons of match-making chimp moms were 1.26 times less likely to sire offspring than the sons of more hands-off mothers.

As 2019 draws to a close, Inverse is revisiting the years 20 most incredible stories about our planet. Some are gross, some are fascinating, and others are truly incredible. This has been #11. Read the original article here.

Read more here:
Science confirms: Moms meddle in their children's love lives - Inverse

Recommendation and review posted by Bethany Smith

Basel, 23 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Sarepta Therapeutics, Inc. (NASDAQ:SRPT), today announced the signing of a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sareptas investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the United States. Under the terms of the agreement, Sarepta will receive an upfront payment of $750million in cash and $400million in equity. In addition, Sarepta is eligible to receive regulatory and sales milestones, and royalties on net sales. Roche and Sarepta will equally share global development expenses.

This collaboration demonstrates Roche's commitment to gene therapy and its transformational potential for patients. It combines Roches global reach, commercial presence and regulatory expertise with Sareptas gene therapy candidate for DMD to accelerate access to SRP-9001 for patients outside the United States. DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. SRP-9001, currently in clinical development for DMD, is designed to deliver the microdystrophin-encoding gene directly to the muscle tissue for the targeted production of the microdystrophin protein.

Commenting on this new collaboration James Sabry, head of Roche Pharma Partnering said, We are excited to enter this licensing agreement with Sarepta. By working together to provide SRP-9001 to patients, we hope to fundamentally transform the lives of patients and families living with this devastating disorder for which there are currently only limited treatment options.

Doug Ingram, president and chief executive officer, Sarepta, said, As a mission-driven organization, we are inspired to partner with Roche with the goal of bringing SRP-9001 to patients outside the United States. This collaboration will not only increase the speed with which SRP-9001 could benefit patients outside the United States, but will also greatly expand the scope of territories within which we could potentially launch SRP-9001 to improve and save lives.

As part of the agreement, Roche also obtains an option to acquire ex-U.S. rights to certain future DMD-specific programs from Sarepta, in exchange for separate milestone and royalty considerations, and cost sharing.

The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions. The parties anticipate that the agreement will close in the first quarter of 2020.

About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve peoples lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the worlds largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit http://www.roche.com.

About Duchenne Muscular DystrophyDMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500 - 5,000 male births worldwide.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com- Nicolas Dunant (Head)- Patrick Barth- Daniel Grotzky- Karsten Kleine- Nathalie Meetz- Barbara von Schnurbein

Read more:
Roche enters licensing agreement with Sarepta Therapeutics to improve the lives of patients living with Duchenne muscular dystrophy - GlobeNewswire

Recommendation and review posted by Bethany Smith

Thousands of years ago, a young Neolithic woman in what is now Denmark chewed on a piece of birch pitch. DNA analysis of this prehistoric "chewing gum" has now revealed, in remarkable detail, what she looked like.

The team nicknamed the young Neolithic woman "Lola" after Lolland, the island in Denmark on which the 5,700-year-old chewing gum was discovered. The Stone Age archaeological site, Syltholm, on the island of Lolland, pristinely preserved the gum in mud for the thousands of years after Lola discarded it.

It was so well-preserved that a group of scientists at the University of Copenhagen were able to extract a complete ancient human genome all of the young girl's genetic material from it. They were also able to extract DNA from ancient pathogens and oral microbes that she carried in her mouth.

Related: In Images: An Ancient European Hunter Gatherer

This is the first time that an entire human genome was extracted from something other than human bones, according to a statement from the University of Copenhagen. The team's analysis revealed that the chewer of the prehistoric gum was female, and likely had dark skin, dark hair and blue eyes. They found that Lola's genes matched more closely to hunter-gatherers from the European mainland than those who lived in central Scandinavia at the time.

The ancient chewing gum also held traces of plant and animal DNA, such as DNA from hazelnuts and duck, which might have been part of Lola's diet, according to the statement. Finally, scientists found genes associated with "lactase non-persistence," meaning Lola likely didn't digest dairy very well.

Other previous archeological finds from the site had suggested "that the people who occupied the site were heavily exploiting wild resources well into the Neolithic, which is the period when farming and domesticated animals were first introduced into southern Scandinavia," lead author Theis Jensen, a postdoctoral fellow from the Globe Institute at the University of Copenhagen, said in the statement.

Finally, the researchers found DNA from oral microbes in the chewing gum, including DNA that could belong to the Epstein-Barr virus, which causes mononucleosis, otherwise known as "mono" or the "kissing disease."

The birch pitch is a blackish-brown substance that's created by heating up birch bark. This substance has been used since the Paleolithic era as glue for hafting stone tools, according to the statement.

But previously, pieces of birch pitch have been found with tooth marks, so archeologists think that as the pitch cools and solidified, it was chewed to make it moldable again before using it to glue.

Other theories suggest that people chewed the slightly antiseptic birch pitch to relieve toothaches or other illnesses. Birch pitch might also have been used for toothbrushing, to suppress hunger or even just for fun as chewing gum, according to the statement.

Ancient "chewing gums" are a relatively new source of DNA to analyze, and can help reveal the microbiome of our ancestors. It may also help explain how bacteria and viruses have changed over time.

"It can help us understand how pathogens have evolved and spread over time, and what makes them particularly virulent in a given environment," senior author Hannes Schroeder, an associate professor from the Globe Institute at the University of Copenhagen, said in a statement. "At the same time, it may help predict how a pathogen will behave in the future, and how it might be contained or eradicated."

The findings were published on Dec. 17 in the journal Nature Communications.

Originally published on Live Science.

View post:
This Is 'Lola,' a 5,700-Year-Old Woman Whose Entire Life Is Revealed in Her 'Chewing Gum' - Livescience.com

Recommendation and review posted by Bethany Smith

FROM genotyping and repronomics to datasets for hard-to-measure traits both on and off-farm, the next era of genetic improvement in Australian red meat involves cutting-edge technology and science barely even imagined in the not-too-distant past.

Success, however, will be in closely linking genetic progress in beef and sheep to consumer outcomes, along with the ability to effect culture change both on-farm and further along the supply chain to drive adoption and return value to livestock producers.

This is the belief of those at the wheel of the National Livestock Genetics Consortium, a skills-based taskforce set up three years ago to provide a formal industry consultation platform for the investment in livestock genetics led by researchers and key industry stakeholders.

DNA WORK: Genotyping - providing reliable DNA tools for improving the accuracy of selection for traits that are hard to measure - is a big theme in the research.

The NLGC is on track to increasing the value of genetics to the red meat industry by $400 million by 2022, through doubling the rate of annual genetic gain in the commercial livestock industry value chain.

To date, it has invested in 55 projects with cultural change to drive adoption and consumer outcomes the high priorities.

NLGC executive officer Michael Crowley said the investment portfolio was mapped across a number of different areas which all focussed on improving the accuracy of selection decisions producers make.

The majority of the portfolio currently focuses on both maintaining and building the essential reference populations needed to provide DNA tools to industry and enhance selection accuracy, he said.

"Examples are the hard-to-measure traits like fertility, new traits like net feed intake and carcase quantity and quality traits like intra-muscular fat and shear force," he said.

Cultural change - that is improvement in the acceptability, trust and use of genetic tools and technologies - will be crucial to realising the full potential of genetics work, the NLGC believes.

Adoption of genetic tools is currently lower than desired, said Meat & Livestock Australia's program manager for adoption David Packer.

The plan for genetics adoption hones in on demonstrating value and growing demand, pathways to learning, simplifying the language and tools and embedding adoption into R&D.

Projects currently underway which address culture change include proof of profit in northern beef, a review of valuing phenotypes and developing technologies to make recording measurements easier for stud producers.

Projects to simplify the process and language of selecting a sire, particularly for commercial producers are also happening. MLA released a genetics marketing campaign in June targeted at commercial producers.

Seamless transfer of information and provision of easy-to-use data sharing products and services will also be critical to future genetic gains.

"The goal here is an accessible data platform, which allows data collected across various R&D projects to be searchable, linkable and re-usable for the future," Mr Packer said.

Linking genetics to consumer outcomes is an ongoing priority.

"The focus is on developing traits that influence improved eating quality outcomes for consumers into a breeding value. This has successfully ensured we can provide tools (through genetic evaluations) for producers to rely on when selecting for both carcase quantity and quality within their flock or herd, and accordingly improved consumer outcomes without negatively impacting productivity," said Hamish Chandler, MLA's livestock genetics program manager.

There are currently 12 cattle and six sheep projects underway which collect both on-farm and off-farm measurements to reinforce the linking of genetics to consumer outcomes.

These include the Beef Information Nucleus (BIN) herds, a retail beef yield project providing predictions before slaughter and upcoming work linking genomics to Meat Standards Australia grading.

In sheep, research is developing technologies to underpin objective measurement and value based marketing.

Cut-based MSA lamb, for example, will underpin supply and price signals.

"Another example is the MLA Resource Flock which is designed to better capture eating quality measurements and consumer sensory data," Mr Chandler said.

"This will lead to more accurate breeding values for eating quality, allowing producers to better select animals which perform for both the producer, in terms of productivity, and the consumer, in terms of eating quality."

Looking ahead, R&D that will continue to focus on linking genetics to consumer outcomes includes sustainability and welfare traits and improved phenotype collection technologies.

The big areas in the research that will deliver the ambitious $400m goal include genotyping, repronomics and BIN projects.

Genotyping is developing and providing reliable DNA tools for improving the accuracy of selection for traits that are hard to measure.

There were now more than 50 000 Merino animals with a genotype used in the genetic evaluation and more than 21,000 of these had been added in the last nine months, Mr Chandler said.

Maternal and terminal breeds have seen similar rates of adoption of genomics.

"Genomics allows a breeder to select animals at a younger age with a higher level of precision, therefore driving genetic gain. It also allows more accurate selection of hard-to-measure traits or traits that are measured later in life, such as eating quality and adult traits respectively," he said.

"In terminal breeds, there is evidence that producers have been able to dramatically improve the rate of progress for eating quality traits through the uptake of genomic technologies."

The flock profile test has allowed commercial ram buyers to use genomics commercially to genetically benchmark their flocks, ultimately leading to more informed decisions around purchasing rams with Australian Sheep Breeding Values (ASBVs) coupled with the sire selection tool RamSelect.

"While reproduction trait improvements cannot yet be attributed to genotyping, we have seen significant improvement within some breed groups and individual flocks towards eating quality traits without detriment to productivity traits," Mr Chandler said.

Repronomics is the intensive recording of early-in-life female reproduction phenotypes using real-time ultrasound across tropical breeds with the aim of providing crucial data for boosting the accuracy of selection for reproduction, particularly in young bulls.

The BIN projects, run with breed societies, are about the development of the datasets necessary for reliable breeding values for traits that are not well measured within industry.

Seamless transfer of information and provision of easy-to-use data sharing products will be critical.

The story Next era of genetic gain first appeared on Farm Online.

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The next era of genetic improvement - Farm Weekly

Recommendation and review posted by Bethany Smith

People often ask me how I select the nominees for best biopharma CEO of the year an honorific that Ive been giving out since 2008. The winnowing process starts with public companies private company CEOs are not considered. (Sorry, startup CEOs, you need to grow up first.) Delivering significant value to shareholders is very important. Beyond that, the process gets more subjective. Theres no algorithm, spreadsheet, or fancy analysis that spits out definitive answers. I solicit potential nominees via social media and ask some trusted sources for advice, but the final list relies a lot on my gut and experience. A big jump in stock price is nice, but how was the outperformance delivered and why? Is there a compelling story behind the achievement?

This years best biopharma CEO finalists four in total come from a list of just over two dozen names. Congratulations to them all. There were two or three worthy candidates who were close but didnt quite make the cut. Apologies, but perhaps next year.

Perhaps next year we can also see a better gender balance; the industry, despite talking the talk lately on diversity, has precious few women CEOs. Emma Walmsley of GlaxoSmithKline (GSK) is the only female CEO among the 25 largest drug makers. Next year, Reshma Kewalramani will join Walmsley when she takes over the top job at Vertex (VRTX) Pharmaceuticals.

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As in previous years, youll have the opportunity to vote for your favorite CEO at the end of this post. Our champion will be announced on Friday. Oh, and stay tuned for my list of the worst CEO nominees, coming Tuesday

Doubt Global Blood CEO Ted Love at your peril. Thats a good lesson coming out of 2019.

Love said he was going to develop a drug that treats sickle cell disease in an entirely new way. Done. Love said he was going to raise much-needed awareness of sickle cell disease and bring patients into the decision-making process on clinical trial design and endpoints that mattered. Done. Love said he was going to convince the FDA that the traditional review methodology for approving a sickle cell drug was not the only way. Done.

The only thing Love didnt promise was that the FDA would approve Global Bloods sickle cell drug three months faster than expected. But thats what happened. The newly approved drug is called Oxbryta. Love delivers and then surprises.

I doubted Love at various times over the past year and he proved me wrong. Im not making that mistake again.

This is Marganores second best biopharma CEO nomination. In 2017, I chose him as a finalist for steering Alnylam to its first Phase 3 clinical trial win with a drug that works via RNA interference, a technology that uses snippets of genetic code to shut down disease-causing genes. That drug, Onpatrro, was approved and launched commercially in 2018.

Why does Maraganore deserves another slot on this hallowed list? Because a second Alnylam RNAi drug called Givlaari was approved in November, three months faster than expected. And with that approval, RNAi can no longer be dismissed as a scientific novelty, albeit one that won the Nobel Prize. RNAi is real. It works, and the direct effects can be seen in patients with rare inherited diseases who are benefiting from treatment. Maraganore deserves a lot of credit for making that happen.

Indirectly, Maraganores leadership in establishing RNAi has spawned renewed interest in RNAi-based drug development deals across the industry. There was a time when Big Pharma embraced RNAi, then abandoned the technology. Maraganore and Alnylam stuck with it. Now, smaller RNAi companies like Dicerna and Arrowhead Pharmaceuticals (ARWR) are scoring lucrative partnerships with Roche (RHHBY), Alexion Pharma, Novo Nordisk (NVO), and Johnson & Johnson (JNJ). The biggest RNAi deal took place at the end of November, when Novartis (NVS) announced plans to acquire The Medicines Co. for nearly $10 billion. Inclisiran, the RNAi drug at the center of the deal, was developed originally at Alnylam.

2019 was the year that Seattle Genetics became more than a one-product story. A string of clinical successes established a legit cancer pipeline that sets the drug maker up for new approvals and accelerated growth. Seattle Genetics stock price more than doubled this year, and with a $20 billion market valuation, the company is now banging on the door to the large-cap biotech club.

The long knock on Seattle Genetics has been its reliance on Adcetris, an antibody-drug conjugate approved to treat two different types of lymphoma that is not quite a commercial blockbuster. The emerging pipeline this year changed the fundamental story.

First, Seattle Genetics and partner Astellas unveiled strong clinical data and submitted a marketing application to the FDA for enfortumab vedotin, a second antibody-drug conjugate targeting bladder cancer. On top of that, the company scored a major victory with the successful outcome from a late-stage clinical trial involving its HER2-targeted breast cancer drug called tucatinib.

In July, van de Stolpe negotiated a deep research partnership with Gilead Sciences (GILD) that brought in $5.1 billion in cash and equity while still allowing Galapagos to maintain its independence.

The deal had upside for both sides. Gilead needed a pipeline recharge and had cash to spend, so it secured a preferential relationship with a highly regarded bench of European scientists and drug developers, plus ownership or option rights on more than two dozen drugs.

Galapagos received acquisition-type money without being acquired and a relationship with one of the most successful and experienced commercial companies in the industry.

Gilead and Galapagos were already collaborating on the development of filgotinib, a drug for rheumatoid arthritis and other diseases of the immune system, but the July partnership turned the relationship into something akin to what Roche had with Genentech before the two companies formerly merged. Galapagos stock price has more than doubled this year.

Heres your chance to vote:

Update: Voting was closed on Dec. 19, 2019.

Go here to see the original:
Here are the nominees for best biopharma CEO of 2019. Vote here! - STAT

Recommendation and review posted by Bethany Smith

Last week, The Daily Wire reported that author J.K. Rowling was smeared as a transphobe and threatened with being canceled because she spoke out in support of researcher Maya Forstater, who was fired from her job with the Centre for Global Development for saying that while transgender individuals can change their outward appearance, male-to-female transgenders remain male and can never be, biologically, women.

What I am so surprised at is that smart people who I admire, who are absolutely pro-science in other areas, and champion human rights & womens rights are tying themselves in knots to avoid saying the truth that men cannot change into women (because that might hurt mens feelings), Forstater said, originally.

Dress however you please, the Harry Potter author replied on social media. Call yourself whatever you like. Sleep with any consenting adult wholl have you. Live your best life in peace and security. But force women out of their jobs for stating that sex is real? #IStandWithMaya #ThisIsNotADrill

Forstaters case is particularly egregious. Not only was she terminated from her position for articulating scientific facts, but when she brought a case against her former employer to a tribunal in the U.K., which found not just that CGD was justified in firing Forstater, but that Forstaters basic beliefs that men can never become biological women was harmful, even if Forstater was simply saying what she believed.

Paying due regard to the qualified right to freedom of expression, people cannot expect to be protected if their core belief involves violating others dignity, the court said. Forstaters absolutist views on the subject of gender were actually violent, the court found, and her opinion violates their dignity and/or creates an intimidating, hostile, degrading, humiliating or offensive environment.

Rowling met with a torrent of abuse for her statement, with LGBTQ+ activists and their allies across the spectrum, threatening Rowlings livelihood, and demanding that she apologize and admit that she was in error when she spoke out in support of someone who merely acknowledges biological and genetic reality.

GLAAD has been among Rowlings most vocal critics, often saying on social media that Rowling is putting transgender individuals at risk because she refuses to believe men can be considered women for the purposes of things like privacy and sport. On Friday, the pro-LGBTQ rights group put out a statement blasting Rowling and challenging her to meet with transgender activists and cherry-picked scientists in order to expand her worldview.

In other words, Rowling should submit to indoctrination and bullying until she agrees that male-to-female transgender individuals are, indeed, women.

J.K. Rowling, whose books gave kids hope that they could work together to create a better world, has now aligned herself with an anti-science ideology that denies the basic humanity of people who are transgender, the groups head of talent said in a statement, according to Variety. Trans men, trans women and non-binary people are not a threat, and to imply otherwise puts trans people at risk. Now is the time for allies who know and support trans people to speak up and support their fundamental right to be treated equally and fairly.

Rowling, of course, never said trans men, trans women, or non-binary people are a threat. She merely spoke out in support of those who acknowledge biology and genetics, suggesting that they shouldnt be punished for their lack of wokeness.

In a move that must have been shocking to GLAAD, Rowling herself ignored them. Her representatives declined GLAADs offer of re-education.

If Rowling continues to stand firm against the wokescolds, she may strike a significant blow for freedom of speech. Although ordinary researchers, writers, and comedians can often be forced to apologize for their wrong opinions Star Wars Mark Hamill, for example, apologized for merelyliking Rowlings tweet Rowlings net worth is well into the billions. People are unlikely to stop consuming Harry Potter books and merchandise simply because some on social media, who once lauded Rowling as a heroine of the Resistance, are now left disappointed and ignored.

But once the pressure has little effect on one person, it may lose its tooth altogether.

Go here to see the original:
GLAAD Tried To Force JK Rowling To Apologize For 'Transphobic' Comments. She Refused. - The Daily Wire

Recommendation and review posted by Bethany Smith

Before social media, if you wanted to learn the beauty secrets of celebrities and fashionistas, your only option was to go out and get a magazine. How quaint.

These days, learning the tips and tricks of the 'beautiful' (as judged by the media and advertising industries) is as simple as logging onto YouTube or Instagram.

So-called Get Ready With Me (or in internet speak, GRWM) videos have become incredibly popular, and despite my better judgement, I find myself watching as many random videos as the algorithms throw up (most of which feature women or non-binary people.)

So you can imagine my delight when I recently came across American actress (and music legend Diana Ross' daughter) Tracee Ellis Ross' GRWM routine.

In the 13-minute video, Ross describes in detail the many, MANY products she uses to keep her skin looking good: multiple serums, eye cream, face cream, moisturiser (yes, that's different to a cream), some odd 'face vibrating' tool, a cold face massager, and finally, a lip mask. If you hadn't guessed, hers is a very expensive skin care regime, costing upwards of $1,000. One cream alone costs more than $500.

Ross completes her 'everyday look' by applying red lipstick and grooming her eyebrows. She proudly states that at 46 years old, she's not a "big make-up girl". "It doesn't bother me" to not wear foundation or concealer. "I feel like I've earnt these stripes," she says as she points to the wrinkles around her eyes. The video has now been watched over a million times in less than a month.

While I applaud Ross for some level of transparency into what it takes to look good (lots of products and lots money, apparently), watching the video, I couldn't help but think she'd reinforced the beauty myth that with the right products, you too could leave your house with minimal make-up and look fabulous.

Whether it's the lotions or potions, treatments or access to the best doctors money can buy, 'healthy' skin isn't cheap.

Then there's the other factor that influences 'good skin': genetics.

Alexa Boer Kimball, a researcher and the chief executive officer at Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, told Popular Science that when it comes to ageing, there are two important factors.

"First, the genes you are born with affect how you age But also, which genes are turned on over time matter, too. That can be affected by your inherent characteristics but also what you are exposed to and what you do" like pollution, stress or smoking.

These days, I'm fortunate to be able to wear my hair as I please without retribution. And it's for that reason that I braid my hair, Santilla Chingaipe writes.

Dr Kimball told the publication that while sunscreen and certain products like moisturisers can make a difference, how much of a difference depends on genetics and environmental factors. In the best-case scenario, you can reduce the signs of ageing by years but not decades, she says.

What does this all mean for those that can't afford to 'look good' and haven't won the genetic lottery? I think these questions are important, and as superficial as beauty may seem, it is an industry worth billions of dollars. It cashes in on selling aspiration: if you buy this face cream that promises to rid your face of all the wrinkles, then success and happiness are plentiful.

I've often fallen for this kind of messaging.

Growing up, I felt the pressure to look a certain kind of beautiful because most of the women I saw on television or magazines looked that way straight hair, flawless skin. I thought if I made myself fit that beauty mould, then job opportunities and love would surely follow.

What I didn't understand was the role race, gender and class play in determining who is considered 'beautiful' and that no matter how much I straightened my hair, black women aren't generally viewed as 'beautiful' because beauty standards are typically rooted in western and Eurocentric ideals.

If it's not youthfulness we're chasing (which requires spending money), it's a certain body type or hair style. At every turn, the patriarchy and capitalism asks us to bend to the myth of beauty.

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In her book, Thick: And other essays, American sociologist Tressie McMillan Cottom writes that beauty can be political:

"It can exclude and include one of the basic conditions of any politics. Beauty has it all. It can be political, economic, external, individualized, generalising, exclusionary. Our dominant story of beauty is that it is simultaneously a blessing, of genetics or gods, and a site of conversion. You can become beautiful if you accept the right prophets and their wisdoms with a side of products thrown in for good measure."

Beauty ideals can make us all self-conscious for some, race complicates the issue.

What happens if you refuse to conform to patriarchal definitions of beauty?

British classicist and broadcaster Mary Beard has talked about the abuse and harassment she's experienced from people over her appearance.

Known for television appearances and fronting history documentaries in the UK, the 64-year-old has chosen to focus on her work rather than what she looks like eschewing make-up and keeping her natural hair colour. The New Yorker has described her as being an avatar for middle-aged and older women, who appreciate her unwillingness to fend off the visible advancement of age.

This act of free will and choice was been met with much vitriol, with some of her critics calling her "too ugly for television". A few years ago, she responded to her bullies by saying, "Grey is my hair colour. I really can't see why I should change it. There clearly is a view of female normative beauty, but more women of 58 do look like me than like Victoria Beckham."

It's clear beauty isn't achievable for everyone. Not in the way we're told to aspire for it no matter how much money we spend trying to buy our way into this ideal, very few people attain it.

Understanding that helped me to stop chasing an ideal that I'd never be able to meet, and instead embrace the body (and face) I was born with.

In many ways, it's easier said than done, because let's be honest it's hard to tune out the constant bombardment of images that push perfection. But if you can recognise how subjective, market-driven and narrow beauty ideals usually are, you can, perhaps, start letting go of some of the pressure to conform.

Read the rest here:
Why we need to stop buying into the beauty myth - ABC News

Recommendation and review posted by Bethany Smith

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

To know Untapped Opportunities in the MarketCLICK HERE NOW

One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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This post was originally published on Market Research Sheets

Read more:
Stem Cell Therapy Market Consumer Outlook 2025 | MEDIPOST Co., Ltd., Osiris Therapeutics, Inc. - Market Research Sheets

Recommendation and review posted by Bethany Smith

By Gerald Tan December 23, 2019 Tatler Focus

The centre offers the latest scalp innovations that address all your hair thinning woes by getting to the root cause

While you are pampering your skin with the most luxurious creams and lotions, dont forget to show your crowning glory some tender loving care, too. Beautiful tresses require plenty of effort and dedication to upkeep, but when you are faced with unfortunate scalp ailments or hair-loss issues, however, maintaining its volume and healthy shine can seem like anuphill task.

Enter hair loss and scalp care centre Papilla Haircare, which might have the solution for all your hair woes.

From state-of-the-art equipment to medicallybacked technologies, here are five things to know about the brand:

Thankfully, advances in science and technology can help alleviate many hairrelated problems. Papilla Haircare has the latest innovative solutions. Located at Ngee Ann City, it is a one-stop hub that utilises the latest medicallybacked technologies. The centre collaborates with doctors and scientists to concoct serums rich in stem cells in its own Korean laboratory to ensure the highest safety standards.

(Related: 7 Natural Beauty Products Your Skin Will Love You For)

Boasting sleek black and gold accents, Papilla Haircares contemporary interiors are a reflection of its cutting-edge services. Its clinically proven programmes are the result of extensive scientific research, meticulously developed by a group of Korean dermatologists and hair transplant surgeons. Thanks to their efficacies, these remedies have also been adopted for post-procedure use at top hair transplant centres in South Korea.

(Related: 5 Foods To Eat For Healthy Hair And Nails)

See the article here:
5 Things to Know About Hair loss and Scalp Care Centre Papilla Haircare - Singapore Tatler

Recommendation and review posted by Bethany Smith

Technavio has been monitoring the global allogeneic stem cells market and the market is poised to grow by USD 1.24 billion during 2020-2024 at a CAGR of over 12% during the forecast period. Request Free Sample Pages

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191218005455/en/

Technavio has announced its latest market research report titled global allogeneic stem cells market 2020-2024. (Graphic: Business Wire)

Read the 131-page research report with TOC on "Allogeneic Stem Cells Market Analysis Report by geography (Asia, Europe, North America, and ROW), by application (regenerative therapy and drug discovery and development), and segment forecasts, 2020-2024".

https://www.technavio.com/report/allogeneic-stem-cells-market-industry-analysis

The new product approvals and special drug designations are anticipated to boost the growth of the market. Based on the application, the allogeneic stem cells market has been segmented into regenerative therapy and drug discovery and development. Manufacturers are increasingly emphasizing innovations and improvisation in the development of regenerative therapies. Many of the regenerative therapeutic candidates have obtained approval for clinical trials in the US, Europe, and APAC due to the efficacy of allogeneic stem cell therapeutics. This is encouraging market players to launch new product lines to stimulate the overall product demand for stem or regenerative therapy using allogeneic stem cell therapeutics and provide better options for their customers. Thus, new product approvals are expected to drive market growth during the forecast period.

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Major Five Allogeneic Stem Cells Market Companies:

Biosolution Co. Ltd.

Biosolution Co. Ltd. is headquartered in South Korea (Republic of Korea) and operates the business under its Unified business segment. The company offers an allogeneic keratinocyte spread medication, Keraheal-Allo, that promotes skin regeneration.

Cynata Therapeutics Ltd.

Cynata Therapeutics Ltd. is engaged in the discovery, development, licensing, manufacturing, marketing, distribution, and sales of innovative therapeutics for the treatment of various diseases. The company provides a mesenchymal stem cell product, Cymerus, which is used to treat graft-versus-host disease.

JCR Pharmaceuticals Co. Ltd.

JCR Pharmaceuticals Co. Ltd. is headquartered in Japan and operates under two business segments, namely Pharmaceuticals, and Medical Devices and Laboratory Equipment. The company offers a regenerative medical product, TEMCELL HS Injection, which uses human mesenchymal stem cells for the treatment of acute graft-versus-host disease.

Lineage Cell Therapeutics Inc.

Lineage Cell Therapeutics Inc. is headquartered in the US and offers products through its Unified business segment. The company provides OpRegen, which is currently being tested in a Phase I/IIa clinical trial. This product is intended for the treatment of dry AMD.

MEDIPOST Co. Ltd.

MEDIPOST Co. Ltd. is headquartered in South Korea (Republic of Korea) and offers products through its Unified business segment. The company provides an allogeneic umbilical cord blood-derived mesenchymal stem cell drug, CARTISTEM, which is used for the treatment of knee cartilage defects.

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Allogeneic Stem Cells Application Outlook (Revenue, USD Million, 2020-2024)

Allogeneic Stem Cells Regional Outlook (Revenue, USD Million, 2020-2024)

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Related Reports on Health Care include:

Cancer Stem Cell Therapeutics Market Global Cancer Stem Cell Therapeutics Market by type (allogeneic stem cell transplant and autologous stem cell transplant) and geography (Asia, Europe, North America, and ROW).

About Technavio

Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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Global Allogeneic Stem Cells Market 2020-2024 | Evolving Opportunities with Biosolution Co. Ltd. and Cynata Therapeutics Ltd. | Technavio - Yahoo...

Recommendation and review posted by Bethany Smith

Turning back time when it comes to our skin, doesnt necessarily have to mean cosmetic procedures and in-depth dermatologist appointments. No matter how old you are, using the right anti-ageing creams regularly can make a visible difference in our skin elasticity, plumpness and reduction of fine lines.

And if you dont think anti-wrinkle creams are for you just yet? You might want to think againthe earlier you start taking care of your skin, the better. This can mean anything from drinking enough water, eating the right foods and especially staying out of the sun, but luckily for us in this day and age, we also have a plethora of products to choose from to help us out along the way.

Whether youre an anti-ageing skincare pro or considering starting to use products for the first time, it can be a totally overwhelming experience trying to find the best cream for you. Thats why weve done the hard work and rounded up the 10 best ever anti-ageing creams that weve not only tried and tested but heard the experts raving about countless times. And the best thing? You wont have to spend a months wages on them.

Before we start, however, lets simplify things with a few key tips and important things to know. When shopping around for legit anti-ageing creams there are some essential ingredients to look out for. Retinol (or vitamin A) speeds up cell turnover, boosts collagen production and is the ultimate anti-ageing ingredient. It can be harsh on the skin to start with, though, so only use every few days to begin with and always use SPF with it, as it can make your skin more sensitive to rays.

Antioxidants like vitamins C and E help fight free radicalsmolecules that can do damage to your skin cells. Peptides help repair skin damage. Glycolic acid is an AHA that increases cell turnover to reveal smoother skin. Ceramides and other hydrators like hyaluronic acid and shea butter all lock in moisture and form a protective layer for your skin. And of course, SPF, which is the number one preventative anti-ageing ingredient.

Any one of these ingredients will aid anti-ageing, but the more you can find in one product, the better. Its also important to know your skin. If you know it has an oily nature, dont overdo it with rich creams, stick to lighter lotions, but if you struggle with drier skin, its the moisture-rich products to pick.

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Elemis Pro-Collagen Marine Cream 50ml (87)

This lightweight, award-winning cream is a great all-rounder. Its gentle so it will suit most complexions but its also highly effective in smoothing, firming and hydrating fine and deeper wrinkles. Somewhere in between a gel and a creamy texture, this goes on so smoothly and wont leave skin greasy.

Olay Regenerist 3 Point Firming Anti-Ageing Cream Fragrance Free with Hyaluronic Acid, 50 ml (19)

You cant really argue with the price of this hero product, and youre more than likely to see it every time you read about the best anti-wrinkle creams. This has had rave reviews since its launch. The winning combination of hyaluronic acid, amino-peptides and niacinamide (vitamin B3) is great for moisturising, plumping and refreshing surface cells all helping to smooth fine lines.

SkinCeuticals A.G.E. Interrupter 48ml (160)

Okay, this cream is on the more expensive side, but you do get a lot of bang for your buck. SkinCeuticals is one of the best anti-ageing brands on the market and this cream in particular works wonders. A.G.E. stands for Advanced Glycation End-Products, which is a big part of the natural ageing process. This cream fights it by boosting collagen levels and slowing down the loss of elasticity in the skin. It also reduces the thinning of the skin and generally improves the skins texture.

Dr Dennis Gross Skincare Ferulic and Retinol Anti-Ageing Moisturizer (72)

As we mentioned, retinol is the absolute gold-standard in anti-ageing skincare. Thiscreams magic is based around its renewing and brightening power, paired with intensely moisturising properties that help strengthen the skins natural barrier allowing it to feel less irritated by the strength of the retinol. Add in the antioxidant-rich ferulic acid and the brands own complex to brighten and reduce dark spots and you have a cream that brightens, tightens and ultimately makes skin look younger.

Sunday Riley C.E.O. Vitamin C Rich Hydration Cream (50ml ) (60)

Were big fans of this cult Sunday Riley cream. Vitamin C is a highly effective ingredient in any anti-aging day cream. The antioxidant will fight signs of aging such as damage from free radicals and reduce fine lines. This cream also calms redness, providing natural beta hydroxy acid to brighten appearance all day.

Ole Henriksen Goodnight Glow Retin-ALT Sleeping Creme 50ml (46)

As powerful and effective as retinol is, it can be a difficult product to use on sensitive skin, no matter how slowly you try and build it up into your daily routine. Bakuchiol is a plant-based alternative that has the same results but is less intense on the skin and so perfect for those on the more sensitive side. Similar to retinol the ingredient helps to boost skin-cell turnover revealing glowy new layers beneath. This cream also nourishes with edelweiss stem cell and is gentle enough for use every night.

Neutrogena Rapid Wrinkle Repair Night Moisturiser (26)

Another great overall cream but with the added bonus of higher than average daily SPF. Neutrogenas dermatologist-approved product is not only great value, but its also highly effective. Still including retinol in its ingredients but in a slightly milder form, it will help bring new cells to the forefront as well as encouraging collagen growth. Start using this every few days to begin with and build up to daily use to avoid any irritation.

RoC Retinol Correxion Deep Wrinkle Daily Moisturiser SPF 30 (21)

This best-selling and reasonably pricednight cream also works with retinol to prevent signs of ageing. Added hydration ease any irritation but dont worryits also oil-free and non-comedogenic, meaning it wont clog pores and cause breakouts.

Caudalie Resveratrol Face Lifting Soft Cream, 50ml (42)

This lightweight cream is great for protecting skin early on from signs of ageing.Resveratrol fights free radicals as well as stopping their formation, increasing and maintaining visible firmness in the skin. With added peptides, nourishing oils, elastin and hyaluronic acid, this is a truly multitasking cream with innovative technology meaning it works its way into the skin throughout the day.

Charlotte Tilbury Magic Skin Cream (49)

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Next: We asked six women with incredible skin for the products they swear by.

This article originally appeared on Who What Wear

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Trust UsThese Are the Best Anti-Ageing Creams in the Business - Yahoo Style

Recommendation and review posted by Bethany Smith

BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for REVLIMID (lenalidomide), in combination with rituximab, for the treatment of patients with relapsed or refractory indolent lymphoma (follicular lymphoma or marginal zone lymphoma). REVLIMID was first approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy, and the label for the combination was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma (NDMM) who are not eligible for transplant. It is currently marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.

This milestone for REVLIMID marks another step in the expansion of our hematology franchise into non-Hodgkins lymphoma (NHL) in China, where significant unmet medical needs remain. Together with the pending approvals of tislelizumab for Hodgkins lymphoma and zanubrutinib for mantle cell lymphoma and chronic lymphocytic leukemia as well as Revlimid for multiple myeloma, Vidaza for myelodysplastic syndromes and acute myeloid leukemia and additional products from the collaboration we have announced with Amgen, we are working to build a market-leading presence in the treatment of hematological cancers in China, said Dr. Xiaobin Wu, General Manager of China and President of BeiGene. We are excited about this opportunity and look forward to working closely with Bristol-Myers Squibb and the NMPA to bring this chemotherapy-free treatment option to patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma in China as soon as possible.

The sNDA is supported by a clinical, non-clinical, and chemistry, manufacturing and control (CMC) data package, including the results from the pivotal Phase 3 AUGMENT study (NCT01938001) sponsored and conducted by Bristol-Myers Squibb. AUGMENT is a randomized, double-blind, multicenter trial in which a total of 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomized 1:1 to receive REVLIMID and rituximab (R2) or rituximab and placebo. With a median follow-up of 28.3 months (range: 0.1 to 51.3 months), R2 demonstrated clinically meaningful and statistically significant improvement in progression-free survival (PFS), evaluated by an independent review committee (IRC), relative to the control arm with a 54% reduction in the risk of progression or death (hazard ratio [HR] = 0.46; 95% confidence interval [CI]: 0.34, 0.62; p < 0.0001). The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm with an improvement by more than 2 years. Overall response rate (ORR), a secondary endpoint, was 78% in the R2 arm vs. 53% in the control arm, as assessed by the IRC. Duration of response (DoR) was significantly improved for R2 vs. control with median DoR of 37 vs. 22 months, respectively (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79). The most frequent adverse event (AE) in the R2 arm was neutropenia (58%), vs. 22% in the control arm. Additional commonly observed AEs in more than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in the control arm), constipation (26% vs. 14%), cough (23% vs. 17%), and fatigue (22% vs. 18%). Adverse events that were reported at a higher rate (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare.

About follicular lymphoma (FL) and marginal zone lymphoma (MZL)

FL and MZL are two major types of indolent lymphomas;1 FL is the most common subtype, constituting approximately 20% to 25% of all NHL,2 followed by MZL (approximately 5% to 17% of all NHLs).3 NHL incidence in China is 88,090 according to the World Health Organizations Globocan 2018 database.4 Given the incurable nature of relapsed or refractory FL/MZL, the efficacy and safety limitations of current treatment options, and the fact that patients are typically older and with comorbidities, a high unmet medical need exists for the development of novel treatment options with new differentiated mechanisms of action and a more tolerable safety profile that can improve the quality of response and PFS in the setting of previously treated FL/MZL.

About REVLIMID

In China, REVLIMID was approved in combination with dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are not eligible for transplant in 2018. It received approval in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone in adult patients who have received at least one prior therapy.

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation. REVLIMIDas combination therapy is approved inEurope, inthe United States, inJapanand in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassingEurope, theAmericas, theMiddle-EastandAsia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy inAustralia and New Zealand.

REVLIMIDis also approved inthe United States,Canada,Switzerland,Australia,New Zealandand several Latin American countries, as well asMalaysiaandIsrael, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and inEuropefor the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMIDis approved inEuropefor the treatment of patients with mantle cell lymphoma (MCL) and inthe United Statesfor the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. InSwitzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

U.S. Indications for REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

REVLIMID is only available through a restricted distribution program, REVLIMID REMS.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus.

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS.

REVLIMID REMS Program: See Boxed WARNINGS. Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. Patients may require a dose interruption and/or dose reduction. MM: Monitor complete blood counts (CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as maintenance therapy, every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on therapy for del 5q MDS, weekly for the first 8 weeks of therapy and at least monthly thereafter. See Boxed WARNINGS for further information. MCL: Monitor CBC in patients taking REVLIMID for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. FL/MZL: Monitor CBC in patients taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2-4, and then monthly thereafter.

Venous and Arterial Thromboembolism: See Boxed WARNINGS. Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on the patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision.

Increased Mortality in Patients With CLL: In a clinical trial in the first-line treatment of patients with CLL, single-agent REVLIMID therapy increased the risk of death as compared to single-agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials.

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID and in patients with FL or MZL receiving REVLIMID + rituximab therapy, an increase of hematologic plus solid tumor SPM, notably AML, have been observed. In patients with MM, MDS was also observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment.

Increased Mortality With Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID + dexamethasone. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with REVLIMID. The patients at risk of TLS are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches.

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion.

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection.

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before starting REVLIMID treatment and during therapy.

Early Mortality in Patients With MCL: In another MCL study, there was an increase in early deaths (within 20 weeks); 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L).

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

Follicular Lymphoma/Marginal Zone Lymphoma

DRUG INTERACTIONS

Periodically monitor digoxin plasma levels due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

Please see the rituximab full Prescribing Information for Important Safety Information at http://www.rituxan.com.

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in the United States, China, Australia, and Europe; BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA (zanubrutinib) and in China, the Company markets ABRAXANE (paclitaxel for injection [albumin bound]), REVLIMID (lenalidomide), and VIDAZA (azacitidine) under a license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.5

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGenes plans and expectations for further development and commercialization of REVLIMID in China and the potential implications for patients. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

______________________1 Bello C, Zhang L, Naghashpour M. Follicular lymphoma: current management and future directions. Cancer Control. 2012;19:187-95.

2 Sousou T, Friedberg J. Rituximab in indolent lymphomas. Semin Hematol. 2010; 47(2):133-42.

3 Zinzani, P. L. (2012). The many faces of marginal zone lymphoma. Hematology, 2012(1), 426432.

4 https://gco.iarc.fr/

5 ABRAXANEis registered trademark ofAbraxis Bioscience LLC, aBristol-Myers Squibb company; REVLIMIDand VIDAZAare registered trademarks ofCelgene Corporation, aBristol-Myers Squibbcompany.

Read more from the original source:
BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma - GlobeNewswire

Recommendation and review posted by Bethany Smith

It was the year before my son Lysander was born, in 2004, that we saw our firstpolarbears, magnificent nomads of imponderable grace roaming the tundra like predatory ghosts in Manitoba, Canada.Polarbearsembody vastness and unspeakable endurance in their very gait. Theirs is an almost phantomic presence. They began to haunt us as an unmatched monarch whose freedom and poise and ability to survive for months without food should humble our species.

It was only recently, returning from Svalbard in the Norwegian Arctic, that we learned from Ole Jorgen Liodden, photographer and population expert, that thepolarbearswere not just being seriously threatened by melting ice but also by the continued onslaught of trophy hunters who have impaired the population for decades. In Nunavut in 2003 hunters killed 373bears, while in 2005 almost 500 were killed. The estimates ofpolarbearsin the 19 subpopulations ranging from Alaska to Russia are anywhere from 20,000 to 25,000, as is estimated byPolarBearsInternational. But as Danish biologist Morten Jorgensen claims in his cautionaryPolarBearson the Edge, this division is arbitrary. The population may be smaller.

Polarbearsare divided into units to better manage their harvesting as if they were a mere commodity.Andrew Derocher, professor of biology at the University of Alberta, wrote that he has little faith in Canadianpolarbearmanagement anymore. We have populations with no estimate for almost 20 years.When it comes topolarbears, the main threat remains climate change. Harvest, however, has impacts and some of them are obvious (eg. direct mortality) but some are more subtle (eg. number of males available for breeding.)"

In Canada, hunting for trophies has taken on insidious proportions for years. As Liodden explains,"Adult males with the best furs and trophy characteristics have been targeted for years and this is definitely affecting local populations.The large males with the fittest genes are removed from the overall population that would have benefited from the strength and experience of these males whilebearsthat are less likely to survive are left to fend for themselves impairing the mating success of the species.Trophy hunting is forcing 'reverse evolution' or evolutionarydegeneration by increasing less desirable genetic characteristics in a population.

The conservation of one of the most majestic species on Earth has been reduced to quota management. If this way of conservingpolarbearscontinues, the harvesting, the actual murder ofpolarbearsas a cash crop, will come to a climax and one day, with the added challenge of climate change, they will quite simply be no more.

I had the occasion to meet Erling Madsen, an Inuit elder awarded byPolarBearsInternational for being asteward ofpolarbearsin his village, Ittooqoormitt in Eastern Greenland. He is the guardian of his people, and with flare guns and occasionally rifles has the job of making sure children are safe frompolarbearsand daily makes sure there are no straybearscoming into the village looking for food. His village is allowed a quota of 35polarbearsa year by the Greenland government, and while Erling explained that in the old days one had to go further afield to findbears, today many more come closer to town because of climate change.

I wondered if this quota did not seem too high, especially since the overall population is decreasing worldwide. Madsen insisted that hunters respected thebears. I asked how he would feel if his people lost thepolarbearforever. He paused as if I had asked something taboo, and with a sigh answered, We would lose our souls.

Not very long ago the Inuit honored thepolarbearand hunted them for survival. As John Houston, who was born on Baffin Island and who learned Inuktikuk as a child, explains, the Inuit hope we who are polluting and melting the very ground of the Arctic will grow up and become mature adults, stop fighting amongst ourselves and acknowledge the truth of the ancient prophecy that the earth and sky can be changed by people. Stop burning thepolarbear. They are Very Important Persons and worthy of our utmost respect. Look into their souls and you will be changed.

Canada, with its vast resources, can make up for any revenue native communities miss out on if they stoppedhuntingpolarbear. As Jorgensen exclaims, the precautionary principle should be heeded. We need to "consider honestly the summative pressure onpolarbearsof all human activities. Stop claiming thatpolarbearconservation is effective today. Speak out against overexploitation and commercial abuse."Canada as a country should take responsibility for its most iconic mammal while it still can. In 10 years time, with the ice dissolving beneath their feet, its might well be too late.

In the old days, certainly before the mid-20th century, thepolarbearwas honored. Kutsikitsoq, an elder, once said, After all, thepolarbearis the one closest to us!

Thepolarbearwas closely identified with man, so much so, that according to another Inuit elder, Inurterssuaq, when one had killed abear, one was to observe a period of mourning as for humans three days for a male, five for a female. Today, trophy hunters, and members of safari clubs, pay Inuit hunters to bag apolarbear, one of the least appropriate species on earth for such killing as they have a low birthrate and high cub death rate.

As opposed to the old days, when an Inuit hunter would face down apolarbearwith a spear and put his very life on the line, today skidoos and high-powered rifles out run their prey.

Commercial exploitation becomes the focus of the relationship, and it invariably becomes a question of taking the harvest to the limit. In 2013, an 11-footpolarbearskin was being sold for $20,500 in Canadian money. In 2014, pelts cost up to $40,000 in U.S. money.One recently was sold to a Chinese client for close to $80,000 U.S. A mountedbearcan earn as much as $100,000 in U.S. money. Skyrocketing prices are fueling greed worldwide, greed that if left unchecked, could eventually lead to extermination. Canada has more than enough resources to make up the loss of revenue for native peoples, they whose world was turnedupside down by the Canadian government not so very long ago. The same trophy hunters are looking for jaguar parts in the Amazon, lions in Africa and tigers in Asia and countless other irreplaceable species around the world. As Jorgensen underscores, Phasing out the unnecessary hunt of a threatened species would send a strong signal of true stewardship of the environment, and it would constitute a strong starting point for building a solid identity in a meaningful future.

Lysander floated on a zodiac near the Svalbard shoreline just a few weeks before his 14th birthday. He had come to the same place when he was a child ten years ago. Spellbound by the ice, he reveled in the presence of a giant of being, the great icebear, a creature he had once molded into a clay figurine incarnating all the marvel and joy of childhood. There was a sense of returning to a place that had helped forge the human imagination during the Pleistocene, the roof of the world whose supreme sentinel was holding on to the last vestiges of its world.

Apolarbearmeandered among the fragmented ice, like a seemingly lost nomad searching for redemption on a scattered planet.

Time is running out for many species on Earth. The bloodlust that runs in our veins serves not our survival but our eventual defeat. As the eloquent writer and explorer of mans place in the universe Loren Eiseley warned, The need is not really for more brains, the need is now for a gentler, a more tolerant people than those who won for us against the ice, the tiger, thebear. The hand that hefted the axe, out of some blind allegiance to the past fondles the machine gun as lovingly. It is a habit man will have to break to survive, but the roots go very deep.

Legislative action worldwide andespecially in Canada should be implemented immediately so that shooting ofpolarbearsis considered a crime. The trade inpolarbearbody parts should be banned. Such trade should shame the foundation of our kind. Trophy hunting needs to be eliminated forever so that the monarch of the north continues to be one of the ultimate sentinels of life on Earth. Its future is slipping through its paws as we rummage through numbers and statistics. Let humanity have a change of heart for a being we will mourn like few others, if that clay figurine our son molded when he was 6 becomes the only thing left to remind us of what was. As for future of the ice on which thepolarbeardepends so very dearly, I leave the last words to Lysander, now 14, who astutely said, The melting ice is the hourglass that measures the remainder of our time on this Earth.

View original post here:
Can we stop killing polar bears while they still roam the top of the world? - The Hill

Recommendation and review posted by Bethany Smith

Olaf is almost two months old. (Submitted by Diane Barber)

Contact: Vanessa Beeson

STARKVILLE, Miss.A Mississippi State University partnership with the Fort Worth Zoo has hatched the first of more than 30 metamorphosed toadlets produced through in vitro fertilization.

A Puerto Rican crested toad named Olaf, hatched at the Fort Worth Zoo this year, is what one might call a work of art. ART, or assisted reproductive technologies, developed by scientists in the universitys Mississippi Agricultural and Forestry Experiment Station and the Forest and Wildlife Research Center, helps amphibians like the Puerto Rican crested toad, considered a threatened species by the U.S. Fish and Wildlife Service.

The technologies include hormone therapies, sperm cryopreservation and in vitro fertilization. MSU also is home to the countrys only National Amphibian Genome Bank, a repository of cryopreserved sperm from approximately 10 of the worlds most threatened and endangered amphibian species.

Carrie Vance, assistant research professor in the Department of Biochemistry, Molecular Biology, Entomology and Plant Pathology who co-leads the project, said Olaf is an example of how ART helps increase the genetic diversity and sustainability of populations of threatened amphibians.

Olaf represents the first time we used cryopreserved sperm from a wild Puerto Rican crested toad as a new genetic line to be combined with an egg from a captive female, said Vance, who also is a MAFES scientist at MSU. Whats more is that both of Olafs parents have since died of natural causes so Olaf is truly the last of this particular genetic line.

Vance pointed out that while cryopreserving sperm from wild males, researchers have been able to use hormone therapies to assist breeding. As opposed to other methods, this technique enables researchers to collect sperm without killing the animal, which Vance believes will result in a wider adoption of the practice.

Previously to introduce genetics from wild individuals into a captive population, the animals were brought into captivity, then paired, and often would never breed anyway. If the collection of sperm from testes macerates was needed, it would require the animal be euthanized, Vance said. This new method means we can collect the sperm and release the specimen back into the wild.

Vance said ART is one facet of a larger species survival plan, which includes steps such as habitat restoration, disease control and establishing an assurance colony in captivity.

ART helps when amphibians have difficulty breeding in captivity. Typically, amphibian breeding is cued by environmental factors such as day length, rainfall and temperature, which are things that can be difficult to control in a 10-gallon aquarium. When they dont breed, the genetic lines are lost, and a zoos entire assurance colony can collapse.

Vance said it comes down to overriding the environmental cues and synchronizing the timing of the actual breeding, noting that while it takes males only hours to generate sperm, it can take weeks for females to produce eggs.

The hormone therapy overrides the environmental factors to trigger the production of reproductive hormones, which cause sperm and egg release. Sperm cryopreservation holds the sperm in perpetuity until the eggs are ready for synchronization.

Vance has partnered with Andy Kouba, professor and head of the Department of Wildlife, Fisheries and Aquaculture in MSUs College of Forest Resources and scientist in the Forest and Wildlife Research Center, for more than 20 years developing innovative reproductive technologies for threatened and endangered species.

The researchers also have applied ART to the Mississippi gopher frog, considered one of the most endangered in the U.S. Their pioneering work resulted in thousands of Mississippi gopher frogs being produced by zoos around the country and reintroduced into their native habitat.

Many of the techniques we use on species like the Puerto Rican crested toad were developed using the Mississippi gopher frog, Kouba said. The Mississippi gopher frog was the first endangered species ever produced from frozen sperm. The offspring are still alive and have subsequently produced a second generation of offspring, considered another first of its kind.

Kouba said seeing the applied conservation in action and being able to reintroduce animals back into the wild is what excites him most about the work.

Globally, it is estimated that 30-40 percent of amphibians are threatened with extinction. In the U.S. that number is closer to 50 percent, Kouba said. Our assisted reproductive technologies have led to millions of tadpoles from threatened and endangered species being released into the wild across many species.

Kouba added that amphibians serve as indicator species for the health of their surrounding ecosystems.

They are the canary in the coal mine, Kouba said. Anything happening in the environment soaks through their permeable skin. Also, they have two life stages, an early aquatic stage and a terrestrial stage, which lets scientists know what is happening in two different environments. As an indicator species, it is important to understand why amphibian populations are disappearing and to try and help the populations recover.

In addition to the Puerto Rican crested toad and the Mississippi gopher frog, other species the team focuses on include the Boreal toad, Houston toad, Chiricahua leopard frog and various species of salamanders. Graduate students on the project include doctoral student Allison Julien of Scotts Valley, California; masters student Isabella Burger of Prattville, Alabama; and Kristen Counsell, a spring 2018 masters graduate of Cedar Falls, Iowa. Masters student Amanda Gillis of Fallston, Maryland, and research associate Emmet Guy of Oxford contribute to the labs salamander research.

Support for the Olaf project includes funding from Disneys Conservation Endowment Fund and the Association of Zoos and Aquariums. Longtime funding partner, the Institute of Museums and Library Services, supported the early development of this work and currently sponsors the labs salamander research. Morris Animal Foundation also has provided previous financial support.

For more on the Mississippi Agricultural and Forestry Experiment Station, visit http://www.mafes.msstate.edu. For more on the Forest and Wildlife Research Center, visit http://www.fwrc.msstate.edu.

MSU is Mississippis leading university, available online at http://www.msstate.edu.

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One-of-a-kind toad born through MSU pioneering technology that's saving threatened species - Mississippi State Newsroom

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By BONNIE J. GORDON

Los Alamos Daily Post

Los Alamos National Laboratory Director Thom Mason presented a talk Thursday evening about leveraging the nations scientific base against national security threats.

Mason was the guest speaker at a meeting of the Los Alamos Committee on Arms Control and International Security meeting at the United Church of Los Alamos.

The Lab is in the business of applying science and technology to constantly changing geopolitical realities, Mason said.

He explained that with the fall of the Soviet Union and the 9/11 attack that occurred in 2001, the focus of nuclear deterrence changed from attacks by nation-states to terrorism by extremist groups.

Hopes were high that Russia and China were moving toward peacefully joining the world community, he said. With the Russian invasion of Ukraine in 2018 and new Chinese leadership that departed from the previous peaceful rise strategy, things have changed dramatically, he said.

Although Ukraine is not in NATO, the Baltic States are, and they feel threatened by Russia, Mason said. The reality is if Russia wanted to move into the Baltic States, the things that prevent it are NATO and the nuclear deterrent.

China also has rattled its saber in its region, he said.

The nuclear deterrent affects the actions of others, Mason said. You dont have to use it for it to be effective.

The deterrent also affects the security decisions of allies like Japan and South Korea who depend on us, rather than developing their own nuclear weapons, Mason said.

They have the capacity to become nuclear powers if they are not convinced we have their backs, he said.

Current nuclear powers have followed the New START (Strategic Arms Reduction Treaty) in committing to reduce nuclear arms. Nuclear testing ended in 1992 when the first START treaty (Strategic Arms Reduction Treaty) was entered into by the U.S. and the USSR. Current nuclear powers have followed the START guidelines to end testing, although not compelled by it, Mason said.

The only way wanna-be nuclear powers get there is through testing, he said. Thats why it shines a bright light every time the earth shakes in North Korea.

Riding the tiger of maintaining the nuclear arsenal without tests, through the use of scientific tools is a big part of LANLs mission, Mason said. Most of the weapons were relatively new when testing ended, having mostly been built in the 1980s, but now its 40 years down the road.

The whole key to deterrence is to make sure the weapons will work, and enemies must have confidence they will work, Mason said.

LANL has a number of life extension programs, including replacing aging components and changes to improve safety and security as well as address environmental concerts, he said.

Particle accelerators at Los Alamos Neutron Science Center (LANSCE) are used to film and understand materials at extremes. The DNNSC free electron laser that Mason hopes will be built at LANL, brings an exquisite ability to understanding how microstructure of material affects its mechanical properties, he said.

Computational tools provide another way forward in both stockpile stewardship as well as other modeling jobs such as tracking climate change, Mason said.

Computational tools can go where experiments cant, he said.

Another task is the development of sensors to be used in treaty verification, Mason said.

LANLs mission is to create what Mason calls a deterrence of knowledge or the demonstrated capacity of the nation to respond to emergency threats.

Potential enemies must be convinced that, No matter what you come up with, well be smart enough to counter it, Mason said.

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LANL Director Thom Mason Speaks To LACACIS On Leveraging Science Against National Security Threats - Los Alamos Daily Post

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OTTAWA Call it the case of the missing icebreaker.

The fate of the Canadian Coast Guards next heavy icebreaker has been wrapped in mystery since the federal government quietly removed the $1.3-billion project from Vancouver shipyard Seaspans order book in May.

But plans to build the icebreaker, which was first promised by Stephen Harpers Conservative government more than a decade ago, have not been cancelled, says Coast Guard Commissioner Mario Pelletier.

Rather, Pelletier said the icebreaker has been sent back to the drawing board as the Coast Guard looks to update the original design to account for changes in technology and the governments requirements.

Its still in the plan, Pelletier told The Canadian Press this week. Actually, were updating our design. It was a really good design. Because its been a number of years, were just updating the design and well see how that unfolds and were going to queue it somewhere.

Exactly when and where the CCGS John G. Diefenbaker, as the icebreaker is to be named, will be built and how much it will ultimately cost remains up in the air.

We're just updating the design and we'll see how that unfolds and we're going to queue it somewhere

But Pelletier expressed confidence the icebreaker it is expected to replace, the CCGS Louis S. St-Laurent in service since 1969 will be able to operate through to the late 2020s thanks to various upgrades. That includes a recent $7.1-million life extension by Quebecs Chantier Davie shipyard.

The Diefenbaker was originally supposed to replace the St-Laurent in 2017.

Before we decided to invest in vessel life extension, we did an extensive survey and they were amazed at the amount of steel left on the ship, said Pelletier, who previously served on the Louis S. St-Laurent when it was still running on steam power.

So yes, the ship is old. (But it has) a lot of steel left so that makes it safe and the propulsion-control system and everything else have been upgraded. They were upgraded in the 90s, were upgraded four or five years ago again. So shes been extremely reliable.

Seaspan was tapped in 2011 to build Diefenbaker as part of a larger order that also included four science vessels for the Coast Guard and two navy supply ships, but it was removed from the Vancouver shipyards order book and replaced with 16 smaller multipurpose vessels in May.

Davie has been jumping at the chance to have the Diefenbaker built at its shipyard outside Quebec City.

The federal government announced Thursday that Davie was the only shipyard to qualify for addition into Canadas multibillion-dollar shipbuilding strategy, through which Ottawa is already building new naval warships, Arctic patrol vessels and Coast Guard science ships.

While that sets the company up to win potentially billions of dollars of federal work building six medium icebreakers for the Coast Guard, it has been lobbying hard for the heavier Diefenbaker as well.

The government has said Ontario-based Heddle Shipyards, which had raised concerns from the start that the selection process was rigged in Davies favour, did not qualify for inclusion in the strategy. The company has said it is looking at its options.

Pelletier said no decision has been made on where the Diefenbaker will be built, adding: The way things are starting up, we are going to start the (multipurpose vessels) and the (six) icebreakers before. When we look at all options for the polar, well see where it can go.

The industry both down south and up north are putting a lot of pressure for us to renew our program icebreakers

The Coast Guard commissioner applauded the governments addition of a third shipyard focused exclusively on building icebreakers as good news for his service given the age of its current fleet, with many ships having already exceeded their expected lifespans.

That has resulted in more unplanned breakdowns, leading to ferry-service disruptions, difficulties resupplying northern and coastal communities and complaints from industry about negative impacts on maritime trade.

The industry both down south and up north are putting a lot of pressure for us to renew our program icebreakers, Pelletier said, referring to the main icebreaker fleet.

The Coast Guard did obtain three second-hand icebreakers for more than $800 million from Davie. The company is still in the process of converting two of them for the Coast Guards use to help fill the gap, but those are considered a temporary measure.

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Back to the drawing board for missing heavy icebreaker: Coast Guard - National Post

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The low-carbohydrate, high-fat ketogenic diet has become hugely popular over the last few years. For many people, the keto diet including variations such as keto cycling or the less restrictive lazy keto has become the go-to eating plan for weight loss and fighting disease.

Two years ago, I interviewed cancer specialist Dr. Patrick Hwu of MD Anderson in Houston about his research into what he calls the fat-burning metabolism diet, or fat-burning diet. Hwu, a tumor immunologist, has been following the ketogenic diet himself for six years, long before it was trending on social media.

As a leading cancer doctor, he has many patients asking him for the ideal diet while they go through treatment and he often suggests keto.

Hwu emphasizes that more research is needed to determine the ideal diet for cancer patients, but as he has seen in himself, the keto diet has been shown to improve biomarkers associated with heart health.

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Keto is a diet that was developed decades ago and originally used for patients with severe epilepsy, some of whom were on the diet for life with no evidence of harm. It consists of low carb, high fat and only moderate protein intake, as opposed to the Atkins diet. Keto isnt as meat-heavy as commonly believed. Hwu relies on certain go to foods like full-fat regular cream cheese, sour cream and avocados as staples. He also consumes a lot of green vegetables and cauliflower.

Since starting the keto diet, Hwu has dropped 25 pounds and has maintained the weight loss. His blood pressure, triglycerides and sugar levels have all decreased, which are healthy signs. His biomarkers, including lipid profile and blood pressure have been excellent, he said.

There have been a number of studies that show the connection between obesity and certain cancers. Hwu feels that keto makes sense because his patients are not hungry on it, it manages their weight and blood sugar levels and keeps insulin and IGF-1 levels low two proteins that have been shown to drive some cancers.

I feel that fat intake has been overly emphasized as a negative factor and that a high intake of carbs and the subsequent spikes in insulin and IGF-1 (an insulin-like hormone in the blood) that they cause are more harmful to health overall, Hwu said.

Hwus colleague, Dr. Jennifer McQuade, an assistant professor and physician scientist in Melanoma Medical Oncology at MD Anderson says they are currently conducting both human and animal studies of the effects of diet, including the ketogenic diet, on cancer. In addition, they are testing a plant-based high-fiber diet aimed at the gut microbiome, which has been shown to impact response to immunotherapy, a type of cancer treatment that utilizes the patients own immune system to fight the disease. They expect results from the studies early next year.

Recent work from the laboratory of Lew Cantley at Cornell has shown that the ketogenic diet can improve cancer control in mice treated with a type of targeted therapy that can cause elevated levels of insulin.

The MD Anderson researchers will test the ketogenic diet in cancer survivors to see if it lowers insulin and IGF-1, they will then move on to combining with targeted therapy.

The keto diet research will be prepared in an MD Anderson kitchen and provided to the patients in a controlled setting.

Meanwhile, Hwu would like to see a greater variety of keto-friendly offerings in grocery stores because the key to sticking with keto is having enough substitutes, so you never feel deprived.

You can bake almost anything with almond flour," said Hwu, "and stevia, erythritol and monk fruit are all safe sweeteners.

Kristin Kirkpatrick

Kristin Kirkpatrick is the lead dietitian at Cleveland Clinic Wellness & Preventive Medicine in Cleveland, Ohio. She is a best-selling author and an award winning dietitian.

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Is the keto diet healthy? Cancer researchers study effects of keto - TODAY

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