Hahn: Science will guide approvals for COVID-19 vaccine | Regeneron's evicanumab receives priority review status | Mexico inks MOUs with J&J, Cansino for COVID-19 vaccine trials
August 13, 2020
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FDA Commissioner Stephen Hahn, speaking at the Reagan-Udall Foundation's virtual meeting, reassured participants that approval decisions for a COVID-19 vaccine "will continue to be based on good science and the same careful, deliberative processes which we have always used when reviewing medical products." The FDA chief also unveiled a new initiative, dubbed the Pandemic Recovery and Preparedness Plan, or PREPP, designed to "help systematically review FDA's actions to date and identify lessons learned."
Full Story: Regulatory Focus (8/11) 
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Health Care & Policy
The FDA granted priority review status to Regeneron's experimental drug evicanumab for high cholesterol that is difficult to treat. The agency set the PDUFA date for Feb. 11.
Full Story: FierceBiotech (8/12) 
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Mexico inks MOUs with J&J, Cansino for COVID-19 vaccine trials
(Mark Ralston/AFP/Getty Images)
Mexico announced that memorandums of understanding have been signed with Johnson & Johnson and China's CanSino Biologics and Walvax Biotechnology to conduct Phase III trials for their respective investigational COVID-19 vaccines, according to Foreign Secretary Marcelo Ebrard. CanSino and Walvax could also base their vaccine production in Mexico as well.
Full Story: Reuters (8/11) 
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Regeneron's SARS-CoV-2 neutralizing antibody cocktail, made of cells from genetically engineered mice and blood from COVID-19 survivors, enabled monkeys to clear the virus and reduced lung damage. Antibody drugs are seen as a stopgap measure for COVID-19 patients until a vaccine is approved, but former FDA Commissioner Scott Gottlieb is among the experts who fear too much time has been lost to scale the manufacturing of these drugs.
Full Story: STAT (tiered subscription model) (8/11) 
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Company & Financial News
Vir Biotechnology will launch Phase II/III clinical trials for its neutralizing antibody VIR-7831 against SARS-CoV-2 this month. A midstage trial for VIR-7832, another SARS-CoV-2 neutralizing antibody, will begin this year.
Full Story: Seeking Alpha (free registration) (8/11) 
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Atomwise, a startup that uses artificial intelligence to speed up the process of drug discovery, raised $123 million in its Series B funding round. The new capital will allow the company to hire more staff, scale its technology and press ahead with joint ventures with researchers including Bayer, Charles River, the Duke University School of Medicine, Eli Lilly and Co. and Merck.
Full Story: VentureBeat (8/11) 
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Industry Deals
Argentina and Mexico will manufacture AstraZeneca's COVID-19 vaccine candidate for most Latin American countries, according to Argentine President Alberto Fernandez. The INSUD Group's mAbxience will be responsible for the production of an estimated 150 million doses to supply the region, except for Brazil.
Full Story: Reuters (8/12) 
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Ag & Environment
Bayer AG and Singapore's Temasek Holdings have launched Unfold, a new company that will develop seeds for vertical farms backed by $30 million from an initial funding round. Unfold also signed a deal for rights to germplasm from Bayer's vegetable portfolio.
Full Story: Bloomberg (tiered subscription model) (8/12),  Crunchbase (8/12) 
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Licypriya Kangujam, an 8-year-old climate activist from India, has made roof sheets and tiles out of recycled plastic and sugarcane bagasse. The sheets are able to reduce temperatures by 5 to 6 degrees Celsius.
Full Story: Manila Bulletin (Philippines) (8/12) 
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The Latest From BIO
As Moderna breaks the record for speed in starting the final stage of human testing for its covid vaccine, BIO CEO Dr. Michelle McMurry-Heath tackles the thorny issue of how to best structure the historic Phase 3 clinical trial. The Boston biotech's chief medical officer reveals the strategy to test vaccine efficacy on communities of color and others hardest hit by the novel coronavirus. Listen to the podcast.
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Biotech solutions to many forms of environmental racism are readily available. With the support of policies driven by the EPA and other government agencies, these solutions can be implemented to the benefit of ALL sectors of our society. Read more.
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
 
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