January 19, 2021
Bio SmartBrief
Today's Top Story
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization, says the industry is battling diseases, particularly COVID-19, through advancements in science and advocating for social justice issues such as diversity. "When it comes to preventing the next pandemic -- when it comes to even preventing the next iteration of COVID, because we know it's constantly mutating and evolving -- we are incredibly prepared," McMurry-Heath said.
Full Story: Forbes (tiered subscription model) (1/15) 
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Health Care & Policy
The FDA approved 53 novel drugs last year despite the pandemic, up from 48 approvals in 2019. Out of the approvals, 21 were considered first-in-class drugs, while 31 were treatment for rare diseases.
Full Story: Regulatory Focus (1/14) 
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Janet Woodcock has been chosen to serve as interim FDA commissioner by the Biden administration. Woodcock was the head of the FDA's Center for Drug Evaluation and Research from 2008 to May 2020.
Full Story: Medical Design & Outsourcing (1/14) 
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FDA releases assay guidance for COVID-19 antibody drugs
The FDA has released potency assay guidance for manufacturers of COVID-19 monoclonal antibodies and therapeutic proteins. The document, which takes effect immediately for the duration of the public health emergency, guides manufacturers through the steps of SARS-CoV-2 virus entry into cells and discusses major considerations for several kinds of viral neutralization assays.
Full Story: Regulatory Focus (1/14) 
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Company & Financial News
As governments begin rolling out COVID-19 vaccination campaigns for adults, drugmakers Moderna, Pfizer and BioNTech, AstraZeneca and Oxford University, and Johnson & Johnson are looking to the next phase of testing -- in children. "People try to minimize how sick kids get with COVID, but that's a mistake. I work intensive pediatric care, and there's a minority who get extremely ill. There are some deaths. It's not a non-entity," said Brigham Willis, senior associate dean for medical education at the University of California at Riverside's School of Medicine.
Full Story: San Jose Mercury News (Calif.) (tiered subscription model)/Southern California News Group (1/18) 
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Global Developments
Specialty vaccines company Valneva hired a Bouygues Construction subsidiary to build a multivaccine manufacturing and temperature-controlled warehouse facility adjacent to its existing facility in Livingston, Scotland, that complies with EU GMP Grade A to D cleanroom standards. Valneva is in talks with the European Commission to produce up to 60 million doses of its COVID-19 vaccine, VLA2001, which uses the same platform as Valneva's USFDA- and European Medicines Agency-approved Japanese encephalitis vaccine.
Full Story: European Pharmaceutical Review (UK) (1/15),  Cleanroom Technology (UK) (1/18) 
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A report from Chinese state media outlet Xinhua indicated that a Sinopharm subsidiary, China National Biotec Group, has conducted a trial of their COVID-19 vaccine on children between the ages of 3 and 17 and claims the vaccine is safe for children and adolescents. The report also indicated the vaccine could be approved before March, although no data is available to confirm the safety claims.
Full Story: FierceBiotech (1/15),  Reuters (1/15) 
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Ag & Environment
Study tests effect of beneficial soil fungus on tomatoes
A team of researchers led by Purdue University scientists inoculated 25 different tomato genotypes with a beneficial soil fungus known as Trichoderma harzianum to determine its impact on plant growth and found that it boosted root growth in several wild-type tomatoes by up to 526% more, and by as much as 90% in the plant's height. The study was funded by the Department of Agriculture's National Institute of Food and Agriculture and conducted via the Tomato Organic Management and Improvement Project.
Full Story: Seed World (1/14) 
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Carbon capture technology startup Blue Planet Systems has received an investment from the Future Energy Fund, which makes investments for Chevron. The two companies signed a letter of intent agreeing to work together on lower-carbon technologies.
Full Story: Reuters (1/14) 
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The Latest From BIO
The Protecting Americans from Tax Hikes (PATH) Act is an important piece of legislation that includes several provisions helpful to startups like small biotechs. Part of the PATH Act, the Payroll Research & Development Credit helps even the smallest biotechs unlock the federal R&D incentives intended to encourage ever-greater investment in R&D in the US. Read more.
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The BIO CEO & Investor Digital Conference, February 16-18, is the premier event where biotech innovators can find investors and strategic partners to advance their company to the next stage in their business life cycle. Find your next investment partner. Register today.
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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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