In rare move, Gilead gives up ‘orphan’ status for experimental coronavirus drug

March 25, 2020

Gilead has asked the Food and Drug Administration to rescind a special regulatory status for its experimental coronavirus drug, but not before stirring up a controversy that had critics accusing the company of manipulating a law designed to spur research […]

Advaite Produces COVID-19 Rapid Response Diagnostic Testing Kits

March 12, 2020

Advaite, an innovative biotech company focused on developing novel diagnostics, announced today that it will begin supplying the global market with its COVID-19 rapid response diagnostic testing kits, ADVAITE RAPCOV, to help efforts to contain the spread of COVID-19 virus […]

Coronavirus Update: Vaccines Rushing into Clinical Trials

March 5, 2020

As the coronavirus outbreak that causes COVID-19 escalates, biopharma companies and government agents are working quickly to develop and test a vaccine, although most estimates are it will take 12 to 18 months before it could get to market. As […]

FDA, News, Regulations

FDA Coronavirus (COVID-19) Update

March 24, 2020

Via: Contract Pharma

The U.S. Food and Drug Administration (FDA), on March 23, announced the following actions in its ongoing response effort to the COVID-19 pandemic: • The FDA issued a safety alert for fecal microbiota transplantation (FMT) procedures. The FDA has issued […]

Manufacturing, Mergers and Acquisitions, Research and Development

Astellas, CytomX Launch $1.7B Cancer Immunotherapy Collaboration

March 24, 2020

Via: Genetic Engineering and Biotechnology News

Astellas Pharma plans to expand its pipeline of next-gen immuno-oncology treatments through a collaboration with CytomX that could generate more than $1.68 billion for the South San Francisco, CA, developer of antibody therapeutics. Through the collaboration, announced Monday night, Astellas […]

FDA, News, Regulations

FDA Warns Americans to Beware of Fake COVID-19 Test Kits

March 23, 2020


Fake in-home test kits for coronavirus are being marketed in the United States and could pose serious health risks, the U.S. Food and Drug Administration says. “We want to alert the American public that, at this time, the FDA has […]

Clinical Trials, Industry, Research and Development, Vaccines

Gilead, flooded with requests, suspends access to experimental coronavirus drug

March 23, 2020

Via: Biopharma Dive

Compassionate use, as Gilead noted in its Sunday statement, was not designed to facilitate widespread access to experimental drugs during a public health emergency. So far, the biotech has provided remdesivir to “several hundred” patients sick with COVID-19 in the […]

Biotech, Industry, News, Vaccines

Biopharma’s leading treatment hopes against COVID-19

March 20, 2020

Via: FierceBiotech

As the biotech industry tries to match the pace of the pandemic with its own research response, we at FierceBiotech are rounding up the industry’s attempts to combat the virus after infection. As this is a rapidly moving situation, we […]