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A Seattle-based study of how COVID-19 spreads through the community has put its project on hold at the FDA’s request until it receives an Emergency Use Authorization (EUA) for its lab-developed test and self-swab kit. Read More
Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said yesterday that he still believes a COVID-19 vaccine could be deployed by the end of the year. Read More
Following considerable public outcry over potential conflicts of interest for government officials who are working on the Trump administration’s initiative to develop COVID-19 treatments and vaccines, Janet Woodcock is temporarily stepping down as director of the Center for Drug Evaluation and Research (CDER). Read More
President Trump says he wants drug pricing legislation passed this year despite the coronavirus pandemic, according to Sen. Chuck Grassley (R-Iowa), the chairman of the Senate Finance Committee. Read More
The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic. Read More
The World Health Organization (WHO) has adopted a resolution calling for the voluntary sharing of patent rights and product data for COVID-19 countermeasures. Read More
HHS is defending the bidding process that led to its $354 million four-year contract with a Virginia-based startup to manufacture active pharmaceutical ingredients (APIs) and finished drugs for emergency situations. Read More
Two senior FDA officials have recused themselves from involvement in agency approval decisions for coronavirus therapeutics or vaccines due to their oversight roles in the administration’s new COVID-19 research initiative. Read More
Gilead Sciences has ramped up the number of remdesivir vials it’s donating to the U.S. government to approximately 940,000 from 607,000, HHS said this week, even as the drugmaker has decided to end two trials it’s conducting on the antiviral. Read More