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The FDA has resumed routine domestic inspections this month after hitting the pause button for all but mission-critical inspections in March 2020, said Acting Commissioner Janet Woodcock yesterday on day-one of the FDA’s five-day Regulatory Education for Industry Annual Conference. Read More
The FDA said it will temporarily allow distribution of generics of Pfizer’s smoking cessation drug, Chantix (varenicline), even though they may contain more than the acceptable daily limit of a potential carcinogen — to ensure an adequate U.S. supply “for the near term.” Read More
The FDA has granted priority review designation to Pfizer’s and BioNTech’s Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in people 16 years of older. Read More
Pfizer has agreed to a $345 million settlement of a class action antitrust suit over the EpiPen, an epinephrine auto-injector used in the emergency treatment of anaphylaxis. Read More
How do you determine a drug’s cost/benefit ratio when you know the cost to procure and administer it could soar to $100,000 each year, but the benefit could be zero? Read More
GlaxoSmithKline released positive topline results from five clinical studies of daprodustat, its investigational drug for treatment of anemia that occurs with chronic kidney disease (CKD). Read More
San Francisco biotech FibroGen’s investigational drug for anemia linked to chronic kidney disease (CKD) should not receive FDA approval, the agency’s Cardiovascular and Renal Drugs Advisory Committee said yesterday. Read More
The Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization’s COVAX program are launching a “marketplace” to make use of unused materials and idle stock to increase the global production of COVID-19 vaccines for underserved populations. Read More