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The FDA released Q&A guidance yesterday on bioequivalence (BE) studies for generic drugs and abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic. Read More
The U.S. government has stepped in to address a serious manufacturing error at Emergent BioSolutions’ Baltimore, Md., facility that wasted 15 million Johnson & Johnson (J&J) vaccine doses. However, putting J&J in charge of the site and barring production of AstraZeneca (AZ)’s vaccine there isn’t likely to halt AZ’s production schedule, a White House official said Monday. Read More
The FDA has identified five main activities it will focus on for improving its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), including two on its reviews of Emergency Use Authorization (EUA) processes and its approaches to inspections, public communications and supply-chain monitoring. Read More
Three members of an FDA advisory committee who reviewed Biogen’s investigational Alzheimer’s drug, aducanumab, have written an op-ed article in the Journal of the American Medical Association alleging an “unusual degree of collaboration” between the FDA and Biogen “potentially compromised the FDA’s objectivity” in conducting its review of the drug. Read More
Bristol Myers Squibb’s blockbuster cancer drug Opdivo (nivolumab) significantly extended the disease-free survival of esophageal/gastroesophageal junction (GEJ) cancer patients with residual pathologic disease when given as an adjuvant treatment, according to phase 3 trial findings. Read More
Johnson & Johnson (J&J) said it is closely monitoring day-to-day operations at its COVID-19 vaccine subcontractor Emergent BioSolutions after a production error at the company’s Baltimore, Md., plant contaminated up to 15 million doses. Read More
Pfizer and BioNTech have accrued the data necessary to submit a biologics license application (BLA) for their COVID-19 vaccine and are seeking full approval as soon as this month, following a recent analysis from their phase 3 trial showing the vaccine held 91.3 percent efficacy up to six months after the second dose. Read More
The federal government is not missing out on a piece of the action over Gilead Sciences’ antiviral Veklury (remdesivir), which the FDA approved last year to treat hospitalized COVID-19 patients, because the patents rightfully belong to the company, the Government Accountability Office (GAO) reported last week. Read More
The U.S. Special Counsel has released details of a former FDA inspector’s allegations against the agency, including that it may have dropped the ball in an inspection of a Merck plant and possibly downgraded certain inspection findings without filing required documentation, claims he described as “troubling” in a letter to the White House. Read More