Archive for February 2022

An FDA inspection of Regeneron Pharmaceuticals’ active pharmaceutical ingredient (API) manufacturing facility in Rensselaer, N.Y., turned up observations of lapses in recordkeeping and cleaning procedures. Source: Drug Industry Daily

The European Medicines Agency (EMA) recommended 92 medicines for authorization by the European Commission in 2021, 53 of which had a new active substance that had not been authorized in the EU before. Source: Drug Industry Daily

The European Medicines Regulatory Network announced yesterday that it has adopted a common standard for the electronic product information (ePI) on medicines in the EU. Source: Drug Industry Daily

FDA’s Office of Prescription Drug Promotion (OPDP) has issued a warning letter to precision medicine developer CytoDyn about a video interview found on the company’s corporate website. Source: Drug Industry Daily

The FDA has announced that it found four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the troubled Emergent BioSolutions manufacturing facility in Baltimore, Md., to be acceptable for use for potential export. Source: Drug Industry Daily

Homology Medicines’ phenylketonuria (PKU) gene therapy study is on clinical hold while the company investigates abnormalities in liver enzymes in patients who received the treatment, which is delivered by a viral vector. Source: Drug Industry Daily

Moderna plans to expand its messenger RNA (mRNA)-based vaccine development pipeline to include herpes, shingles and various forms of cancer. Source: Drug Industry Daily

Newly confirmed and sworn-in FDA Commissioner Robert Califf spelled out some of his priorities in a Feb. 17 memo to the agency’s staff and repeated them in a series of tweets from his brand-new Twitter account — @DrCaliff_FDA. Source: Drug Industry Daily

Disappointing pharmacies who have had a beef with pharmacy benefit managers (PBMs) for years, the U.S. Federal Trade Commission voted against beginning an investigation into how PBM drug price negotiating practices affect independent and specialty pharmacies. Source: Drug Industry Daily

The advocacy group Public Citizen is accusing Pfizer of building a “Paxlovid patent wall.” Source: Drug Industry Daily