Sanofi and GlaxoSmithKline (GSK) will very soon be taking their COVID-19 vaccine candidate to U.S. and European regulators as both a primary series and booster, touting its 58 percent efficacy…
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…
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…
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…
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…
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…
The advocacy group Public Citizen is accusing Pfizer of building a “Paxlovid patent wall.” Source: Drug Industry Daily
Sanofi and Regeneron have stopped their investigation of Dupixent (dupilumab) as a treatment for chronic spontaneous urticaria (CSU) in patients who don’t respond to Genentech’s Xolair (omalizumab). Source: Drug Industry…