The European Medicines Agency (EMA)’s human medicines committee endorsed nine new drugs during its June meeting, including Valneva’s adjuvanted COVID-19 vaccine for use in people age 18 to 50 years.…
A serious backlog of FDA inspections is causing problems for sponsors of biosimilars who are being especially affected by the delays, according to presenters at the Drug Information Association annual…
The FDA claims it prevented a total of 317 drug shortages in 2021 — marking the highest number of potential shortages avoided since the agency began reporting them to Congress…
Bipartisan legislation on lowering insulin costs is headed to a vote on the Senate floor “very soon,” according to U.S. Senate Majority Leader Chuck Schumer. Source: Drug Industry Daily
In a draft guidance issued today, the FDA lists three reasons the agency might rescind a Breakthrough Therapy designation (BTD), citing a change in the data supporting the designation or…
On Thursday, the House Committee on Appropriations voted 31 to 26 to adopt a bill that would increase the FDA’s nonuser fee funding by 10 percent in 2023. Source: Drug…
Enanta Pharmaceuticals is accusing Pfizer of patent infringement, claiming Paxlovid (nirmatrelvir tablets; ritonavir tablets) is in violation of Encanta’s patent for its under-development antiviral COVID pill. Source: Drug Industry Daily
Glicerinas Industriales (Glinsa) has received a warning letter from the FDA after refusing to let the agency inspect its facility in Jalisco, Mexico. Source: Drug Industry Daily
At long last, PTC Therapeutics has announced positive results from a study of Translarna (ataluren), the company’s drug for patients with nonsense mutation Duchenne muscular dystrophy. Source: Drug Industry Daily
The Center for Biologics Evaluation and Research yesterday released an updated guidance agenda for 2022 that includes the following planned guidances on tissues and advanced therapies in addition to those…