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In a draft guidance issued today, the FDA lists three reasons the agency might rescind a Breakthrough Therapy designation (BTD), citing a change in the data supporting the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…

The buzz at the Drug Information Association’s (DIA) annual meeting — being held in person this week in Chicago after two “virtual” years — is focused largely on user fee…

With positive new phase 3 interim results in hand, AstraZeneca is poised to file for regulatory approval for eplontersen, an antisense drug to treat complications of transthyretin amyloidosis (ATTR), a…