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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. Read More
“By incentivizing coordination, we can empower patent examiners and in turn boost competition, including for prescription drugs,” Sen. Durbin said. Read More
Moderna is also collaborating with the UK’s National Institute for Health Research on a phase 3 study investigating the company’s bivalent Omicron-containing booster candidate. Read More
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 already released this year: Read More
Glicerinas Industriales (Glinsa) has received a warning letter from the FDA after refusing to let the agency inspect its facility in Jalisco, Mexico. Read More
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. Read More
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. Read More
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 reauthorization as a legislative package makes its way through the Senate following the passage of a House version on June 8. Read More
The FDA has issued a warning letter to Hybrid Pharma — a Deerfield Beach, Fla.-based compounder — for producing adulterated drugs and failing to have any approved applications on file for the products. Read More
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 rare and fatal disease. Read More