After years of trying to pass legislation that would allow the U.S. government to negotiate with drugmakers on prescription drug prices for the Medicare program, the Democrat-controlled U.S. House of…
Bavarian Nordic is chiding the FDA after the agency recommended intradermal (ID) administration of Jynneos, the company’s monkeypox vaccine, in its Aug. 11 Emergency Use Authorization (EUA). Source: Drug Industry…
A new FDA study of character-space-limited (CSL) communications to promote prescription drugs showed that patients understood a drug’s risk better when the risk was included in an initial tweet rather…
New evidence shows that an additional 135 million COVID-19 vaccine doses manufactured at the troubled Emergent BioSolutions’ Bayview, Md., facility will need to be destroyed following the discovery of quality…
Catalent announced that it will shell out $475 million to acquire Metrics Contract Services, a specialty contract development and manufacturing organization (CDMO) with a 333,000 square-foot facility in Greenville. Source:…
The FDA slapped Akorn, a sterile drug manufacturer, with a Form 483 over unexplained discrepancies and batch failures following an inspection of its Decatur, Ill., plant conducted from March 28…
BeiGene’s anti-PD-1 monoclonal antibody tislelizumab has racked up more positive phase 3 numbers, proving itself just as good as sorafenib in extending the lives of patients with unresectable hepatocellular carcinoma.…
Abecma (idecabtagene vicleucel), a first-in-class CAR-T cell treatment codeveloped by Bristol Myers Squibb and 2seventybio, significantly improved progression-free survival relative to standard therapy in patients with relapsed multiple myeloma, the…
A federal court in Kansas has ruled that a class action antitrust lawsuit against Mylan over marketing and distribution of its EpiPen can go forward. Source: Drug Industry Daily
The FDA is reviewing a Biologics License Application (BLA) for an innovative, first-in-class treatment for potentially fatal Clostridium difficile infections — an enema-delivered human stool transplant. Source: Drug Industry Daily