Archive for September 2022

The FDA’s Vaccines and Related Biological Products Advisory Committee agreed yesterday — somewhat grudgingly — that Rebyota (RBX2660), Rebiotix’s standardized fecal microbiota suspension, is a safe and effective treatment for recurrent Clostridium difficile infections (CDI). Source: Drug Industry Daily

Spectrum Pharmaceutical’s experimental cancer drug Pozenveo (poziotinib) got the thumbs down from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in a vote of nine to four yesterday. Source: Drug Industry Daily

Scottsdale, Ariz.-based BioLab Sciences has received an FDA warning letter for selling human tissue products without approved Biologics License Applications and for persistent deviations from current good manufacturing practice (cGMP) practices. Source: Drug Industry Daily

Reauthorization of FDA’s user fee legislation moved ahead a step on Thursday as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee agreed to include a slimmed-down version of user fee legislation and smaller policy riders on a short-term government funding bill, or continuing resolution (CR).…

In another move to address the opioid crisis, the FDA has issued a guidance — effective immediately — that clarifies some supply chain requirements for the overdose treatment Naloxone (naloxone hydrochloride) to help make the treatment more accessible. Source: Drug Industry Daily

Makers of generics and biosimilars who have a hard time obtaining the samples of the reference product they need to develop their alternative products can turn to the FDA for documentation to present to reluctant brand-name owners. Source: Drug Industry Daily

Following a month-long inspection in August, the FDA reprimanded Catalent for numerous quality lapses observed at its Bloomington, Ind., plant — where the drugmaker has performed manufacturing activities for both Moderna’s and Johnson & Johnson’s COVID-19 vaccines. Source: Drug Industry Daily

In many ways, there are more questions than answers in the FDA’s long-awaited and recently published Overdose Prevention Framework. Source: Drug Industry Daily

In briefing documents, the FDA expressed four major concerns about Pozenveo (poziotinib), Spectrum Pharmaceutical’s experimental lung and breast cancer drug, ahead of today’s meeting of the FDA’s Oncologic Drugs Advisory Committee. Source: Drug Industry Daily

In addition to being interchangeable with their reference products, biosimilars approved in the EU are interchangeable with an equivalent biosimilar, the European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) said in a joint statement. Source: Drug Industry Daily