Archive for June 2022

The Health Resources & Services Administration (HRSA) has contacted drugmaker UBC to admonish the company for limiting its participation in the federal 340B drug discount program, which was designed to serve low-income patient populations in the U.S. Source: Drug Industry Daily

Just ahead of its user fee decision date, Spero Therapeutics was slapped with a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection (cUTI), including pyelonephritis — a type of kidney inflammation with limited oral treatment…

Gilead Sciences has reached a $33 million settlement with a Florida clinic accused of fraudulently applying to the company’s patient assistance program via homeless people and those in low-wage jobs in order to get access to Gilead’s pricey human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) drugs for free, then selling them on the black market.…

The FDA has released its Spring 2022 regulatory agenda, pushing back the timing of several previously announced proposed and final rules, and signaling its intention to issue a proposed rule on compounded drug products by the end of the year. Source: Drug Industry Daily

For circumstances when drugmakers feel labeling alone isn’t enough to ensure safe selection and use, the FDA is proposing a rule that would expand the pool of nonprescription drugs with “self-selection systems” that would identify the appropriate patients and guide them in taking the medicines safely. Source: Drug Industry Daily

The FDA should be allowed to reform the citizen petition process and change how complex generic drugs are approved, the Brookings Institution and the University of Southern California (USC) propose in a recently published paper. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Under a new five-year action plan for accelerating the development of treatments for rare neurodegenerative diseases, the FDA will focus on incorporating new technologies and innovative trial approaches beginning with the study of amyotrophic lateral sclerosis (ALS). Source: Drug Industry Daily

Sarepta Therapeutics has been hit with an FDA clinical hold on its trial of SRP-5051 (vesleteplirsen) for the treatment of Duchenne muscular dystrophy after a trial participant experienced a serious adverse event (SAE) that could have been life-threatening. Source: Drug Industry Daily

The FDA has expanded the scope of its 2013 drug manufacturing guidance on penicillin cross-contamination to cover compounds containing a non-penicillin beta-lactam ring, a chemical structure essential for antibacterial activity. Source: Drug Industry Daily