The FDA has approved Recarbrio (imipenem-cilastatin and relebactam), from Merck & Co. Inc., of Kenilworth, N.J., to treat adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
Intravenous artesunate, the international standard of care to treat severe malaria, has finally won full FDA approval for the condition, which affects about 300 of the approximately 2,000 people diagnosed with malaria in the U.S. each year.
As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed. In a question-and-answer guidance released late Tuesday, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics.
Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator.
Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease.
Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
Women, black and Hispanic/Latinx participants were underrepresented in pivotal clinical trials for drugs approved from 2007 to 2017, according to a new report by the Tufts Center for the Study of Drug Development. In the pivotal clinical trials, 44.9% of patients were women. Participants who identified as black or of African descent were the most underrepresented participant group, representing 5.4% of participants in clinical trials.
Only hours after Blueprint Medicines Corp. disclosed an FDA complete response letter for avapritinib in fourth-line gastrointestinal stromal tumor (GIST), Deciphera Pharmaceuticals Inc.’s kinase inhibitor, ripretinib, won the agency’s approval for the same indication, well ahead of its Aug. 13 PDUFA date.
The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism.
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