FDA
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
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The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”
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Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
UCB’s oral drug for seizures related to Lennox-Gastaut syndrome is now approved in the U.S. for patients ages two years and older.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
Novavax announced today that its protein-based Covid-19 vaccine, NVX-CoV2373, is included in two new clinical trials that will evaluate the vaccine as a potential Covid booster.
The FDA delayed Bristol Myers Squibb’s (BMS) target date for Reblozyl, approved the company’s melanoma drug and Japan accepted BMS’ NDA for Breyanzi.
Pfizer has announced it received Breakthrough Therapy Designation from the FDA for its vaccine candidate intended to prevent infections caused by the respiratory syncytial virus (RSV).
The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
The FDA approved Pluvicto (targeted radioligand therapy) for use in adults with PSMA-positive mCRPC that has already metastasized to other body parts.