FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
FEATURED STORIES
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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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.
Esai, Biogen, Diadem and ProMis all presented their findings on biomarker research at this year’s International Conference on Alzheimer’s and Parkinson’s Diseases.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
Merck’s Keytruda has become an approved treatment for yet another indication: unresectable or metastatic advanced endometrial carcinoma. Know more about it here.
Ztalmy is Marinus’ oral suspension medication for patients ages two years and older who experience seizures linked with cyclin-dependent kinase-like 5 deficiency disorder.
BMS achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of melanoma.
It was a busy week for clinical trial announcements. Here’s a look.