FDA
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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The company added an indication to Lynparza’s label for the treatment of adults with metastatic castration-resistant prostate cancer, while cutting an antibody for Crohn’s disease and ulcerative colitis.
Abrysvo’s approval in adults aged 60 years and above comes ahead of an expected August decision in the pediatric setting.
Efforts are underway to fast-track approval for costly gene therapies and make them affordable to a wider patient group via reimbursement through Medicare and Medicaid.
Following a series of stumbles in Type 1 diabetes, Lexicon’s dual SGLT inhibitor sotagliflozin finally won the FDA’s approval in heart failure and will be marketed as Inpefa.
The FDA approved Braeburn Pharmaceuticals’ new buprenorphine treatment option with extended-release medication that could pave the way for greater patient compliance.
The regulator approved Xacduro for treating hospital-acquired and ventilator-associated bacterial pneumonia. The NDA was filed by Entasis Therapeutics, which Innoviva acquired in 2022.
With the FDA’s approval on Monday, Ayvakit is the first and only treatment for adults with indolent systemic mastocytosis, a rare hematologic disorder, according to Blueprint Medicines.
Indivior’s Opvee is an emergency nasal spray medication to reverse opioid overdose approved for patients aged 12 years and above with signs of respiratory or central nervous system depression.
The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.
With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.