FDA
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
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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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Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
Both companies received agency requests for more evidence of the effectiveness of their therapies.
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.
The biologics center director reportedly became personally involved after the team reviewing the rare blood disorder filing asked for an extension to the CNPV-accelerated timeline.
Stifel analysts said the label for cardiac myosin inhibitor Myqorzo is in line with their expectations and is differentiated compared with BMS’ Camzyos.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market.
The tickets could go to the lipid-lowering pill enlicitide decanoate and the antibody-drug conjugate sacituzumab tirumotecan, though a spokesperson for the HHS did not confirm the news.
The FDA rejected the use of Exdensur, however, for chronic rhinosinusitis with nasal polyps.
Speaking on Bloomberg TV on Monday, FDA Commissioner Marty Makary contradicted recent reporting that suggested the agency was planning to add a black box label—its most serious warning—to COVID-19 vaccines.