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As biotechs faced investors at the J.P. Morgan Healthcare Conference this week, they emphasized agreement with the FDA on clinical trial design and regulatory pathways to approval. Atara, meanwhile, lamented the agency’s “complete reversal of position” after its therapy for a rare surgical complication was rejected.
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It doesn’t matter how many times you have traversed Union Square; no one knows which way is north, or where The Westin is in relation to the Ritz Carlton. A Verizon outage brought that into focus on Wednesday.
Primarily known as an immunology and neuroscience company, AbbVie wanted to put the biopharma world on notice during its J.P. Morgan presentation: its oncology portfolio is underappreciated. This week, the Illinois-based company dove into the sizzling PD-1/VEGF space with a licensing deal with China-based RemeGen.
Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA.
Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy developers that is reinforcing fragmentation, stalling innovation and delaying access to treatments.
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a stop to all shipments of the Duchenne muscular dystrophy therapy Elevidys following a third patient death linked to the underlying platform.
Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys.
In advance of CMS’ negotiated price for the blood thinner taking effect next year, partners Bristol Myers Squibb and Pfizer pitched the direct-to-consumer program as a way to allow uninsured, underinsured and self-pay patients to pay less out of pocket.
Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.
The life sciences job market continues to shift. BioSpace’s Q2 2025 U.S. Life Sciences Job Market Report is now available, offering exclusive insights into the latest hiring trends, layoffs, and workforce dynamics across the life sciences industry.