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Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
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.
IPO
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
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Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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In this episode of Denatured, you’ll hear from Jason Jones, head of global business development at Cellular Origins and Alexander Seyf, founder & CEO of Autolomous. They discuss how the push to scale cell and gene therapy manufacturing is accelerating interest in automation, digitization, robotics and deeper collaboration across the ecosystem.
Gilead Sciences has inked three deals this year so far totaling $14.77 billion, a marked escalation of the company’s usual M&A pace. Executives detailed the rationale for buying Arcellx, Ouro Medicine and Tubulis GmbH and whether they are interested in further deals.
Looking for a biopharma job in Texas? Check out the BioSpace list of 10 companies hiring life sciences professionals like you.
“Your tenure has overseen a DESTRUCTION of shareholder value—a direct result of chronic operational shortcomings and failures on fiduciary duty,” Shah Capital wrote to Novavax’s leadership in an open letter published Wednesday.
After a Phase 2 flop, Brinsupri exits the race to market for the chronic skin disease hidradenitis suppurativa, but other companies, including Incyte, Novartis and UCB, have recently notched clinical and regulatory victories.
Another bidder, which remains unidentified, dropped out of the bidding process. Analysts at William Blair now think it unlikely that another suitor could offer a counter-proposal to Merck’s outstanding $6.7 billion acquisition offer.
The approval of Eli Lilly’s oral obesity drug officially ignites an intense competition with Novo Nordisk’s oral Wegovy; Gilead Sciences and Neurocrine Biosciences keep the M&A train chugging; Trump hits pharma with his long promised tariffs, and the FDA proposes many changes with 2027 budget.
Some bosses stretch you. Others make work more bearable. Both can earn your loyalty. Only one is building your future. Leadership coach Angela Justice explains how to tell the difference.
As cell and gene therapy developers face rising pressure to produce therapies faster and at lower cost, the industry is leaning on robotics, digital systems and partnerships to bridge the gap between innovation and delivery.
As Daré Biosciences approaches a pivotal year with a key product launch ahead, the company kicked off an open public offering, providing a chance for individuals to get involved for as little as $250.