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After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
FDA
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
FDA
As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters.
Roche is jumping into degrader-antibody conjugates, a modality that in recent years has attracted investments from Merck KGaA and Bristol Myers Squibb.
BioSpace’s Biopharma Job Market Report reveals early signs of recovery for 2026. A rise in job postings, a surge in contract roles and strong M&A and IPO activity point to future hiring growth and shifts in hiring strategy.
Sidewinder Therapeutics’ bispecific antibody-drug conjugates target pairs of receptors found on cancer cells, which the company claims improves their specificity and minimizes off-target effects.
Industry leader Steve Ubl has served as PhRMA’s CEO for more than a decade, the longest tenure of any head of the trade group.
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.