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The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
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At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
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.
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.
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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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While industry groups decried the Trump administration’s new drug pricing order, analysts say it lacked details and the teeth to make a major impact without an act of Congress.
Lexeo wants to more quickly move investigational gene therapy LX2006 into a registrational study and hopes for a potential efficacy readout in 2027.
The package revives President Donald Trump’s much-maligned Most Favored Nation rule but goes further into the private markets and beyond, leveraging the patent system, drug importation and more.
In addition to eliciting greater weight loss than Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound does not come at the expense of safety, according to newly released comprehensive tolerability data—findings that Leerink analysts say confirm the GLP-1 drug’s edge in the closely watched market race.
Last month, Roche committed $50 billion in U.S. manufacturing funds, with which it will construct at least four new facilities.
The Plavix lawsuit dates back to 2014, when Hawaii first sued BMS and Sanofi, alleging that they failed to properly inform patients in the state that the drug is likely to be less effective for them.
The FDA and CDC have also recommended pausing the use of Ixchiq in seniors 60 years and older while safety investigations are ongoing.
While Quantum computing has been reported to be five years away for many years now, companies are preparing for it by setting foundations with AI in development.
As the Trump administration slashes funding for HIV-related research and infrastructure, Gilead, Immunocore and more are targeting the next goalpost: a cure.
To more effectively treat neurodegenerative conditions, we first need diagnostic tools that lend a more complete picture of protein aggregates in the brain.