News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
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.
THE LATEST
The discounts should be compared against the drugs’ “ultimate net price” rather than their indicated list price to gauge the true impact of the negotiations, BMO Capital Markets analysts said.
Imfinzi is the first immunotherapy approved for perioperative use to treat gastric and gastroesophageal junction cancers.
A coordinated national effort is emerging to bring alternatives to animal testing into routine preclinical use, backed by a fresh FDA roadmap and a global coalition of scientific and industry partners.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.