News

The staffing changes will focus resources on work that creates the highest impact for patients, according to Genentech. The number of employees affected is unknown, but longtime veteran Vishva Dixit is out.
FEATURED STORIES
As the industry faces policy changes and significant cuts to federal funding, local ecosystems can bolster companies through innovative resources to sustain growth and keep the U.S. at the center of biomedical innovation.
Over the past decade, Eli Lilly has bought out more biotechs than any of the other top 12 pharmas by revenue—with 10 of those acquisitions arriving just this year.
Members of the American Biotech Innovation Alliance (ABIA) want to build a national biotech strategy—just like China did years ago.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
A lower court had previously ruled for Sarepta in the companies’ long-running dispute, finding that REGENXBIO’s AAV patent was invalid because its elements were naturally occurring. The appeals court on Friday said that this original decision adopts a “narrow” view of the invention.
The centerpiece of the takeover is anito-cel, a CAR T therapy under development for relapsed or refractory multiple myeloma. An FDA decision on the therapy is expected by December 2026.
Head-to-head trials are often reserved for approved therapies as drugmakers try to one-up each other to gain further market share. In this case, Novo Nordisk ran the test at the candidate stage, and the bet did not pay off.
The U.S. Congress greenlit a historic $315 million in federal ALS research funding for 2026 amid Rare Disease Month, spotlighting biotech progress like VectorY Therapeutics’ first patient dosing in its TDP-43-targeting PIONEER-ALS trial and EverythingALS’ pharma consortia driving biomarker innovations and trial alignment.
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
FDA
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
Tracy Beth Høeg addressed FDA staffers for the first time in her role as the fifth CDER chief under President Donald Trump, announcing inquiries into the use of SSRIs in pregnancy and RSV antibodies in infants despite well-documented safety of these treatments.
In this episode of Denatured, you’ll be listening to Jane Hughes, President of R&D and Co-founder of Verdiva Bio, and Jon Rees, CEO and Co-founder of MitoRx Therapeutics. We’ll discuss next-generation obesity solutions tackling GLP-1’s muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.