News
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.
FEATURED STORIES
Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
THE LATEST
A combination of Gilead Sciences’ domvanalimab and Arcus Biosciences’ zimberelimab, along with chemo, has shown an “encouraging” overall response rate in a mid-stage study.
Although it hit primary and secondary endpoints in a Phase II study, Ventyx Biosciences concluded that the results weren’t strong enough to face the stiff competition for the indication.
BioSpace has published its annual 2024 Best Places to Work list.
For $80 million upfront and the promise of more than $1.2 billion in milestones, Novartis has bought the global rights to develop an oral HDAC6 inhibitor from Chong Kun Dang Pharmaceutical.
The cell therapy-focused biotech will use most of the net proceeds from its initial public offering to fund Phase II clinical trials for its lead program, a novel CAR T-cell candidate.
In the third quarter, Vertex Pharmaceuticals reported revenue of $2.48 billion, a 6% increase from the same period in 2022. However, these figures fell short of Wall Street’s consensus estimates.
The Department of Health and Human Services in a court filing last week said that the blockbuster treatment could be “deselected” from the drug price negotiation list, given the recent approval of Amgen’s Stelara biosimilar.
Although Kodiak Sciences initially scrapped its development of tarcocimab tedromer after late-stage failures, new data has convinced the company to give the eye drug another shot.
After its deal with Tubulis in April 2023, Bristol Myers Squibb is continuing its antibody-drug conjugate buying spree by acquiring an asset from South Korea’s Orum Therapeutics.
Seeking to weather declining sales from its COVID-19 business in the third quarter, Pfizer is laying off approximately 200 employees at its manufacturing facility in Kalamazoo, Michigan.