Checkpoint wins FDA approval of checkpoint inhibitor in advanced skin cancer,...
The FDA approved Checkpoint Therapeutics’ anti-PD-L1 antibody cosibelimab in a form of advanced skin cancer, the company announced Friday. The immune checkpoint drug will be marketed as Unloxcyt and...
View ArticleNeurocrine gets FDA approval in rare adrenal gland condition
A turbulent 2024 for Neurocrine is ending on a high note, after the biotech won FDA approval to treat congenital adrenal hyperplasia, a condition marked by adrenal gland dysfunction. The Friday
View ArticleHRSA pushes back against another 340B rebate model, this time from Sanofi
The US Health Resources and Services Administration on Friday warned Sanofi against implementing its planned rebate model for some of its outpatient drugs under the drug discount program for low income...
View ArticleWhat a Trump FTC means for biotech and pharma dealmaking
President-elect Donald Trump’s two picks for the Federal Trade Commission are likely to usher in more life sciences deals while maintaining the agency’s pressure on pharmaceutical intermediaries. A...
View ArticleViridian readies for Tepezza rivalry with new Phase 3 data in thyroid eye...
Viridian Therapeutics’ stock jumped Monday after the company unveiled another Phase 3 look at its potential competitor to Amgen's Tepezza in thyroid eye disease. Veligrotug met all its primary and...
View ArticleAstraZeneca denied full FDA approval of Andexxa after adcomm
AstraZeneca said the FDA declined to fully approve its anticoagulant reversal drug Andexxa, less than a month after an advisory committee meeting at which the agency and a group of outside advisors...
View ArticleFood as medicine could get boost from Trump presidency
The concept that doctors can improve patients’ health by prescribing certain foods, just as they do medicines, has been hovering on the fringes of the healthcare industry for decades. Recently, that...
View ArticleShinobi adds Borges as science chief, Katz as top medical officer
Shinobi Therapeutics, an off-the-shelf cell therapy developer, told Endpoints News it has hired its first chief scientific and medical officers as it also nabs two leaders in the cell therapy field for...
View ArticleMerck winds down TIGIT, LAG-3 programs meant to temper Keytruda erosion
After multiple clinical failures, it’s finally the end of the road for Merck’s TIGIT program. The company is dropping development of its anti-TIGIT candidate vibostolimab after two more Phase 3 studies...
View ArticleFDA rejects J&J’s subcutaneous Rybrevant over manufacturing issues
The FDA has issued a complete response letter to Johnson & Johnson for the subcutaneous version of its lung cancer drug Rybrevant after issues were found during a pre-approval inspection of a...
View ArticleTeva and Sanofi report Phase 2b data for duvakitug in IBD
Teva and Sanofi announced positive mid-stage results ahead of schedule for their inflammatory bowel disease candidate as they look to keep pace in an anti-TL1A race with Merck and Roche. The duo’s...
View ArticleEmployee lawsuit over J&J's own health costs may loosen PBMs' grip
Ann Lewandowski knows all about pharmacy benefit managers, or PBMs, the companies that shape the US drug market. Her job as a policy advocate at Johnson & Johnson was to tell patient and physician...
View ArticleUCB, Novartis say a Phase 2a Parkinson's study failed
UCB and Novartis ended development on the lead program in their partnership after reporting a Phase 2a failure in Parkinson’s disease. The companies said Monday that minzasolmin, a small molecule...
View ArticleChicago’s biotech scene is growing up. What’s fueling it?
CHICAGO — Over the years, a handful of cities have tried catching up to the flourishing biotech hubs in Boston or the San Francisco Bay Area. Chicago, the third-largest city in the US, is putting ...
View ArticleHealth tech investing during Trump 2.0
With the presidential inauguration roughly a month away, we checked in with some top health tech investors about what they're predicting. Most don't expect huge changes, though they anticipate some...
View ArticlePfizer projects stability for 2025 amid turbulence in DC
Pfizer is targeting a steady 2025, promising pipeline trims, cost cuts and smaller deals as it works to reassure investors about its path forward. What it's not projecting is much growth. Its revenue...
View ArticleIn surprise move, FDA's No. 2 Bumpus to leave agency at end of 2024
FDA Principal Deputy Commissioner Namandjé Bumpus told FDA staff that she will leave the agency by the end of the year, according to emails reviewed by Endpoints News. Bumpus, the agency's former chief...
View ArticleRegeneron looks to expand label of Eylea HD early next year
The high-dose version of Regeneron's eye treatment Eylea hit its primary endpoint in a late-stage study for macular edema following retinal vein occlusion, a common eye disease where fluids build up in...
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