AstraZeneca 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 irritable 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...
View ArticleSandoz agrees to $275M settlement in generic antitrust litigation
Sandoz has agreed to pay $275 million to settle multidistrict generic price-fixing claims brought by a group that includes some insurers and employee benefit plans. The deal doesn’t force Sandoz to ...
View ArticleMajor PBM reforms feature in Congress' year-end spending bill
An end-of-year spending bill will include major reforms to the ways pharmacy benefit managers operate, including significant new restrictions on the fees and rebates that have huge influence over the...
View ArticleJazz Pharmaceuticals CEO and co-founder announces retirement
Jazz Pharmaceuticals CEO Bruce Cozadd is ready to play his outro. On Monday, Cozadd announced plans to retire, nearly 22 years after co-founding Jazz and 15 years after becoming chief executive ...
View ArticleSiteOne Therapeutics, a pain biotech that's partnered with Vertex, nabs $100M
About eight years after its Series B, a small biotech working on non-opioid treatments has raised its Series C to gather clinical proof of concept in acute and chronic pain. And it’s a big round ...
View ArticleAurion’s eye cell therapy improves vision in small study, plots Phase 3 trial
Aurion Biotech said its cell therapy for treating the cornea improved vision at the highest dose, which it plans to further study in a Phase 3 trial beginning later next year. The Seattle-based biotech...
View ArticleExclusive: Insitro finds new ALS drug target in Bristol Myers deal
The AI-focused biotech insitro is advancing a new idea to potentially treat ALS, one of the most intractable and brutal diseases. The South San Francisco-based startup has identified a new drug target...
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