Vaxcyte's Phase 2 pneumococcal vaccine data disappoint investors
Vaxcyte’s stock price {$PCVX} dropped by 50% on Monday after the company reported new Phase 2 data from a study evaluating an experimental pneumococcal vaccine in infants. The company said VAX-24 was...
View ArticleFDA reschedules opioid-focused advisory meeting
A meeting of outside experts to discuss the FDA’s post-marketing requirements for opioid medications is now slated for May 5 after being postponed earlier this year. The meeting — originally scheduled...
View ArticleHeart gene therapy company Tenaya to lay off 30% to 40% of staff
Heart gene therapy maker Tenaya Therapeutics is laying off 30% to 40% of its staff by the end of the year, the company’s CEO Faraz Ali told Endpoints News by email. Tenaya had 97 employees ...
View ArticleFDA changes may not be over after Marks exit, with more cuts and departures
A top official pushed out over vaccines. Senior staff heading for the exit. Thousands of workers targeted for firing. A new commissioner who has yet to visibly take charge ...
View ArticleDC court sides with HHS in Vertex's fertility program fight
Vertex lost a legal battle against the federal government on Monday over its proposed fertility support program that would have offered up to $70,000 in services for certain gene therapy patients. A DC...
View ArticleFederal judge nixes FDA's lab-developed test rule
The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s regulation, a Texas federal court held on Monday. The decision is a ...
View ArticleJ&J’s third talc bankruptcy bid is stopped by Texas federal judge
A federal judge on Monday dismissed a Johnson & Johnson subsidiary’s third attempt to settle tens of thousands of talc cases through bankruptcy. Judge Christopher Lopez cited multiple issues with...
View ArticleSanofi continues its bet on R&D by poaching GSK’s head of development
Sanofi is boosting its research and development team by hiring GSK’s former head of development Chris Corsico, according to an internal company communication obtained by Endpoints News. Corsico will...
View ArticleLilly claims Phase 2 win for siRNA approach to mixed dyslipidemia
Eli Lilly’s RNA candidate has reduced levels of a protein linked with cardiovascular disease risk in a mid-stage trial in patients with high cholesterol. Solbinsiran, a small interfering RNA,...
View ArticleRNA editing startup AIRNA raises $155M for liver and lung disease therapy
When the transatlantic startup AIRNA launched in 2023, it was already years behind other companies that were trying to bring a new form of genetic medicine known as RNA editing into the clinic. But...
View ArticleBig ambitions at Merck and AstraZeneca — along with a few giant pitfalls —...
Step back from the multitude of details that go into every big pharma pipeline, and you'll see the influence that blockbusters have on the entire field. These days, making your mark in R&D at the ...
View ArticleTalkspace makes AI therapy podcasts for patients
Talkspace is using AI to make mini podcast episodes from patients’ therapy sessions. Virtual mental health companies have increasingly used AI to personalize experiences for users. Companies like...
View ArticleFirings sweep across FDA, gutting leadership and whole offices
Mass firings and forced resignations swept through the FDA on Tuesday, as part of thousands of planned job cuts at federal health agencies being implemented by the Trump administration. Some employees...
View ArticlePrazer Therapeutics raises $20M; Carisma lets go of most staff
Plus, news about Cerevance, Oncopeptides, LifeMine, Bavarian Nordic and Eagle Pharmaceuticals: South Korean biotech’s Series B: Prazer Therapeutics nabbed a $20 million Series B from Premier Partners,...
View ArticleQ&A: Isomorphic Labs CEO Demis Hassabis on $600M raise, AI biotech's future
Isomorphic Labs wants to achieve "maximum acceleration" on its drug discovery research progress, Demis Hassabis told Endpoints News. In an interview on Monday shortly after announcing the startup's...
View ArticleGubra’s AbbVie-partnered amylin looks competitive with Zealand’s in early trial
GUBamy, the amylin obesity candidate developed by Gubra and licensed to AbbVie for $350 million last month, demonstrated encouraging weight loss in an early trial. The Danish company
View ArticleCompass Therapeutics' cancer trial succeeds, needs more data
Compass Therapeutics said Tuesday that adding its bispecific antibody to chemotherapy significantly improved response rates compared to chemotherapy alone in a Phase 2/3 biliary tract cancer study. Not...
View ArticleAxsome reports Phase 3 depression fail for Sunosi
Axsome Therapeutics said Tuesday that a Phase 3 trial for its narcolepsy drug Sunosi failed to meet its primary goal in major depressive disorder. The company was testing Sunosi in patients who had MDD...
View ArticleZus Health CEO Jonathan Bush on the future of health records
My primary care doctor and my OB-GYN have no idea what each other did or prescribed at my last appointments with each. They rely on me to fill them in (even though they work in ...
View ArticleEuropean regulator proposal would ‘streamline’ biosimilar process
The European Medicines Agency is looking to simplify the way it approves biosimilars by removing the need for “extensive” clinical data, which would likely cut the cost of entry into the market. The...
View ArticleFDA cuts hit drug ad review office, in seeming contradiction with Kennedy's...
HHS Secretary Robert F. Kennedy Jr. has made clear that he would like to ban direct-to-consumer drug advertisements on television and elsewhere. Instead, on Tuesday, he got rid of many of the FDA...
View ArticleEli Lilly sues Empower, Strive over tirzepatide products
Eli Lilly has sued two large compounding pharmacies, alleging they deceive patients and put them at risk with compounded versions of the obesity drug tirzepatide in combinations or forms that haven’t...
View Article‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul
WASHINGTON — The size and scope of the FDA that began Tuesday won’t be the same as the day nears a brutal conclusion for agency staffers that were laid off or forced to resign. Sitting in ...
View ArticleJudge orders HHS, other agencies to 'undo' probationary worker firings
The HHS and other federal agencies must reverse the terminations of probationary government workers that were fired in the states challenging the cuts, under a new order issued late Tuesday by a...
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