Inspirna, which was preparing for a Phase 3 cancer trial, has folded
A New York City drug developer led by well-known executives and backed by some of the top names in biotech investing is shutting down, a blow to a company that was prepping for a pivotal ...
View ArticleLifeMine’s restructuring; Europe won’t renew authorization for PTC’s Duchenne...
Plus, news about Opthea, Apollomics, LaunXP and AstraZeneca: LifeMine reduces headcount: The Boston biotech went through a “company-wide restructuring,” according to employees’ LinkedIn posts. The...
View ArticleLilly's heart drug study shows potential for once-a-year dosing
Phase 2 results on Eli Lilly’s experimental heart disease drug showed it could be dosed far less frequently than competing treatments in development from Novartis and Amgen, giving Lilly a way into an...
View ArticleBiotech markets fall as industry takes stock of Marks' exit at FDA
The departure of one of the FDA’s highest-profile regulators, whose career was defined by advancing new technologies to patients, rattled investors and companies who were already feeling insecure....
View ArticleAstraZeneca’s cholesterol pill is set for Phase 3, but lags behind Merck rival
AstraZeneca has great ambitions for its mid-stage oral cholesterol drug, believing that it could reach peak sales of more than $5 billion. Positive data presented Monday at the American College of...
View ArticleMerck’s PAH drug slashed risk of serious events in halted trial
New data unveiled Monday showed that Merck’s Winrevair can significantly cut the risk of death, lung transplantation and hospitalization in patients with a rare form of high blood pressure in the ...
View ArticleCorcept shares soar after Phase 3 win in ovarian cancer
Corcept Therapeutics’ oral glucocorticoid receptor antagonist has improved survival outcomes in a late-stage test in patients with a challenging form of ovarian cancer, sending its shares up 76% at...
View ArticleVaxcyte's Phase 2 pneumococcal vaccine data disappoint investors
Vaxcyte’s stock price {$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...
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