US drugmakers seek clinical trials abroad as confidence in FDA wavers
When Siren Biotechnology CEO Nicole Paulk learned last month that top FDA official Peter Marks had resigned, she began looking outside the US for a place to host a planned clinical trial ...
View ArticleCROs raise the alarm as clients delay R&D plans over funding, tariff worries
Contract research organizations Icon and Medpace have both reported high rates of canceled or delayed R&D projects on the back of the Trump administration's funding cuts and potential...
View ArticleFuture House debuts free AI agent for science platform
Open source doesn't necessarily mean easy access, and now the nonprofit Future House is trying to bridge that gap for AI tools in science by launching a new platform. On Thursday, Future House
View ArticleZocdoc launches an AI voice assistant
Zocdoc, the health tech company known for helping patients book doctor visits online, is launching an AI assistant to schedule appointments — over the phone. The AI agent, Zo by Zocdoc ...
View ArticleModerna’s vaccine revenue miss disappoints Wall Street
Moderna tried to assuage investors Thursday that enhanced scrutiny of its vaccines in the US wouldn’t hamper its progress. Ultimately, though, middling execution of the business may have proved to be...
View ArticleLilly CEO Ricks urges Trump to drop drug tariff plan
Eli Lilly CEO David Ricks continued his pushback against the Trump administration's plan to put tariffs on pharmaceutical products made outside the US, making some of the industry's most forceful...
View ArticleBristol Myers to close cell therapy site in Illinois
Bristol Myers Squibb is ending operations at a viral vector production site in the Chicago suburbs, a spokesperson for the company confirmed to Endpoints News. The move comes almost two years to the...
View ArticleExperts refute RFK Jr.'s claim that placebo-controlled trials for vaccines...
HHS Secretary Robert F. Kennedy Jr. claimed that moving forward, all new vaccines will need to be tested in placebo-controlled trials before they can win FDA approval, calling it "a radical departure...
View ArticleFDA adcomms to review data on long-term opioid use, overdoses
FDA advisors next week will discuss the risks of long-term opioid use during a joint-committee meeting that will examine two completed post-marketing studies the agency requested more than a decade...
View ArticleAmgen's obesity drug MariTide starts Phase 3, new program in Phase 1
While Pfizer recently pulled the plug on its most advanced obesity candidate, Amgen has moved its own key weight loss play into Phase 3 studies. Amgen has emerged with one of the leading efforts in ...
View ArticleHHS launches $500M universal vaccine platform as RFK Jr. shakes up US vaccine...
The US Department of Health and Human Services rolled out a new $500 million initiative to develop universal vaccines for “pandemic-prone” viruses such as influenza and Covid-19. The effort announced...
View ArticleCytokinetics' stock drops after heart drug PDUFA pushed back due to lack of REMS
Cytokinetics said late Thursday that the PDUFA date for its heart disease therapy aficamten would be delayed by three months to Dec. 26. The lag would allow the FDA to review ...
View ArticleInvestors unveil plans for $1.3B cancer hub in London suburbs
Aviva Capital Partners and development company Socius are planning a new £1 billion ($1.3 billion) hub dedicated to cancer research in the town of Sutton, just outside central London. The cancer hub...
View ArticleFormer Tome CEO joins Flagship startup; NGM Bio chief steps down as...
Flagship Pioneering has recruited Rahul Kakkar to lead its genetics-based drug discovery startup Quotient Therapeutics. Kakkar was most recently CEO of Tome Biosciences, a high-profile gene editing...
View ArticleHow SalioGen's attempt to turn ‘jumping genes’ into medicines fell apart
In the spring of 2022, Ray Tabibiazar summoned his scientists for a pep talk. His startup, SalioGen Therapeutics, had just raised $115 million for a technology dubbed Gene Coding that was framed as a...
View ArticleKura gets $45M milestone payment from Kyowa Kirin; Pliant’s restructuring
Plus, news about AstraZeneca, Otsuka and BioMarin: Kura Oncology records $45M milestone: It received the payment from Kyowa Kirin after the FDA submission of ziftomenib in April. The companies first ...
View ArticlePathos AI gets AstraZeneca funding as biotech plans to raise up to $400M
Pathos AI, a Chicago biotech led by executives of the healthcare AI group Tempus, is looking at a funding round of up to $400 million, per a new regulatory
View Article#AACR25: Roche's first results for Werner drug that uses synthetic lethality
CHICAGO — A new type of targeted cancer drug that blocks a “DNA caretaker” protein called Werner helicase has captured the attention of several big pharma companies in recent years, and the first data...
View ArticleFeng Zhang’s protein nanoparticle startup Aera Therapeutics turns to lipid...
When CRISPR pioneer Feng Zhang met with investors to discuss his new drug delivery technology over dinner in the summer of 2021, it didn’t take long to pitch the idea.
View ArticleFDA withdraws compliance deadlines for makers of bone allografts
The FDA on Friday said it's pulling two final guidance documents published earlier this year that sought to help entities manufacturing cell- and tissue-based medical products to make better donor...
View ArticleWhite House budget proposes billions in cuts at NIH, CDC
The White House’s budget request proposes nearly $18 billion in cuts to NIH spending, and more than $3.5 billion slashed at the CDC. And the changes would include major consolidation at both agencies....
View ArticleAfter FDA firings, drug reviewers are asked to volunteer for administrative work
Leadership in the FDA's Office of New Drugs sent an email to staff Friday afternoon asking if anyone would volunteer to take on more administrative work, following the firing of many of the agency's...
View ArticleVertex drops AAV gene therapy research, tRNA therapy partnership
Vertex is pulling back on its genetic medicine research, ending all work related to adeno-associated viruses, or AAVs — the viral vectors commonly used to deliver gene therapies into the body, the...
View ArticleEarnings season continues; FDA delays PDUFA date; AACR recap; and more
Welcome back to Endpoints Weekly, our roundup of the top headlines in biopharma. Earnings season continued this week, with more comments from pharma executives on the potential impact of tariffs, new...
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