Two new ACIP picks were paid experts against Merck in court
Two of HHS Secretary Robert F. Kennedy Jr.’s new appointees to the CDC’s vaccine advisory board have previously served as paid expert witnesses for plaintiffs suing Merck over its HPV and MMR shots....
View ArticleFDA approves UroGen's bladder cancer hydrogel after negative adcomm vote
The FDA on Thursday approved UroGen’s application for its bladder cancer drug, despite a negative vote from an advisory committee last month. The drug, which UroGen will brand as Zusduri, is ...
View ArticleAnother care navigation deal
Capital Rx’s acquisition of Amino Health is the latest in a wave of consolidation in the care navigation space among companies that work with employers to connect their health plan ...
View ArticleCureVac CEO on the $1.25B BioNTech deal
After 25 years of trying to lead biopharma's mRNA revolution across infectious diseases and cancer, German biotech CureVac made the surprise announcement Thursday morning that it would exit to its...
View ArticleKennedy's doubts over vaccine placebos don't align with science, experts say
Much of HHS Secretary Robert F. Kennedy Jr.'s recent stated skepticism about vaccines is based on claims that many of the shots have never been tested against “inert” placebos. But experts interviewed...
View ArticleNovo Nordisk plans Phase 3 trials of oral, injectable amycretin
Novo Nordisk plans to go straight to Phase 3 with its experimental weight loss drug amycretin in the first quarter of 2026, the Danish drug giant said Thursday. The rush to late-stage testing signals...
View ArticleAppeals court upholds halt on Minnesota generic drug pricing law
A Minnesota drug pricing law violates the Constitution by allowing the state to essentially control prices outside of its borders, an appeals court ruled on Thursday. The US Court of Appeals for the...
View ArticleModerna wins FDA approval for expanded use of RSV shot in more adults
A little more than a week after Moderna’s new Covid-19 vaccine was approved, the FDA has expanded who can receive the company’s RSV shot. The agency approved mResvia on Thursday for at-risk adults aged...
View ArticleAstraZeneca, CSPC ink AI drug development deal for $110M upfront
AstraZeneca is further tightening its relationship with China, announcing a new research partnership with CSPC Pharmaceuticals on Friday. CSPC will receive $110 million upfront for the partners to...
View ArticleBristol Myers gets a key strategist with 'Team Shibs'; Idorsia to change CEOs...
Just a few months ago, Chris Shibutani was asking Bristol Myers Squibb executives about their strategy during the drugmaker's quarterly earnings calls. As of Monday, the recently departed Goldman Sachs...
View ArticleRein Therapeutics study on clinical hold; Beam updates sickle cell therapy data
Plus, news about Enliven Therapeutics, Merck's Keytruda and Celldex: FDA places hold on Rein study: The agency has “non-clinical requests” for Rein Therapeutics’ Phase 2 trial in idiopathic pulmonary...
View ArticleWith HIV prevention under attack, how might Gilead’s new PrEP injection fare?
A groundbreaking new therapy that can almost entirely prevent HIV is days away from an FDA decision — but a mix of recent federal politics and historically slow launches may get in its way. At stake ...
View ArticleFDA Commissioner Marty Makary calls for more consolidation
FDA Commissioner Martin Makary sent an email to staff this week announcing plans to further consolidate the agency’s operations outside of medical product reviews and inspections. Human resources,...
View ArticleFDA's oncology adcomm to review GSK's Blenrep relaunch plans
The FDA’s Oncologic Drugs Advisory Committee will meet on July 17 to discuss a potential relaunch of GSK’s multiple myeloma drug Blenrep. The committee will consider GSK's application to bring Blenrep ...
View ArticleKalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’
KalVista Pharmaceuticals said Friday that the FDA pushed back its decision on whether to approve its on-demand oral drug for hereditary angioedema, citing “heavy workload and limited resources” at the...
View ArticleFormer CEO Anne Wojcicki wins bid for 23andMe
23andMe said it agreed to sell itself to co-founder and former CEO Anne Wojcicki for $305 million, ending a bidding war for the struggling consumer genetic testing company. Wojcicki’s price of ...
View ArticleRFK removes all ACIP members, names new ones; National Resilience to close...
Welcome back to Endpoints Weekly! It was another busy news week, so let’s dive in. Our reporters tracked a number of updates from DC, including the removal of all 17 members of the CDC’s vaccine ...
View Article#EHA25: Gilead, Arcellx continue to tout safety of multiple myeloma cell...
Gilead and Arcellx reported that their multiple myeloma CAR-T therapy continued to show potentially better safety than Legend Biotech and Johnson & Johnson’s Carvykti, with comparable efficacy....
View ArticleLilly posts encouraging early-stage weight loss data on amylin candidate
Eli Lilly’s under-the-radar amylin analog allowed obese patients in a Phase 1 trial to lose up to 11.3% of their body weight. The drug appears to be more effective than similar offerings from companies...
View ArticleSupernus to acquire Sage Therapeutics for about $561M
Sage Therapeutics has finally found a buyer. It will be acquired by Supernus Pharmaceuticals for approximately $561 million, the companies announced Monday morning. Supernus is paying $8.50 per share,...
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