GSK taps Sanofi vet to lead vaccine R&D; Bristol Myers names head of...
→ GSK has made a key hire for a crucial part of its business, appointing Sanjay Gurunathan as global head of vaccines and infectious disease R&D. Over the course of 25 years with Sanofi, Gurunathan...
View ArticleBiopharma leaders carving a path for the industry’s LGBTQ+ community
Welcome to the fourth edition of Endpoints News’ special report on scientists, executives, investors and other stakeholders in the biopharma’s LGBTQ+ community. Every year since the inaugural report in...
View ArticleOtsuka details positive Phase 3 IgAN data as it awaits FDA decision
Otsuka has shared the specifics of a late-stage win for a rare kidney disease treatment that’s on track to become its first wholly-owned product to be sold in the US. The biotech’s monoclonal antibody,...
View ArticleAt a crossroads, biotechs are passing on reverse mergers in 2025
Reverse mergers have once again lost their luster. An alternative to going public, reverse mergers once carried a negative stigma. But the financing vehicle gained newfound attention in recent years as...
View ArticleUS pharma imports normalize after March tariff stockpiling
After a rush of imports into the US in March as pharma companies sought to get ahead of the Trump administration’s tariffs, trading patterns have fallen back to normal, according to US government data...
View ArticleMIT scientists debut AI model Boltz-2 that predicts drug binding affinity
A trio of young MIT scientists unveiled a new AI bio model on Friday that predicts binding affinities, a major challenge to discovering drugs that has previously evaded progress with other AI methods....
View ArticleKelun's $250M PIPE; Valneva moves chikungunya vaccine to Phase 3 for kids
Plus, news about Trevi Therapeutics: Kelun Biotech’s $250M stock sale: The Sichuan company upsized its PIPE from $200 to $250 million and included investors from around the globe, including sovereign...
View ArticleIs there still hope for Summit's cancer drug buried in the data?
Although Summit Therapeutics didn’t present any data at ASCO's annual meeting, it still dominated the conversation at McCormick Place in Chicago. The company put out a press release the same Friday...
View ArticleUpdated: Omada Health rose 21% in its public market debut
Omada Health ended its first day of trading up 21% in a strong signal for the second digital health company to break into the public market this year. The virtual chronic care company's stock ...
View ArticleEMA considers serious eye condition a ‘very rare’ side effect of semaglutide
The European Medicines Agency said Friday that the product information for Novo Nordisk’s Ozempic and Wegovy should be updated to list a serious eye condition as a “very rare” side effect. A
View ArticleHighlights from #ASCO25; Biotech’s icy market; Sanofi’s $9B acquisition; and...
Happy Saturday, dear readers! It’s another edition of Endpoints Weekly, your one-stop shop for all of the week’s biggest biopharma news. So grab a cup of your favorite morning blend and let’s jump into...
View ArticleAvidity to seek accelerated approval for FSHD drug; Axsome to run another trial
Plus, news about Mosanna Therapeutics, Concentra Biosciences, Elevation Oncology, Keros, TuHURA Biosciences and PolyPid: Avidity Biosciences says FDA is open to accelerated approval for FSHD drug: The...
View ArticleNewAmsterdam's experimental cholesterol drug reduces presence of Alzheimer's...
NewAmsterdam Pharma’s stock ticked upward on Monday after a biomarker analysis of its experimental cholesterol-lowering drug showed promise in Alzheimer’s disease. The drug, a CETP inhibitor known as...
View ArticleMerck unveils Phase 3 data for oral PCSK9 inhibitor enlicitide decanoate
Merck’s drug candidate for high cholesterol has succeeded in two late-stage trials in different groups of patients, a milestone the company says should bring it a step closer to launching the first...
View ArticleFederally-funded cancer research comes to a perilous crossroads
Paul Nghiem and the physician-scientists who make up the Merkel Cell Carcinoma Collaborative (MC3) Institute have a lot riding on an upcoming decision at the National Cancer Institute about their $15.7...
View ArticleTwist Bioscience urges Trump administration for tariffs on synthetic DNA
While many major pharmas are speaking out against the threat of tariffs on their industry, one company is urging the government to increase taxes on imported synthetic DNA. Twist Bioscience CEO Emily ...
View ArticleFDA approves Merck's RSV antibody drug for babies
The FDA approved Merck’s RSV antibody for babies, teeing up a rivalry with Sanofi and AstraZeneca’s Beyfortus. The decision adds a new entrant to the RSV prevention space for the youngest kids, and...
View ArticleFDA limits stomach, esophageal cancer labels for Merck's Keytruda, Bristol...
The FDA late last month sent letters to Merck and Bristol Myers Squibb telling them that their blockbuster cancer drugs Keytruda and Opdivo should be limited to metastatic gastric, gastroesophageal...
View ArticleFormer HHS lawyer criticizes politicization of Novavax vaccine decision
The FDA's infusion of a political appointee into the approval decision for Novavax's Covid-19 vaccine "imperils public health and innovation," former HHS employees and others wrote in a JAMA viewpoint...
View ArticleFDA reinstates generic drug policy group let go in April firings
The FDA has reinstated a generic drug policy team that was laid off in April, one that was at least partially responsible for leading the agency to a record number of new generic drug approvals ...
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