Clik here to view.
FDA greenlights Geron’s imetelstat to treat anemia in certain cancer patients
The FDA approved Geron’s imetelstat to treat certain anemic myelodysplastic syndrome (MDS) patients who are dependent on blood transfusions. The approval comes after the FDA’s Oncologic Drugs Advisory...
View ArticleFederal judge dismisses antitrust claims brought against Bristol Myers by...
A federal judge in New Jersey district court on Thursday dismissed anticompetitive claims brought against Bristol Myers Squibb by a number of insurers over an alleged scheme to delay generic entry for...
View ArticleFDA raises questions about Lilly's Alzheimer's drug; Adcomm votes against...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleAmber raises $100M Series A for two-in-one urinary incontinence treatment
Amber Therapeutics completed its $100 million Series A raise to support its implantable therapy for mixed urinary incontinence through a registrational trial in 2026. The proceeds should give Amber a...
View ArticleGSK wins expanded FDA approval for RSV shot in at-risk adults ages 50 to 59
The FDA on Friday expanded GSK’s RSV vaccine to people ages 50 to 59 who are at an increased risk of the virus, marking another win for the blockbuster shot. GSK’s Arexvy, which was first approved in...
View ArticleModerna’s Covid-19 and flu combo vaccine succeeds in Phase 3 study
Moderna’s Covid-19 and influenza combination vaccine was comparable to shots separately marketed for the two infections in a Phase 3 trial, the company announced Monday morning. Plans are underway to...
View ArticleGSK nixes SpringWorks licensing deal focused on Blenrep-Ogsiveo for blood cancer
GSK is walking away from an expanded partnership deal with SpringWorks Therapeutics, winding down further research activities that would combine Blenrep and Ogsiveo. The UK pharma sent SpringWorks a...
View ArticleAlumis files for IPO ahead of Phase 3 studies for second-generation TYK2...
Precision immunology startup Alumis has filed to go public, pitching itself to Wall Street just three months after raising $259 million from private investors. Alumis didn’t include an estimated figure...
View ArticleShionogi inks deal for preclinical hearing loss therapies; Alvotech’s...
Shionogi licenses hearing loss treatments in deal up to €400M: The Japan-based pharma company paid Cilcare €15 million ($16.1 million) upfront for the option to license two preclinical hearing loss...
View ArticleSkye's stock sinks following eye disease failure as company shifts focus to...
Skye Bioscience is abandoning its entire eye disease pipeline following a Phase 2a trial failure, and it’s pivoting to one of the hottest categories in the industry — obesity. The San Diego-based...
View ArticleOculis touts Phase 2 results in dry eye disease, but most data aren't...
Oculis teased that its dry eye disease therapy worked in a mid-stage trial, but it stopped short of reporting statistically significant data across most endpoints. The ophthalmology biotech identified...
View ArticleEU launches two advice pilots for clinical trial applications as part of R&D...
The EU has initiated two pilot programs aimed at boosting the quality of clinical trial applications amid a broader effort to better integrate clinical research into the European health system. The two...
View ArticleClik here to view.
Teladoc names insurance executive as new CEO
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) After two months of searching, Teladoc Health has hired Chuck Divita to be its new CEO as the telehealth...
View ArticleFDA establishes new meeting type to advise on drug safety technology
The FDA’s drug center is creating a new way for sponsors to talk with the agency about how they’re using artificial intelligence and other technologies to conduct pharmacovigilance, the regulator...
View ArticleKyowa Kirin invests $530M in first manufacturing site in North America
Kyowa Kirin is investing $530 million into a 171,700 square-foot manufacturing facility in Sanford, North Carolina, which will make biologic therapies, including antibodies, for clinical trials and...
View ArticleGSK stands by Orange Book patents that FTC has asked to rescind
British drugmaker GSK says it has no current plans to pull a group of patents that have been challenged by the US Federal Trade Commission as “junk.” In April, the FTC expanded an ongoing campaign...
View ArticlePaxlovid did not beat placebo in Stanford-led long Covid treatment trial
Pfizer’s Covid-19 antiviral did not improve symptoms in patients with long Covid compared to placebo — the latest disappointment for patients with the post-infection condition. Scientists at Stanford...
View ArticleFDA advisors back Lilly’s Alzheimer’s drug, setting stage for approval after...
An FDA advisory committee gave its strong backing to Eli Lilly’s Alzheimer’s drug donanemab, giving further support for the agency’s expected approval after a surprise delay earlier this year. The...
View ArticleClik here to view.
Ipsen and Genfit’s elafibranor secures FDA thumbs up in rare liver disease
Ipsen’s drug candidate for a rare liver disease secured accelerated approval from the FDA on Monday, making good on a licensing deal with Genfit that dates back to 2021. The candidate dubbed...
View ArticleExclusive: Auxilius raises $10M to help biotechs manage clinical trial finances
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) The cost to develop a drug and the complexity of clinical trials has increased over the years. And as...
View Article