Ipsen returns to Marengo Therapeutics for new trispecific deal
Ipsen and Marengo Therapeutics are expanding a deal to include two trispecific antibody assets that tackle so-called cold tumors, which do not typically respond well to immunotherapies. The companies...
View Article#EASL24: Aligos, Arbutus, Atea, Barinthus and Bluejay unveil hepatitis results
At this year’s EASL International Liver Congress, Vir took center stage Wednesday to report early Phase 2 data for its hepatitis D approach, and then saw its stock $VIR jump as much as 15% upon data...
View ArticleNeuroscience company Rapport Therapeutics lists on Nasdaq
Rapport Therapeutics expects to raise $154 million from its initial public offering and a concurrent stock sale to private investors, the company announced Thursday evening. Rapport, a neuroscience...
View ArticleAbbVie and Alphabet's Calico added to Operation Warp Speed for rare diseases
AbbVie and Alphabet’s Calico announced Friday that their potential treatment for the rare neurological disease known as vanishing white matter disease will be part of the FDA’s new Operation Warp Speed...
View ArticleItalian antitrust agency investigates Novartis, Biogen and others over...
Italian antitrust authorities are investigating four companies over alleged collusion to delay the introduction of a new biosimilar to Roche’s blockbuster eye drug Lucentis. The Italian Competition...
View ArticleClik 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 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 ArticleNew obesity biotech Syntis Bio launches with early-stage alternative to GLP-1s
Syntis Bio is joining a growing group of smaller companies that are moving into the obesity treatment space — but not with a GLP-1. Instead, the Boston-based biotech is launching SYNT-101, an oral...
View ArticleOscar stakes its future on companies dumping worker health benefits
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) More than 153 million people get health coverage through their employers. Oscar Health is banking on...
View ArticleClik here to view.
BIO's new CEO takes a patriotic pivot to win back Congress, pushing industry...
SAN DIEGO — Facing an existential moment in how drugs are developed and sold, biotech’s key lobbying group has entrusted a new leader, who is wrapping himself in the US flag to regain a seat at the...
View Article