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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...
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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...
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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...
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ARCH backs lab instrument company that wants to help demystify how cells talk...
Moleculent emerged from stealth on Tuesday with $26 million to develop next-generation lab equipment that can look at how cells interact with each other in exquisite detail, joining a hot and litigious...
View ArticlePivoting to ‘ADC-like’ approach, Versant-backed startup gets $90M Series C
Bright Peak Therapeutics announced a $90 million Series C, though its scientific focus and pipeline looks different than it did three years ago. Shortly after the company raised a $107 million Series B...
View ArticleADC startup raises €30M; Cyrus Biotechnology to spin out Levitate Bio
Plus, news about ProKidney: ADC makers return with new startup: Adcytherix raised €30 million ($32.1 million) in a seed round to develop antibody-drug conjugates. The startup is led by Jack Elands, who...
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Verily gets into the GLP-1 business with new program to manage cardiac and...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Verily has launched a new virtual program to help patients manage cardiometabolic diseases with care...
View ArticleSanders pushes subpoena vote to force testimony of Novo Nordisk exec on GLP-1...
Senate HELP Committee chair Bernie Sanders (I-VT) is moving to subpoena Doug Langa, Novo Nordisk’s EVP of North America operations, to testify, following an investigation by the committee this spring...
View ArticleNJ federal judge rules Teva inhaler patents are 'improperly listed' in Orange...
Five of Teva’s inhaler patents are “improperly listed” in the FDA’s Orange Book, a federal judge ruled Monday, in a win for Amneal Pharmaceuticals’ efforts to market a generic version of one of Teva’s...
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Lilly exec points to Medicare as more pay full list price for Zepbound than...
A larger share of Medicare patients are having to pay the full list price for Lilly’s obesity drug Zepbound than for Mounjaro, a top executive said at a recent banking conference. Patrik Jonsson,...
View ArticleFDA funding would stay flat under House bill scheduled for markup
A House panel later today is scheduled to mark up the FDA’s appropriations bill for fiscal year 2025, the beginning of Congress’ process for funding the agency in the upcoming year. Under the proposal,...
View ArticleAvidity eyes registrational path for rare muscle disease drug after early...
Avidity Biosciences’ antibody oligonucleotide conjugate has shown signs of efficacy in an early-stage test in patients with a rare muscle-wasting disease. Just last month, Leerink analysts were...
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