FDA 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...
View ArticleLife science CDMO Agilent cuts over 180+ employees in California
Agilent Technologies, a life science CDMO and laboratory product developer, is laying off 184 staffers across six locations in California. The company previously said it had restructuring plans this...
View ArticleChina biotech ban does not make the cut as add-on to defense spending bill
A bipartisan bill that would essentially ban US biotech companies from using certain Chinese suppliers failed to muster the support needed to hitch a ride to passage as part of a wider spending bill...
View ArticleUltragenyx reports longer-term Phase 2 data for rare bone disorder drug in...
Four years after betting up to $304 million on a drug for a rare genetic bone disorder, Ultragenyx and its partner Mereo BioPharma reported positive data in a Phase 2/3 trial. The two companies are...
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Foresite Capital closes $900M sixth fund, backing the likes of Xaira and IPO...
Foresite Capital, fresh off one of the largest-ever biotech launches, has closed on its sixth fund just 13 years into its life as an incubator and investor in life sciences startups. At $900 million,...
View ArticleAlzheon raises $100M; Regeneron ends mid-stage trial
Plus, news about Genmab, BioNTech, Bristol Myers Squibb, BridgeBio, Junshi, Tevogen, Actuate, GSK, Ochre Bio, Evotec and ProKidney: Alzheon raises $100M Series E: The company’s lead program is...
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