FDA OKs Sarepta study of new immune suppression approach with Elevidys;...
Plus, news about Nuvalent and Phrontline:xzx 🟢 FDA clears Sarepta’s next step: Sarepta said it will study its Duchenne muscular dystrophy gene therapy Elevidys with a new ...
View ArticlePharma faces deadline to bring IRA fight to Supreme Court as first set of...
Court battles over Medicare drug price negotiations are coming to a head. Two drugmakers are up against deadlines next month to appeal their Inflation Reduction Act challenges to the US Supreme Court....
View ArticleWhat a team of ex-Amazon employees are building next in healthcare
The team behind PillPack (and their colleague from Amazon) launched their new startup, General Medicine, about six months ago. It aims to be a better way for consumers to shop ...
View ArticleCMS unveils negotiated prices for Ozempic, Wegovy and other drugs from second...
The government on Tuesday announced final prices for the second round of drugs negotiated by Medicare under the Inflation Reduction Act, including for Novo Nordisk’s blockbuster weight loss drugs...
View ArticleOtsuka’s anti-APRIL antibody gets FDA approval for kidney disease IgAN
Otsuka secured FDA accelerated approval for its antibody drug in a disease that impacts the kidneys’ ability to filter waste. The Japanese drugmaker said late Tuesday the agency greenlit sibeprenlimab...
View ArticleKallyope scraps one of two mid-stage migraine drugs
Kallyope has canned one of its investigational migraine medicines, Endpoints News has learned. The New York City-based biotech terminated a Phase 2a trial of its experimental migraine drug, dubbed...
View ArticleSanofi headquarters raided in broader French tax fraud investigation
French authorities raided Sanofi’s headquarters in Paris on Tuesday as part of a probe into alleged tax fraud involving multiple companies. A Sanofi spokesperson confirmed that the authorities made a...
View ArticleCormorant eyes another $400M healthcare fund
Cormorant Asset Management is looking at raising $400 million for another fund, according to an SEC filing this week. The Boston-based biotech investor began raising this month, and so far has ...
View ArticleChina's Zhongmou seeks to create a ‘one-size-fits-all’ rival to Luxturna
An under-the-radar Wuhan-based biotech startup says that its gene therapy for an inherited form of vision loss has generated early but promising results in a handful of patients. The startup, Zhongmou...
View ArticleFDA pushes back Ascendis' dwarfism drug decision date by three months
The FDA has extended its review for Ascendis’ once-weekly treatment for achondroplasia, also known as dwarfism. The decision delay centers around the trial protocol for the treatment’s post-marketing...
View ArticleImfinzi's latest label expansion; FDA seeks more information on BiomX's...
Plus, news about Ming Yu Pharmaceutical, Elpiscience Biopharmaceuticals, Chengdu Olymvax Biopharmaceuticals and Valneva: 🚦 AstraZeneca’s Imfinzi approved for perioperative use in stomach cancers: The...
View ArticleDelayed panel on vaccine injury payments to meet next month
A panel that reviews issues related to the federal vaccine injury compensation program is set to meet next month, after almost a year of being stuck in limbo under HHS Secretary Robert F. Kennedy Jr ...
View ArticleNovo submits high-dose Wegovy for FDA approval using voucher
Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...
View ArticleLundbeck backs out of bidding war for sleep disorder biotech Avadel
Alkermes wins. On Wednesday, Danish drugmaker Lundbeck said it was giving up on its effort to try to steal Avadel from a $2.1 billion deal with Alkermes signed ...
View ArticleNovo’s MFN prices to supersede IRA prices for Ozempic, Wegovy, CMS says
The new negotiated prices for Novo Nordisk’s GLP-1 drugs under the Inflation Reduction Act have raised questions about how they will impact the prices Novo agreed to under its separate “most favored...
View ArticleGenerate:Biomedicines to start Phase 3 studies for TSLP antibody
In a milestone for the next wave of AI-focused biotechs, Generate:Biomedicines is headed to Phase 3. The Somerville, MA-headquartered biotech said Monday it is launching two large studies for its lead...
View ArticleProtego gets $130M for AL amyloidosis drug from leaders behind Vyndaqel
A San Diego biotech hoping to crack into a rare protein misfolding disease has drummed up $130 million in investor support to get into a potential pivotal trial next year. Protego Biopharma, from the ...
View ArticleGene writing startup Tessera strikes $150M partnership with Regeneron
Regeneron Pharmaceuticals is expanding its investment in gene editing through a new partnership with Tessera Therapeutics, a well-funded startup that is preparing to test its first experimental therapy...
View ArticleIntroducing Endpoints Signal — intelligence for fresh biopharma insights
Today we’re launching Endpoints Signal — a new biopharma intelligence platform that gives Endpoints News subscribers a trusted read on where biopharma is headed, and why. Signal is powered by surveying...
View Article"Heavy AI" is taking over biopharma | Signal Pulse Report
Signal Pulse Report: We asked 441 Endpoints News readers how AI is actually showing up in their jobs. What stuck out first: 48% of respondents now describe themselves as heavy AI users in the...
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