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Jazz reports Phase 3 success for Zepzelca in first-line maintenance for small...
Jazz Pharmaceuticals announced Tuesday that adding its small cell lung cancer drug Zepzelca to a maintenance treatment regimen for extensive-stage small cell lung cancer cut the risk of death in a...
View ArticleGSK sues Moderna over mRNA vaccine patents, seeks 'reasonable royalty'
GSK on Tuesday unveiled a lawsuit filed against Moderna in Delaware federal court, alleging that its patented inventions provide the “foundation” for Moderna’s mRNA vaccine portfolio. GSK said it’s...
View ArticleSacklers call opioid-related fraud claims 'utterly meritless'
Months after Purdue Pharma’s bankruptcy plan was foiled by the Supreme Court, its previous owners are bracing for a legal battle with creditors. The Sacklers responded on Monday to claims they...
View ArticleGLP-1 side effect treatment data released by Neurogastrx
Neurogastrx believes its drug could treat one of the most troublesome side effects of one of the industry’s biggest blockbusters. On Wednesday, the Boston-area biotech said that its experimental drug,...
View ArticleTakeda parts ways with Wave Life Sciences even with Huntington’s trial win
Takeda will not move forward with Wave Life Sciences on a Huntington’s disease drug, ending their collaboration that first started in 2018 with a $110 million upfront from the Japanese pharma. In an...
View ArticleQ&A: Sanofi’s R&D head reflects on his first year, a post-Dupixent future,...
Almost a year ago, Sanofi made history for the wrong reasons. Last October, CEO Paul Hudson announced strategic changes including boosting R&D spending and pulling the company’s long-term guidance...
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Life sciences investor KdT Ventures raises $100M fourth fund
Life sciences VC shop KdT Ventures disclosed its $100 million fourth fund on Wednesday morning, just over two years after announcing an $80 million fund. The seven-year-old firm said the new money will...
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Facing a critical week, Pfizer confronts an unsparing foe in Starboard
Starboard Value may have lost its first skirmish with Pfizer. But the activist investor has a track record of protracted, bruising fights for control of companies that’s likely to make it a formidable...
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FDA places hold on Novavax's Covid-flu and standalone influenza vaccines
Novavax’s post-Covid path ran into a speed bump Wednesday, as the company announced a clinical hold on its Covid-influenza combination vaccine and its standalone flu shot. The FDA placed the hold after...
View ArticleMedicaid startup Waymark publishes study proving its program slashes ER visits
Investors have been placing bets into startups that help members of low-income households on Medicaid insurance get care. A paper published Wednesday shows that its model is working. San...
View ArticleExscientia’s $15M milestone from Sanofi; Lilly to take Gateway Labs to China
Plus, news about TenNor Therapeutics, Gan & Lee Pharmaceuticals, Orasis and Optus Pharmaceuticals: Exscientia receives $15M milestone from Sanofi: The companies are advancing two programs as part...
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FDA leaders kick off rare disease hub to increase cross-center collaboration
FDA officials, including the directors of CBER and CDER, on Wednesday launched a rare disease innovation hub at a public meeting, with an aim to better collaborate and communicate across the two...
View ArticleFirst clinical test of RNA editing restores missing protein in genetic...
An experimental therapy designed to change a single letter of short-lived mRNA molecules has corrected a genetic mutation that prevents people from making a vital protein, Wave Life Sciences announced...
View ArticleCompounding association to ask for clarity around tirzepatide's shortage status
The Alliance for Pharmacy Compounding (APC) wants clarity around the FDA’s decision to reconsider tirzepatide’s removal from its national shortage list. Compounders are allowed to distribute their own...
View ArticleBavarian Nordic's mpox vaccine was safe and spurred promising immune response...
Bavarian Nordic’s mpox vaccine Jynneos generated a similar immune response in adolescents as it did in adults, offering encouraging results that suggest the shot would be similarly effective. The new...
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Sage shakes up senior management, slashes pipeline, sheds 33% of staff
After a string of mid-stage failures this year, plus a blow to its major depression commercial plans last year, Sage Therapeutics is trimming its workforce by 33%, including more than halving its...
View ArticleTerray Therapeutics raises $120M Series B for its AI ways of designing molecules
Terray Therapeutics has raised a $120 million Series B round, aiming to get its first drug candidate into the clinic while advancing in its AI-fueled approach to making molecules. Founding CEO Jacob...
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Canadian CDMO broadens CGT footprint with new $145M facility
CDMO OmniaBio on Thursday opened a commercial-stage cell manufacturing facility that has AI capabilities worth around CAD $200 million ($145 million) in its hometown of Hamilton, Ontario. Mitchel...
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Hospitals gush about new AI note-taking tools. It may leave the human medical...
When Eva Weinlander treats patients, there’s often a person in the room working as a scribe, typing away at the patient’s medical note while she focuses on providing care. But lately, Weinlander, a...
View ArticleAustralia rejects Leqembi, citing safety risks associated with the...
Australia’s regulatory agency rejected Biogen and Eisai’s Alzheimer’s drug Leqembi, noting that the drug’s efficacy doesn’t outweigh the safety risks. Australia’s Therapeutic Goods Administration (TGA)...
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