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GSK's RSV vaccine Arexvy shows long-term protection in Phase 3 trial
GSK said a dose of its RSV vaccine protected against illness over three years, according to new data presented at the CHEST 2024 Annual Meeting. In the Phase 3 trial, called AReSVi-006, a dose of...
View ArticleBaxter plots recovery after Hurricane Helene, MilliporeSigma’s €290M facility
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Baxter said that it is increasing manufacturing at its sites outside...
View ArticleSen. Warren urges FTC to ‘carefully scrutinize’ Novo-Catalent deal over...
Sen. Elizabeth Warren (D-MA) has put the spotlight on Novo Holdings’ acquisition of Catalent, expressing concerns that the deal could give Novo Nordisk “unprecedented visibility” into its competitors’...
View ArticleImmatics heads to Phase 3 with melanoma cell therapy, seeks to raise $150M
Immatics said its PRAME-targeted T cell therapy shrank tumors by at least 30% in just over half of melanoma patients in an early-stage trial, and the company plans to start a pivotal study by the end...
View ArticleEli Lilly inks another obesity pact, doubling down on small Swiss partner
Eli Lilly is returning to KeyBioscience, a nimble Swiss biotech, seven years after originally linking arms with the startup to work on dual amylin calcitonin receptor agonists for obesity and other...
View ArticleSeven patients diagnosed with blood cancer after Skysona treatment, new data...
Seven young boys treated with bluebird bio’s gene therapy for a rare neurological disease have been diagnosed with blood cancer months or years after treatment, according to data published on Wednesday...
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Updated: FDA approves Roche's new treatment for subset of breast cancer patients
The FDA has approved Roche’s inavolisib plus Pfizer’s Ibrance and fulvestrant in a subtype of breast cancer over a month before the target action date, the agency announced Thursday. The treatment,...
View ArticleFDA adcomm supports first potential drug for ultra-rare, fatal Barth syndrome
Heartbreaking anecdotes from the patients, parents and doctors of children with the ultra-rare and fatal Barth syndrome won over an FDA advisory committee on Thursday, likely setting up a tough...
View ArticleSanofi discontinues Denali-partnered MS trial after Phase 2 failure
Sanofi is ending a Phase 2 clinical trial that’s testing a drug from Denali for multiple sclerosis, putting a stop to the development plan. Denali said in an SEC filing Thursday that Sanofi notified...
View ArticleBiotech startups Upstream, CAMP4 price Friday IPOs
Boston-area biotechs Upstream Bio and CAMP4 Therapeutics are headed to the Nasdaq on Friday, the latest companies to IPO in what appears to be a recovery for startups trying to raise capital on the...
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Lilly follows the trend of new AI hires; Pfizer fills key UK position as...
Thomas Fuchs → Eli Lilly has joined the club of pharma companies that have lined up AI execs. Thomas Fuchs will be Lilly’s first-ever chief AI officer on Oct. 21 and comes from the Icahn School of...
View ArticleExclusive: PhRMA attacks federal government's response to rebate model for 340B
The pharma industry’s DC-based lobbying group urged the federal government on Friday to get on board with alternative models for 340B drug price discounts. In a letter to the Health Resources and...
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VC firm targets $35M second fund to back startups led by scientists
A small venture capital firm that backs up-and-coming scientists plans to raise a $35 million second fund, three years after coming onto the scene. SciFounders, based in the San Francisco Bay Area, is...
View ArticleTurnstone rejigs staff and exec team, eases preclinical work as cash runs low
Just over a year after going public, Turnstone Biologics is axing staff, adjusting its leadership team and changing its pipeline focus to extend its cash runway for another two years. The San Diego...
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Perspective’s early data on lead-based radiopharma asset suggest lower dose...
In early-stage trials called dose escalation studies, drug developers usually want to test progressively higher doses of their therapies. Not Perspective Therapeutics. The radiopharma biotech announced...
View Article#CPHI24: European drugmakers look to reshore manufacturing but warn of price...
As European manufacturers localize their supply chains and production, they are also warning that drug prices could creep up if the European Commission doesn’t provide more regulation on drug...
View ArticleTeva to pay $450M to settle allegations of kickbacks and generic drug...
Generics giant Teva Pharmaceuticals will pay $450 million over six years to settle two allegations that the company violated the Anti-Kickback Statute and the False Claims Act, the Department of...
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Sanofi lands on private equity firm CD&R as potential buyer of consumer...
Sanofi has chosen US private equity firm Clayton, Dubilier & Rice to advance acquisition talks for its consumer health unit, the pharma confirmed Friday. The company says it entered into...
View ArticleStealth BioTherapeutics CEO discusses surprise adcomm support for ultra-rare...
This week, Stealth BioTherapeutics CEO Reenie McCarthy faced a seemingly insurmountable roadblock with the company’s drug for the ultra-rare, fatal mitochondrial disease Barth syndrome. FDA reviewers...
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Valneva and Pfizer eye 2027 launch for partnered Lyme disease vaccine
Valneva is eyeing a 2027 launch for its Pfizer-partnered Lyme disease vaccine, CEO Thomas Lingelbach said Thursday during the company’s investor day. Pfizer has sole commercial responsibility for the...
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