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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
Heart-breaking 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, ending the development plan. Denali said in an SEC filing Thursday that Sanofi notified the company...
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...
View ArticlePfizer hemophilia drug marstacimab is approved by FDA
Whew. Pfizer — after a week in which it began a showdown with an activist investor, was betrayed by and then reunited with two former top executives, and ended work on an RSV drug — finally has some...
View ArticlePfizer's situation with Starboard; Meet Endpoints' 2024 Women in Biopharma;...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleEli Lilly obesity drug may go back on shortage, FDA says, in win for...
The FDA said it will reconsider the removal of Eli Lilly’s GLP-1 drug tirzepatide from its official shortage list, after a trade group representing large compounding pharmacies challenged the move. A...
View ArticlePfizer details results from failed Phase 3 trial of Duchenne muscular...
The full results from Pfizer’s pivotal study of its Duchenne muscular dystrophy gene therapy show patients saw no significant functional benefit one year after receiving the therapy despite the...
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GSK touts data from two late-stage trials with long-acting drug in chronic...
GSK announced another batch of positive data from its respiratory program with the investigational drug depemokimab, this time in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Both...
View ArticleTPG and Blackstone working on bid to buy eye care company Bausch + Lomb — report
Private equity firms TPG and Blackstone are working on a potential deal to buy Brent Saunders-led eye care company Bausch + Lomb, the Financial Times reports. Citing “people familiar with the matter,”...
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