FDA’s drug evaluation wing launches new AI oversight panel
The FDA is hoping that rapidly-advancing artificial intelligence capabilities will not pass it by. The agency’s Center for Drug Evaluation and Research (CDER) has launched its own AI Council, according...
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Updated: Alnylam’s new Phase 3 ATTR data bring uncertainty to standard of...
Alnylam Pharmaceuticals is continuing to make its case for vutrisiran to become the drug of choice for a heart muscle disease, and while the company reported positive results at a major medical meeting...
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J&J's human resources leader to retire; Amgen becomes the newest pharma with...
Kristen Mulholland → Kristen Mulholland will take over for the retiring Peter Fasolo as chief human resources officer at J&J on Oct. 1. “Peter has led J&J’s talent strategy for the past 16...
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NuCana stops Phase 2 as chemotherapy derivative 'unlikely' to meet primary...
Chemotherapy biotech NuCana’s stock $NCNA tanked nearly 50% in premarket trading Friday following a Thursday announcement that it had stopped a Phase 2 trial due to disappointing data. The company said...
View ArticleNovo offers detailed look at semaglutide’s cardiac outcomes in Phase 3 trial...
LONDON — After a recent spate of setbacks, Novo Nordisk has raised the curtain on data detailing semaglutide’s ability to cut the risk of heart failure and cardiovascular death in a late-phase test of...
View ArticleJacobio's China rights deal; Reneuron off the London exchange
Stem cell biotech Reneuron Group leaves the London Stock Exchange’s AIM: The company plans to stop trading on the exchange amid financial struggles, as it continues to look for investors. Reneuron...
View ArticleMerck opens London lab as it makes push into immunology and the UK
Merck has opened the doors to a new lab in London, part of the US drugmaker’s plans to grow its footprint in the UK and leverage its scientific expertise as it works to refill its pipeline. Merck, also...
View ArticleFDA approves Emergent vaccine for mpox as company plans to donate 50,000 doses
Emergent BioSolutions scored an expanded FDA approval for its single-dose vaccine, ACAM2000, to now include the prevention of mpox disease in people at high risk for an infection of the virus. The...
View ArticleIpsen sells priority review voucher for highest price since 2016
Ipsen Pharmaceuticals sold its priority review voucher to an unidentified “large global pharmaceutical company” for $158 million, it said this week, the highest publicly announced price for one of the...
View ArticleBiosecure vote slated for September
The House is planning to vote on the closely-watched Biosecure Act at the start of next month, the latest progression in efforts to rein in the influence of key China-based drug manufacturers. The...
View ArticleNovo Nordisk reveals post-hoc cardiovascular data for semaglutide
Novo Nordisk bolstered its heart disease data for semaglutide on Friday with additional analyses from a handful of trials. In a pooled analysis of certain heart failure patients from four studies,...
View ArticleFDA authorizes Novavax's updated Covid booster
The FDA has authorized emergency use of Novavax’s updated Covid booster, just over a week after clearing updated versions of mRNA boosters from Pfizer and Moderna. Novavax’s shot is the only...
View ArticleFDA authorizes Novavax Covid booster; Recursion nears key data readouts;...
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View ArticleBayer’s Kerendia cuts heart death, failure and hospitalization by 16% in...
Less than a month after announcing success in a late-phase trial, Bayer has unveiled detailed results from its drug Kerendia in a subset of people with heart failure, sparking plans for a regulatory...
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Sanofi’s BTK inhibitor goes 1-for-3 in key MS trials, slows disability...
The potential of Sanofi’s closely-watched BTK inhibitor in multiple sclerosis is coming into clearer view, amid plans to narrow the focus of the French company’s business drug development and get out...
View ArticleArrowhead spotlights key pancreatitis figures from Phase 3 lipid disease...
Arrowhead Pharmaceuticals has unveiled highly anticipated pancreatitis results from a late-phase trial of plozasiran for a rare lipid disorder, several months after reporting topline data. Arrowhead...
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Exclusive: Duke spinout launches in hopes of prevailing with brain cancer...
Adaptin Bio is launching with plans to bring a bispecific T cell engager for glioblastoma, a deadly form of brain cancer, into the clinic. The company received FDA clearance to start its clinical...
View ArticleUpdated: Vaxcyte surges on Phase 1/2 data for 31-valent pneumococcal vaccine
Vaxcyte shares $PCVX jumped more than 40% Tuesday morning on the heels of Phase 1/2 data for its 31-valent pneumococcal conjugate vaccine, VAX-31, being tested in adults over 50. The company tested...
View ArticleExclusive: PatientPartner raises $7M to help pharma companies match patients...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) PatientPartner, a startup that matches patients with mentors who’ve gone through similar medical...
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AI-focused biotech Recursion underwhelms with first Phase 2 readout
Recursion reported mixed data Tuesday from its first Phase 2 study, in a disappointing start to an expected frenzy of clinical results. The Salt Lake City-based biotech has forecast a stretch of about...
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