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FDA grapples with its role in AI, and how to guide industry's adoption
As drug companies embrace artificial intelligence as a part of their research and development operations, regulators at the FDA are working to decide how and when they will play a role in overseeing...
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Big drugmakers have cut outside R&D spending amid broad pullback, key...
One of the drug industry’s biggest service providers shared a chilling message for the industry on Wednesday: Expect early pipelines to shrink and research work to decrease as big pharma companies cut...
View ArticleUPenn sues BioNTech, says it owes 'significant' Covid-related royalties
The University of Pennsylvania is bringing BioNTech to court over royalties the school believes it’s owed on the company’s Pfizer-partnered Covid vaccine. In a lawsuit filed Monday, Penn alleged that...
View ArticleFDA reprimands Bristol Myers over misleading efficacy claims on Krazati website
The FDA told Bristol Myers Squibb in an Aug. 1 letter that a website for its cancer drug Krazati had misleading claims around its efficacy. In its letter, the agency said the promotional website gives...
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Health insurers are covering fewer telehealth companies, Talkspace says
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Talkspace CEO Jon Cohen told investors Tuesday that health insurers have been reducing the number of...
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Oscar Health's guidance gets a boost from ex-Medicaid members
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Medicaid’s loss is Oscar Health’s gain. The health insurance upstart is enrolling lots of new members...
View ArticleSarepta faces lower revenue for Duchenne gene therapy ahead of expected sales...
Sarepta Therapeutics recorded lower-than-expected quarterly sales of its gene therapy for Duchene muscular dystrophy, sending the company’s shares down nearly 10% in after hours trading. The biotech...
View ArticleSanofi’s Sarclisa scores in Phase 3 transplant-eligible multiple myeloma test
Sanofi’s Sarclisa added to standard of care has prolonged survival without worsening of disease in a late-stage study in certain multiple myeloma patients, reinforcing the drug’s potential as a...
View ArticleFDA approves Novartis’ complement inhibitor Fabhalta for rare kidney disease
Novartis received accelerated approval from the FDA for a treatment for IgA nephropathy, an autoimmune disease in which too many of an antibody build up in the kidney. The drug, known as iptacopan, is...
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UK's NHS, Vertex strike pact, accelerating Casgevy rollout in beta thalassemia
Vertex Pharmaceuticals and NHS England have struck a “landmark” agreement to provide gene therapy Casgevy to beta thalassemia patients, starting with access for up to 460 people. The deal comes as the...
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Lilly ups full-year revenue guidance again as supply hurdles ease, leading to...
Eli Lilly is once again upping its revenue expectations for the full year as its diabetes and obesity medicines become less supply-constrained, and it has “increased confidence” in production ramp-up...
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Entero Therapeutics lays off most staff, pauses R&D to seek strategic...
Just months after Entero Therapeutics completed the merger that brought in its new lead candidate, the debt inherited from the deal is creeping up on the company. Entero abruptly disclosed on Wednesday...
View ArticleBreaking: Recursion and Exscientia to merge in one of AI bio's biggest M&A deals
Recursion and Exscientia agreed to merge in an all-stock deal, the two AI-focused biotechs said Thursday morning. The merger is one of the biggest M&A deals for the nascent but fast-evolving AI...
View ArticleRoivant to 'unveil' pipeline addition next month; Bavarian Nordic gets $156M...
Plus, news about Evotec, Bristol Myers Squibb and Precigen: Roivant hints at another deal: The drugmaker may make an addition to its pipeline, saying it has plans for “unveiling one such program next...
View ArticleQ&A: PhRMA CEO Stephen Ubl on the IRA, challenges to the FDA’s authority and...
As we approach the 2024 presidential election, Stephen Ubl, president and CEO of the pharmaceutical industry’s DC-based trade group PhRMA, said “the political process has really never been more...
View ArticleTIGIT drugs take another hit as Merck stops Phase 3 lung cancer trial for...
Merck is winding down a late-stage test of its anti-TIGIT candidate vibostolimab in small-cell lung cancer after it showed early signs of poor efficacy, in another blow to the TIGIT space. The Phase 3...
View ArticleIntellia’s gene editing therapy succeeds in Phase 2 genetic swelling...
Intellia Therapeutics’ CRISPR-based treatment for a rare genetic disease called hereditary angioedema reduced the bouts of swelling associated with the disease in a mid-stage test, the company...
View ArticleFDA approves Amneal Pharma's extended-release Parkison's treatment
Amneal Pharmaceuticals’ extended-release capsule for Parkinson’s disease has been approved by the FDA following an initial rejection last year. The treatment, which will be marketed as Crexont, is a...
View ArticleApellis and Sobi land another late-stage win for rare kidney disease drug
Empaveli, the kidney disease drug from Apellis Pharmaceuticals and Sobi, reported a Phase 3 trial success that could help the treatment keep pace with a competing therapy from Novartis. On Thursday,...
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Lilly’s anti-tau pill for Alzheimer’s fails in Phase 2 study
One month after the long-awaited approval of its first Alzheimer’s drug, Eli Lilly said that another experimental medicine aimed at slowing dementia failed in a Phase 2 study of 330 people. The drug,...
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