Exelixis’ Cabometyx misses survival endpoint, but will still file in prostate...
Exelixis’ second-quarter earnings report revealed a primary endpoint statistical significance failure, a potential market launch into a new indication and an ADC cut. Despite Cabometyx plus Roche’s...
View ArticleNovo Nordisk doubles US Wegovy prescriptions as shortages start to ease, but...
Nearly all of Novo Nordisk’s blockbuster GLP-1 Wegovy and Ozempic drugs have been taken off the FDA shortage list as the company reports a doubling of prescriptions in the US since the beginning of the...
View ArticleMadrigal finally reveals first wave of sales for MASH drug Rezdiffra
Madrigal Pharmaceuticals is “off to a strong start” with its recently approved MASH drug Rezdiffra, CEO Bill Sibold said on Wednesday. The company pulled $14.6 million in the first full quarter of...
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Private Danish iron deficiency biotech to buy G1 Therapeutics for $405M
A decades-old, relatively unknown private biotech focused on iron deficiency is buying a commercial-stage oncology company nestled in North Carolina. Holbæk, Denmark-headquartered Pharmacosmos will...
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Inspection delays hold back BeiGene's Tevimbra progress once again
BeiGene will need to wait a bit longer for an FDA decision on cancer immunotherapy, Tevimbra, citing a delay in scheduling clinical site inspections. The disclosure, included in BeiGene’s...
View ArticlePfizer invests $98M in Australian manufacturing to help develop new...
Pfizer has allocated 150 million Australian dollars (around $98 million) to install upgrades and build a new manufacturing facility at its existing site in Melbourne in an effort to advance new...
View ArticlePfizer got a $1.2B payout for its stake in Cerevel
AbbVie’s $8.7 billion deal for Cerevel has led to a significant payout for Pfizer. Pfizer created Cerevel with Bain Capital in 2018, spinning out several neuroscience assets into the new company. It...
View ArticleStoke Therapeutics’ partial hold lifted; Recursion gets $30M from Roche
Plus, news about Seres Therapeutics, Nestlé Health Science, Pfizer, Evotec and Relay Therapeutics: FDA lifts partial hold on Stoke Therapeutics’ Dravet syndrome drug: The antisense oligonucleotide,...
View ArticleIDRx raises $120M for targeted GIST drug following leadership change
Under new leadership, IDRx has raised $120 million to push its targeted treatment for a rare digestive tract cancer through early-stage studies. The company plans to use the money to continue clinical...
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CVS ousts Aetna president as it tries to fix its health insurance business
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) CVS Health is taking steps to turn around its health insurance business, as high medical costs from...
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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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