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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...

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UPenn 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...

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FDA 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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Sarepta 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...

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Sanofi’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...

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FDA 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 crushes expectations with GLP-1 franchise, as supply constraints ease

Hopes were high coming into Eli Lilly’s second-quarter earnings results. But they should have been even higher. On Thursday, the Indianapolis drugmaker announced that it was once again upping its...

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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...

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Updated: Recursion to acquire Exscientia to bolster pipeline in one of AI...

Recursion and Exscientia, two longtime bellwethers of AI bio, agreed to merge in an all-stock deal valued at an estimated $688 million. The biotechs’ leaders said they will benefit from combining their...

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Roivant 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...

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Q&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...

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TIGIT 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...

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Intellia’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...

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FDA 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...

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Apellis 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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FDA approves Citius Pharma's non-Hodgkin lymphoma drug Lymhpir

Citius Pharmaceuticals scored an approval from the FDA on Thursday for its treatment for a rare form of non-Hodgkin lymphoma, bringing to the market a reformulation of a cancer immunotherapy that was...

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WuXi Biologics gains some traction in Europe in the face of Biosecure threat...

WuXi Biologics appears to be making some progress in Europe in recent days, after securing a new biotech partner and EMA certifications for its manufacturing sites in China. On Thursday, the German...

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Lilly contributes to isotope supplier fundraise; Layoffs at Ajinomoto   

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Eli Lilly is injecting some funding into Ionetix for the isotope...

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