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Novo makes oral obesity drug partnership with Lexicon worth up to $1B

Novo Nordisk is going all-in on next-generation obesity medicines, and on Friday announced a licensing deal with a Texas biotech to get access to its oral small molecule drug. Under the deal, Lexicon...

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BioNTech details promising mid-stage data for its PD-L1xVEGF in aggressive...

BioNTech has highly encouraging survival data for its bispecific antibody combining checkpoint blockade with VEGF-A inhibition as a first-line treatment for a serious form of lung cancer. And if the...

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European regulator rejects Lilly's Alzheimer’s drug over side effects

Eli Lilly’s Alzheimer’s drug Kisunla has failed to get support from the European Medicines Agency over serious side effects and three patient deaths. The agency’s human medicines committee (CHMP)...

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DBV’s financing for peanut allergy patch; Eisai divests proton pump inhibitor...

Plus, news about Palatin, Spero and BioAtla: DBV Technologies’ $306M financing: The French biotech could get up to that amount to help advance its peanut allergy patch for children through an ...

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Milestone's shares dive after FDA again rejects drug for abnormal heart rhythm

Milestone Pharmaceuticals’ nasal spray failed for a second time to secure US approval to treat an arrhythmia disorder called paroxysmal supraventricular tachycardia. The FDA’s complete response letter...

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CHMP acts on Opdivo, Tevimbra, Xoanacyl, Kisunla and others

Bristol Myers Squibb, BeiGene, AstraZeneca and Pfizer secured European backing for label expansions, and a French pharma got its first drug approval recommendation, in a list of actions by the European...

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J&J wins patent feud against Viatris over schizophrenia drug

Johnson & Johnson scored an appeals court win in its bid to block generic competition for its long-acting schizophrenia drug. The US Court of Appeals for the Federal Circuit on Friday

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FDA approves Sanofi's RNAi drug for hemophilia A and B

The FDA on Friday said it approved a new RNAi-based hemophilia treatment from Sanofi that the company licensed from Alnylam. Patients with hemophilia A or B will now be able to ...

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Novartis’ radiopharma drug Pluvicto gets an expanded label

Novartis’ prostate cancer radiopharmaceutical Pluvicto has netted a highly anticipated and highly delayed expanded indication. The FDA on Friday approved the drug for certain patients before they have...

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Amgen loses challenge to Colorado drug review board

A federal judge on Friday dismissed Amgen’s lawsuit against Colorado's drug affordability board and its call for a price cap on the company's blockbuster autoimmune drug. District Judge Nina Wang...

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Bluebird gets new M&A bid, seeking to top private equity offer

A rival group is seeking to buy cell therapy biotech bluebird bio, in an effort to outbid a private equity offer by Carlyle and SK Capital, the company confirmed on Friday afternoon. The rival buying ...

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Lykos’ interim CEO is set to step down

Lykos Therapeutics’ interim CEO Michael Mullette is planning to step down, according to a source familiar with the decision. Mullette relayed the move to staff in February, saying that he would stay on...

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COVID research cuts target work on antivirals and vaccines to prevent future...

On Tuesday, drug discoverer and biotech entrepreneur Alpha Lee told scientists at a chemistry meeting about a new molecule to combat the Zika virus. There are no treatments designed to stop the...

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FDA's Peter Marks resigns, in disagreement with Kennedy

Peter Marks, the head of the FDA's Center for Biologics Evaluation and Research and one of the agency's highest-profile officials, has suddenly resigned amid a simmering disagreement with the Trump...

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HHS cuts and more from DC; Lyndra winds down; 23andMe files for bankruptcy;...

Welcome back to Endpoints Weekly, where we recap the week’s biggest news from the biopharma industry. Let’s start in DC. The Senate confirmed nominations this week for Johns Hopkins researcher Marty...

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Vertex’s second-generation diabetes cell therapy fails early-stage study

Vertex Pharmaceuticals announced Friday afternoon that it won't move forward with its type 1 diabetes cell therapy that's delivered in a device meant to get rid of the need for immunosuppression ...

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Exclusive: SV Health debuts Parkinson's biotech with backing from AbbVie and...

SV Health Investors, fresh off a $250 million fund for dementia-focused biotechs, has unveiled its latest effort, this time to advance new Parkinson's disease treatments. The London-based healthcare...

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BiomX’s phage therapy BX211 succeeds in Phase 2 diabetic bone infection study

BiomX’s antibacterial virus candidate has reduced the size of foot ulcers in patients with diabetic bone infection enrolled in a mid-stage trial. The finding could strengthen the company’s case for an...

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Transcend's neuroplastogen notches Phase 2 win to treat PTSD

Transcend Therapeutics’ PTSD treatment succeeded in a mid-stage study, propelling the scrappy company of less than 20 people toward a Phase 3 trial that could begin at the start of next year. The...

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Alphabet’s Isomorphic Labs raises $600M in biotech’s largest round of 2025 

Google’s bet on AI in drug discovery just got a lot bigger. Isomorphic Labs said Monday it raised $600 million from Thrive Capital, GV and Alphabet in its first external financing. The raise is the ...

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