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AstraZeneca cuts UK funding pledge; Viking says it has ‘enough’ API for trials

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. AstraZeneca said it is "very disappointed" in the UK government's...

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Digital health dealmaking is heating up

We’re in dealmaking season for publicly traded digital health companies. In the last week and a half, Progyny said it’s buying BenefitBump, a parental leave benefits navigation company. Teladoc,...

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Hospital group blasts Lilly's 340B rebate model, requests to join lawsuit...

A trade group representing 1,600 hospitals says Eli Lilly’s proposed 340B rebate model would be a “significant burden” to its members, and wants to intervene in the company’s lawsuit against the...

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Bristol Myers prunes pipeline amid new round of cost cuts

Bristol Myers Squibb is ending work on a handful of assets, including an immunology medication that was in two Phase 3 trials. The pipeline cuts disclosed Thursday follow news of a

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Acelyrin and Alumis to merge in deal combining cash, assets

After running into clinical hurdles with its “diamond in the rough” strategy, Los Angeles immunology biotech Acelyrin is handing over its last remaining clinical asset and $448 million in cash and...

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Roche heads to FDA with Gazyva results in a form of lupus

Almost 16 years after Rituxan's disappointing data in lupus, Roche's Genentech found success with a different B cell-killing drug called Gazyva in lupus nephritis — and it’s taking the antibody to the...

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Sionna inks $191M IPO for cystic fibrosis pipeline as Aardvark eyes $89M for...

Cystic fibrosis biotech Sionna Therapeutics will raise $191 million in its upsized Nasdaq debut on Friday, and metabolic disease biotech Aardvark Therapeutics outlined plans for a potential $89 million...

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Longtime Sandoz exec announces retirement; Lilly appoints head of India

→ Francisco Ballester is retiring as president, region international at Sandoz on March 1, and Peter Stenico will replace him. Ballester has held this role for six years and was president of Latin...

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Novo Nordisk takes aim at Roche in hemophilia A, but is way behind

Novo Nordisk said Friday that its hemophilia A preventive Mim8 was effective in its pediatric trial, opening it up to a larger patient population after the treatment succeeded in its pivotal ...

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Bain buys Mitsubishi Tanabe Pharma in $3.3B bet on Japan

The Mitsubishi Chemical Group is selling its centuries-old pharmaceutical business to Bain Capital in a carve-out worth about $3.3 billion. The deal comes after Japan’s Ministry of Health, Labour and...

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Bioluminescence Ventures to shut down 15 months after launch

The life science investment firm Bioluminescence Ventures will close its doors less than two years after its founding, despite raising nearly half a billion dollars to put into new companies, Endpoints...

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Belgian regulator recommends blocking Indian drugmaker's API production

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Doctors complete fourth xenotransplant of gene-edited pig kidney

A 66-year-old man whose kidneys were failing is now the fourth person who has received a gene-edited pig kidney, Massachusetts General Hospital announced Friday. Tim Andrews, a resident of Concord, NH ...

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Major FDA staff cuts would slow drug reviews, experts say

The Trump administration's reported plans to potentially lay off thousands of FDA employees could slow the agency’s reviews of new drugs, experts say, in addition to impacting other core agency...

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Sanofi, AstraZeneca back Teva's call to rehear case on patent listings

Sanofi, AstraZeneca and two leading trade groups want clarity around an appellate decision that called for Teva to delist five inhaler patents from the FDA’s Orange Book. The drugmakers, along with...

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Post-Hoc: China tensions both help and hurt Illumina

In the souring US-China relationship, there are winners and losers. DNA sequencing giant Illumina is both. Illumina got bad news this week when China blacklisted it, which could end in restrictions or ...

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Senators ask FDA to dig into 'misleading' Super Bowl ad from Hims

Sens. Dick Durbin (D-IL) and Roger Marshall (R-KS) are calling on the FDA to take action against a Super Bowl ad coming on Sunday from Hims & Hers that they say "misleads patients" by omitting ...

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Q4 earnings updates; Biogen details revised research strategy; RFK Jr....

Welcome back to Endpoints Weekly! Our team tracked fourth-quarter earnings reports from about a dozen companies this week. We’ll walk you through the highlights, including Bristol Myers Squibb’s next...

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AbbVie wins FDA approval for new antibiotic

The FDA approved AbbVie and Pfizer's drug Emblaveo in combination with an older antibiotic to treat complicated intra-abdominal infections. AbbVie, which owns the US commercial rights to the...

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Pliant shares plummet as Phase 2b lung fibrosis study paused

Pliant Therapeutics has slammed the brakes on enrollment and dosing in a mid-stage study of its lung disease candidate in a scenario that some analysts say they have “never seen before.” The West Coast...

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