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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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Decade after $8B deal, Roche offloads InterMune to mysterious specialty pharma

Roche's $8 billion InterMune acquisition, disclosed a decade ago, is now being handed to a specialty pharmaceutical company. Cayman Islands-based Legacy Pharma is run by Mark Thompson, the former CEO...

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Roivant discontinues lung disease drug; Bio-Thera, Intas make biosimilar deal

Plus, news about Caliway Biopharmaceuticals, Orca Bio, Alterity Therapeutics and Ascentage Pharma: Roivant discontinues rare lung disease drug: The termination, disclosed in Roivant’s fourth-quarter...

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Boehringer Ingelheim touts success in second Phase 3 lung fibrosis trial

Boehringer Ingelheim said its experimental treatment for a chronic lung disease succeeded in a pivotal study, and it's taking the results to the FDA to seek approval. It’s the second successful Phase 3...

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Hims’ Super Bowl ad has drawn criticism from lawmakers — and now Novo Nordisk

Novo Nordisk hit back at telehealth company Hims’ controversial Super Bowl commercial touting cheaper versions of brand-name weight loss drugs. The Danish pharma company behind blockbuster shots...

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Trump’s tariff impact likely ‘minimal’ for brand-name drugmakers  

Several brand-name drugmakers believe they will withstand any drug pricing impacts from President Donald Trump’s tariffs — and manufacturers that contract with pharma companies will likely be...

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States sue Trump administration over billions in NIH indirect cost cuts

Twenty-two state attorneys general sued the Trump administration on Monday in a bid to halt a new cap on indirect costs for universities receiving billions of dollars worth of NIH grants nationwide....

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Eli Lilly inks $630M deal for Phase 1 MASH candidate

Eli Lilly is betting up to $630 million on an experimental MASH treatment from a South Korean biotech. The pharma giant announced a deal on Monday to license a Phase 1 ...

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Merck KGaA confirms interest in acquiring cancer biotech SpringWorks

German pharma company Merck KGaA confirmed that it is in talks to acquire SpringWorks Therapeutics, though a deal has yet to be announced. Merck confirmed the discussions hours after Reuters ...

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