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...
View ArticleSionna 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...
View ArticleLongtime 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...
View ArticleNovo 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 ...
View ArticleBain 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...
View ArticleBioluminescence 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...
View ArticleDoctors 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 ...
View ArticleMajor 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...
View ArticleSanofi, 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...
View ArticlePost-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 ...
View ArticleSenators 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 ...
View ArticleQ4 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...
View ArticleAbbVie 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...
View ArticlePliant 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...
View ArticleDecade 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...
View ArticleRoivant 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...
View ArticleBoehringer 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...
View ArticleHims’ 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...
View ArticleTrump’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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