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...
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...
View ArticleStates 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....
View ArticleEli 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 ...
View ArticleMerck 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 ...
View ArticleUpdated: Judge halts NIH cuts nationwide after groups, 22 states sue
A federal court in Massachusetts temporarily blocked the Trump administration’s new cap on indirect cost reimbursements for NIH grant recipients nationwide. District Judge Angel Kelley on Monday...
View ArticleVertex operations chief Stuart Arbuckle to retire
Vertex chief operating officer Stuart Arbuckle plans to retire in July, the company announced Monday afternoon. He will be succeeded by Charlie Wagner, who will continue to be CFO in addition to...
View ArticleNovartis returns for its anticoagulant in up to $3.1B buy of Blackstone’s Anthos
Nearly six years to the day after offloading its factor XI inhibitor to Blackstone Life Sciences, Novartis is swooping up the monoclonal antibody for $925 million upfront and up to $3.1. billion total...
View Article#ASCOGU: Pfizer’s prostate cancer data leak shows promising results in...
Clinical trial results from a Phase 1 study by Pfizer leaked days before a late-breaking presentation scheduled for Thursday, showing that the drugmaker’s prostate cancer candidate cut the risk of...
View ArticleInventiva cuts pipeline, lays off nearly entire research team in bid to get...
Inventiva is trimming its pipeline and enacting layoffs in an effort to get its lead MASH drug approved, the company announced Monday afternoon. The plan will center around its MASH candidate ...
View ArticleIN8bio’s Phase 1 AML data; Layoffs at Q32 Bio and Third Harmonic
Plus, news about Arvinas and Invizyne Technologies: IN8bio’s Phase 1 data in acute myeloid leukemia: In an investigator-sponsored study, all nine patients who received the company’s allogeneic...
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