GLP-1 news galore; Top 100 venture investors; Doug Ingram to step down; and more
Happy Saturday, and welcome back to Endpoints Weekly. Our senior biopharma journalist Elizabeth Cairns covered a flurry of readouts this week from Eli Lilly and Novo Nordisk. We’ve summarized the data...
View ArticleMerck looks to expand Welireg label following combo readouts with Keytruda,...
Merck is seeking approval for two new combination regimens using its drug Welireg to treat kidney cancer, even though it doesn't yet have data confirming it extends patients' lives. On Saturday, it...
View ArticleNovartis' Rhapsido shows promise in Phase 2 food allergy data
Novartis laid out a preliminary case to move its recently approved hives drug Rhapsido into the broader market of food allergy. In a Phase 2 study, Novartis said all three doses of Rhapsido produced...
View ArticleChina obesity biotech QL Biopharm gets $72M, including support from OrbiMed
A late-stage Chinese biotech in one of the hottest areas of drug development has corralled 500 million Chinese yuan (about $72 million) in a Series C from OrbiMed, Qiming Venture Partners and other...
View ArticleUniQure says FDA prefers randomized trial for Huntington's treatment
Will Huntington’s disease patients be willing to risk a 12-hour sham brain surgery if it means a gene therapy for their fatal condition might ultimately be approved? That’s the implied question at the...
View ArticleBavarian Nordic CEO Paul Chaplin exits, months after failed $3B takeover
Following the collapse of a $3 billion bid for Bavarian Nordic by private equity firms in November, CEO Paul Chaplin is stepping down after more than three decades at the company due ...
View ArticleCandid to go public via reverse merger with Rallybio
Candid Therapeutics will go public through a reverse merger as it seeks to prove whether T cell engagers can shake up the treatment of autoimmune diseases. The San Diego and Shanghai biotech ...
View ArticleFDA lifts hold on second Intellia Phase 3 gene editing trial
The FDA has allowed Intellia to restart a Phase 3 study of a gene editing therapy for a heart disease caused by misfolded proteins, lifting a hold that was ordered after a patient in the ...
View ArticleRoche gets third pivotal win with MS drug, but liver signal could be a problem
Roche will seek approval of its multiple sclerosis pill after the asset succeeded in a third Phase 3 trial. But the study also found liver side effects, including one case of the worrying liver damage ...
View ArticleAardvark's stock plummets on study pause; BioNTech heads to Phase 3 with...
Plus, news about Disc Medicine, Cullgen, Pulmatrix, Gyre Therapeutics, Zymeworks, Royalty Pharma, Lynk Pharmaceuticals, Grünenthal, and Kyowa Kirin: ⏸️ Aardvark pauses late-stage trial: The company...
View ArticleUnited Therapeutics to take pulmonary hypertension drug to FDA for approval
United Therapeutics said its pulmonary arterial hypertension drug ralinepag succeeded in a Phase 3 study, setting the drugmaker up for an FDA approval request this year and a potential launch in 2027....
View ArticleTwo more members added to ACIP ahead of March meeting
HHS Secretary Robert F. Kennedy Jr. named two new members to a key CDC vaccine panel less than three weeks before it’s set to convene. Sean Downing and Angelina Farella were appointed to the Advisory ...
View ArticleEsperion to buy Corstasis and its nasal spray for edema for $75M upfront
Esperion Therapeutics will spend $75 million to acquire Corstasis Therapeutics, the maker of the only nasally administered diuretic approved in the US. The product, called Enbumyst, was approved in...
View ArticleCMS' Chris Klomp on what it will take for AI to succeed in healthcare
For AI to succeed in healthcare, it must be deregulated, reimbursed and able to access data easily, HHS chief counselor and CMS' Medicare Director Chris Klomp said Monday. The three criteria must be...
View ArticleICER to CMS: Lower Takeda blockbuster's price to Stelara's level
The drug pricing watchdog ICER is calling on the Centers for Medicare and Medicaid Services to lower the price of Takeda's blockbuster ulcerative colitis and Crohn’s disease drug Entyvio so that it's...
View ArticleCorrected: Hims’ pharmacy partner won’t reintroduce GLP-1 pill pulled from...
Editor’s note: This article was corrected after publication to reflect that Strive does not plan to reintroduce a semaglutide pill, though it does plan to reintroduce the liposomal base it uses to...
View ArticleBoehringer Ingelheim tried to use a tempting, tough cancer target for liver...
Boehringer Ingelheim is giving up on a Phase 2 MASH program using an experimental cancer drug that goes after the CD47 pathway, one of oncology’s most alluring and troublesome therapeutic approaches....
View ArticleTheravance ends R&D, lays off 50% of workers after Phase 3 fail
Theravance Biopharma will wind down its entire R&D organization and lay off 50% of its overall workforce after another Phase 3 fail for an experimental medicine called ampreloxetine. The US-Irish...
View ArticleProlium's $50M Series A raise; COUR Pharma touts liver drug follow-up
Plus, news about Acadia Pharmaceuticals, Poplar Therapeutics and Antiverse: 🅰️ RTW’s Prolium gets $50M: The New York-based biotech Prolium Bioscience has $50 million in Series A funds from RTW...
View ArticleEveryOne Medicines shuts down, ending custom cure venture that banked on new...
EveryOne Medicines, the first biotech company formed to develop individualized therapies for genetically unique diseases, will close, Endpoints News has learned. The decision to wind down operations...
View ArticleFDA explains how some copycat drugs can still win three years of exclusivity
The FDA has just outlined which applications might be newly eligible for three years of exclusivity, including ones where a drug may have been approved in a previous form. Building off definitions from...
View ArticleKyowa Kirin ends OX40 trials after Amgen balked, safety concern
Kyowa Kirin is ending all clinical trials of rocatinlimab, its experimental anti-OX40 antibody that Amgen walked away from earlier this year, after additional safety concerns arose in recent weeks. The...
View ArticleAfter years of dispute with FDA, Vanda will get a public hearing for jet lag...
The FDA has agreed to the rare step of holding a formal evidentiary public hearing for Vanda Pharmaceuticals, in which the company will argue that the agency should not have rejected its sleep disorder...
View ArticlePrime Medicine reverses course to seek FDA approval of shelved therapy
While other drugmakers have criticized the FDA’s recent judgment on rare disease treatments, Prime Medicine says the agency’s rhetoric pushed it to move forward with a rare immune disease therapy it...
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