SystImmune’s $250M milestone; Teva’s Uzedy approved to treat bipolar disorder
Plus, news about Avidity, Biophytis, the Novo Nordisk Foundation, ADC Therapeutics and Apogee Therapeutics: 💸 SystImmune to get $250M from Bristol Myers Squibb: The milestone payment is the result of...
View ArticleModerna previews cancer antigen therapy in melanoma ahead of ESMO
Moderna has shared early data in patients with an advanced form of skin cancer who received its cancer antigen therapy designed to elicit targeted T cell responses. The biotech’s mRNA-4359 combined...
View ArticleFDA hands OAI classification to Novo Nordisk’s troubled Indiana site
The FDA issued an “official action indicated” classification to Novo Nordisk’s facility in Bloomington, IN after two biotechs received site-related regulatory delays. Scholar Rock, one of the companies...
View ArticleCalifornia enacts state law building on PBM reforms
California Gov. Gavin Newsom signed into law what his office called a “sweeping reform” of PBM practices last week. The legislation, SB 41, prohibits spread pricing, calls for greater transparency and ...
View ArticleFDA on pace for lowest number of new drug approvals since 2022
The FDA in 2025 is set to approve its lowest number of new drug and biologic applications since 2022, even as more than a dozen companies await the regulator's decisions on their new molecular entities...
View ArticleThree big questions ahead of third-quarter pharma earnings
A few months of momentum have cemented hope that the worst of biotech’s bear market is in the rearview mirror, galvanizing industry insiders who have clung to cautious optimism for multiple years ...
View ArticleTakeda, Nabla Bio sign second research deal for AI-made proteins
The Japanese pharma giant Takeda has signed a second research deal with the AI specialist Nabla Bio, expanding the scope of a collaboration that started three years ago. The two companies announced the...
View ArticleEx-Biofourmis CEO's new startup OutcomesAI raises $10M
OutcomesAI raised $10 million in seed funding to cut down on nursing costs, Endpoints News learned exclusively. The Boston-based startup is made of two parts: AI voice agents that handle routine...
View ArticleNovavax's second-largest shareholder calls for sale of vaccine maker
One of Novavax's largest shareholders is calling for a sale of the company after previously launching a proxy campaign for a board overhaul last year. Shah Capital wrote to Novavax's board on Monday...
View ArticleBristol Myers, insitro extend ALS drug research deal
Bristol Myers Squibb and insitro announced late last year that they had found a promising new target against amyotrophic lateral sclerosis. The companies are now hunting for the right molecule to act ...
View ArticleJohnson & Johnson to spin out orthopedics business
Johnson & Johnson will spin out its orthopedics business as it continues to seek ways to slim down. The new company will be called DePuy Synthes, and the transaction should take about 18 to 24 ...
View ArticleObesity biotech Kailera gets $600M to start Phase 3 this year
Kailera Therapeutics, one of the most closely-watched private obesity biotechs, has raised a $600 million Series B to begin Phase 3 trials by year's end. The Tuesday morning financing is the ...
View ArticleCylinder Health adds evidence to its approach of treating GI symptoms
A new peer-reviewed study shows the effectiveness of Cylinder Health's digital tool for improving symptoms of people with gastrointestinal conditions. Cylinder's program provides app users with...
View ArticleKardigan raises $254M to test cardio drugs from Sanofi, BMS and Ionis
Cardiovascular drug developer Kardigan has nabbed $254 million to advance three clinical-stage drugs that it got from pharma companies. It's the startup's second major funding announcement this year...
View ArticleLila Sciences closes $350M Series A, bringing in Nvidia
The idea of connecting AI models to the physical world has gained steam over the past few months, supporting some new, richly funded and wildly ambitious startups. On Tuesday, Lila Sciences — one of...
View ArticleFDA delays decision on Denali drug; Astellas’ Vyloy fails mid-stage...
Plus, news about Spyre Therapeutics, Candel Therapeutics, Boehringer Ingelheim, Quantro Therapeutics, Clover, EVerZom and Apollomics: 🏛️ FDA pushes back decision on Denali Therapeutics’ Hunter syndrome...
View ArticleQ&A: Nobel winner Fred Ramsdell on basic research in biotech, and the future...
Fred Ramsdell made headlines last week when he missed the phone call to tell him he won the Nobel Prize in Physiology or Medicine because he was backpacking near Yellowstone National Park. Ramsdell,...
View ArticleBioCryst to acquire Astria for $700M, adding a second HAE drug
BioCryst Pharmaceuticals plans to buy Astria Therapeutics for around $700 million in cash and stock. The deal, announced Tuesday, means BioCryst will get a drug intended to prevent hereditary...
View ArticleA gene therapy pioneer reckons with the reality for ultra-rare diseases
Jim Wilson is a serial founder and one of gene therapy's most influential figures. But even he has been unable to convince investors to go in on treatments for ultra-rare genetic diseases. “The pitch...
View ArticleSupreme Court passes on fight over FDA stem cell regulation
The US Supreme Court on Tuesday declined to take up a case over the FDA’s authority to regulate unproven stem cell treatments. The justices denied a petition from the California Stem Cell Treatment...
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