FDA won’t allow Invivyd’s Pemgarda to treat Covid; Antibiotic biotech launches
Plus, news about BioCryst, AN2 Therapeutics, OS Therapies and Eyenovia: FDA is not expanding Invivyd’s Covid-19 EUA: The regulators declined to allow Pemgarda’s existing EUA to include treatment of...
View ArticleFDA lifts hold on Entrada's Duchenne drug after two years
Entrada Therapeutics announced Monday that the FDA lifted the clinical hold on its Duchenne muscular dystrophy drug, and it plans to start a Phase 1b study in the US in 2026. The biotech
View Article23andMe's CEO submits bid to take company private for $74.7M
Anne Wojcicki, the CEO of 23andMe, has submitted a new offer to take the company private with private equity firm New Mountain Capital months after the board rejected her last one. 23andMe's board...
View ArticleSome FDA medical device staff reinstated just days after firings
Some of the more than 200 staffers laid off at the FDA's Center for Devices and Radiological Health (CDRH) returned to work Monday, about a week after hearing their roles would be cut, several device ...
View ArticleDeerfield sues Alcon over alleged scheme to obstruct Aurion's IPO
An unusual legal battle over a biotech startup's IPO plans escalated to another level on Valentine's Day, according to two new lawsuits filed Monday. Aurion Biotech has been mired in dueling lawsuits ...
View ArticleEli Lilly expands Zepbound single-dose vial options at lower price
Eli Lilly will start selling additional single-dose vials of its weight loss drug Zepbound at a lower price for certain patients. The company launched single-dose vial formulations for the two lowest...
View ArticleAlnylam eyes bigger diseases in more tissue types at ‘inflection point’ for...
Alnylam may be gearing up for its biggest commercial launch yet in its nearly 23-year history, but the company’s top scientists believe they are just starting to scratch the full potential of its...
View ArticleWhere the money is: The top 100 venture investors in biotech
It’s no great surprise that RA Capital weighed in — again — as the most ubiquitous venture player in private biotech rounds through 2024. Or that ARCH participated in somewhat fewer, though overall...
View ArticleBridGene nets another Takeda deal amid plans to raise more funding and go public
Takeda must have liked what it got from the chemoproteomics work out of BridGene Biosciences. The Tokyo-based drugmaker announced Tuesday that it is once again enlisting the help of the startup, this...
View ArticleEndpoints' LGBTQ+ list: Nominate for 2025
For the fourth year running, Endpoints News will highlight the biotech leaders who are paving the way for the LGBTQ+ community. Nominations are now open via this form ...
View ArticleHims eyes growth in its weight loss business, despite end of semaglutide...
Hims & Hers expects revenue from its weight loss business to soar in 2025, even though a recent FDA move could make it tougher for pharmacies and telehealth companies to offer certain compounded...
View ArticleIs the GLP-1 compounding boom over? Not exactly
We’re about to see what happens when compounding goes from filling a gap left by a supply shortage, to more directly competing with pharma. The end of the semaglutide shortage ...
View ArticleRepare to lay off 75% of staff; Castle Creek inks $75M royalty deal
Plus, news about BioCity Biopharma, Kiniksa, Inceptor Bio, Ryvu Therapeutics, RedHill, VarmX, Paradox Immunotherapeutics and Lava Therapeutics: Repare Therapeutics lays off 75% of staff: The biotech in...
View ArticleLilly pays $10M upfront for Organovo’s FXR agonist program
Eli Lilly is buying Organovo’s farnesoid X receptor (FXR) agonist program, which includes a drug in Phase 2 development for ulcerative colitis and metabolic dysfunction-associated steatohepatitis...
View ArticleIndian drugmakers join forces to boost national biomanufacturing sector
Several contract research, development and manufacturing organizations based in India are banding together to form a trade group with an aim to bolster the nation’s production footprint and talent...
View ArticleThermo Fisher buys Solventum's purification business for $4.1B
Thermo Fisher Scientific is spending $4.1 billion in cash to acquire US healthcare company Solventum’s purification and filtration business, along with its 2,500 employees. The manufacturer expects the...
View ArticleChinese ADC biotech lets Hong Kong IPO filing lapse
Duality Biologics, an ADC startup that's attracted multiple biopharma partnerships, has let its plans to list on the Hong Kong Stock Exchange fizzle out. The Shanghai-based biotech's
View ArticleJ&J seeks to stop Samsung Bioepis from licensing Stelara biosimilar
Johnson & Johnson is suing Samsung Bioepis for allegedly breaching the terms of a contract regarding the launch of the Korean biotech’s Stelara biosimilar. The lawsuit, filed Monday in federal...
View ArticleBoehringer Ingelheim wins jury verdict in Zantac retrial in Illinois
An Illinois jury ruled in favor of Boehringer Ingelheim in Zantac litigation brought by two prostate cancer patients, the company confirmed. The verdict followed two mistrials in ...
View ArticleEmalex clears Phase 3 for Tourette syndrome, will seek FDA approval
Emalex Biosciences said its daily oral tablet helped reduce relapses for children and adults with Tourette syndrome in a Phase 3 study, and now plans to take the drug to regulators for approval. The...
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