FDA says Ozempic, Wegovy shortage is over
The FDA said Friday that the shortage of semaglutide, the main ingredient in Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy, has been resolved after more than two years. The move could ...
View ArticleEli Lilly stockpiles $548M of oral weight loss drug ahead of launch
Eli Lilly has amassed a stockpile of soon-to-be-launched drugs and related materials, primarily its oral GLP-1 candidate orforglipron, worth more than half a billion dollars. Orforglipron will be ready...
View ArticleMore biotechs announce share buybacks; Cosette to buy Mayne Pharma
Plus, news about MeiraGTx, Hookipa and Poolbeg Pharma: A pair of $500M share buybacks: Exelixis and Neurocrine Biosciences each laid out plans to buy back half a ...
View ArticleBluebird bio to sell to investment funds after struggling to make money from...
A pair of investors will acquire bluebird bio in a deal worth only $29 million upfront after the gene therapy maker ran out of time and options. The company has struggled financially even as it ...
View ArticleTeva launches Stelara biosimilar at 85% discount as wider field emerges
Teva and its partner Alvotech on Friday followed Amgen in launching a biosimilar to Johnson & Johnson's blockbuster immunosuppressive biologic Stelara, offering a steep discount. The Stelara...
View ArticleCBER's deputy director departs as staff shakeup continues
Celia Witten, deputy director of the FDA's Center for Biologics Evaluation and Research, has left the FDA, adding to a wave of departures at the agency and across the federal health infrastructure as...
View ArticleFDA approves first drug to treat ultra-rare lipid storage disease
The FDA on Friday approved Mirum Pharmaceuticals' Ctexli to treat adults with cerebrotendinous xanthomatosis (CTX), a rare, progressive and genetic disease. The approval is based on the...
View ArticleBourla praises Trump as RFK Jr. preps vaccine review; Will CRISPR matter?;...
Good morning, and welcome back to Endpoints Weekly. Some of our biggest news this week came out of DC, where Pfizer CEO and incoming PhRMA chair Albert Bourla spoke in support of the Trump...
View ArticlePost-Hoc: Pharma CEOs' alternative reality with Trump
Tiki Barber gave me a brief glimmer of hope this week. “There’s an elephant in the room,” the former New York Giants football star said, perched in a leather chair, talking with GSK CEO Emma ...
View ArticleSanofi, Teva bolster case for IBD drug with Phase 2 data, despite potential...
Sanofi and Teva’s inflammatory bowel disease candidate could make €1 billion ($1.05 billion) a year by 2032, Leerink analysts said on Sunday. The blockbuster projection comes after the partners shared...
View ArticleAmgen plans further $200M investment in new tech facility in India
Amgen said it will spend an additional $200 million on its new technology center in Hyderabad, India, throughout 2025, with other investments to come over the next few years. “Hyderabad is rapidly...
View ArticlePfizer hires former top FDA deputy Patrizia Cavazzoni as CMO
Patrizia Cavazzoni, the FDA’s former head of drug regulation, will become Pfizer’s new chief medical officer, Endpoints News has learned. Cavazzoni led the FDA’s Center for Drug Evaluation and Research...
View ArticleFDA 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...
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