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More 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 ...

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Bluebird 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 ...

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Teva 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...

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CBER'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...

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FDA 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...

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Bourla 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...

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Amgen 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...

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Pfizer 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...

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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...

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FDA 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

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23andMe'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...

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Some 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 ...

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Deerfield 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 ...

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Eli 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...

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Alnylam 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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Where 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...

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BridGene 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...

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Endpoints' 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 ...

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Hims 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...

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Is 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 ...

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