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Exclusive: Fertility startup to begin Phase 3 study of stem cell therapy for IVF

Fertility startup Gameto has received permission from the FDA to see if its ovary-in-a-dish technology can make in vitro fertilization a less grueling process, the company told Endpoints News in an...

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Inhibikase shelves Parkinson’s asset after Phase 2 flop

Inhibikase Therapeutics is slamming the brakes on its Parkinson’s disease program after the candidate failed to improve symptoms in a mid-stage test in treatment-naïve patients. The biotech’s...

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Sanofi is in the market for M&A, thanks to ‘strong’ balance sheet

Sanofi is likely to increase its M&A this year since it has more cash in its pockets, as the French pharma also monitors China as a possible source of new drug innovation, CFO François Roger ...

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Roche aims for derisked deals and ruthless portfolio cuts in 2025

Roche’s M&A strategy in the coming year revolves around derisked mechanisms and high unmet needs, CEO Thomas Schinecker said Thursday. And further dealmaking over assets from China-based biotechs...

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Merck stops another Winrevair study early based on positive results from...

Merck announced Thursday that it prematurely stopped a Phase 3 study of Winrevair, a drug approved last year for a rare form of high blood pressure in the lungs. The Phase 3 HYPERION study looked ...

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Takeda CEO Christophe Weber to retire in June 2026, Julie Kim to take over

Takeda CEO Christophe Weber will step down next June after more than 10 years leading the Japanese drugmaker. Julie Kim, the current president of Takeda’s US business unit, will succeed Weber in June...

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How Define Ventures thinks health tech startups will exit in 2025

Define Ventures has its eye on around 20 or so health tech startups that it thinks will go public or be bought up over the next few years. The startups are part of what Define ...

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Tectonic gets Phase 1b win in heart condition where Eli Lilly recently failed

A Phase 1b readout in a specific heart condition is causing an earthquake for one newly public biotech. Tectonic Therapeutic on Thursday morning reported the successful result of its study testing ...

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Ironwood's layoffs; Shionogi’s RSV pill succeeds in Phase 2

Plus, news about Immunome, Deerfield, Switch Therapeutics, ReCode Therapeutics, Atara Biotherapeutics and Genfit: Ironwood halves workforce: The Boston drugmaker is letting go of about 50% of its...

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Cargo Therapeutics cuts lead CAR-T program, 50% of staff

Cargo Therapeutics is stopping a Phase 2 study of an experimental CAR-T therapy after the trial generated disappointing data, and it's laying off about half of its workforce as a result. The San...

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Bright Green budgets $3.5B for new builds; European Commission opens...

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. API producer Bright Green is investing $3.5 billion to build...

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Takeda scraps programs as it raises full-year guidance 

Several months into a multiyear quest to “rigorously prioritize" its pipeline, Takeda is cutting a handful of programs. The company revealed the changes on Thursday in its third-quarter earnings...

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Rentschler exits cell and gene business due to low demand, will prioritize...

German CDMO Rentschler Biopharma is closing down its cell and gene therapy operations and shuttering a facility in the UK, which could affect up to 30 employees, a company spokesperson told Endpoints...

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Hims is making its Super Bowl debut with an ad that goes straight for pharma

The telehealth startup Hims & Hers comes out swinging against pharmaceutical companies in a provocative new ad slated to air during the Super Bowl. The minute-long spot blames the weight ...

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Blackstone secures $1.6B so far for new life sciences fund targeted at $5B+

The world's biggest alternative asset manager is further cementing itself in the life sciences industry with another fund dedicated to drug development. Blackstone confirmed on its earnings call on...

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FDA approves Axsome's acute migraine treatment after 2022 rejection

More than two and a half years after the FDA rejected its migraine treatment, Axsome Therapeutics received an approval for the drug on Thursday to treat acute migraines with or without aura. The drug,...

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Regeneron wins appeals court orders backing halt on Eylea biosimilars

Two biotech companies failed to reverse orders barring them from selling biosimilars of Regeneron’s eye disease drug Eylea in rulings from a federal appeals court. The US Court of Appeals for the...

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Vertex's non-opioid pain drug Journavx is approved by FDA

The FDA approved Vertex’s non-opioid drug for moderate to severe acute pain, bringing to market the first in a new class of alternatives to painkillers. The drug, known as suzetrigine, will have the...

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Maze and Metsera biotech IPOs to begin trading Friday

Obesity drug developer Metsera and kidney disease biotech Maze Therapeutics priced their Nasdaq IPOs on Thursday evening. Metsera {$MTSR} will raise $275 million and Maze {$MAZE} will raise $140...

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Novartis claims best earnings in years, validating shift to pure-play strategy

Novartis said Friday that last year was one of its "strongest" financial performances in its history following a multiyear reorg as a pure-play pharma company, bolstered by steady ...

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