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Eli Lilly sues Empower, Strive over tirzepatide products

Eli Lilly has sued two large compounding pharmacies, alleging they deceive patients and put them at risk with compounded versions of the obesity drug tirzepatide in combinations or forms that haven’t...

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‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul

WASHINGTON — The size and scope of the FDA that began Tuesday won’t be the same as the day nears a brutal conclusion for agency staffers that were laid off or forced to resign. Sitting in ...

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Judge orders HHS, other agencies to 'undo' probationary worker firings

The HHS and other federal agencies must reverse the terminations of probationary government workers that were fired in the states challenging the cuts, under a new order issued late Tuesday by a...

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New CDMO emerges, acquires cell and gene manufacturer Landmark Bio

New CDMO Artis BioSolutions has come out of stealth and is snapping up cell and gene therapy manufacturer Landmark Bio for an undisclosed amount. The new San Diego-headquartered manufacturer, which is...

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Arie Belldegrun nabs two leaders for Vida Ventures amid plans for fourth fund

Arie Belldegrun's life sciences venture firm secured a pair of new managing directors after parting ways with two leaders last fall. Vida Ventures said Wednesday that it hired Matthew Cohen, most...

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Edgewise's heart drug shows promise in Phase 2 trial

Edgewise Therapeutics’ cardiac sarcomere modulator has passed a mid-stage test in patients with a genetic heart muscle disease. The biotech’s EDG-7500 produced “meaningful” reductions in left...

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Atsena raises $150M to target rare form of blindness with gene therapy

There's still money to be raised by gene therapy startups with good clinical data. On Wednesday, North Carolina biotech Atsena Therapeutics said it had raised a $150 million Series C to try and be the ...

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Exclusive: Former Pfizer CSO Mikael Dolsten to advise AI unicorn Formation Bio

Can AI make an avatar of Mikael Dolsten? The former chief scientific officer of Pfizer will try to find out now that he's starting a new chapter at Formation Bio after nearly 16 years at ...

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Sanofi licenses autoimmune asset from Nurix; Sumitomo Pharma’s changes

Plus, news about Gilead, Roche, Desentum, Inhibrx and Pila Pharma: After 2020 deal, Sanofi licenses Nurix’s autoimmune disease asset: The discovery-stage program targets a “previously undruggable”...

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Tang Capital's Concentra nabs a win, making a deal to buy Allakos

Tang Capital's shell company Concentra Biosciences secured its first major deal since late 2023. Allakos has agreed to be acquired by Concentra for $0.33 per share in cash, and the California biotech...

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BIO CEO on tariffs, MAHA and the future of the biotech industry

John Crowley is clear-eyed about the obstacles he faces. As CEO of the trade group BIO, he’s been tasked with mounting a political comeback for an industry that has taken its punches from Democrats and...

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Eli Lilly adds obesity startup knownwell to its direct-to-consumer service

Eli Lilly’s direct-to-consumer service has added another telehealth startup to its line-up of providers who can prescribe its medications, as it prepares to see more demand for obesity drugs following...

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New FDA Commissioner Marty Makary addresses staff a day after firings

New FDA Commissioner Marty Makary took to the stage at the regulator's Maryland headquarters on Wednesday, in his first public communication to much of the agency since Tuesday's mass firings....

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FTC's fight against PBMs is paused

The FTC’s legal fight against three major pharmacy benefit managers is on hold after two agency commissioners have been removed by the Trump Administration. The commissioners, Rebecca Slaughter and...

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Biopharma execs rethink Trump impact after FDA cuts

This week’s sweeping layoffs at the FDA have caused some biopharma leaders to change their tune on the Trump administration. After President Donald Trump’s victory in November, many biopharma CEOs...

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Trump tariffs exempt pharma companies for now

Editor’s note: This is an updated and corrected version of a story that ran on April 2 after the administration’s announcement, which contained several (apparently conflicting) documents. We’ve...

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Trump's tariff rollout leaves many questions for drugmakers

A rapid cascade of seemingly conflicting details from President Donald Trump’s tariff announcement left large drugmakers on Wednesday trying to figure out the impact on the industry, with many...

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Exclusive: Neurona bags $102M to treat epilepsy with cell therapy

A few cell and gene therapy biotechs are doing alright this week. The latest is Neurona Therapeutics, which exclusively told Endpoints News that it collected another $102 million in an upsized,...

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Sarepta, Roche pause Elevidys trials in Europe following patient death

Sarepta and Roche are hitting the brakes on three trials of their Duchenne gene therapy Elevidys in response to a request by the European Medicines Agency. The drugmakers are pausing enrollment and...

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Novartis’ Chinook-originated kidney disease drug gets accelerated approval

One of Novartis’ most important clinical catalysts of the year came Thursday, with the accelerated approval in the US of its rare kidney disease drug. Atrasentan, which is now named Vanrafia, is a...

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Daymark Health raises $11.5M to care for cancer patients

Oncologist Justin Bekelman started Daymark Health to better support cancer patients outside the clinic. The startup launched on Thursday with a $11.5 million seed round co-led by Maverick Ventures and...

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MoonLake discloses up to $500M in financing; OSR’s deal with innovation fund 

MoonLake Immunotherapeutics gets financing worth up to $500M: The company will get $75 million upfront from Hercules Capital. MoonLake, which went public in 2022, had about $448 million in cash before ...

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Another TIGIT trial fails as BeiGene scraps Phase 3 drug

What was once a promising area of cancer immunotherapy has had another late-stage failure. BeiGene said Thursday that a Phase 3 study for its anti-TIGIT drug, called ociperlimab, was halted for ...

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Aldeyra gets second CRL for dry eye disease drug

The FDA once again rejected Aldeyra's potential dry eye disease treatment, known as reproxalap, as the agency requested more trial data after the resubmitted drug approval request "failed to...

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