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BioCryst sells Orladeyo business in Europe; UCB gets a Phase 3 win for Fintepla

Plus, news about XOMA Royalty, Turnstone Biologics, CorMedix, the Novo Nordisk Foundation, Achieve Life Sciences and Cidara Therapeutics: BioCryst sells Orladeyo business in Europe: The company will...

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CEOs push EU for cell, gene therapy incentives in Biotech Act

Upcoming European legislative changes should include new incentives to boost early capital for developing cell and gene therapies, more than 30 biotech CEOs urged this week to EU lawmakers. Several...

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FDA loosens safety requirements for CAR-Ts in move to boost access

The FDA is eliminating a safety monitoring program for all CAR-T therapies, saying the cell therapies can be used safely and effectively without it. The agency said Thursday it determined the ...

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FDA extends impurity data submission deadline for drugmakers

It's been more than six years since the FDA found potentially cancer-causing impurities, known as nitrosamines, in drugs to treat high blood pressure and heart failure. And yet, the agency announced...

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J&J dealt blow in fight over its 340B rebate model

A federal judge said the government did not run afoul of the law when it required Johnson & Johnson to seek approval before implementing its proposed 340B rebate model. The Friday decision marks...

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Sources say FDA commissioner sought rejection of KalVista’s rare disease...

Welcome back to Endpoints Weekly! Thanks for spending your Saturday with us. We start this week’s recap with reporting from Endpoints News’ senior biopharma correspondent Andrew Dunn on the FDA’s...

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Unicycive gets a CRL for chronic kidney disease pill as third-party...

Unicycive Therapeutics’ phosphate binder drug has failed to secure FDA approval for certain chronic kidney disease (CKD) patients, marking another hitch in its goal to shift into a commercial-stage...

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Hikma pledges $1B to expand US manufacturing presence

Hikma Pharmaceuticals has promised to spend $1 billion on growing its US manufacturing and R&D footprint by 2030. The drugmaker said its latest investment — which it refers to as “America Leans on...

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AbbVie bags Capstan’s in vivo CAR-T work with $2.1B buyout deal

Almost three years ago, longtime biotech vet Laura Shawver cheerfully heralded the arrival of her latest startup with a colorful observation on the confluence of its mRNA and CAR-T tech. “To me, it’s...

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INmune Bio’s Alzheimer’s drug fails Phase 2; BridgeBio sells some ATTR-CM...

Plus, news about Laverock Therapeutics, Bristol Myers Squibb, Sobi, Pliant Therapeutics, Bayer and Takeda: INmune Bio’s Alzheimer’s disease drug fails Phase 2 study: The company was testing XPro, a TNF...

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Apple Tree Partners' biotechs 'face imminent collapse' as firm battles...

Apple Tree Partners, a venture firm and creator of dozens of biotechs like Akero Therapeutics and Chinook Therapeutics, says multiple portfolio companies are at risk of closure as it fights its main...

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Amgen's stomach cancer drug boosts survival in Phase 3, but side effects...

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Khosla Ventures backs ‘therapeutic plasma exchange’ startup Circulate Health

Circulate Health, a startup offering a potential anti-aging procedure, has raised $12 million in seed funding led by Khosla Ventures, the companies told Endpoints News in exclusive interviews. The...

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CBER chief Prasad details why he overrode Novavax reviewers

CBER Director Vinay Prasad says the benefits of Covid-19 vaccination have depreciated and may no longer outweigh the risks in adults who aren’t prone to more severe illness. “Even rare...

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Arcturus claims Phase 2 success in first data since shift to mRNA therapeutics

Arcturus said a Phase 2 mRNA therapeutic program achieved its goals in a rare disease population, though the results are early and Wall Street appeared skeptical. The biotech touted the new ...

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Sage plans to lay off almost every employee after reaching deal with Supernus

After announcing a buyer earlier this month, Sage Therapeutics now plans to lay off virtually all of its employees. The company disclosed the workforce reduction in a WARN notice in Massachusetts ...

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Pfizer ends Phase 1b/2 trial for final Trillium CD47 drug

Pfizer has terminated a trial testing the second of two CD47 programs it received from the 2021 buyout of Trillium Therapeutics, marking a setback for the $2.3 billion acquisition. The company axed a...

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Supreme Court passes on Oklahoma’s drug middlemen spat

The US Supreme Court on Monday declined to take up a case that could have clarified the extent to which states can regulate pharmacy benefit managers without preempting federal law. The justices denied...

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Protagonist unveils 'triple-G' obesity pill, but human trials are nearly a...

Protagonist Therapeutics is a late entrant into the obesity space, but it cannot be accused of following the crowd. The California-based biotech unveiled its only obesity candidate, which is still in ...

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Exclusive: Bob Langer-founded Syntis Bio gets $33M Series A for obesity, rare...

A Boston biotech working on a different approach to oral obesity drugs collected a $33 million Series A, with plans to enter the clinic later this year, the company exclusively told Endpoints News....

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