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...
View ArticleSources 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...
View ArticleUnicycive 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...
View ArticleHikma 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...
View ArticleAbbVie 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...
View ArticleINmune 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...
View ArticleApple 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...
View ArticleKhosla 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...
View ArticleCBER 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...
View ArticleArcturus 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 ...
View ArticleSage 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 ...
View ArticlePfizer 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...
View ArticleSupreme 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...
View ArticleProtagonist 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 ...
View ArticleExclusive: 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....
View ArticleBeckley touts positive mid-stage psychedelic data, advancing atai merger
Beckley Psytech said its intranasal treatment bested a small-dose comparator in a Phase 2b trial of patients with treatment-resistant depression, notching another win for the burgeoning psychedelic...
View ArticleUnnatural Products taps argenx's help for ringed molecules, expands internal...
Unnatural Products has signed on argenx as its latest partner to take forward its approach to ringed molecules. Argenx will deliver unspecified upfront money in the double-digit millions to the Santa...
View ArticleSama Fertility raises $3.8M to make IVF more accessible
Sama Fertility has raised $3.8 million to help people undergo IVF, mostly at home, Endpoints News learned exclusively. With seed funding, Sama is launching a program called SimpleIVF, which requires...
View ArticleKevin Tang's Concentra snags another buyout, this time for IGM Biosciences
Kevin Tang is on a hot streak. Concentra Biosciences, the shell company from his hedge fund Tang Capital, has secured its fourth buyout of a struggling biotech so far in 2025. This time, Concentra is ...
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