FTC to sue major PBMs over insulin rebates, claiming they inflated patient cost
The Federal Trade Commission said that it is suing the three major US pharmacy benefit managers over their role in the insulin market, claiming that the companies’ practice of using large rebates has...
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European regulators reaffirm Apellis’ rejection, add eight positive...
Apellis has had its European ambitions dashed once again after regulators reaffirmed their decision to not recommend the company’s treatment for geographic atrophy due to age-associated blindness. The...
View ArticleFDA OKs the first-ever self-administered vaccine, for flu
Americans can now vaccinate themselves against the flu without the assistance of a healthcare worker. For the first time, the FDA approved a vaccine that people can administer themselves, clearing the...
View ArticleJ&J will defend its proposed 340B changes as US threatens penalties
The US’ Health Resources and Services Administration threatened Johnson & Johnson with fines for unilaterally reshaping the company’s involvement in the multibillion-dollar federal drug discount...
View ArticleWhy did Eli Lilly ask a patient on a compounded GLP-1 drug for their medical...
This week, a letter surfaced in which Eli Lilly asked for a patient to release medical information so it could contact her treating physician and get more information on the compounded weight loss drug...
View ArticleJ&J subsidiary files for third bankruptcy to settle talc claims
A Johnson & Johnson subsidiary filed for bankruptcy in its third attempt to settle a vast majority of cases alleging its talc products caused cancer. The $8 billion settlement plan would resolve...
View ArticleA small startup is challenging Epic's control over patient health records
A software startup has sued Epic on antitrust grounds, arguing that the electronic health records giant has orchestrated a scheme to destroy the startup’s business and maintain its monopoly over...
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Biogen, UCB declare Phase 3 lupus win and prep a second trial, but details...
Biogen and UCB said Tuesday morning that data from a Phase 3 study for the lupus program dapirolizumab pegol were strong enough to convince it to launch a second pivotal trial to confirm the benefit...
View ArticleFlagship’s AI biotech Generate lands $65M upfront in Novartis deal, as first...
The AI-focused biotech Generate:Biomedicines announced another pharma partnership Tuesday, agreeing to work on several protein therapies with the Swiss drugmaking giant Novartis. Novartis will pay $50...
View ArticleConstructive Bio raises $58M for synbio work, and Nobel laureate joins board
A UK-based synthetic biology startup has brought in $58 million from private investors to fund its work engineering cell systems that can manufacture new and existing molecules. The company, called...
View ArticleClive Meanwell's new obesity biotech, Metsera, unveils early GLP-1 data with...
Metsera, the well-funded obesity biotech from Population Health Partners and ARCH Venture Partners, has unveiled its first clinical data just a few months after emerging with $290 million and a broad...
View ArticleHouse passes reauthorization of rare pediatric voucher program
The US House of Representatives on Monday afternoon unanimously passed a wide-ranging bill via voice vote that will reauthorize the rare pediatric priority review voucher program through 2029, among...
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Updated: Gene therapy maker bluebird bio cuts costs again, lays off staff
Bluebird bio is cutting more jobs and expenses in the latest bid to manage its fragile finances as it supports the launch of its sickle cell gene therapy Lyfgenia. The company announced earlier Tuesday...
View ArticleHealth plan startup Centivo raises $75M
Centivo, a startup that sells health insurance to employers, raised $75 million in fresh funds months after it bought a virtual primary care startup to use in its offerings. The startup’s goal is to...
View ArticleSanofi hires Mike Quigley as next chief scientist, internal memo says
Sanofi has appointed Mike Quigley, a former executive at Gilead and Bristol Myers Squibb, as the French pharma’s next chief scientific officer, Endpoints News has learned. Quigley will replace Frank...
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Samsara adds three venture partners to help steer and advise portfolio companies
Biotech investment firm Samsara BioCapital has added three new venture partners in recent months to expand its network, support first-time CEOs in its portfolio and guide more companies by way of board...
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Checking up on past Endpoints 11 winners: Who went public, who got bought and...
You win some, you lose some — that’s the risk of trying to predict the next hot biotechs. Since 2018, the Endpoints 11 awards have identified startups with the right ingredients to become a great drug...
View ArticlePCI Pharma earmarks $356M to expand injectable device capacity in US and Ireland
PCI Pharma Services is pouring $365 million to expand its US and Irish footprint for commercial and clinical packaging of drug-device products to meet “evolving” market needs. The CDMO, which...
View ArticleCapricor to begin filing DMD drug with FDA next month; Surrozen’s $10M milestone
Plus, news about Adaptimmune, Roche, LIfT BioSciences, VerImmune, and Revance Therapeutics: Capricor Therapeutics to file Duchenne cardiomyopathy treatment with the FDA: The San Diego-based biotech in...
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Wave rides new Phase 2 DMD data as it sets sights on accelerated approval
Wave Life Sciences said new Phase 2 biomarker data for its exon-skipping therapy are promising for certain patients with Duchenne muscular dystrophy, and it plans to discuss accelerated approval plans...
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