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Gilead notches another Phase 3 win for Trodelvy in triple-negative breast cancer

Gilead’s Trodelvy has passed another late-stage test in certain patients with metastatic triple-negative breast cancer (TNBC) — a win the company says could pave the way for the drug to become a...

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Federal judge blocks RFK Jr. from reorganizing HHS

The Trump administration has been barred from carrying out its sweeping plan to restructure and downsize the Department of Health and Human Services, following a court order that also applies to about...

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GLP-1s may cut cancer risk; Gyre’s stock falls after hep B data and offering

Plus, news about Sanofi, Servier, BioNova, Arcutis, Roche, Satellos Bioscience, Fore Biotherapeutics, Cinclus Pharma and Zentiva: GLP-1 drugs could cut cancer risk: An academic, observational study...

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#ASCO25: Kura spells out pivotal AML trial win as it gears up to compete with...

Kura Oncology said one-quarter of patients with certain forms of advanced acute myeloid leukemia went into complete remission after receiving its targeted therapy. In 112 patients from both its Phase...

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CHMP clears path for GSK’s Blenrep relaunch, recommends four other drugs 

GSK, Roche and SpringWorks Therapeutics were among those that secured a positive opinion for new drugs from the European Medicines Agency’s human medicines committee (CHMP) on Friday. The agency gave the

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US warns drugmakers against misrepresenting cost of imported products

The US Customs and Border Protection warned drugmakers against trying to evade import rules by misrepresenting the value of their products, in what appears to be an effort to head off a tactic the...

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Trump unofficially taps CMS chief Oz to spearhead 'most favored nation' talks

President Donald Trump unofficially asked CMS Administrator Mehmet Oz to lead the administration’s talks with drugmakers to lower prices, pushing his "most favored nation" policy. “I’d like to ask Oz...

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About 5% of CBER and CDER left after FDA staff cuts, analysis finds

Nearly one out of every 20 staff in the FDA offices that oversee drugs and biologics are gone after the Trump administration cut thousands of agency roles and

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Analyzing the Endpoints 100; ‘Most favored nation’ targets revealed; Biotech...

Welcome back to another edition of Endpoints Weekly. We had another busy week chock-full of news, so let’s jump into the headlines. We kick off this week with founding editor John Carroll’s latest...

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TCG's R&D venture team makes a T cell engager deal with Shanghai biotech

The Column Group's drug R&D team, known as TCG Labs Soleil, has been busy churning out new portfolio companies since it unveiled with a $400 million-plus fund in February. And on Tuesday ...

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Exclusive: ProteinQure raises $11M Series A for peptide drugs

When Lucas Siow and his three fellow co-founders started ProteinQure in 2017, they had nine years of combined work experience, and Siow accounted for seven of those years. The hard lessons came early...

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Investors pump $130M into protein degrader startup GlycoEra

Protein degrader shop GlycoEra, spun out of vaccines company LimmaTech in 2021, has corralled $130 million in Series B funding to get into the clinic. The transatlantic outfit's experimental medicines...

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Syndeio debuts with $90M+ to bring together synapse repair drugs

An Indianapolis-headquartered biotech reentered the neuroscience scene with more than $90 million in funding on Tuesday morning, rolling up assets from Gate Neurosciences and Boost Neuroscience, with...

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Prothena’s amyloidosis drug flops again, spending and staff cuts are on the way

Prothena said last week it had abandoned its lead product after a Phase 3 amyloidosis failure and is planning “substantial” layoffs. The company previously ditched the same drug, birtamimab, after a...

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Updated: Patient dies in Rocket gene therapy trial, which is put on clinical...

Rocket Pharmaceuticals said Tuesday morning that a patient in its gene therapy trial for Danon disease died after receiving a novel immune suppression drug, raising questions about the future of the...

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Blackstone's GRIN inks epilepsy licensing deal with Angelini, closes $140M...

Italian drugmaker Angelini Pharma is set to help GRIN Therapeutics take its neurodevelopmental disorder medicine to regions outside North America. Angelini will pay $50 million upfront and up to $520...

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Exclusive: Brooklyn Health raises $6.5M to standardize mental health assessment

Trials for mental health drugs sometimes fail not because the medicine does not work, but because the measure of its effects is unreliable. Brooklyn Health’s technology aims to change that and share...

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Biogen taps City Therapeutics in RNAi deal worth up to $1B

Biogen is diving into the RNAi field with City Therapeutics, a biotech led by several former Alnylam leaders. City will apply its RNAi engineering chops and Biogen will supply drug delivery technology...

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Gilgamesh’s psychedelic shows rapid effect in depression study

Gilgamesh’s drug showed swift and durable effects as a treatment for major depressive disorder in a mid-stage study, demonstrating promising results for one of the few companies in the psychedelics...

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ITM reveals up to $262M debt financing; Caris Life Sciences to go public

Plus, news about Lexeo, TreeFrog Therapeutics, Hansa Biopharma, AbbVie, Elpiscience Biopharmaceuticals, Immutep, Hedera Dx, C4X Discovery, Sanofi, XOMA and BioInvent: ITM Isotope Technologies Munich...

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