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
View ArticleAnalyzing 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...
View ArticleTCG'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 ...
View ArticleExclusive: 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...
View ArticleInvestors 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...
View ArticleSyndeio 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...
View ArticleProthena’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...
View ArticleUpdated: 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...
View ArticleBlackstone'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...
View ArticleExclusive: 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...
View ArticleBiogen 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...
View ArticleGilgamesh’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...
View ArticleITM 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...
View ArticleFDA approves Liquidia's inhaled hypertension drug in two settings
The FDA approved Liquidia’s treprostinil program for two related kinds of high blood pressure, turning up the heat on rival United Therapeutics and its Tyvaso franchise. Treprostinil, now branded as...
View ArticleLilly to buy non-opioid pain biotech SiteOne for up to $1B
Eli Lilly is deepening its presence in the non-opioid pain field by buying California biotech SiteOne Therapeutics, which is in a similar arena as the recent landmark approval for Vertex's pain drug....
View ArticleRFK Jr. ends routine Covid vaccine guidance for kids, pregnant women
The CDC will no longer recommend routine Covid-19 vaccines for healthy kids and pregnant women after HHS Secretary Robert F. Kennedy Jr. axed existing guidance. Kennedy, joined by FDA Commissioner...
View ArticleBoundless Bio changes plans for cancer drug after toxicity issues
Boundless Bio has hit the reset button in the face of toxicity issues, nixing ongoing treatment arms in an early-stage cancer study in favor of a new combination for its CHK1 inhibitor. And in a ...
View ArticleSernova chair resigns following insider trading charges by DOJ
Canadian cell therapy biotech Sernova said Sunday that its board chairman Ross Haghighat has resigned after being indicted by the Department of Justice on Friday, with 16 counts of insider trading ...
View ArticleFDA rejects Savara’s rare lung disease drug over limited manufacturing data
The FDA has rejected Savara’s application for its rare lung disease candidate over insufficient chemistry, manufacturing and controls data, the clinical-stage biotech said Tuesday. Savara said it...
View ArticleFDA leadership preps for summer biopharma listening tour across six cities
FDA Commissioner Marty Makary, newly minted CBER chief Vinay Prasad and Principal Deputy Commissioner Sara Brenner are visiting six US cities in June and July to meet with biotech and pharma executives...
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