#ASCO25: Roche confirms OS benefit for PI3K inhibitor Itovebi in breast cancer
The final overall survival results are in for Roche’s PI3K inhibitor, known as Itovebi, in certain forms of breast cancer. And they bode well for the company and patients. After a median 34.2 months of...
View ArticleGSK’s Nucala wins COPD approval, stoking rivalry with Dupixent
GSK’s blockbuster respiratory drug Nucala was approved Thursday for certain patients with chronic obstructive pulmonary disease, setting up a showdown with Sanofi and Regeneron’s Dupixent. The label...
View Article#ASCO25: Merus’ Phase 2 overall survival data reach ‘home run’ scenario —...
Merus completed its rollout of Phase 2 head and neck cancer data on Thursday, touting overall survival results that at least one analyst said amount to a best-case outcome. In the trial, patients got...
View Article#ASCO25: Volastra unveils first human data of its oral KIF18A drug
Volastra Therapeutics has been bullish about KIF18A as a solid tumor drug target. And now, more than five years after launch, the company is reporting first human data from its in-house drug, VLS-1488....
View ArticleGeoffrey Porges exits Schrödinger with CFO swap; A new board seat for...
Geoffrey Porges, a longtime biotech analyst and well-known Wall Street figure, stepped down as CFO of the New York biotech Schrödinger. Porges spent about two decades covering biopharma as ...
View ArticleGilead 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...
View ArticleFederal 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...
View ArticleGLP-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...
View Article#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...
View ArticleCHMP 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
View ArticleUS 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...
View ArticleTrump 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...
View ArticleAbout 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 last week said it has 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 ArticlePatient dies in Rocket gene therapy trial, on clinical hold by FDA
Rocket Pharmaceuticals said Tuesday morning that a patient in its gene therapy trial for Danon disease died after an "acute systemic infection." The FDA placed a clinical hold on the Phase ...
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