#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
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