European court reinstates Advanz's liver disease drug after EC revocation
Advanz Pharma scored a win for its liver disease treatment Ocaliva after the General Court of the European Union temporarily suspended the European Commission’s decision to revoke the conditional...
View ArticleJ&J increases talc settlement by $1.1B after negotiating with plaintiffs,...
Johnson & Johnson agreed to increase its talc settlement plan by $1.1 billion after negotiating with plaintiffs’ lawyers, according to one of the attorneys. The bankruptcy plan would settle 99% of...
View ArticleCBER chief forecasts better global regulatory convergence around cell and...
Peter Marks, who’s responsible for the FDA’s oversight of cell and gene therapies, expects regulators around the world will be better at collaborating on gene therapy approvals within the next five...
View ArticleFDA raises antimicrobial resistance concerns ahead of adcomm for Iterum's UTI...
The FDA has raised concerns about potential “inappropriate use” of Iterum’s oral candidate for uncomplicated urinary tract infections (uUTIs) ahead of a Monday advisory committee meeting. If approved,...
View ArticleExclusive: Lilly-backed OrsoBio raises $67M for slate of obesity drugs as...
California biotech startup OrsoBio is betting the future of obesity drugs lies in combination approaches. To get there, OrsoBio told Endpoints News that it raised $67 million in a Series B, just 10...
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Roche's Spark loses CEO to RNA upstart; Ex-Elevation Oncology chief takes...
Ron Philip → Ron Philip has stepped down as CEO at Roche’s Spark to run the show at Orbital Therapeutics, an RNA biotech tied to Beam Therapeutics that launched in April 2023 with a hefty $270 million...
View ArticleGSK’s Nucala cuts exacerbations in Phase 3 COPD trial, but numbers remain...
GSK’s Nucala passed a late-phase test in chronic obstructive pulmonary disorder, setting the stage for a showdown against a new group of contenders that is looking to refresh the treatment paradigm for...
View ArticleBicara, Zenas outline plans for $180M IPOs amid restored optimism for biotech...
Bicara Therapeutics and Zenas BioPharma are now a step closer to kicking open a mini-IPO window for drug developers this fall. The startups outlined plans on Friday morning for IPOs of nearly identical...
View ArticleBasilea records $25M milestone; Connect Biopharma reduces workforce in China
Plus, news about the Gladstone Institutes, ImmunityBio, Keen Vision Acquisition Corporation and Medera: Basilea Pharmaceutica earns $25M milestone from Pfizer: The payment was triggered after the...
View ArticleMilestone’s arrhythmia drug on track for China filing with new Phase 3 data
Milestone’s calcium channel blocker succeeded in a late-phase trial in China in people with an abnormal heart rhythm disorder, supporting ongoing efforts for an approval in the country as the FDA...
View ArticleBridgeBio sticks to script for ATTR-CM as Alnylam cleans up ‘typo’ snafu
Amid the brouhaha over Alnylam’s disappointing and perhaps confusing HELIOS-B data presentation last week, competitor BridgeBio is — at least publicly — attempting to stay above the fray and stick to...
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FDA grants full approval to Travere’s Filspari for IgAN
Travere Therapeutics won full approval for Filspari, which treats a rare autoimmune disease that affects the kidneys. Filspari, also known as sparsentan, received an accelerated approval in 2023 for...
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Astellas CEO talks future beyond Xtandi as Japanese drugmaker puts roots in...
CAMBRIDGE, MA — When looking to the future of the drug industry, the allure of Boston is strong. This week, the Japanese drugmaker Astellas became the latest company to open a research hub in the...
View ArticleNon-viral delivery startup Vesigen Therapeutics trims staff as it evaluates...
Cambridge, MA-based startup Vesigen Therapeutics is laying off staff and “evaluating strategic options,” CEO Paulash Mohsen confirmed to Endpoints News via email Friday afternoon. Multiple employees...
View ArticleFederal judge rejects pharma industry’s request to halt Maryland’s 340B law
A federal judge in Maryland has rejected a request from drugmakers and industry group PhRMA to stop a Maryland law that would lift restrictions on the amount of discounts directed at hospitals serving...
View ArticleExclusive: Influential Democrat will oppose Biosecure Act ahead of House vote
An influential member in Congress is slated to publicly disavow the closely watched Biosecure Act ahead of a planned House vote next week, according to a letter reviewed by Endpoints News. The...
View ArticleNotable shakeups this week; Recursion's mixed data; Eli Lilly's $1B bet; and...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleInvestors pour $370M+ into Ken Song's autoimmune biotech after his RayzeBio...
Ken Song knows how to step on the gas pedal. His new company, called Candid Therapeutics, emerged from stealth on Monday morning with more than $370 million to its name and two clinical-stage T cell...
View ArticleBicycle Therapeutics makes an early case for its Padcev competitor: #ESMO24
Bicycle Therapeutics disclosed in an abstract Sunday that 45% of bladder cancer patients responded to its experimental treatment in an early-stage study. In 38 patients evaluated for efficacy, one saw...
View ArticleImmunovant shares mid-stage Graves’ disease data; FDA lifts Rezolute’s hold
Plus, news about Xencor, Bambusa Therapeutics, Grin Therapeutics and Vaxcyte: Immunovant reports Phase 2a Graves’ disease data: Patients taking batoclimab for 12 weeks saw a 76% response rate and an...
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