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Lilly unveils more positive late-stage data for its once-weekly insulin
On Thursday, Eli Lilly dropped more data for its once-weekly insulin candidate in adults with type 2 diabetes. In two Phase 3 trials, dubbed QWINT-1 and QWINT-3, Lilly’s efsitora alfa showed...
View ArticleExclusive: ZipBio launches using generative AI to make compact proteins
As several well-funded companies race to make generative AI models that can design new protein therapies from scratch, one small startup has found a new use for existing AI systems: compressing large...
View ArticleAstellas to close facility in California; Takeda can make more of its ADHD drug
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Astellas Gene Therapies is shuttering its facility in San Francisco...
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MDLive veterans nab $7.5M Series A for virtual specialty care startup
(This story is from our Health Tech newsletter. If you’d like to sign up, just click here.) Circadian Health, a startup that provides virtual specialist care for chronic diseases, has raised $7.5...
View ArticleNovartis pays $15M upfront to license Voyager program; Boehringer advances...
Plus, news about Jnana Therapeutics, Vaxcyte, C-Further, Genprex, PharmaEssentia, FORUS Therapeutics, Pharma Two B and Hepion: Novartis licenses Voyager program: Voyager will get $15 million upfront...
View ArticleThe Endpoints 11 event is coming: Meet biotech’s hottest new startups
For the last few months, our team at Endpoints News has been looking over dozens of new startups to find the ones we think are pursuing the most interesting scientific ideas, backed with the right...
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Lykos CEO Amy Emerson resigns
Amy Emerson resigned as CEO of Lykos Therapeutics, a biotech that spent a decade advancing MDMA-assisted therapy as a treatment for post-traumatic stress disorder and faced a debilitating FDA rejection...
View ArticleCigna offers discounted Stelara biosimilar, building on Humira move
Evernorth, the health services arm of insurance behemoth Cigna, is planning to make a Stelara biosimilar available for $0 out-of-pocket for select patients. The move, announced Thursday, applies to...
View ArticleEuropean 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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