J&J seeks to stop Samsung Bioepis from licensing Stelara biosimilar
Johnson & Johnson is suing Samsung Bioepis for allegedly breaching the terms of a contract regarding the launch of the Korean biotech’s Stelara biosimilar. The lawsuit, filed Monday in federal...
View ArticleBoehringer Ingelheim wins jury verdict in Zantac retrial in Illinois
An Illinois jury ruled in favor of Boehringer Ingelheim in Zantac litigation brought by two prostate cancer patients, the company confirmed. The verdict followed two mistrials in ...
View ArticleEmalex clears Phase 3 for Tourette syndrome, will seek FDA approval
Emalex Biosciences said its daily oral tablet helped reduce relapses for children and adults with Tourette syndrome in a Phase 3 study, and now plans to take the drug to regulators for approval. The...
View ArticleCompounders sue FDA over end of semaglutide shortage
Drug compounders have sued the FDA to put the weight loss and diabetes drug semaglutide back on an official shortage list, fighting a regulatory decision that imperils the companies' business. “If ever...
View ArticleCandel's viral therapy shows promising survival in small pancreatic cancer study
To Candel Therapeutics CEO Paul Peter Tak, the biotech’s viral immunotherapy has passed the "bloody obvious test" in pancreatic cancer, and it’s preparing to start a larger trial next year. The biotech...
View ArticleLeo Pharma says its yearslong makeover is about to pay off
For the first time since 2018, dermatology-focused Leo Pharma projects that it could turn a profit this year. Its Wednesday guidance comes on the heels of a broad multiyear restructuring — a plan ...
View ArticleCourt orders CVS to comply with the FTC’s PBM-related investigation
The Federal Trade Commission is continuing its investigation into anticompetitive PBM practices, with a new court order that will require CVS Health to share more requested documents about its PBM....
View ArticleEikon raises $351M Series D, pipeline advances to Phase 3
One of biotech's best-funded startups has just raised a huge new round to take its lead drug into final-stage testing. On Wednesday, Eikon Therapeutics announced a $351 million Series D round, one of...
View ArticleMerck says Keytruda could be up next for IRA price cuts
Merck said its “once-in-a-lifetime” drug Keytruda could be subject to price reductions under the Inflation Reduction Act, which would lead to a decline in sales. It expects Keytruda to be chosen for ...
View ArticleGinkgo uncertain over the future of US government funding, stock drops
Ginkgo Bioworks’ stock $DNA fell by around 13% premarket Wednesday after the company dampened its 2025 sales forecast. “We are being conservative with our revenue guidance in 2025 given uncertainty...
View ArticleUpdated: Lilly joins Trump administration to announce $27B manufacturing...
WASHINGTON — Eli Lilly touted a huge new US manufacturing investment at an event on Wednesday, trotting out the news with a member of President Donald Trump’s cabinet as part of what has been a...
View ArticleHarbour BioMed inks deal up to $395M; ORIC refines plans for two drugs
Plus, news about Idorsia, Enveda, Zymeworks, BerGenBio and Ignota Labs: Harbour BioMed does another deal: The Shanghai-based biotech’s subsidiary, called HBM Alpha Therapeutics, inked a pact with an...
View ArticleRegeneron, two Chinese biotechs tout promise of their hearing loss gene...
Several small clinical trials have demonstrated that gene therapies have restored hearing in children with a rare form of genetic deafness. In an update at the Association for Research in...
View ArticleAstraZeneca’s SERD hits primary endpoint in late-stage trial, but first-line...
AstraZeneca wasn't expected to have data from the Phase 3 trial of its oral SERD until the second half of this year so the positive interim results that the UK drugmaker
View ArticleRegeneron shakes up accelerated approval plans for lymphoma bispecific
Regeneron is now expecting an accelerated approval decision this summer on its T cell engager for one form of lymphoma, while it's giving up on accelerated approval for a different form of the disease....
View ArticleMedicare spending on set of diabetes drugs skyrocketed — report
The use of a subset of common diabetes drugs skyrocketed in the US Medicare program over a five-year period ending in 2023, according to a new report from the HHS inspector general. The
View ArticleFDA meeting to pick next winter's flu shot is canceled
A meeting by a panel of science advisors to choose flu strains to include in a vaccine for next fall has been canceled on short notice, according to a member of the committee, raising concerns ...
View ArticleSorriso Pharmaceuticals outlines Phase 1b ulcerative colitis data for oral...
Private startup Sorriso Pharmaceuticals laid out Phase 1b data at a medical conference last weekend as part of its effort to bring an oral antibody to market for IBD patients. The results come after...
View ArticleKallyope quietly reports Phase 2 obesity data, begins mid-stage migraine trial
Kallyope, a New York City biotech that has raised about $480 million over the past decade, quietly released results of its Phase 2 study in obesity in ...
View ArticleMerck mulls new site in Delaware; Granules India buys peptide CDMO
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Merck has received a $30 million strategic fund from the state of...
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