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While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
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As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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Roche said the Phase II results help build the case for advancing CT-388 into late-stage testing, which is set to get underway this quarter.
The cornerstone of the deal is SIM0709, which Simcere designed to target both TL1A and IL-23, crucial players in facilitating inflammation. Boehringer Ingelheim will advance the asset for inflammatory bowel diseases.
While Baseline Therapeutics declined to disclose its starting capital, the startup said it will use the funds to push its GLP-1 asset BT-001 into late-stage development, with two trials planned this year.
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
True inspection readiness is about the integrity of a company’s entire system.
Investors are apparently taking bets on when Revolution will be acquired. A handful of pharmas could be interested as Merck backs off.
After a spate of patient deaths in 2025 linked to the company’s Duchenne gene therapy, Sarepta shared new data showing benefits of the therapy three years after dosing.
Corcept’s overall survival data “look competitive” with AbbVie’s Elahere and Merck’s blockbuster Keytruda, Truist Securities said Thursday.