Clinical research
Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.
The seven proposals in the Bio Advance plan include easing clinical trial starts, boosting manufacturing and establishing a new White House office to coordinate the government’s biotech policy.
Beam Therapeutics’ risto-cel provided at least 12 consecutive months of freedom from severe pain crises for patients with sickle cell disease in a mid-stage trial, setting the stage for an FDA application as early as this year.
The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3 program.
If approved, the oral GLP-1 would be Eli Lilly’s second marketed drug for obstructive sleep apnea after the GIP/GLP-1 injectable Zepbound secured the first approval in the space in December 2024.
Vir Biotechnology is targeting a mid-2027 regulatory submission for its monthly chronic hepatitis delta regimen, with head-to-head data against Gilead’s Hepcludex expected next quarter.
Full data from the Phase 3 HORIZON trial of Novartis’ pelacarsen failed to show any apparent benefit, leading analysts to further reduce the odds of success for Lp(a)-lowering competitors such as Amgen’s olpasiran.
At the American Heart Association conference, investigators were supportive of further studying Novo’s IL-6 inhibitor ziltivekimab in patients with less severe cardiovascular and kidney disease.
In this episode of Denatured, you’ll hear from from Lewis Bender, CEO at Intensity Therapeutics and Paul-Peter Tak, president, CEO and board director at Candel Therapeutics. We explore how intratumoral therapies trigger systemic anticancer immunity from a local injection, and redefine a foundational platform in immuno-oncology.
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