News
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
FEATURED STORIES
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
THE LATEST
Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker.
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline.
As Congress considers a bill that aims to distance U.S. biopharma from five Chinese companies, the industry must emphasize the importance of prioritizing patient care over power plays.
Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand therapies and synthetic lethality assets are also attracting attention.
Astellas Pharma’s new life sciences center houses its first U.S.-based SakuLab, an incubator space for external partners, as well as its engineered small molecules unit.
Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
If approved in chronic obstructive pulmonary disease, Nucala will compete with Verona’s Ohtuvayre and—pending a potential approval later this month—Sanofi and Regeneron’s blockbuster Dupixent.
Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.
Thursday’s announcement comes after the insurance giant last week said it would remove AbbVie’s Humira from its major formularies starting in 2025, replacing the blockbuster with more affordable biosimilars.