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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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Read our takes on the biggest stories happening in the industry.
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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Drug discovery can be an uphill battle, especially lately given recent upheaval at the FDA and muted investment activity. BioSpace spoke to four industry executives about key issues facing those working in this space, starting with planning around uncertainty.
As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a resubmission for FDA approval.
The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.
Of the 11 companies participating in the spring cohorts of the Drive program run by MassBio and SCbio, eight have locations in Massachusetts. One cohort focuses on biotech and the other on biomarkers and diagnostics.
Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors.
While peptides are currently the dominant approach to GLP-1 agonism, Ambrosia Biosciences is pursuing a small-molecule approach.
The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused.
The FDA advised IO Biotech last year to hold off on filing an approval application for its cancer vaccine Cylembio, pointing to a failed Phase 3 study in frontline advanced melanoma. The biotech has now gone under.
As AI reshapes deeply specialized scientific work, R&D professionals must learn to navigate the shift to a skills-centered market. The key is knowing which skills to develop and how to leverage AI as scientific modalities evolve, technologies advance and regulatory complexity increases.
Convergent Therapeutics’ Dr. Philip Kantoff and Plus Therapeutics’ Dr. Marc Hedrick discuss how unmet medical needs, maturing isotope supply chains and innovative delivery are positioning targeted radiation as oncology’s next big platform.