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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
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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.
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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.
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Principal Scientist Anders Cai Holm Hansen explains how CDMO AGC Biologics uses its global, single-use network and a strategy emphasizing “scale-out” manufacturing, to derisk demand uncertainty, speed timelines and conserve cash for emerging drug developers.
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
In the future of AI-driven biopharma, reusable data is the most undervalued asset.
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.”
A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.
The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters.
Roche is jumping into degrader-antibody conjugates, a modality that in recent years has attracted investments from Merck KGaA and Bristol Myers Squibb.
BioSpace’s Biopharma Job Market Report reveals early signs of recovery for 2026. A rise in job postings, a surge in contract roles and strong M&A and IPO activity point to future hiring growth and shifts in hiring strategy.
Sidewinder Therapeutics’ bispecific antibody-drug conjugates target pairs of receptors found on cancer cells, which the company claims improves their specificity and minimizes off-target effects.