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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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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.
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AstraZeneca joins Johnson & Johnson and Bristol Myers Squibb in appealing a previous legal loss for its challenge to the government’s drug price-setting program.
Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.
Pfizer selects its candidate for the oral GLP-1 race as Eli Lilly strives to overtake Novo Nordisk in the injectable weight-loss drug space. Meanwhile, pressure builds to reduce drug prices in the U.S.
Restructuring can invite lawsuits if companies aren’t careful. Following local, state and federal rules is critical, as is keeping the employee handbook current.
This week, Carina discusses how to transition into a career in biotech when you don’t have lab experience. Plus, handling difficult interviews and getting a “dry” promotion.
Backed by Bain Capital, Cardurion Pharmaceuticals will use the Series B funds to advance two assets for heart failure and other cardiovascular conditions.
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.
To help keep pace with the demand for GLP-1 therapies, CordenPharma has announced a sizeable $980 million investment in its U.S. and European sites.
To improve its reviewers’ understanding of cell and gene therapy manufacturing, the agency has launched a program that will involve a tour of manufacturing facilities and daily workshops for its staffers.
After discontinuing its long-acting insulin product Levemir, Novo has again found itself under legislative scrutiny, with three Democratic senators seeking a sit-down with the pharma.