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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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FibroGen takes another hit as its antibody hopeful fails in a second indication. The biopharma says that it is cutting costs to extend its cash runway.
A year after treatment, Vertex’s VX-880 has eliminated the need for insulin injections in two Type 1 diabetes patients in a Phase I/II clinical trial of its investigational stem cell-based therapy.
New Phase II data, published in the New England Journal of Medicine, showed Lilly’s oral GLP-1 receptor agonist orforglipron induced nearly 15% weight loss in obese and overweight adults.
CMS has stated that it will cover new Alzheimer’s drugs if the therapies are fully approved. But significant financial questions remain.
Results of a Phase IIb trial of the company’s anti-TL1A antibody showed more than a third of ulcerative colitis patients entered remission while receiving the experimental treatment.
Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.
A day after the FDA denied Intercept’s application for its non-alcoholic steatohepatitis treatment, the pharma announced it has axed all NASH investments and one-third of its staff.
Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.
Regeneron envisions new dosing for Eylea’s label and it’s the moment of truth for BioMarin’s gene therapy for hemophilia A. For that and more, see inside.
Shares of Sarepta dropped 11% a day after securing accelerated approval for the first gene therapy to treat Duchenne muscular dystrophy over concerns about the potential for label expansion.