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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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The FDA has issued special designations that could improve the lives of millions with recurrent glioblastoma or hemophilia diagnoses.
Pfizer intends to sell off its stake when the de-merger occurs and seek the most profitable sale of its share of Haleon to maximize value for company stockholders.
Axsome Therapeutics published results of its Phase III trial of AXS-05 that demonstrated rapid, substantial and statistically significant improvement in depressive symptoms.
The report suggests that AbbVie’s sales will be approximately $65.7 billion within the next six years, with Roche right behind at $65 billion.
Bristol Myers Squibb (BMS) has announced late-breaking data showing deucravacitinib significant efficacy at the primary endpoint for the treatment of systemic lupus erythematosus (SLE).
Sage Therapeutics and partner Biogen shared news that their phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD).
With a swirl of rumors around the changes in ownership in the pharma industry, this invariably triggers reviews of business strategies. Because of this, wider skillsets from related sectors are needed.
Although Bruce Goldsmith will no longer serve on the executive team, he will remain with Passage Bio for a short period as a strategic advisor to the interim CEO.
The AbbVie Immunology Scholarship provides financial support to students living with chronic, immune-mediated diseases who are pursuing higher education in the United States.
The U.S. FDA has requested some additional data from BioMarin Pharmaceuticals for the BLA it filed for the hemophilia A therapy valoctocogene roxaparvovec.