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Spero Therapeutics is putting over $1 billion on the line in exchange for rights to develop SP001, an anti-CD40L antibody, for IgG4-related disease. A Phase 2 study is planned for the second quarter of 2027.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The trial evaluated crenezumab’s ability to slow Alzheimer’s disease in cognitively unimpaired people with a specific gene mutation that causes early-onset Alzheimer’s disease.
Covis announced that the U.S. Food and Drug Administration has granted the company a hearing for its controversial drug Makena, which is intended to reduce preterm births.
This week sees Exelixis, BioInvent, ImmunoGen and Oxford BioTherapeutics coming together to develop antibody-based therapies for cancer.
Biogen has terminated its asset purchase agreement with Karyopharm Therapeutics, putting a halt to the development of KPT-350 (BIIB100), which was being evaluated as a treatment for ALS.
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Dr. Soon-Shiong and ImmunityBio are on the final leg of what they hope will be the FDA approval of their drug N-803 (anktiva) for the treatment of bladder cancer.
Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.
Representation of women in biotech is nearing parity, but this is not reaching the executive level, where there is still stark disparity.
A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).
Since 2020, the life sciences industry has worked to rebound from the COVID-19 pandemic. But one sector’s growth has far outpaced the others–the biotech industry.