After years of battling to drum up private sector interest in a disease that afflicts only 25,000-30,000 Americans, the Cystic Fibrosis Foundation decided to take matters into its own hands. In doing so, it is charting new territory for disease-related charities. No longer content with making only small grants to academic institutions, the foundation has cut deals with biotechs that have it looking very much like a drug or biotech company itself, including significant alliances with Aurora Biosciences and Altus Biologics.
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Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.
Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.
As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?
Swiss major confident that new oncology drugs will fill revenue gap.
With low valuations for biopharma companies that recently went public and little hope of a near-term turnaround as uncertainty lingers, IPO numbers may stay low for the rest of 2025.
After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.
Swiss major confident that new oncology drugs will fill revenue gap.
