With two complete response letters in the rearview mirror, Abbvie Inc.’s Vyalev (foscarbidopa/foslevodopa) has been approved by the U.S. FDA for treating Parkinson’s disease. The drug is the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced disease. Read More
Clarity Pharmaceuticals Ltd. will begin early next year its pivotal phase III trial for its copper-based radiopharmaceutical, 64Cu-SAR-bisPSMA, for diagnosing prostate cancer in patients with biochemical recurrence following positive U.S. FDA feedback. Read More
The BioWorld Biopharmaceutical Index (BBI) climbed 16.92% in the first three quarters of the year, bolstered by second quarter (Q2) results despite disappointing clinical news from several players. The BBI maintained its lead over both the Nasdaq Biotechnology Index, which increased by 9.09%, and the Dow Jones Industrial Average, which saw a 12.31% rise. Read More
Insider trading isn’t always about profits. Sometimes it’s avoiding losses. That’s the basis of the U.S. SEC’s complaint against Matthew Groom, an information technology consultant to Spero Therapeutics Inc. Groom agreed Sept. 15 to a $28,000 settlement to resolve the complaint stemming from a trade of Spero shares that enabled him to avoid $13,000 in losses when news of the company’s downsizing and issues with its lead product became public two years ago. Read More
During an Innovation Ignited webinar sponsored by Johnson & Johnson, experts talked about how precision medicine has helped advance the field of oncology and how those lessons can be applied to immunology. Read More
In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Athos, Alzamend, Beacon, Hutchmed, Merck, Neurogastrx, NS Pharma, Wave Life. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Astria, GSK, ipsen, Novavax, Theriva, Tonix, Urogen. Read More
