Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acadia, Avadel, Biogen, CSL Vifor, Eisai, Intercept, Limmatech, Travere, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avacta, Cerus, Concentra, Eterna, Factor, Kezar, Lexicon, Orano Med, Poseida, Radiomedix, Roche, Sage, Sanofi, Viatris.
U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
According to World Health Organization data, endometriosis affects about 10% of reproductive-age females globally. That already makes endometriosis a wildly underresearched and underfunded disease in relation to its prevalence. Plus, Rama Kommagani thinks even 10% is an underestimation. “Diagnosis is very underreported, particularly in low- and middle-income countries,” Kommagani, who is an associate professor of pathology at Baylor College of Medicine, told BioWorld.
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.
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.
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.
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