Gene therapy has finally become the “new normal” with serial breakthroughs unlocking “tremendous value” for patients and society, while at the same time the U.S. health care system is shaping up to enable access to these costly treatments, according to Tim Hunt, CEO of the Alliance for Regenerative Medicine. Read More
California’s First District Court of Appeal opened an avenue, in that state at least, for lawsuits against drug and device companies based on their pipeline development priorities. Read More
Among the firms updating progress at the J.P. Morgan Healthcare Conference (JPM) in San Francisco this week was Relay Therapeutics Inc., coming off a $30 million financing to boost its Dynamo platform and candidates. Read More
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment. Read More
Current risk genes for some diseases such as multiple sclerosis (MS) may have emerged in the past as protection against infection by different pathogens. A group of researchers led by scientists from the University of Copenhagen has analyzed the ancient DNA of European populations and has revealed how MS, Alzheimer’s disease (AD) and diabetes arose as populations migrated. This evolution would explain the modern genetic diversity and the incidences of these pathologies observed today in the old continent. Read More
Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affimed, Atea, Biomedical Research & Bio-Products, Elicio, Innovent, Ironwood, Medicenna, Neuraptive, NGM, Novocure, Renibus, Summit, Theracosbio, Tonix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adimab, Amgen, C4, Crispr, Evotec, Lantheus, Linkedup, Lykos, Maps, Perspective, Revive, Tianti, Vertex, Walden, Xeris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Astellas, Biogen, Corbus, Focal Medical, GC Cell, Genmab, Mediwound, Novelmed, Nuvation, Pfizer, Sellas, Seres, Shorla Oncology, Skye, Vertex. Read More
