LONDON – Relaxing of control measures such as mask wearing and social distancing at a time when most of a population has been vaccinated against COVID-19 greatly increases the probability of the emergence of a vaccine-resistant strain, according to a new modeling study. Read More
Peptidream Inc., fresh off expanding a multibillion-dollar research and license agreement with Takeda Pharmaceutical Co. Ltd. earlier this week, has inked a brand new deal with Alnylam Pharmaceuticals Inc. Valued at up to $2.2 billion, including milestones, the new deal is aimed at the discovery and development of peptide-siRNA conjugates for the delivery of therapies to a wide range of cell types and tissues beyond the liver, the central target of Alnylam's marketed products to date. Read More
Minovia Therapeutics Ltd. will collaborate with Astellas Pharma Inc. to research, develop and commercialize cell therapy programs for treating diseases brought on by mitochondrial dysfunction. The candidates will come from Astellas’ genetically engineered, induced pluripotent stem cells. Haifa, Israel-based Minovia will receive $20 million in cash up front. Read More
Although 14 of the 17 stocks that make up BioWorld’s Neurological Disease Index (NDI) dropped in value over the last month, the index is still ahead by about 9% this year, with a huge surge by Prothena Corp. plc leading the way. Read More
China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards. Read More
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector. Read More
The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the manufacturer’s intended use. While the final rule says that mere knowledge of off-label use cannot be the sole determinant of the manufacturer’s intended use, the rule still allows the FDA to infer intended use by “any relevant source of evidence,” a term that may be sufficiently squishy to be functionally equivalent to the controversial totality-of-the-evidence standard. Read More
Biopharmas raising money in public or private financings, including: Biomap, Immuneering, Immutep, In8bio, Lifesci, Neukio, Omega, Rani, Tenaya. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Annovis, Atreca, Cassava, Celsion, Daewoong, Endo, Ionis, Mycovia, Newsoara, Palisade, PTC, Regeneron, Roche, Sanofi, Sapience, Satsuma, Scynexis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adhera, Hillevax, J&J, Melior, Neopharm, NRG, Protagonist, Rhythm, Siga, Takeda, Urogen, Zandcell. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alzamend, Arrowhead, Basilea, Dicerna, Everest, Fusion, Genentech, Eli Lilly, Nuvox, Oncopeptides, Scancell, Transcenta, Viatris, Vico. Read More
