Based on positive phase III study data, Applied Therapeutics Inc. plans to take its CNS-penetrant aldose reductase inhibitor to the U.S. FDA to talk about an NDA for treating the rare disease sorbitol dehydrogenase (SORD) deficiency. Interim data from 12 months of treatment showed govorestat (AT-007) hit the study’s primary endpoints along with several key secondary endpoints. The double-blind, placebo-controlled registrational study of patients ages 16 to 55 is ongoing, with another 12 months of data yet to come. SORD, a hereditary axonal neuropathy created by sorbitol dehydrogenase gene mutations, affects about 3,300 people in the U.S. and about 4,000 in Europe, according to Applied Therapeutics. Read More
Raising $94 million in a series A round, South San Francisco-based Firefly Bio Inc. has emerged from stealth to advance its Firelink linker platform technology to develop degrader-antibody conjugates (DACs) to treat cancer. A combination of antibody-drug conjugates (ADCs) and targeted protein degradation therapies, DACs are a new class of medicines that have recently gained attention for their ability to replace toxic ADC payloads and to eliminate cancer-driven proteins. Read More
Ono Pharmaceutical Co. Ltd. inked deals with Shattuck Labs Inc. and Numab Therapeutics AG aimed at bolstering its pipeline in oncology and autoimmune and inflammatory diseases. Ono struck a drug discovery collaboration and option agreement with Shattuck Labs to generate bifunctional fusion proteins for pathways involved in autoimmune and inflammatory diseases. It also signed a global research, development and commercialization deal with Numab for its NM-49, a multispecific antibody designed to activate tumor-associated macrophage phagocytosis for treating cancers. Read More
Seeking the root causes and possible solutions to the chronic drug shortages plaguing the U.S. health care system, the FTC and Health and Human Services jointly issued a request for information regarding how group purchasing organizations and drug wholesalers may be contributing to the shortages of generic drugs. Read More
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Annovis, Carrick, Greenwich, Grifols, Kiromic, Mink, Oncolytics, Opthea, Replicate, Santhera. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABVC, Amo, Avicanna, Aurinia, Celularity, Ipsen, Merrimack, SPI.Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atara, BMS, Citius, Dermavant, Galderma, Ipsen, Precision, Projenx, Unravel. Read More
