Anavex Life Sciences Corp. reported top-line data from the 33-subject phase III study with Anavex 2-73 (blarcamesine) in adult females with Rett syndrome, turning up a statistically significant improvement over placebo for the primary efficacy endpoint as well as for all the secondary efficacy endpoints. The sigma-1 receptor activator, given as a once-daily, oral liquid, proved well-tolerated, too, with good compliance by patients, Anavex said. Read More

Sio Gene Therapies Inc. is retrenching the business as it terminated the company’s AXO-Lenti-PD license agreement with Oxford Biomedica plc for treating Parkinson’s disease. Also, Sio’s CEO, Pavan Cheruvu, is leaving the company. Sio said it is deprioritizing its Parkinson’s disease program due to several factors, including resource requirements and development timelines “to reach meaningful value inflection for the program and an increasingly challenging market and regulatory environment” for the indication. Read More

During the most infectious COVID-19 month since the pandemic began, January recorded an increase of 82.3 million confirmed cases worldwide, an amount that is fourfold the average monthly increase over the past year. It comes at a time when the highly transmissible omicron variant continues to circulate, bolstered by a new subvariant, BA.2, which is outcompeting its predecessor. Meanwhile, regulatory agencies are authorizing antivirals, swapping monoclonal antibodies based on their efficacy against omicron, and approving new vaccine options, including Novavax Inc.’s protein-based vaccine Nuvaxovid (NVX-CoV2373). Read More

Last week, Incyte Corp. said it was pulling its NDA seeking accelerated approval for the PI3K-delta inhibitor parsaclisib in three non-Hodgkin lymphoma subtypes, a move that followed recent decisions by Gilead Sciences Inc. and Secura Bio Inc. to withdraw from U.S. commercialization their respective PI3K-delta inhibitors in indications for which they’d received accelerated approval. But the recent spate of headlines is hardly “a condemnation” on the entire class of drugs, said Dan Gold, CEO of MEI Pharma Inc., which is aiming for a potential accelerated approval filing of its own PI3K-delta drug, zandelisib, this year. Read More

A remarkably brief exposure to a multidrug cocktail enabled frogs to re-grow largely functional limbs after amputation, investigators from Tufts University reported in the January 26, 2022, issue of Science Advances. Twenty-four hours of exposure to five factors – brain-derived neurotrophic factor (BDNF), growth hormone (GH), 1,4-dihydrophenonthrolin-4-one-3carboxylic acid (1,4-DPCA), resolvin D5 (RD5) and retinoic acid (RA) – set off regeneration processes that continued for 18 months. Read More

More than a year into U.S. President Joe Biden’s four-year term, the FDA commissioner seat remains open. While Robert Califf secured a critical endorsement Jan. 31 in his quest for a second term in the post, his hope for a sequel may still be up in the air. Read More

As part of a settlement in a class action suit, Vyera Pharmaceuticals LLC and its parent company, Phoenixus AG, of Baar, Switzerland, agreed last week to pay up to $28 million to a proposed class of third-party payers that covered Daraprim (pyrimethamine). Read More

Russia’s Ministry of Health is looking to extend its role on the global stage. Over the next few months, the ministry, along with other regulatory agencies in Russia, said it plans to start the accreditation process of coming into compliance with World Health Organization (WHO) standards. Read More

New hires and promotions in the biopharma industry, including: Alligator, AMR, Avrobio, Beigene, Biomea Fusion, C4X, Centogene, Checkmate, Clover, Cortexyme, Covis, Cyclica, Enara, Gamida Cell, Immuneid, Kiora, Lyell, Nanoscope, Obseva, Qualigen, Seagen, Sosei, Stemson, Tenax. Read More

Biopharmas raising money in public or private financings, including: Arcellx, Aytu, Ethris, Sierra Oncology, Zymeworks. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Can-Fite, Madrigal, Scancell, Shionogi, Taysha, Viracta. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aqualung, Aspen, Biogen, Debiopharm, Inventiva, Ionis, Kaleido, Merck, Pfizer, Tollys. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Altimmune, Celltrion, Cybin, Eagle, Filament, Genentech, Immunoprecise, Janssen, Kite, Nordic, Novelmed, Reata, Regeneron, Sanofi, Veru, Viridian. Read More