The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame. Read More
After a steady upward trend since the beginning of the year, the BioWorld Infectious Diseases index has hit a speed bump for the first time and dropped almost 8% so far in August. Companies in the group focusing on treatments for COVID-19 took the brunt of the valuation decline as investors became notably anxious about other drug developers making it to market sooner with their COVID-19 therapies. Read More
Kinnate Biopharma Inc., a San Diego-based company focused on the discovery and development of small-molecule kinase inhibitors for genomically defined cancers, has raised $98 million in a series C financing. Read More
While the COVID-19 pandemic has brought disruptions to R&D, market activities in the biopharmaceutical sector have remained active during the first half of this year in China. Venture capital investments, IPOs and partnering activity showed upward trends, except for M&A activity, which has declined for two years. Read More
Annexon Biosciences Inc.’s handsome $250 million IPO this summer verified the mounting interest in its two front-running C1q inhibitors: ANX-005, which has turned up promising phase Ib data in Guillain-Barre syndrome (GBS), with a phase II/III effort planned for next year, and ANX-007, due to enter a phase II experiment in geographic atrophy (GA) during 2021 as well. Read More
Strong top-line results from Immunovant Inc.’s phase IIa clinical trial of IMVT-1401 in treating moderate to severe generalized myasthenia gravis increased the competition with Momenta Pharmaceuticals Inc. and Argenx SE in the crowded anti-FcRn space. Read More
HONG KONG – Telangana, India-based Dr. Reddy’s Laboratories Ltd. has launched Avigan (favipiravir), Fujifilm Holdings Corp.’s potential COVID-19 treatment, in India. Read More
New hires and promotions in the biopharma industry, including: Amylyx, Emergent, Geovax, Harpoon, Illumina, Immunovia, Innovation, Saniona, Starton, Vor. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Pharma, Cardiol, Cerecor, Dermavant, Mycovia, Novartis, Oncolytics, Oncology Venture, Outlook, Silverback. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Almirall, Autifony, Bavarian Nordic, Boehringer Ingelheim, Heat Biologics, Hitgen, Mannin, Oncology Venture, OS Therapies, PTC, Q Biomed, Roche, Therapure, Trevena, Tyme, VBI Vaccines. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3Sbio, Alimera, Hansa, Hifibio, Catalyst, Kye, Revive, TLC. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Apotex, Auspex, Glenmark, Johnson & Johnson, Sandoz, Teva, Taro. Read More