Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Bio-Thera, Harbour, Immunoforge, Kintor, M6P, Opko, Passage, Pfizer.
Marking the first time monoclonal antibodies developed by separate companies will be tested in combination against COVID-19, Vir Biotechnology Inc.’s VIR-7831 will be added to Eli Lilly and Co.’s bamlanivimab in the ongoing phase II BLAZE-4 study in low-risk patients with mild to moderate disease. The collaboration comes as early research indicates some antibodies in development appear to lose activity when pitted against emerging SARS-CoV-2 variants. VIR-7831 (also known as GSK-4182136), partnered with Glaxosmithkline plc, is designed to bind to a different epitope of the SARS-CoV-2 spike protein than bamlanivimab. A dual-action antibody, VIR-7831 is designed to both block viral entry into healthy cells and clear infected cells.
Phase II data with San Diego-based Heron Therapeutics Inc.’s pain drug HTX-011 (Zynrelef) graced the online pages of the Journal of the American Podiatric Medical Association in early January, whetting investor thirst for an FDA decision regarding approval, slated by May 12. And the agency’s go-ahead, if it comes, could have special meaning for Pacira Biosciences Inc. with competing analgesic Exparel (bupivacaine).
The U.S. biosimilar market is coming of age under the BsUFA II agreement, but there are a few steps the FDA could take to help it develop more predictably. For starters, the agency should conduct pre-approval inspections earlier in the 12-month biosimilar review cycle to give sponsors time to address unexpected issues, industry representatives told the FDA Jan. 27 in response to an independent interim assessment of the enhanced transparency and communication processes included in the current user fee agreement.
About 91% of funds recorded in 2020 for all biopharma collaborations with nonprofit entities and 75% of all grant money went directly to therapeutic and vaccine efforts to fight COVID-19. BioWorld has tracked 912 bio/nonprofit deals worth $19.86 billion and 658 grants awarded to the industry and valued at $12.98 billion for a combined total this year of 1,570 and $32.84 billion.
Slate Bio Inc., a startup developing an interleukin 2 fusion cytokine for the potential treatment of autoimmune and inflammatory diseases, has closed a $1.75 million seed financing led by Epidarex Capital. Financing for the company, a spinout of the University of Virginia, also came from the UVA Licensing & Ventures Group Seed Fund, Center for Innovative Technology's GAP Biolife Fund, VTC Seed Fund, Pharmadirections Inc., company management and others.
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