Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Biontech, Clinigen, Cytodyn, Enzychem, Pfizer, Protokinetix.
New England Biolabs Inc. (NEB) has launched its research use only product that can be utilized for the detection of the novel coronavirus, SARS-CoV-2 RNA. It is intended to serve as an alternative to RT-qPCR, enabling visual detection of amplification of SARS-CoV-2 nucleic acid in half an hour.
The checkpoint molecule CD47 has high hopes riding on it in oncology as being the innate immune equivalent of PD-1. Multiple companies are developing blockers against CD47 and/or its ligand, SIRPa, for the treatment of various tumors.
BEIJING – Known for its transgenic mouse platforms to develop antibodies, U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. closed a series C funding round July 9 to raise $102.8 million to advance its late-stage clinical programs and COVID-19 pipeline.
HONG KONG – Tokyo-headquartered Fujifilm Holdings Corp. will increase production of Avigan on the back of a partnership with India’s Dr. Reddy’s Laboratories Inc. and Dubai-based Global Response Aid, an affiliate of logistics company Agility.
CAJICA, Colombia, and BEIJING – Last week Sinovac Biotech Ltd., of Beijing, announced the approval by Anvisa, the Brazilian health care surveillance agency, to start phase III trials to test the efficacy and safety of its inactivated COVID-19 vaccine being developed by Sinovac Life Sciences, a subsidiary of the Chinese company, in the Latin American country.
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