As more COVID-19 antibody testing becomes available, one question has been on everybody’s mind: Does the presence of antibodies to SARS-CoV-2, the virus responsible for the global pandemic, mean that people are protected from future infection? To that end, Genscript Biotech Corp., of Piscataway, N.J., has applied for emergency use authorization (EUA) with the U.S. FDA to market a test that specifically recognizes neutralizing antibodies to SARS-CoV-2.
HONG KONG – China’s Shanghai Junshi Biosciences Co. Ltd. has struck a deal with Merck KGaA for a clinical trial program in China to investigate the efficacy and safety of Junshi’s anti-PD-1 monoclonal antibody (MAb), Tuoyi (toripalimab) in combination with Merck’s Erbitux (cetuximab) as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck (SCCHN).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Clarity, FSD, Genmab, Novartis, Pierre Fabre, Revive, Specialised Therapeutics, Treadwell, Trevena.
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
Swept up into a coronavirus whirlwind, the biopharma industry has ramped up development of therapeutics and vaccines and altered business plans to fight the SARS-CoV-2 virus in a way that nobody could have imagined only months ago.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avita Medical, Citius, College Park Industries, Fibralign, Icometrix, Lumendi, Medx, Mölab, Mybio, Myndtec, Maness Veteran Medical, Nuprobe, Ourcrowd, Pathgroup, Protech Home Medical, Qualigen Therapeutics, Respira Technologies, Steeper Group, Surgery Exchange, Technopath Clinical Diagnostics, Terumo.