HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.
Enthusiasm stayed high but abated somewhat throughout the day as Wall Street took in the positive interim phase III results from Biontech SE and Pfizer Inc. with the COVID-19 vaccine candidate BNT-162b2.
Preparing for a Biden presidency in which COVID-19 will be a top priority, the Joe Biden-Kamala Harris transition team named a board of scientists and public health experts Nov. 9 to advise the team on how to respond to the surging pandemic in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amo, Astrazeneca, Axovant, Bayer, Beigene, Eusa, Impel, Liminal, Novavax, Orphazyme, Sorrento.
The latest global regulatory news, changes and updates affecting biopharma, including: Final analysis: hydroxychloroquine offers no benefit; FDA finalizes PDUFA VI fee guidance.
DUBLIN – Memo Therapeutics AG raised CHF13.8 million (US$15.3 million) in a first close of a series B round to take forward a patient-derived monoclonal antibody therapy for COVID-19, MTX-Covab, which will move into a phase I/II trial in Germany in the new year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Genscript.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioelectronics, Careprotocol, Decision Diagnostics, Djo, Genassist, Hancock Jaffe, Mesa Biotech, Orthoalign, Progenity, Scott Specialties, Verida.