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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA tweaks export final guidance per CARES Act; OIG: CMS should act to recover payments for device credits.
Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld.
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