LONDON – While the pandemic raged, Brexit was simmering on the back burner, but now as infections wane, the industry is turning its attention back to being ready for the U.K. cutting ties with the EU at the end of December.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA, Aptorum, Bio-Thera, Curadigm, Cyclerion, Fairhaven, Liminal, Ocular, Orphazyme, Pharmapark, Takis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Aprea, Celltrion, Janssen, Phasebio, Sinopharm.
The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
Diversified health care player Abbott Laboratories did better than expected when it reported second quarter earnings. The Abbott Park, Ill.-based company is one of the earliest to start reporting for this period, which in the U.S. was characterized by an initial heavy impact from the ongoing pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Telemedicine Association, Heraeus, Zimmer Biomet.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Med, 7D Surgical, Abiomed, Invo Bioscience, M.I. Tech, Todos Medical.
Courtesy of a $50 million series A, Adagio Therapeutics Inc. will join a raft of other companies attempting to end the COVID-19 pandemic with antibodies.
LONDON – Pharmaceutical companies and academic researchers working on COVID-19 vaccines are being targeted by Russian state-sponsored hackers, according to the U.K. National Cyber Security Centre (NCSC). The U.K. view is endorsed by the U.S. National Security Agency and Canada’s Communications Security Establishment, and the three agencies have issued a joint statement advising companies how to protect against these attacks.
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