Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Celltrion, Chemocentryx, Chi-Med, Roche, Sorrento, Zynerba.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apnimed, Epygenix, Intensity, Mimedx, Novartis, Octapharma, Principia, Rhovac, Rigel, Virometix.
A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage.
LONDON – After years of progressing at snail’s pace, COVID-19 has forced through a rapid adoption of digital tools across the spectrum of health in the U.K., from general practitioner appointments, to hospital referrals, elderly care homes and community nursing. “At game changing speed” the health and care system, “has gone from one extreme to another,” said Harpreet Sood, a general practitioner in inner city London and board member of Digitalhealth London.
TORONTO – “With COVID-19 it’s not been an easy time to raise capital.” In virtually the same breath Joshua Liu, CEO of Toronto-based health-tech startup SeamlessMD Inc. credited the pandemic with nudging investors to spend CA$4 million (US$3 million) to grow his company’s cloud-based patient engagement app, boosting a library of digital plans for surgery, cancer and chronic care and adding machine learning-based risk prediction to remote patient monitoring.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axim Biotechnologies, Baxter International, BioIQ, Biomérieux, Care G.B., Corza Health, General Biologicals, Invotek, Labcorp, Mediwound, Medtronic, Myomo, Nanox, Opgen, Pacgen, Pathogenx, PhysIQ, Premier, Solutions in Critical Care, Takeda, Tempus, Todos, Varian, Vibrent Health, Vitalconnect, Vivera.
A new randomized controlled trial (RCT) of COVID-19 convalescent plasma (CCP) treatment for moderately ill COVID-19 patients run at 39 Indian hospitals found no association between CCP therapy and reduced mortality or progression to severe disease.
CAJICA, Colombia – Latin American countries are rushing to sign deals to gain access to SARS-CoV-2 vaccines, with Brazil, the largest in the region, right in the race. Already, the country has the third most COVID-19 cases globally, behind only India and the U.S.
LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.
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