The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Medicare & Medicaid Services, HHS.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3Sbio, Alimera, Hansa, Hifibio, Catalyst, Kye, Revive, TLC.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acessa Health, Altair, Avellino, Avero Diagnostics, Baril, Cerebain Biotech, Edap, Enwave, Essilorluxottica, Grandvision, Hal Optical Investments, Hologic, Maravai Lifesciences, Mediwound, Otsuka America Pharmaceutical, Pct, Pkg, Premier Medical Laboratory Services, Proscia, Proteus Digital Health, Sonde Health, Sugentech, Team Technologies, Trilink Biotechnologies, Valencia Technologies, Vericel.
Academic tech transfer offices are largely still working from home, but the groups have been as busy as ever according to a report from Primary Research Group Inc. that surveyed 37 colleges and universities.
The idea of patent pools such as the COVID-19 Technology Access Pool (C-TAP) created by the World Health Organization a few months ago has drawn a lot of support from low- and middle-income countries and a handful of wealthier ones, but not so much from industry.
Continuing a trend that began in June, the largest biopharma deals of 2020 have all occurred this summer, led by the $6.3 billion global partnership on cancer immune therapies between Tango Therapeutics Inc. and Gilead Sciences Inc. earlier this month.
As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.
DUBLIN – Adrenomed AG has reported encouraging, albeit limited, data for its antibody adrecizumab in eight COVID-19 patients in Germany with life-threatening acute respiratory distress syndrome (ARDS). The drug was made available on a named-patient basis to critically ill patients undergoing mechanical ventilation.
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