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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Guardant Health, Helixbind.
Through the use of sequencing data, researchers in Hong Kong presented a case study providing the strongest evidence yet that individuals can become reinfected with SARS-CoV-2 after clearing a first infection.
Despite two significant coronavirus outbreaks in the last two decades that killed hundreds of people, dominated international headlines, and grabbed millions in research dollars, SARS-CoV-2 still caught researchers, national scientific advisors, pharmaceutical companies flatfooted when it emerged in late 2019. Why?
The COVID-19 pandemic has had an enormous impact on elective and nonessential procedures, and with them the medical device companies they depend on, but early signs of recovery are encouraging, according to Raghav Tangri, of (DRG), which is part of Clarivate. That said, Tangri told BioWorld that while the second quarter is expected to be the most strongly impacted period this year, the speed of recovery will depend on a number of factors, including the possibility of a second wave of the coronavirus outbreak and how soon a vaccine is available.
The U.S. Department of Health and Human Services (HHS) has ordered the FDA to cease requiring developers of lab-developed tests (LDTs) to go through the agency’s premarket review mechanisms before offering an LDT. The context of the order might at first blush be interpreted as limiting the scope of the order to the public health emergency (PHE) to the COVID-19 pandemic, but the statement expands the temporal scope by referencing a need for rulemaking on the FDA’s part, one of several indications that this order is intended to outlast the PHE.
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