In a bid to build public confidence and demonstrate its transparency in determinations about potential COVID-19 vaccines, the FDA will convene its Vaccine Advisory Committee for a virtual meeting Oct. 22 to discuss the general development of the vaccines for the U.S. market.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Coghlin Companies, Cogmedix, Concord Medical, Dominion Aesthetics, Formsense, Genesis Medtech, Nowdiagnostics, Ontrak, Todos Medical.
Generex Biotechnology Corp.’s wholly owned subsidiary Nugenerex Health partnered with Worldwide Digitech (WWDT) LLC to create a 50/50 joint venture, Nugenhealth LLC. The new company will draw on WWDT’s software to develop an end-to-end software-as-a-service (SaaS) solution for chronic care management using remote patient monitoring.
Pooled testing was hailed early in the COVID-19 pandemic as a way to quickly and efficiently increase the number of people tested for the virus. But the approach has fallen short of its promise for a variety of reasons, from supply and labor shortages to high community infection rates. Now, a new testing method – recently approved for use by laboratories in Israel – could help chip away at some of those issues.
With COVID-19, questions about how infections cause lasting immunity, or don’t, and how you know and what it all means for vaccines have become a matter of public focus. But some immunologists have been pondering those questions for years. “The immune system has a very good memory,” Bali Pulendran told BioWorld. “Clearly, some viruses and some pathogens can enter the body and stimulate the immune system, and the immune system can remember that encounter for decades.”
LONDON – The U.K. is funding a national program of research to investigate the major unanswered questions related to the immune response to COVID-19. The aim of the research, involving teams of immunologists in 17 research institutions, is to unpick the immunological backdrop of one of the most notable aspects of COVID-19 infection, which is the huge spectrum of severity of symptoms.
A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.
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.
