Government

The latest news in COVID-19 includes support for an investigation into the origins of the virus, a new naming system, and legal discussions of whether employers can mandate vaccination.
Several biotech executives provided their thoughts on lessons learned from the pandemic and what they hope or expect to see moving forward in the industry.
A real-world study published by the FH Foundation confirms COVID-19 increased heart attack rates significantly in patients with these conditions.
FDA
The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
FDA
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.
Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC’s recommendation if booster shots are necessary.
Lilly said it is cooperating fully with the DOJ and is in the process of conducting its own investigation into the allegations made against the company.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
FDA
Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
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