Shares of immunotherapy developer Enlivex Therapeutics Ltd. (NASDAQ:ENLV) climbed as much as 69% Dec. 3 after interim data showed the apparent benefits of its lead candidate, Allocetra, for severe and critical COVID-19 patients.
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
The latest global regulatory news, changes and updates affecting biopharma, including: DEA gets on board with partial Rx fills; USPTO touts early results of amendment pilot; FDA posts combo product feedback final guidance.
With hospitalizations rapidly rising as the COVID-19 pandemic washes across the world in a winter wave, researchers are racing to develop treatments that protect the increasing number of ventilated patients. One option focuses on protecting muscles critical to breathing.
CAJICA, Colombia – Chembio Diagnostic Systems Inc., a point-of-care diagnostic company focused on infectious diseases, received the approval from Anvisa, the Brazilian health care surveillance agency, to distribute its tests in the Latin American market. The approval adds yet another test to the hundreds already approved in Brazil, where the market for such tests is quickly getting crowded sending prices down. Brazil is one of the countries most affected by COVID-19 with almost 6 million cases and 166,000 deaths, the third highest number of cases in the world.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Etiometry, Modulim, Nico.Lab, Roche, University of California.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA slaps two companies for illicit COVID offerings; FDA approves new PET imaging agent for prostate cancer.
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