Glenmark’s Favipiravir Shows Promise for COVID-19 Patients
India-based Glenmark Pharmaceuticals says its antiviral favipiravir has shown promise as a COVID-19 treatment in mild to moderate patients. Source: Devices & Diagnostics Letter
U.S. to Pay Nearly $2 Billion for Pfizer-BioNTech COVID-19 Vaccine
HHS and the Department of Defense have signed their largest deal to date under Operation Warp Speed — a $1.95 billion contract with Pfizer and BioNTech for large-scale production and…
Apotex Subsidiary Signa Gets FDA Warning Letter
Signa, a Mexican subsidiary of Canadian generic drugmaker Apotex, has received an FDA warning letter for failure to correct manufacturing problems for active pharmaceutical ingredients (API) that were later released…
Gilead Takes $300 Million Stake in Cancer Antibody Developer Tizona
Gilead Sciences said it is buying a 49.9 percent stake in Tizona Therapeutics, a company developing first-in-class cancer immunotherapies, for $300 million in a transaction expected to close in the…
Dynavax Teams Up with Medigen on COVID-19 Vaccine
The vaccine generated a strong immune response in preclinical studies. Source: Devices & Diagnostics Letter
Glenmark’s FabiFlu Shows Promise for COVID-19 Patients
The drug was generally well tolerated, with no serious adverse events or deaths, the company said. Source: Devices & Diagnostics Letter
Jazz Pharmaceuticals’ Xywav Approved for Narcolepsy
The FDA required a boxed warning for the drug because of its potential for misuse and abuse. Source: Devices & Diagnostics Letter
Lawmakers Call for Answers on COVID-19 Antibody Test Scams
Among other questions, the lawmakers asked what resources the agencies are using to assess the extent of the scams and what actions they are taking against those involved. Source: Devices…
Genfit Ends Phase 3 Trial of NASH Drug Elanfibranor After Finding No Benefit
Genfit said it will now focus on developing the drug for the treatment of primary biliary cholangitis, a chronic liver disease. Source: Devices & Diagnostics Letter
Norlase Gets CE Mark for Leaf Laser
The Leaf received 510(k) clearance from the FDA in October 2019. Source: Devices & Diagnostics Letter