Archive for July 2020
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
Read MoreU.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 nationwide delivery of 100 million doses of their COVID-19 vaccine. Source: Devices & Diagnostics Letter
Read MoreApotex 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 into the U.S. market. Source: Drug Industry Daily
Read MoreGilead 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 third quarter of this year. Source: Devices & Diagnostics Letter
Read MoreDynavax Teams Up with Medigen on COVID-19 Vaccine
The vaccine generated a strong immune response in preclinical studies. Source: Devices & Diagnostics Letter
Read MoreGlenmark’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
Read MoreJazz 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
Read MoreLawmakers 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 & Diagnostics Letter
Read MoreGenfit 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
Read MoreNorlase Gets CE Mark for Leaf Laser
The Leaf received 510(k) clearance from the FDA in October 2019. Source: Devices & Diagnostics Letter
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