Archive for June 2020
Ridgeback Biotherapeutics to Launch Two Trials of Its COVID-19 Antiviral
Ridgeback Biotherapeutics in July will launch two phase 2 trials of its investigational antiviral EIDD-2801 as a potential COVID-19 treatment. Source: Devices & Diagnostics Letter
Read MoreNIH and Novartis End Late-Stage Hydroxychloroquine Trials
Faced with mounting evidence that hydroxychloroquine is ineffective in treating COVID-19, three trials of the drug have been terminated. Source: Devices & Diagnostics Letter
Read MoreGilead Sciences Gears Up for Clinical Trials of Inhaled Remdesivir
Gilead Sciences has gotten approval from the FDA to launch a phase 1 trial of an inhaled version of its antiviral remdesivir for the earlier treatment of COVID-19 patients. Source: Devices & Diagnostics Letter
Read MoreFDA Warns Canadian Sterile Drugmaker for Aseptic Practices
Canadian sterile drug manufacturer Viatrexx was hit with an FDA warning letter for serious violations of aseptic practices observed during an agency inspection. Source: Devices & Diagnostics Letter
Read MorePreceptis’ Ear Tube System Receives FDA Clearance
The system enables ear tube placements in five minutes. Source: Devices & Diagnostics Letter
Read MoreMainstay Medical’s Chronic Low Back Pain Device Approved
The company plans to launch the product in the first half of 2021. Source: Devices & Diagnostics Letter
Read MoreGlenmark Pharmaceuticals Gets Indian Approval for Favipiravir as a COVID-19 Treatment
Glenmark is also conducting phase 3 trials of favipiravir as a COVID-19 monotherapy. Source: Devices & Diagnostics Letter
Read MoreAkili Grabs CE Mark for Children’s Digital ADHD Treatment
The FDA last week cleared EndeavorRx for marketing in the U.S. Source: Devices & Diagnostics Letter
Read MoreKeytruda Approved in China for Esophageal Squamous Cell Carcinoma
Keytruda is now approved in China for three different types of cancer. Source: Devices & Diagnostics Letter
Read MoreEuropean Pharma Groups Calls for Cooperation Between EU and UK Regulators
With just six months to go before the end of the transition period in the UK’s exit from the European Union, European drug industry groups said they are “extremely concerned” about the lack of progress in trade talks and they are urging negotiators to agree to drug supply chain protections outside of the talks. Source:…
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