Devices & Diagnostics Letter
Glenmark 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 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 MorePreceptis’ Ear Tube System Receives FDA Clearance
The system enables ear tube placements in five minutes. 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 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 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 MoreLarge Hydroxychloroquine Study Gets Under Way
Enrollment for a large, global trial of chloroquine and hydroxychloroquine for the prevention of COVID-19 is getting under way in the United Kingdom. Source: Devices & Diagnostics Letter
Read MoreTriNetX, Harvard Pilgrim Health Care Institute to Monitor COVID-19 Drug Usage
TriNetX is partnering with the FDA’s Sentinel Operations Center at the Harvard Pilgrim Health Care Institute (HPHCI) to monitor priority drugs used for treating hospitalized COVID-19 patients. Source: Devices & Diagnostics Letter
Read MoreAstraZeneca Receives $1.2 Billion BARDA Contract for COVID-19 Vaccine
AstraZeneca has nabbed an HHS contract worth up to $1.2 billion to speed development and production of the University of Oxford’s promising COVID-19 vaccine candidate. The deal also would lock in the distribution of 300 million doses of the vaccine for the U.S. Source: Devices & Diagnostics Letter
Read MoreFDA Adds Morphine, Epinephrine to COVID-19 Compounding List
The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic. Source: Devices & Diagnostics Letter
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