Valneva and Dynavax Collaborate to Develop COVID-19 Vaccine
Dynavax used the adjuvant in its FDA-approved hepatitis B vaccine. Source: Devices & Diagnostics Letter
Insmed’s Brensocatib Enters Trial as Possible COVID-19 Treatment
Insmed is sponsoring a clinical trial in the UK of its bronchial drug Brensocatib as a potential COVID-19 treatment. Source: Drug Industry Daily
New York Files Opioid Fraud Charges Against Mallinckrodt
The state of New York has filed civil charges against Mallinckrodt for its alleged role in the opioid epidemic. Source: Drug Industry Daily
AstraZeneca Tests Diabetes Drug as COVID-19 Treatment in Phase 3 Trial
AstraZeneca has begun a phase 3 clinical trial to evaluate its diabetes drug Farxiga (dapagliflozin) as a possible treatment for hospitalized COVID-19 patients. Source: Drug Industry Daily
FDA Bans Electrical Stimulation Devices for Aggression and Self-Harm
The FDA issued a final rule banning electrical stimulation devices (ESDs) used to reduce aggressive or self-harming behavior, saying that better treatment options are now available. Source: The GMP Letter
NeuroMetrix Ordered to Pay $4 Million for Deceptive Advertising
Under a settlement with the Federal Trade Commission, devicemaker NeuroMetrix agreed to pay at least $4 million and stop making deceptive claims that its Quell transcutaneous electrical nerve stimulation device…
483 Roundup: FDA Cites Six Firms for Quality Failures
Six devicemakers drew the FDA’s attention for lax validations, CAPAs, training and other failures found during agency inspections. Source: The GMP Letter
Warning Letter Roundup: FDA Warns Four Devicemakers
The FDA issued warning to four devicemakers for lax design controls, inaccurate labeling and other serious failures at their manufacturing facilities. Source: The GMP Letter
FDA Eases Adverse Event Reporting Requirements During the Pandemic
The FDA announced in a new guidance that it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Source: The GMP Letter
HHS Gives Liability Cover for Coronavirus Countermeasures
HHS is providing immunity from legal liability for activities related to medical countermeasures against COVID-19. Source: The GMP Letter
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