President Trump is lashing out at the FDA’s decision to hold off issuing an Emergency Use Authorization (EUA) for using convalescent plasma to treat COVID-19 patients. Source: Devices & Diagnostics…
The diagnostic runs on real-time PCR detection systems, including Applied Biosystems’ QuantStudio 5 and Bio-Rad’s CFX96. Source: Devices & Diagnostics Letter
Mylan has launched the product in 120mg and 240mg delayed-release capsule forms. Source: Devices & Diagnostics Letter
Merck said its blockbuster cancer drug Keytruda (pembrolizumab) in combination with chemotherapy significantly improved survival in patients with locally advanced or first-line metastatic esophageal cancer in a phase 3 clinical…
Pfizer’s and BioNTech’s experimental COVID-19 vaccine BNT162b2 has been chosen for a phase 2/3 efficacy study of 9,000 participants following its success in a phase 1 trial. Source: Drug Industry…
The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Source: Drug Industry Daily
The Department of Justice has made another move against a drugmaker in its investigation of an alleged industry-wide kickback scheme, accusing Teva Pharmaceuticals of funneling kickbacks for its multiple sclerosis…
An independent review of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has led to calls for major reforms at the agency due to its mishandling of safety concerns…
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certificates are being issued by certification bodies titled “certificates or compliance,” or “attestation of compliance,” that have no legal…
FDA inspections at four U.S. facilities revealed problems with design controls, medical device reporting, and corrective and preventive actions. Source: The GMP Letter