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The National Institute of Allergy and Infectious Diseases (NIAID) has stopped enrolling severely ill COVID-19 patients in a phase 3 trial of Merck’s Rebif (interferon beta-1a) with Gilead Sciences’ remdesivir because of serious adverse events. Read More
The University of Oxford is gearing up to launch a trial of the anti-inflammatory drug adalimumab as a treatment for COVID-19 patients in community care homes. Read More
The House Oversight Committee has released two new staff reports from its ongoing drug pricing investigation that shed light on the tactics employed by Bristol Myers Squibb, Celgene and Teva Pharmaceuticals to raise the prices of two blockbuster drugs and turn massive profits, the same day committee Democrats grilled the company’s CEOs at its drug pricing hearing. Read More
Former FDA Commissioner Mark McClellan says it’s possible that a COVID-19 vaccine will be available for some portions of the population before year’s end but that it was never realistic to expect one before the Nov. 3 presidential election. Read More
Canadian Prime Minister Justin Trudeau said he is willing to consider U.S. plans for importing prescription drugs from Canada but that the needs of his own country come first. Read More
The House of Representatives yesterday passed a bipartisan bill in a voice vote to extend the FDA’s rare pediatric drug priority review voucher program by four years. Read More
The FDA has issued Aquestive Therapeutics a complete response letter (CRL) for its Libervant (diazepam buccal film) for the management of seizure clusters. Read More
The FDA’s safety program designed to reduce opioid abuse and misuse is not well suited to tackling the continuing epidemic in the U.S., mainly due to a lack of cooperation from makers of opioids, the HHS Office of the Inspector General (OIG) says is a new report. Read More