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The FDA has published final guidance detailing ways for sponsors of complex generic drug products to improve their discussions with the agency, offering recommendations for requesting and conducting drug development meetings, pre-submission meetings and mid-review-cycle meetings. Read More
Three pharma groups have filed a federal lawsuit seeking to block a Trump administration final rule allowing imports of Canadian prescription drugs into the United States. Read More
The European Commission (EC) has entered into an advance purchase agreement with Moderna for up to 160 million doses of its COVID-19 vaccine candidate, mRNA-1273, which has demonstrated 94.5 percent efficacy in a phase 3 clinical trial. Read More
Bankrupt pharma major Purdue Pharma pled guilty in federal court yesterday to multiple criminal charges related to its promotion of the opioid painkiller OxyContin (oxycodone) and agreed to pay more than $8 billion in fines and penalties, with the company’s owners, the Sackler family, agreeing to pay another $225 million. Read More
The U.S. is ready to distribute Pfizer’s COVID-19 vaccine despite its need for extremely cold temperatures, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, said yesterday, adding that the company is taking a “very aggressive approach” to testing the distribution strategy. Read More
European Commission President Ursula von der Leyen urged the G20 leaders to commit to providing $4.5 billion for the World Health Organization’s Access to COVID Tools (ACT) Accelerator program. Read More
The National Institutes of Health (NIH) should disclose more information about the licensing of its intellectual property and the impact on the affordability of drug products, the Government Accountability Office said in a new report to Congress. Read More
The FDA will analyze initial promotional materials from drug companies within five business days of receiving them to see if they qualify for priority “core launch” review, said Susannah O’Donnell, leader of the review team in the agency’s Office of Prescription Drug Promotion (OPDP) in a Friday update on the program. Read More