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The Canadian government has issued an interim order to prevent the export to the United States of drugs that are in short supply north of the border. Read More
The new head of the European Medicines Agency (EMA), Emer Cooke, said she is “hopeful” that the agency will grant a conditional marketing authorization for a COVID-19 vaccine by Christmas. Read More
The European Commission (EC) last week adopted an ambitious drug access strategy inspired by the COVID-19 pandemic that proposes allowing generics manufacturers to sidestep having to get patent permissions during public health emergencies. Read More
Sputnik V will be “two or more times cheaper than foreign vaccines based on mRNA technology with similar efficacy rates,” Russia’s sovereign wealth fund said. Read More
Financial terms of the EU contract were not disclosed, but Moderna CEO Stephane Bancel said the company planned to charge governments between $25 and $37 per dose. Read More
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