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The European Commission (EC) and Gilead Sciences say EU member states aren’t obligated to pay for the up to 500,000 treatment courses of Veklury (remdesivir) negotiated under a joint procurement agreement with the company in October — and the commission says that the European Medicines Agency (EMA) may reconsider the conditional marketing authorization it granted for the drug in July. Read More
The European Medicines Agency (EMA) on Tuesday received emergency vaccine clearance applications from Pfizer and Moderna and said that it could approve the highly effective coronavirus vaccines within weeks, if the data support it. Read More
Sponsors of drug trials should determine what effect the use of acid-reducing agents (ARA), such as antacids, proton pump inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday. Read More
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 UK’s RECOVERY trial, which is evaluating multiple treatments for COVID-19, will add the inexpensive anti-inflammatory drug colchicine to the list of therapies being tested in hospitalized patients. Read More
Novavax said it will begin a delayed phase 3 trial in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, “in the coming weeks” and that its 15,000-person late-stage trial in the UK is now fully enrolled. Read More
Moderna on Monday submitted a request for FDA Emergency Use Authorization (EUA) for its coronavirus vaccine, mRNA-1273, making it just the second company to date that’s taken a candidate far enough to file an application for emergency clearance. Read More
AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. Read More