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The global police organization Interpol issued a warning yesterday to countries to prepare for a new wave of organized criminal activity, including cyber hacking of drugmakers as governments prepare to ship their vaccines. Read More
President Trump has scheduled a COVID-19 vaccine summit for Dec. 8 with pharma executives, government leaders, scientific experts and others just days before an FDA advisory panel meets to discuss Emergency Use Authorization (EUA) for Pfizer’s vaccine candidate. Read More
In a watershed moment in the pandemic, the UK became the first Western nation to authorize a COVID-19 vaccine for emergency use, granting Pfizer clearance for its highly effective shot Wednesday, though the move drew immediate criticism from the EU. Read More
The diagnostic can be used to help with the allocation of plasma donations from recovered COVID-19 patients to infected patients, the company said. 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
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
Specifically, the agency is allowing certain dry heat systems to be used on authorized FFRs that do not have exhalation valves, do not use a duck-bill design and do not contain antimicrobial or antiviral agents. 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