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An FDA expert panel on vaccines met on Friday to review strains to include in influenza vaccines for the next flu season and heard that the COVID-19 pandemic has changed the production landscape. Read More
The UK’s RECOVERY trial, which is assessing multiple potential COVID-19 treatments, has stopped enrollment in its arm evaluating colchicine, an anti-inflammatory drug used to treat gout. Read More
Merck’s anti-parasitic drug Stromectol (ivermectin) did not help speed recovery in patients with mild COVID-19, researchers in Cali, Colombia, found in a small clinical trial. Read More
Amgen has agreed to acquire Five Prime Therapeutics, a South San Francisco biotech company, for $1.9 billion, a deal that will net the biopharma titan a pipeline that includes a promising investigational gastric cancer drug. Read More
Eli Lilly said its investigational drug, tirzepatide, reduced blood sugar and body weight in adults with type 2 diabetes significantly more than Novo Nordisk’s blockbuster Ozempic (semaglutide), in a head-to-head clinical study. Read More
As authorized COVID-19 vaccines are modified to protect against emerging strains of the pandemic disease, the UK will require only short clinical trials enrolling small numbers of volunteers to prove the altered vaccines are safe and effective, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read More
Germany’s CureVac has partnered with pharma giant Novartis to potentially manufacture hundreds of millions of doses of the small company’s COVID-19 vaccine candidate, CVnCoV, which is now under review by the European Medicines Agency (EMA). Read More
The European Medicines Agency (EMA) has begun a rolling review of the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Research Institute, but the European Commission doesn’t appear in a rush to secure doses. Read More
The FDA has released more meeting minutes from its talks with industry on reauthorization of the Prescription Drug User Fee Act (PDUFA), noting that there is interest in seeing the agency commit to expanding its use of real-world data in drug reviews, its capabilities for cell and gene therapy products, and other changes. Read More
The Government Accountability Office (GAO) released a new report yesterday warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools and address its lack of foreign inspections as soon as possible. Read More