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The FDA granted an Emergency Use Authorization (EUA) for a third COVID-19 vaccine Saturday, clearing Johnson & Johnson’s (J&J) single shot following unanimous support from its vaccines advisory panel. Read More
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Read More
Merck plans to acquire Massachusetts-based Pandion Therapeutics for an estimated $1.85 billion to broaden its portfolio of autoimmune disease therapies. Read More
The FDA sent letters to two companies Feb. 17, withdrawing part of the approvals it had granted them for their hemophilia products last year in response to their supplementary biologics license applications, due to the agency overlooking a pediatric exclusivity designation that is still in effect. Read More
A new UK study has found that statins did not have any overall effect on muscle symptoms in patients who had previously reported them when taking the medications, suggesting that statins may not responsible for the muscle pains associated with taking them. Read More
The European Medicines Agency (EMA) has issued new guidance outlining requirements for drug manufacturers that modify their COVID-19 vaccines to protect against several emerging variants to SARS-CoV-2. Read More
The FDA has announced that it is working on guidance for states and for compounders on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.” Read More
The FDA has approved Pfizer’s and BioNTech’s request for a revised Emergency Use Authorization (EUA) permitting their COVID-19 vaccine to be stored at normal pharmaceutical freezer temperatures. Read More
Despite facing significant delays in supplying the European Union with its ordered AstraZeneca (AZ)/Oxford COVID-19 vaccine doses, AZ has said that it is using a large number of doses made via its international supply chain to meet its second-quarter supply commitments with Europe. Read More
The Pfizer/BioNTech COVID-19 vaccine showed the same effectiveness for all age groups — including individuals over age 60 — confirmed a new study from Israel that included almost 1.2 million individuals. Read More
Significantly more hospitalized COVID-19 patients aged 70 and up were alive and free of respiratory failure after treatment with GlaxoSmithKline’s (GSK) investigational monoclonal antibody otilimab in a phase 2 clinical trial, the company said Thursday. Read More