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