The European Medicines Agency's special review process that was used to help EU member states issue emergency use approvals for dexamethasone in COVID-19 patients is now being applied to two antibody combinations from Regeneron/Roche and Lilly.
The European Medicines Agency is carrying out a review of two monoclonal antibody combinations with potential in treating COVID-19, under a special procedure that assists the EU member states in making medicinal products available in emergency situations before they have been formally approved.
The two combinations in question are casirivimab/imdevimab and bamlanivimab/etesevimab. The first is being co-developed as REGN-COV2 by
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.
Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.
