The team behind Russia’s first COVID-19 vaccine has asked for scientific advice from EU drug regulators in view of a possible submission for marketing authorization.
The European Medicines Agency has held a preliminary meeting with the developers of the Russian Sputnik V COVID-19 vaccine to discuss the product’s development program with a view to evaluating it for possible EU approval. The agency clarified that the vaccine is not under review.
The team behind Sputnik V has also requested scientific advice on the vaccine from the EMA. However, claims that the...
PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.
The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
