The Pink Sheet’s list of EU centralized approvals of new active substances now includes three new products including Lusutrombopag Shionogi for treating severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Lusutrombopag Shionogi (lusutrombopag) is among the three new additions to the Pink Sheet's regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure. The other two new additions are Rizmoic (naldemedine) and Besremi (ropeginterferon alfa-2b).
The great majority of new, innovative medicines and vaccines that are marketed in the EU go through the centralized procedure....
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.
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 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year
