Europe – EMA accepts application for leukaemia drug from Otsuka and Astex
The application is supported by positive results from the phase 3 ASCERTAIN clinical trial which demonstrated an exposure equivalence of an oral fixed-dose of...
Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for...
General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021....
UK – Roche’s Polivy recommended by NICE for lymphoma therapy
In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse...
UK – MHRA introduces new restrictions for fluoroquinolone antibiotics
From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines...
Europe – EMA Management Board: highlights of June 2022 meeting
At its 16 June 2022 meeting in Amsterdam, the European Medicines Agency's (EMA) Management Board elected Christelle Ratignier-Carbonneil as vice-Chair of the Board for a three-year...
UK – MHRA approves Pfizer/BioNTech’s adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5
Approval has today been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech COVID-19 vaccine that targets the Omicron...
UK – Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment recommended by NICE
The final draft guidance issued by NICE means that patients will be eligible to receive the antifibrotic treatment, which is currently recommended for patients...
UK – Ipsen reacts to NICE’s Cabometyx verdict
Ipsen has expressed its disappointed regarding the National Institute for Health and Care Excellence’s (NICE) preliminary guidance which does not recommend Cabometyx – also...
USA – Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver
The World Trade Organization’s (WTO) agreement to a partial patent waiver for COVID-19 vaccines “sends a dangerous signal” to the pharmaceutical industry and all...
Europe – EU recommendations for 2024/2025 seasonal flu vaccine composition
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn...
