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...
Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic...
The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution...
Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease...
Europe – Phasing out of extraordinary COVID-19 regulatory flexibilities
EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19...
UK – NICE publishes final draft guidance recommending three COVID-19 treatments
This includes those who are immunosuppressed, or who have other conditions such as heart disease, respiratory disease, diabetes or neurological disorders.
The agency’s latest guidance...
UK – AstraZeneca/Daiichi Sankyo’s Enhertu recommended by NICE for advanced breast cancer
The recommendation follows updated results from the DESTINY-Breast03 phase 3 trial, announced by the companies earlier this month, in which Enhertu demonstrated a statistically...
UK – UK’s MHRA approves first drug under international recognition procedure
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international...
Switzerland – Nouvelles autorisations de médicaments complémentaires et de phytomédicaments
Chaque année, un grand nombre de médicaments complémentaires et de phytomédicaments ainsi que de bonbons et pastilles pour la gorge et contre la toux...
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In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated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...
Europe – New vaccine to protect people in the EU and worldwide against dengue
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...
