Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants
The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to...
Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity
The EU Medical Device Regulation (MDR) created confusion for medical device manufacturers in Europe, including drug-device combination (DDC) producers. As stakeholders seek more guidance...
UK – NICE recommends Takeda’s Ninlaro triplet regimen
Therapy involves patients living with relapsed or refractory multiple myeloma
Takeda has announced that the National Institute for Health and Care Excellence (NICE) has recommended...
Europe – EU recommendations for 2023-2024 seasonal flu vaccine composition
EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from...
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...
UK – MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer...
Eli Lilly’s Verzenios (abemaciclib) has received a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA), in combination with endocrine therapy for...
Europe – Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global regulatory workshop on COVID-19 observational studies and...
Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron...
Europe – First therapy to treat transplant patients with post-transplant lymphoproliferative disease
The European Medicines Agency (EMA) has recommended a marketing authorisation in the European Union (EU) for Ebvallo (tabelecleucel) for the treatment of adult and paediatric...
USA – mRNA technology for universal flu vaccine shows early promise in US study
The World Health Organization cites vaccination as the current principal means of reducing or counteracting influenza mortality and morbidity burden, but the constantly evolving...
