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...
UK – Illegal medicines worth more than £30 million seized in the UK in...
This includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical...
Europe – Report: How EU ensured safety of medicines during COVID-19
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders...
Europe – EU regulators and industry clash on pharmaceutical reform package
European Union officials said a proposal to reform the EU pharmaceutical legislation will go a long way towards providing equal access to new medicines,...
Europe – First gene therapy to treat haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene dezaparvovec) for the treatment of severe and moderately severe haemophilia...
Europe – EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine VidPrevtyn Beta as a booster in adults previously vaccinated with an mRNA or...
UK – Guidance published on the new international regulatory recognition routes for medicines approvals
Following announcement in May of the new scheme to replace the current EC Decision Reliance Procedure (ECDRP) on 1 January 2024, this guidance informs the sector on how...
Europe – New recommendations to strengthen supply chains of critical medicines
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities...
UK – AstraZeneca/Merck’s Lynparza recommended by NICE for advanced prostate cancer
The PARP inhibitor has been specifically recommended for NHS use alongside anti-androgen therapy Zytiga (abiraterone) and prednisone or prednisolone in adults with untreated hormone-relapsed...
UK – Pfizer’s Talzenna recommended by NICE for advanced breast cancer
Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable.
Additionally,...
