Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9...
EMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and...
UK – NICE fails to recommend Boehringer Ingelheim and Lilly Alliance’s empagliflozin
In a blow to patients who currently lack recommended treatment options for chronic heart failure with preserved or mildly reduced ejection fraction, Boehringer Ingelheim...
Europe – Actions to support the development of medicines for children
Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and...
Europe – Public consultation on a multi-stakeholder platform to improve clinical trials in the...
On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a...
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In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated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 – Gilead’s CAR-T cell therapy recommended by NICE for lymphoma
Specifically, the therapy is now recommended for adult patients with diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) who have...
UK – NICE recommends Alexion’s asfotase alfa across England
Alexion Pharma’s asfotase alfa – also known as Strensiq – has been recommended by the National Institute for Health and Care Excellence (NICE) for...
Europe – Mandatory use of CTIS from 31 January 2023 for all new clinical...
On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications and will serve as the single-entry point...
Europe – EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next...
UK – UK to introduce new regulatory framework for point of care manufacturing
The framework will ensure that there are no regulatory barriers to innovative manufacturing and that these products have the same assurances of safety, quality...
