DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”

A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic.

European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA.

European regulators have rejected Pfizer Inc.’s tanezumab, casting further doubts on whether the FDA will okay the troubled drug that is intended as a non-opioid alternative for osteoarthritis pain.

DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics.

DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear.

DUBLIN – The European Medicines Agency (EMA) has reiterated its support for Astrazeneca plc’s Vaxzervia COVID-19 vaccine, following an interim analysis of a data review, which the agency’s Committee on Human Medicinal Products (CHMP) has conducted over the past two weeks.

DUBLIN – Amid a bitter dispute between the European Commission (EC) and Astrazeneca plc over supplies of the latter’s SARS-CoV-2 vaccine, the EC’s drug regulator, the EMA, recommended approval of the product in question, COVID-19 Vaccine Astrazeneca (formerly AZD-1222).

DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29.