News

AbbVie sues EMA to stop release of Humira data

In a move which appears at odds with a push for transparency within the pharmaceutical industry, AbbVie is suing the European Medicines Agency to prevent it from releasing data related to its blockbuster Humira.

After FDA knockback, Bayer, J&J expand Xarelto programme

Days after US regulators turned down their bid to expand the label on Xarelto to include the reduction of the risk of cardiovascular events in acute coronary syndrome patients, Bayer and Johnson & Johnson have unveiled a number of studies designed to look at other indications for the bloodthinner.

Genomics revolution bearing R&D fruit – report

The pharmaceutical industry is in the midst of a new era of next-generation high-throughput screening which will drive a significant improvement in R&D productivity, according to a report published by broker Liberum Capital.

New anti-inflammatory causes stir at ACC

A single dose of the investigational anti-inflammatory inclacumab, developed by Roche and Genmab,  considerably reduces damage to heart muscle during angioplasty.

Takeda files bowel drug vedolizumab in Europe

Takeda Pharmaceutical Co has filed vedolizumab, its investigational, gut-selective monoclonal antibody, in Europe for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease.

Eisai ‘appalled’ by German rejection of Fycompa

Eisai has expressed its outrage at the German reimbursement regulatory body’s ruling that the benefits of the Japan-headquartered firm’s first-in-class antiepileptic Fycompa are unproven.

Europe reveals new symbol for meds monitoring

The European Commission says that an inverted triangle will shortly appear on the inside leaflet of certain drugs “to easily identify medicinal products that are undergoing additional monitoring”.

GSK submits diabetes drug albiglutide in EU

GlaxoSmithKline has announced the submission of a marketing authorisation application for albiglutide, which will have the brand name Eperzan, to the European Medicines Agency.