The US Food and Drug Administration has approved a new drug to treat chronic myelogenous leukaemia – the second therapy to be approved for CML in about two months. The drug, Synribo (omacetaxine mepesuccinate), comes from Teva.
The European Medicines Agency has started an infringement procedure against Roche for alleged deficiencies in its medicine-safety reporting system. It is the first time the agency has started a procedure of this kind against a company.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a new diagnostic for patients who are being evaluated for Alzheimer’s disease – the first of its kind.
The US Food and Drug Administration has expanded the approved indication for an artificial heart valve manufactured by Edwards Lifesciences Corp to include patients with aortic valve stenosis who are eligible for surgery but at a high risk of complications.
The US Food and Drug Administration has approved ocriplasmin (Jetrea), the first pharmaceutical product for treating for symptomatic vitreomacular adhesion, which occurs when the vitreous gel of the eye fails to detach from the retina.
The US Food and Drug Administration has approved a new indication for Humira (adalimumab) to include the treatment of moderate-to-severe ulcerative colitis in adults. It is the seventh US approval for the drug which is marketed by Abbott Laboratories.
The US Food and Drug Administration has approved Stivarga (regorafenib), a multi-kinase inhibitor, to treat patients with metastatic colorectal cancer. Developed by Bayer AG, the drug was approved under the agency’s priority review procedure.
The US Food and Drug Administration has said it will review its regulatory guidelines and consult experts on clinical trial design in a renewed push to stimulate the development of new antibiotic drugs – a public health priority.
The European Medicines Agency’s CHMP is recommending that Avastin (bevacizumab) be given approval for use in combination with chemotherapy to treat women with recurrent, platinum-sensitive ovarian cancer.
In what is being described as the largest initiative of its kind, 10 large pharmaceutical companies have announced the setting up a non-profit organisation through which they will collaborate to accelerate and improve clinical research.