Dapagliflozin, a treatment for Type 2 diabetes that has been co-developed by AstraZeneca Plc and Bristol-Myers Squibb Company, has been recommended for approval in Europe. In January, the same drug was turned down by the FDA.
SkyePharma Plc’s asthma treatment, Flutiform, has been given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use. This brings the drug one step closer to a marketing authorisation in Europe.
Eric Abadie, the chair of the European Medicines Agency’s Committee for Medicinal Products for Human Use, has resigned and the agency’s executive director, Guido Rasi, has accepted the resignation with immediate effect, the EMA said.
Drug regulators in the European Union have reached an agreement on what kinds of data submitted to them from companies can be made public, effectively making the pharmaceutical sector more responsive to public demands for information.
Alkermes Pharma Ireland Ltd has withdrawn its marketing authorisation application from the European Medicines Agency for the drug, megestrol, which was intended to be used to treat unexplained weight loss in patients with AIDS and cancer.
AstraZeneca Plc has filed a lawsuit against the US Food and Drug Administration seeking to overturn the agency’s decision to deny the company’s petition to withhold approval of generic versions of its antipsychotic, Seroquel (quetiapine).
The US Food and Drug Administration has approved an allogeneic cell therapy- the first of its kind – to treat vascular wounds caused by surgery to treat mucogingival conditions in adults. The product, Gintuit, was developed by Organogenesis Inc of Massachusetts, US.
The US Food and Drug Administration has revised the safety labels for statins, the cholesterol-lowering drugs, to include a warning about an increased risk of raised blood sugar levels and the development of Type 2 diabetes.
From 1 March, the European Medicines Agency will begin publishing information on new drug applications that it receives from companies. The measure is part of an ongoing policy to make the European regulatory procedures more transparent.
A meningococcal vaccine and a new treatment for non-Hodgkin’s B-cell lymphoma were among four new medicines to receive positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 17 February.