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Alkermes Pharma Ireland Ltd has withdrawn its marketing authorisation application from the European Medicines Agency for the drug, megestrol, which was intended to be used to treat unexplained weight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.
The management of Amsterdam Molecular Therapeutics NV is proposing to de-list the company and transfer its gene therapy assets to a new private concern following a regulatory rejection of its lead product Glybera. Shareholders will vote on the proposal on 30 March.
The European Medicines agency has issued contraindications and warnings for aliskiren medicines which include the Novartis drug Rasilez. The drug shouldn’t be used in patients with diabetes or renal impairment who take ACE inhibitors.
The US Food and Drug Administration has approved the synthetic steroid, mifepristone (Korlym), as a treatment for adults with endogenous Cushing’s syndrome, a rare disease caused by the overproduction of cortisol. It is the first approved treatment for this condition.