The Roche group’s new kinase inhibitor for metastatic melanoma, Zelboraf (vemurafenib), has been given a positive opinion by the European Medicines Agency, following its approval by the US Food and Drug Administration in August.
Since 2003, the European Medicines Agency and the US Food and Drug Administration have been working actively behind the scenes to coordinate decision-making. This doesn’t mean issuing the same opinions on new products. But it does mean sharing intelligence, and taking a common approach to problem-solving.
A decision by the US Food and Drug Administration to allow non-prescription use of an emergency contraceptive for all women of child-bearing age has been overruled by Secretary of Health and Human Services, a political appointee.
AstraZeneca Plc has announced plans to make 22 compounds available to medical researchers in the UK free of charge in a bid to promote more drug discovery. The compounds are not the focus of current research at the company.
The US Food and Drug Administration has issued new draft guidance to help manufacturers develop and seek approval for artificial pancreas device systems for type 1 diabetes. To date, no such device has been approved for marketing in the US.
Guido Rasi, the new executive director of the European Medicines Agency, said the agency needs to take a fresh look at how patients gain access to the medicines that it regulates. This means further strengthening the network of European drug regulators and taking account of the role that government payers play in making it possible for patients to gain access to new drugs.
The European Medicines Agency’s main scientific committee, the CHMP, has recommended that Caprelsa (vandetanib), a treatment for aggressive and symptomatic medullary thyroid cancer, be granted a conditional marketing authorisation.
The US Food and Drug Administration has approved a new treatment for acute lymphoblastic leukaemia (ALL), the most common form of childhood cancer. The drug, Erwinaze (asparaginase Erwinia chrysanthemi), is from EUSA Pharma Inc.
The US Food and Drug Administration has approved a new recombinant fusion protein, Eylea (aflibercept), to treat patients with wet, age-related macular degeneration, a leading cause of vision loss and blindness in the elderly.
The US Food and Drug Administration is revoking its approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use. The decision was announced by Commissioner Margaret Hamburg on 18 November 2011 following a long review of the drug’s use in patients.