Amsterdam Molecular Therapeutics Holding NV is to appeal against a negative opinion issued by the European Medicines Agency for its gene therapy to treat a protein deficiency linked to pancreatitis. The opinion was issued on 23 June 2011.
Nexium (esomeprazole magnesium), a treatment for acid-related conditions of the stomach, has received its first regulatory approval in Japan, according to AstraZeneca Plc, the drug’s developer. The approval is for use in adult patients.
An advisory panel to the US Food and Drug Administration has endorsed the agency’s decision in late 2010 to remove the breast cancer indication for Avastin (bevacizumab) despite strenuous objections from the drug’s manufacturer, Roche.
The European Medicines Agency has issued a negative opinion to an application from Amsterdam Molecular Therapeutics BV for a gene therapy to treat patients with an enzyme deficiency that is linked with pancreatitis.
Boehringer Ingelheim GmbH’s new Type 2 diabetes drug, Trajenta (linagliptin) has received a positive opinion from the European Medicines Agency’s main scientific committee. This follows US Food and Drug Administration approval on 2 May.
The European Medicines Agency has recommended that a new artemisinin-based combination therapy be approved to treat malaria in adults, children and infants aged six months or older. The agent combines dihydroartemisinin and piperaquine.
The European Medicines Agency is recommending restrictions on the use of dexrazoxane, currently indicated for certain cancer patients, because of an increased risk of acute myeloid leukaemia and myelodysplastic syndrome.
The Committee for Medicinal Products for Human Use (CHMP) is continuing a review of pioglitazone-containing medicines which are used to treat diabetes amid concerns that long-term use could increase the risk of bladder cancer.
An advisory panel of the US Food and Drug Administration has voted not to recommend approval of canakinumab for the treatment of gouty arthritis attacks in patients who cannot get relief from NSAIDS, according to the drug’s sponsor, Novartis.
The US Food and Drug Administration has issued a draft guidance for companies that may be planning to develop and submit an application for marketing for an artificial pancreas system for people with Type 1 diabetes.