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The US Food and Drug Administration has issued a draft guidance for companies that may be planning to develop and submit an application for marketing for an artificial pancreas system for people with Type 1 diabetes.
The US Food and Drug Administration has approved Nulojix (belatacept), a new treatment to prevent organ rejection in adult patients who have had a kidney transplant. The developer is Bristol-Myers Squibb Company.
Immatics Biotechnologies GmbH of Tübingen, Germany has started vaccination of the first patients in a Phase 3 trial of its therapeutic vaccine for renal cell cancer. The primary endpoint is overall survival in combination with sunitinib.
The European Union’s public-private partnership for drug development research, the Innovative Medicines Initiative, is to formally collaborate with the US Critical Path Institute, in a move to share more information from pre-competitive research.