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.
Ablynx NV is set to receive a €5 million milestone payment from Boehringer Ingelheim following the German company’s decision to progress an antibody-derived therapeutic protein for Alzheimer’s disease into late preclinical development.
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.
Evotec AG and the Roche group have announced a three-year collaboration to discover biomarkers that could be used to predict the dosage and efficacy of targeted oncology drugs under development at the Swiss multinational.
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.
AstraZeneca Plc is to sell its Swedish-based dental and healthcare businesses to Dentsply Ltd of the UK for about $1.8 billion in cash. The unit, Astra Tech, specialises in dental implants and medical devices for urology and surgery.
Privately-owned Axxam Spa of Milan, Italy has received funding from the US Alzheimer’s Drug Discovery Foundation to discover new small molecule drugs for Alzheimer’s disease that block the puringeric receptor, P2X7. The size of the grant was not disclosed.
Oxford BioMedica Plc said that its gene therapy for wet age-related macular degeneration was shown to be safe and well-tolerated following the administration of a first dose in a Phase 1 study at the Wilmer Eye Institute at Johns Hopkins Hospital in the US.