Company News

European regulator refuses another gene therapy

Country
United Kingdom

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.

Trajenta receives positive EMA opinion

Country
United Kingdom

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.

EMA recommends new malaria agent

Country
United Kingdom

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.

Evotec and Roche to jointly develop biomarkers

Country
Germany

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.

AstraZeneca to sell medical device unit

Country
United Kingdom

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.

Italian firm receives Alzheimer’s funding

Country
Italy

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 reports on gene therapy

Country
United Kingdom

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.

FDA panel votes against canakinumab

Country
Switzerland

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.

French imaging company in IPO

Country
France

A France-based medical imaging company, Mauna Kea Technologies, has announced plans to make an initial public offering of its shares on NYSE Euronext in Paris with the goal of raising about €38.9 million.