Europe

European Commission and Mario Monti seek to increase patient access to generic medicines

Wednesday, February 8, 2012 10:06 AM

The European Generic Medicines Association (EGA) and Assogenerici, the Italian association for generic medicines, welcome the European Commission’s formal call on Italy to comply with European Union rules on the marketing authorization of generic medicines.

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NICE refuses to recommend Janssen’s Zytiga for prostate cancer

Wednesday, February 8, 2012 09:58 AM

The National Institute for Health and Clinical Excellence (NICE), the U.K. healthcare guidance body, has issued new draft guidance not recommending the use of Zytiga (abiraterone), developed by Janssen, in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed on or after docetaxel-containing therapy.

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Boehringer Ingelheim, GWT and TU Dresden sign diabetes research collaboration

Tuesday, February 7, 2012 11:14 AM

Boehringer Ingelheim, GWT and the Department of Medicine of the TU Dresden have signed a research collaboration agreement to develop new insights into the causes of diabetes and the link between excessive blood glucose, the hallmark of diabetes, and the serious complications of the disease that can affect many organ functions.

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Alize licenses Asparec therapy for treatment of leukemia

Monday, February 6, 2012 02:08 PM

Alize Pharma II, a drug development company focused on oncology and metabolism and part of the Alize Pharma group, has signed a license agreement with EUSA Pharma for Asparec, a new L-asparaginase product currently in phase I clinical development for the treatment of acute lymphoblastic leukemia.

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Humane Society urges European Union to lead cutting-edge research

Tuesday, January 24, 2012 10:43 AM

Humane Society International/Europe (HSI) urged the European Union to lead the world in cutting-edge research and testing as it kicked off discussions about how to spend its Horizon 2020 research funding budget. Horizon 2020, devised to strengthen the E.U.’s position in science, is being debated by the E.U. Parliament’s Industry, Research and Energy Committee.

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Delcath's Ireland location achieves ISO 13485 Certification

Wednesday, December 28, 2011 10:26 AM

Delcath Systems has reported that the company's Galway, Ireland location has achieved ISO 13485:2003 Certification--an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regulatory requirement of the EU's Medical Device Directive, and represents an important step toward commercialization of the Delcath Hepatic CHEMOSATR Delivery System following its European CE Mark approval in April 2011.

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Alkermes initiates phase III ALKS 9070 study for schizophrenia

Monday, December 19, 2011 01:42 PM

Alkermes has initiated a phase III clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070 is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system (CNS) disorders.

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Prestwick, Pharma Plexus form strategic alliance

Tuesday, December 13, 2011 11:44 AM

Prestwick Chemical, a chemical services company for the life sciences industry, has formed a strategic alliance with Pharma Plexus Holland, a provider of pharmaceutical optimization and development services. The two companies will work together on a significant lead optimization project recently won from a major pharmaceutical company.

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VAXIMM initiates oral therapeutic cancer vaccine trial

Tuesday, December 13, 2011 09:14 AM

VAXIMM has started the first clinical trial of its investigational oral therapeutic cancer vaccine VXM01. The placebo-controlled phase I dose escalation study intends to enroll up to 45 pancreatic cancer patients at the Heidelberg University Hospital (Heidelberg, Germany). The patients will receive several doses of VXM01, a therapeutic cancer vaccine that targets the tumor vasculature. The results of the initial double blind period of the study are expected in the first half of 2013.

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Marken launches SOLO to manage clinical trials distribution

Wednesday, December 7, 2011 12:53 PM

Marken has launched Solo, their proprietary web based system used to manage the regulatory, inventory and operational supply chain complexities of clinical trials. The system, which has been developed exclusively for Marken, is designed to manage all aspects of Marken’s global depot network including: receipt of clinical supplies and kits, dispatches, returns, warehouse movements and QA releases. Solo is a secure, validated, web-based system which is fully accessible to Marken’s clients on a 24/7 basis from any location in the world. Marken has designed Solo to integrate with multiple client-directed IXR (Interactive Reporting) systems.

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