European Commission

Regulatory update on GSK-Novartis three-part transaction

Thursday, January 29, 2015

GlaxoSmithKline has received clearance from the European Commission (E.C.) of its proposed three-part transaction with Novartis, which includes the acquisition of Novartis’s vaccines business (excluding influenza vaccines), the creation of a consumer healthcare joint venture between GSK and Novartis and the divestment to Novartis of GSK’s marketed oncology portfolio, related R&D activities and rights to two pipeline AKT inhibitors.

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EMA recommends suspending medicines over flawed studies

Monday, January 26, 2015

A number of medicines for which authorization in the European Union (E.U.) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, according to the EMA. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.

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Array to acquire Novartis BRAF inhibitor encorafenib (LGX818)

Friday, January 23, 2015

Array BioPharma, based in Boulder, Colo., has reached a definitive agreement with Novartis Pharma to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in phase III development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals.

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Johnson & Johnson forms Ebola vaccine development consortia

Monday, January 19, 2015

Johnson & Johnson has formed a consortia with leading global research institutions and non-government organizations to work in conjunction with Janssen Pharmaceutical to accelerate the development of its Ebola vaccine regimen. The Innovative Medicines Initiative (IMI) plans to award these consortia grants totaling more than $116 million from the Ebola+ program to support the development, manufacturing and patient education for the vaccine regimen.

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Clinical Network Services partners with Biologics Development Consultancy

Monday, November 3, 2014

Clinical Network Services (CNS), an Australian, New Zealand and U.K. CRO focused on virtual, small and medium-sized biotech companies, and Biologics Development Consultancy (BDC), a Netherlands-based team of consultants providing regulatory and product development advice on development and commercial production, have signed a cooperative partnership agreement. CNS, and in particular the BioDesk consultancy, and BDC will mutually expand the expertise they can offer their clients.

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European Union to boost Ebola research with $30.9 million

Thursday, October 23, 2014

The European Commission (E.C.) has announced $30.9 million from the European Union (E.U.) budget for urgently needed Ebola research. The funding will go to five projects, ranging from a large-scale clinical trial of a potential vaccine, to testing existing and novel compounds to treat Ebola. The money from Horizon 2020, an E.U. research and innovation program, will be provided via a fast-track procedure in order to start work as soon as possible. The commission also is working with industry on the further development of vaccines, drugs and diagnostics for Ebola and other haemorrhagic diseases within the Innovative Medicines Initiative.

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