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The FDA's Advisory Committee for Pharmaceutical Science has overwhelmingly approved the agency's strategy for developing new international harmonization approaches for drug development, but members expressed reservations about the development of new guidance to supplement the international standards.
UK-based GlaxoSmithKline (GSK) announced that the FDA has approved
its FluLaval influenza vaccine for the active immunization of adults 18 years and older against flu caused by influenza virus types A and B.
Indian drugmaker Ranbaxy Laboratories has announced that its wholly owned subsidiary, Ranbaxy Pharmaceuticals Canada, and Janssen-Ortho have entered into a licensing and supply agreement for a generic fentanyl patch, sold under Ranbaxy's label as RAN Fentanyl Transdermal System, in Canada.
Codexis, Inc., a privately held biotechnology company, announced the company has expanded into direct sales of pharmaceutical intermediates with receipt of the first commercial orders from leading generics manufacturers for ATS-8, the key chemical intermediate in atorvastatin.
KAN Research Institute, Eisai's research subsidiary, has begun research operations in its new facilities in the Kobe Medical Industry Development Project site.
Plexxikon Inc. and Roche announced they have entered into an agreement to develop and commercialize PLX4032, Plexxikon's investigational targeted cancer therapy which selectively
inhibits B-RafV600E, a mutated form of the BRAF kinase gene.
Starpharma Holdings Limited announced the signing of an agreement to acquire US-based Dendritic Nanotechnologies, Inc. (DNT) for US$6.97m (A$9.36m) payable through the issue of Starpharma shares.
The European Commission continues to be accused by European industry of pushing 'green policies' that are stifling progress and global competitiveness -- the controversial REACH chemicals legislation remains a sore point.
Biotica Technology Ltd. a private UK biotechnology company, announced the signing of an exclusive research collaboration and license agreement with Wyeth Pharmaceuticals, a division of Wyeth.
As the African Union moves towards establishing a formal peacekeeping brigade, a new study has suggested the need for troops on missions to be supplied with HIV medication, reports UN Integrated Regional Information Networks (IRIN).