PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.

HONG KONG – Prestige Biopharma Pte. Ltd., a Singapore-headquartered pharmaceutical company under the Prestige Group, has agreed to grant exclusive license to U.K.-based multinational company Mundipharma International Ltd. for distribution and sale of its trastuzumab biosimilar, Tuznue, in western European markets, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness.

HONG KONG – To improve public health care in Brazil, Bioneer Corp., a South Korean biotech, and Brazilian government-run Institute of Technology on Imunobiologicals (Bio-Manguinhos) will focus on business development and R&D of in vitro diagnostics and new drugs.

"If you plan to be around five or 10 years from now, you have to have a Chinese strategy." That poignant comment in a BioWorld Today article came from Joshua Boger in 2011. The founder and former CEO of Vertex Pharmaceuticals Inc., and now executive chairman of Alkeus Pharmaceuticals Inc., had just returned from China where Shanghai Syntheall Pharmaceuticals Co. Ltd., a manufacturing subsidiary of Wuxi Apptec Co. Ltd., is the manufacturing site for starting materials for Vertex's hepatitis C drug Incivek (telaprevir). A combined massive government investment, a growing appetite for capitalism, and a shift from pharmaceutical industry service...