Merck Serono is reconsidering development of its monoclonal antibody matuzumab for the treatment of metastatic colorectal cancer after a Phase II study failed to meet its efficacy endpoint, the company announced Aug. 29.
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EDITOR’S PICK – China’s Ministry of Health has sent a voluntary eight-page notice to the World Health Organization outlining steps the country has taken recently to improve food safety, according to an Aug. 29 report by the Associated Press.
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Bayer and Onyx Pharmaceuticals announced Aug. 27 that a trial evaluating Nexavar (sorafenib) in Asia-Pacific patients with hepatocellular carcinoma will be stopped early to allow all patients to receive the drug based on positive study results and the recommendation of an independent data monitoring committee.
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SHANGHAI – Chinese drug stores are no longer allowed to rent shelf space to drug suppliers, previously a common marketing practice, or to put OTC and prescription drug products and non-drug products next to each other on store shelves. Sale of prescription drugs off the open shelf is also prohibited under a rule issued Aug. 13 by the State Food and Drug Administration.
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CAMBRIDGE, MA-A new global organization should be established to promote the harmonization of regulatory requirements between countries, Lester Crawford proposed Aug. 22 at the FDA Regulatory and Compliance Symposium.
Continue reading " Ex-FDA Commissioner Crawford Calls For New Global Harmonization Effort" »
SHANGHAI – A traditional medicine used to treat osteoporosis has been declared a technological secret by the Chinese government, providing the Tongjitang Chinese Medicine Company with five years of marketing exclusivity under State Food and Drug Administration rules.
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Merck has opened an Asia Pacific headquarters in Singapore, the firm announced Aug. 21.
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Forest Laboratories and Daiichi Sankyo are building upon an ongoing collaboration for Benicar and Benicar HCT with the signing of a new deal to co-promote the fixed-dose antihypertensive Azor, whose approval is anticipated in September. The companies announced the signing of a letter of intent to enter into a collaboration Aug. 21.
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Chi-Med's wholly owned research and development subsidiary Hutchison MediPharma will collaborate with Eli Lilly on the discovery and development of pharmaceutical targets in oncology and inflammation, Chi-Med announced Aug. 20.
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