http://www.pharmaasia.comPharmaAsia - Regulatory and Legalen-USCopyright 2012 Ten Alps Communications Asia. All rights reserved.Thu, 24 May 2012 12:47:11 +0800http://www.pharmaasia.com/article/phosphagenics-signs-agreement-with-nippon-zoki/9385The companies have struck a material transfer agreement which enables Nippon Zoki to test and assess Phosphagenics’ patented TPM/diclofenac topical non-steroidal pain formulation for its suitability as a prescription item in the USA and Japanese markets.http://www.pharmaasia.com/article/phosphagenics-signs-agreement-with-nippon-zoki/9385Thu, 3 May 2012 00:00:00 +0800http://www.pharmaasia.com/article/us-fda-clears-investigational-new-drug-application-phase-2b-trial-for-immuron-s-nash-fatty-liver-therapeutic/9342Immuron announced that the United States Food and Drug Administration (US FDA) had cleared an Investigational New Drug (IND) submission to commence a Phase 2b clinical trial of its bovine colostrum-derived therapeutic (IMM-124E) for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Fatty Liver.http://www.pharmaasia.com/article/us-fda-clears-investigational-new-drug-application-phase-2b-trial-for-immuron-s-nash-fatty-liver-therapeutic/9342Tue, 6 Mar 2012 00:00:00 +0800http://www.pharmaasia.com/article/merck-receives-european-approval-to-expand-use-of-rebif/9340Merck announced that the European Commission (EC) has approved extension of the indication of Rebif (interferon beta-1a), its treatment for relapsing forms of multiple sclerosis (MS).http://www.pharmaasia.com/article/merck-receives-european-approval-to-expand-use-of-rebif/9340Fri, 2 Mar 2012 00:00:00 +0800http://www.pharmaasia.com/article/genetic-technologies-receives-clia-certificate-of-compliance-from-centers-for-medicare-and-medicaid-services-usa/9332Genetic Technologies announced that it has received the Certificate of Compliance for its Australian laboratory under the US Clinical Laboratories Improvements Amendments (CLIA) regulations as administered by the Centers for Medicare and Medicaid Services (CMS).http://www.pharmaasia.com/article/genetic-technologies-receives-clia-certificate-of-compliance-from-centers-for-medicare-and-medicaid-services-usa/9332Tue, 21 Feb 2012 00:00:00 +0800http://www.pharmaasia.com/article/mabcure-signs-license-agreement-with-biotech-investment-corp/9322MabCure has signed a license agreement with Biotech Investment Corp. (Biotech), a Nevada-based biotechnology investment company. The agreement is an exclusive worldwide license to certain MabCure hybridoma clones producing antibodies against prostate cancer. In addition to the license fee paid to MabCure, Biotech will issue to MabCure 15 percent of its outstanding shares on a fully diluted basis and will pay a royalty of 12.5 percent on revenues.http://www.pharmaasia.com/article/mabcure-signs-license-agreement-with-biotech-investment-corp/9322Tue, 7 Feb 2012 00:00:00 +0800http://www.pharmaasia.com/article/drug-process-licensing-associates-launches-pharma-database/9308PHILL, which stands for PHarmaceutical InteLLigence, is a database of bulk drug and intermediates producer information pertinent to members of the chemical and pharmaceutical industry. It also includes regulatory information such as Drug Master Files, Veterinary Master Files, Certificates of Suitability and Drug Approvals.http://www.pharmaasia.com/article/drug-process-licensing-associates-launches-pharma-database/9308Fri, 27 Jan 2012 00:00:00 +0800http://www.pharmaasia.com/article/merck-appoints-heads-of-corporate-auditing-corporate-strategy/9297Merck announced that Friederike Rotsch has been appointed head of corporate auditing. She reports to Karl-Ludwig Kley, chairman of the executive board of Merck. At the same time, the company announced that Isabel De Paoli will assume the leadership of corporate strategy. She too will report directly to Kley.http://www.pharmaasia.com/article/merck-appoints-heads-of-corporate-auditing-corporate-strategy/9297Tue, 10 Jan 2012 00:00:00 +0800http://www.pharmaasia.com/article/biogen-idec-and-elan-receive-notification-of-pdufa-date-extension/9257Biogen Idec and Elan are working with the FDA to help facilitate a timely review of the REMS changes and the sBLA.http://www.pharmaasia.com/article/biogen-idec-and-elan-receive-notification-of-pdufa-date-extension/9257Thu, 20 Oct 2011 00:00:00 +0800http://www.pharmaasia.com/article/beigene-in-licenses-two-clinical-stage-oncology-compounds/9246BeiGene will collaborate with Janssen in phase III clinical trials in melanoma and explore additional solid tumor indications in solid tumors prevalent in China and Asia.http://www.pharmaasia.com/article/beigene-in-licenses-two-clinical-stage-oncology-compounds/9246Sat, 15 Oct 2011 00:00:00 +0800http://www.pharmaasia.com/article/victoza-now-available-to-people-with-type-2-diabetes-in-china/9236Approved by the Chinese State Food and Drug Administration (SFDA) on 15 March 2011.http://www.pharmaasia.com/article/victoza-now-available-to-people-with-type-2-diabetes-in-china/9236Mon, 10 Oct 2011 00:00:00 +0800