Regulatory and Legal
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Phosphagenics signs agreement with Nippon Zoki
The 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.
Regulatory and Legal | 03 May 2012
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US FDA clears investigational new drug application, phase 2B trial for Immuron’s NASH/Fatty liver therapeutic
Immuron 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.
Regulatory and Legal | 06 March 2012
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Merck receives European approval to expand use of Rebif
Merck 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).
Regulatory and Legal | 02 March 2012
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Genetic Technologies receives CLIA certificate of compliance from Centers for Medicare and MedicAid Services, USA
Genetic 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).
Regulatory and Legal | 21 February 2012
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MabCure signs license agreement with Biotech Investment Corp
MabCure 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.
Regulatory and Legal | 07 February 2012
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Drug Process Licensing Associates launches pharma database
PHILL, 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.
Regulatory and Legal | 27 January 2012
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Merck appoints heads of corporate auditing, corporate strategy
Merck 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.
Regulatory and Legal | 10 January 2012
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Biogen Idec and Elan receive notification of PDUFA date extension
Biogen Idec and Elan are working with the FDA to help facilitate a timely review of the REMS changes and the sBLA.
Regulatory and Legal | 20 October 2011
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BeiGene in-licenses two clinical-stage oncology compounds
BeiGene 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.
Regulatory and Legal | 15 October 2011
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Victoza now available to people with type 2 diabetes in China
Approved by the Chinese State Food and Drug Administration (SFDA) on 15 March 2011.
Regulatory and Legal | 10 October 2011
