Regulatory and Legal
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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
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Nycomed and Almirall announce a licensing agreement for ebastine in China and other key Southeast Asia markets
• With this agreement, Almirall extends the global reach of the product, present now in more than 30 countries worldwide.
Regulatory and Legal | 29 September 2011
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Novartis receives approval in Japan for two innovative therapies
Approvals demonstrate ongoing Novartis commitment to bringing innovative treatments to patients in Japan.
Regulatory and Legal | 27 September 2011
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AstraZeneca announces first approval of FASLODEX in Japan
In Japan, it is estimated that annually 10,000 women with metastatic breast cancer will have their cancer recurring or progressing post endocrine therapy.
Regulatory and Legal | 26 September 2011
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Sanofi Pasteur acquires exclusive, worldwide license for acne vaccine and treatment
Pre-clinical vaccine was developed by researchers at the University of California, San Diego.
Regulatory and Legal | 21 September 2011
