Regulatory and Legal
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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
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Bristol-Myers Squibb and Saladax Biomedical expand collaboration for diagnostic assays for Alzheimer’s disease
Companies will collaborate globally on the development and regulatory approvals for certain diagnostic assays.
Regulatory and Legal | 20 September 2011
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Drug Process Licensing Associates publishes third process patent
Patent filed for Sitagliptin used to lower blood sugar levels in patients with type 2 diabetes.
Regulatory and Legal | 20 September 2011
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Novartis drug Afinitor gains EU approval
Novartis announced that the European Commission has approved Afinitor (everolimus) tablets for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumors (NET) of pancreatic origin in adults with progressive…
Regulatory and Legal | 05 September 2011
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FDA approves Shire’s FIRAZYR for acute attacks of hereditary angioedema
Shire plc announced that the US Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. “Until now, HA…
Regulatory and Legal | 25 August 2011
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Launch of Lexapro commenced in Japan
H Lundbeck A/S announced that its partners Mochida Pharmaceutical Co Ltd and Mitsubishi Tanabe Pharma Corporation (MTPC) have launched Lexapro 10mg (escitalopram) in Japan, for which Mochida obtained the marketing approval following the NHI (National…
Regulatory and Legal | 22 August 2011
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CEL-SCI receives key Chinese patent for its investigational cancer therapy Multikine
CEL-SCI Corporation announced that the Chinese patent office has issued a key patent covering CEL-SCI’s investigational cancer drug, Multikine (Leukocyte Interleukin, Injection). The patent, Chinese patent number ZL200480025403.6, is titled, “A M…
Regulatory and Legal | 18 August 2011
