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Kendle's Indian center gets govt approval
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| Kendle, a global clinical research organization, has received approval from Indian authorities to proceed with the development of a new operations center in a Special Economic Zone in the upcoming Ahmedabad-Gandhinagar Knowledge Corridor |
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Mesoblast gets US patent for bone repair products
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| Australia's regenerative medicine company, Mesoblast said that the US Patent and Trademark Office has granted a key patent that provides exclusive commercial protection for its bone tissue generating products in the US |
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Glenmark receives FDA nod for Parkinson's drug
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| Glenmark Generics (GGI), a subsidiary of Glenmark has received ANDA approval from the US FDA for Ropinirole Hydrochloride tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg , 4 mg and 5 mg and will immediately commence marketing and distribution |
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WuXi's Shanghai facilities pass EMEA inspection
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| WuXi PharmaTech has received the formal certificate of GMP compliance from the Medical Products Agency of Sweden, acting on behalf of the European Medicines Agency (EMEA), for its c-GMP drug facilities in Shanghai, China |
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WuXi's toxicology facility gets AAALAC accreditation
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| China-based WuXi PharmaTech's Suzhou non-clinical safety testing facility received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) |
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European CHMP adopts negative opinion on ceftobiprole
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| Basilea Pharmaceutica has announced that the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin |
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FDA approves new indication for CRESTOR
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| AstraZeneca announced that the US Food FDA has approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease |
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