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POLICY DEVELOPMENTS
FDA approves new indication for CRESTOR
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
Strides Arcolab gets FDA nod for Labetalol injection
Strides Arcolab has received US FDA approval for its ANDA for Labetalol HCl injection. Labetalol is the third product launched under the partnership between Strides and Sagent Pharmaceuticals
TODAY'S NEWS
  PPD, SRI sign agreement for vax clinical research services
  ABRAXANE meets primary endpoint in phIII trial for advanced NSCLC
  HealthLinx soon to launch OvPlex in Singapore
  Gelcompany first sale of HPE system in Saudi Arabia
  RIKEN researchers trace proteins that help plants keep time
  Biotron ties up with ACLIRES for conducting trial for BIT225
 
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POLICIES
 
Kendle's Indian center gets govt approval
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
 
Mesoblast gets US patent for bone repair products
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
 
Glenmark receives FDA nod for Parkinson's drug
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
 
FDA, EMA to accept single report for orphan drug
Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the US and the EU
 
WuXi's Shanghai facilities pass EMEA inspection
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
 
WuXi's toxicology facility gets AAALAC accreditation
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)
 
European CHMP adopts negative opinion on ceftobiprole
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
 
Novartis oral MS compound Gilenia granted US priority review status
Gilenia has been granted priority review status by the US Food and Drug Administration (FDA), which accepted the regulatory submission made in December 2009 for this medicine
 
FDA approved over 50 new cancer indications in 32-month period
The FDA's Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007
 
FDA approves new indication for CRESTOR
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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