Pharmaceuticals - Generic / Specialty

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TWi Pharmaceuticals receives FDA approval

Monday, 7 Apr 2014

TWi Pharmaceuticals Inc:Received final approval from U.S Food and Drug Administration, for Nifedipine Extended-Release Tablets(30 mg, 60 mg and 90 mg).

Merck and Sanofi Pasteur Gardasil approved in EU-PR Newswire Europe

Monday, 7 Apr 2014

Sanofi SA:European Commission grants marketing authorization for quadrivalent Human Papillomavirus (HPV) vaccine Gardasil developed by Sanofi Pasteur and Merck & Co Inc joint venture Sanofi Pasteur MSD - PR Newswire Europe.Authorization is granted for 2-dose schedule at 0 and 6 months in children aged from 9 to 13 years.Approval of this new schedule for Gardasil follows positive opinion from European Medicines Agency (EMA) granted in February, based on Canadian study performed by Dobson et al.Study demonstrated that 2-dose 0, 6 month schedule in 9-13 year old girls elicited immune response comparable/non-inferior to that of 3 doses in 16-26 year old women, population where quadrivalent vaccine efficacy has been shown.Results were sustained at 36 months of follow-up.

Merck and Sanofi Pasteur Gardasil approved in EU-PR Newswire Europe

Monday, 7 Apr 2014

Sanofi SA:European Commission grants marketing authorization for quadrivalent Human Papillomavirus (HPV) vaccine Gardasil developed by Sanofi Pasteur and Merck & Co Inc joint venture Sanofi Pasteur MSD - PR Newswire Europe.Authorization is granted for 2-dose schedule at 0 and 6 months in children aged from 9 to 13 years.Approval of this new schedule for Gardasil follows positive opinion from European Medicines Agency (EMA) granted in February, based on Canadian study performed by Dobson et al.Study demonstrated that 2-dose 0, 6 month schedule in 9-13 year old girls elicited immune response comparable/non-inferior to that of 3 doses in 16-26 year old women, population where quadrivalent vaccine efficacy has been shown.Results were sustained at 36 months of follow-up.

Escalon Medical Corp receives FDA 510(k) clearance for the Sonomed Escalon VuPad

Friday, 4 Apr 2014

Escalon Medical Corp:Receives U.S. Food and Drug Administration (FDA) 510(k) clearance for its new tablet-based ultrasound imaging system, the Sonomed Escalon VuPad.

Biotec Pharmacon says Woulgan Biogel receives CE-marking

Friday, 4 Apr 2014

Biotec Pharmacon ASA:Says the company's Woulgan Biogel has received CE -marking as an advanced medical device.Says Biotec BetaGlucans and its international partner Smith & Nephew will immediately commence market evaluation trials.Biotec BetaGlucans AS is a wholly-owned subsidiary of Biotec Pharmacon ASA.

ZERIA PHARMACEUTICAL receives approval for Prefemin

Friday, 4 Apr 2014

ZERIA PHARMACEUTICAL CO LTD:Received manufacturing and sales approval in Japan for Prefemin, a drug for treatment of premenstrual syndrome and irregular mense.

MEDRx receives patent recognition

Friday, 4 Apr 2014

MEDRx Co Ltd:Received patent recognition from Japan Patent Office, for external preparation containing fatty acid salt and benzoate as well as its preparation method, with valid period until 2029.The preparation includes Lidocain tape.

Ilyang Pharmaceutical receives patent

Friday, 4 Apr 2014

Ilyang Pharmaceutical Co., Ltd:Receives a patent on April 3, for an N-phenyl-2-pyrimidine-amine derivatives and a fabricating method thereof.

Astellas announces European regulatory submission for XTANDI capsules for chemotherapy-naive metastatic prostate cancer

Thursday, 3 Apr 2014

Astellas Pharma Inc:Says the company and Medivation Inc announces the submission of a variation to amend the European Marketing Authorization Application for XTANDI capsules for the treatment of adult men with metastatic castration-resistant prostate cancer.

FDA accepts filing of Medicines Co's US biologic license application for fibrocaps hemostatic agent

Thursday, 3 Apr 2014

Medicines Co:Says that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin.

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