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Brazil plans to update the regulatory framework, expand production of medical products

Brazil plans to update the regulatory framework, expand production of medical products

15-08-2014

The Brazilian Ministry of Health has opened a public consultation to establish the criteria for product…

BrazilFederal governmentPharmaceuticalProductionRegulation

FDA FOCUS: FDA Regulations and Drug Shortages in America

FDA FOCUS: FDA Regulations and Drug Shortages in America

15-08-2014

In the first of a new monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola…

FDAFood and Drug AdministrationPharmaceuticalPharmaceutical sciencesRegulationUSA

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

15-08-2014

USA-based Amgen initiated a voluntary recall on June 26 for nine packaged lots of anemia drug Aranesp…

AmgenAnemiaAranespBiotechnologyMarkets & MarketingOncologyRegulation

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

Invasive meningococcal diseaseLP2086PfizerPharmaceuticalRegulationrLP2086USAVaccines

Ligand signs Captisol license deal with Avion Pharmaceuticals

Ligand signs Captisol license deal with Avion Pharmaceuticals

15-08-2014

Ligand Pharmaceuticals has signed a commercial license agreement with fellow USA-based Avion Pharmaceuticals,…

Avion PharmaceuticalsBiotechnologyBusiness FinanceCaptisolLicensingLigand PharmaceuticalsUSA

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

15-08-2014

Swiss drug major Roche has received approval from the US Food and Drug Administration for its drug Avastin…

AvastinCervical cancerOncologyPharmaceuticalRegulationRocheSwitzerland

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