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Mexico backs marketing of Aegerion’s Juxtapid for HoFH

Mexico backs marketing of Aegerion’s Juxtapid for HoFH

20-01-2014

US emerging biotech firm Aegerion Pharmaceuticals says that the Mexican Federal Commission for the Protection…

Aegerion PharmaceuticalsJuxtapidMexicoPharmaceuticalRare diseasesRegulationSouth America

Brazil initiates public consultation on interchangeability of biosimilar drugs

Brazil initiates public consultation on interchangeability of biosimilar drugs

17-01-2014

Biosimilar drugs, also known as follow-on biologics, may soon be substituted in place of the reference…

BiosimilarsBrazilPharmaceuticalRegulationSouth America

moksha8 files Viibryd and Colobreathe in Brazil; amends Forest alliance

06-01-2014

Brazil-based pharma firm moksha8 has filed applications with the Brazilian regulatory authority, ANVISA,…

BrazilColoBreatheForest LaboratoriesLicensingMerck SeronoMoksha8NeurologicalPharmaceuticalRare diseasesRegulationSouth AmericaViibryd

Rapid uptake of rheumatoid arthritis biosimilars expected in Brazil and Mexico

19-12-2013

Biosimilars will be quickly acquired and used in public health institutions in the treatment of patients…

Anti-Arthritics/RheumaticsBiosimilarsBrazilGenericsMarkets & MarketingRegulationSouth America

Brazil’s ANVISA and ProGenericos sign cooperation agreement

Brazil’s ANVISA and ProGenericos sign cooperation agreement

18-12-2013

Brazil's National Health Surveillance Agency, ANVISA has signed a memorandum of technical and operational…

BiosimilarsBrazilGenericsRegulationResearchSouth America

Brazil's regulatory processes impair the growth of pharma industry

Brazil's regulatory processes impair the growth of pharma industry

06-12-2013

The Brazilian pharmaceutical market is considered the second with the greatest growth potential in the…

BrazilPharmaceuticalRegulationSouth America

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

28-11-2013

The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar…

BiosimilarsDoxelibGenericsLegalLibra LaboratoryOncologyRegulationSanofiSouth AmericaTaxotere

Emerging markets to see fastest growth, as pharma industry faces challenges

05-11-2013

Globally, the scientific foundation on which the pharma industry rests has improved vastly over the years.…

Asia-PacificMarkets & MarketingPharmaceuticalRegulationSouth America

Synergy between food and pharma driving South America's economy

04-09-2013

UBM Live announced that this year's recent CPhI South America, which took place last month at the Expo…

Markets & MarketingPharmaceuticalRegulationSouth America

Mexico's pharma and health care industry improving; report

28-08-2013

Market research group Business Monitor has just released its latest findings on Mexico's pharmaceuticals…

Markets & MarketingPharmaceuticalRegulationSouth America

Market access barriers for multinationals, but Argentina still offers attractive pharma opportunities

31-05-2013

Several barriers impede market access but the regulatory landscape in Argentina is changing and attractive…

BiotechnologyMarkets & MarketingPatentsPharmaceuticalRegulationSouth America

Argentina's pharma market to almost triple over one decade, says GlobalData

24-04-2013

Argentina's pharmaceutical market is expected to grow from a value of around $5.6 billion in 2012 to…

GenericsMarkets & MarketingPatentsPharmaceuticalProductionRegulationSouth America

Sinovac Biotech flu vaccine OKed in Mexico; EV71 results; financials

18-04-2013

In what was a busy news day for Sinovac Biotech (Nasdaq: SVA), a leading provider of vaccines in China,…

BiotechnologyEV71FinancialRegulationResearchSinovac BiotechSouth America

Brazil's ANVISA to beef up international inspections

04-04-2013

The operations of Brazil's National Health Surveillance Agency, ANVISA, in international inspections…

ManagementPharmaceuticalProductionRegulationSouth America

Pfizer and Protalix' Gaucher drug Uplyso approved in Brazil

19-03-2013

US drugs behemoth Pfizer (NYSE: PFE) and Israel-based Protalix BioTherapeutics (NYSE MKT:PLX) said that…

BiotechnologyElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationSouth AmericaUplyso

Venezuelan govt increasing control over pharmaceutical sector

14-08-2012

Venezuela's national government has changed its policy with regard to the pharmaceutical sector. This…

FinancialGenericsPharmaceuticalPricingRegulationSouth America

New biologics and biosimilars approval guidelines in Mexico

04-05-2012

In Mexico, new guidelines are now in effect for the market authorization of biologics and biosimilars,…

BiotechnologyGenericsRegulationSouth America

Mexico defines orphan drugs, but questions remain; US patent deal

14-03-2012

Earlier this year, on January 31, new provisions of the Mexican General Health Law (GHL) came into force,…

PatentsPharmaceuticalRegulationSouth America

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