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2350 to 2374 of 2712 results

Sanofi files for Japanese approval of diabetes drug Lyxumia

11-06-2012

French drug major Sanofi (Euronext: SAN), has submitted a marketing authorization application for lixisenatide…

Asia-PacificDiabeteslixisenatideLyxumiaPharmaceuticalRegulationSanofiZealand Pharma

More guidelines needed to grow regenerative medicine market, report finds

11-06-2012

Standardized research guidelines are needed to control and encourage the development of gene therapy…

BiotechnologyFinancialGlobalPoliticsRegulationResearch

German model for assessment of new medicines slammed by EU pharma leaders

11-06-2012

Leading pharmaceutical companies in Europe, represented in the European Federation of Pharmaceutical…

BiotechnologyEuropePharmaceuticalPoliticsPricingRegulation

Business in Japan versus to Japan, by P Reed Maurer

11-06-2012

A pharmaceutical company without a presence in Japan but with a hot new product ready for Phase III clinical…

Asia-PacificBiotechnologyMarkets & MarketingPharmaceuticalRegulation

FDA backs Roche's personalized breast cancer therapy Perjeta

11-06-2012

The US Food and Drug Administration on Friday approved Swiss drug major Roche (ROG: SIX) subsidiary Genentech's…

BiotechnologyGenentechNorth AmericaOncologyPerjetapertuzumabPharmaceuticalRegulationRoche

Call for harmonization of new drug standards in East Africa

10-06-2012

Speaking at a five-day workshop in Dar es Salaam last week, East Africa Community (EAC) members states…

GenericsPharmaceuticalRegulationRest of the World

1,000th designation of an orphan medicinal product in EU

10-06-2012

According to a European Commission statement, over 30 million European citizens suffer from a rare disease.…

BiotechnologyEuropePharmaceuticalRare diseasesRegulation

EMA framework for conflicts of interests completed

10-06-2012

The European Medicines Agency said on Friday that its management board adopted a new "breach of trust…

EuropePharmaceuticalRegulation

FDA clears GlaxoSmithKline's Horizant for PHN

08-06-2012

The US Food and Drug Administration (FDA) has approved UK Pharma giant GlaxoSmithKline's (LSE: GSK) Horizant…

GlaxoSmithKlineHorizantNeurologicalNorth AmericaPharmaceuticalRegulationXenoPort

US FDA delays approval of Novo Nordisk's ultra-long acting insulins

08-06-2012

The US Food and Drug Administration has extended the regulatory review period for the ultra-long-acting…

DegludecDegludecPlusDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulation

Boehringer Ingelheim updates US labelling of Pradaxa for stroke

07-06-2012

Independent German drug major Boehringer Ingelheim has updated the US prescribing information for Pradaxa…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

Alimera's Iluvien approved in Portugal

06-06-2012

Portugal's National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e…

Alimera SciencesEuropeIluvienOphthalmicsPharmaceuticalRegulation

EMA agrees more time for Vivus to prepare for Qnexa oral hearings

05-06-2012

US drug developer Vivus (Nasdaq: VVUS) says that the European Medicines Agency's Committee for Medicinal…

EuropeMetabolicsPharmaceuticalQnexaRegulationVivus

Janssen files NDA with FDA for canagliflozin in type 2 diabetes

01-06-2012

Janssen Research & Development, a subsidiary of health care giant Johnson & Johnson (NYSE: JNJ) has submitted…

canagliflozinDermatologicalsJanssenJohnson & JohnsonMitsubishi TanabeNorth AmericaPharmaceuticalRegulation

US House of Reps Passes FDA Reform Act

01-06-2012

Just days after the US Senate overwhelming approved the Food and Drug Administration Safety and Innovation…

GenericsLegalNorth AmericaPharmaceuticalPoliticsRegulation

EMA boosts EU transparency with on-line publication of suspected side effect reports

31-05-2012

The European Medicines Agency yesterday began publishing suspected side effect reports for medicines…

BiotechnologyEuropePharmaceuticalRegulation

NZ's PHARMAC consults on funding for Iressa and Tarceva

31-05-2012

The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to:

Asia-PacificAstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarceva

2350 to 2374 of 2712 results

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