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2307 to 2331 of 2737 results

EMA approves GlaxoSmithKline's Votrient for soft tissue sarcomas

09-08-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) says that the European Medicines Agency has approved Votrient…

EuropeGlaxoSmithKlineOncologyPharmaceuticalRegulationVotrient

World's first (official) biosimilar antibody goes to reumatoid arthritis

09-08-2012

The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory…

BiotechnologyCellTrionGenericsGlobalinfliximabJohnson & JohnsonMarkets & MarketingRegulationRemicadeRemsima

NICE rejects Alimera's Iluvien for DMO in draft guidance

08-08-2012

In draft guidance published today (August 8) by UK drugs watchdog the National Institute for Health and…

Alimera SciencesEuropeIluvienOphthalmicsPharmaceuticalPricingRegulation

Pluristem cleared to start Phase I/II PLX cell study for muscle regeneration in Germany

08-08-2012

In a second piece of good news this week, Israeli biotech company Pluristem Therapeutics (TASE: PLTR)…

BiotechnologyEuropePluristem TherapeuticsPLX cellsRegulationResearch

ViroPharma gets FDA backing for industrial scale Cinryze manufacturing

07-08-2012

US biotech firm ViroPharma (Nasdaq: VPHM) says that the US Food and Drug Administration has approved…

BiotechnologyCinryzeNorth AmericaProductionRegulationReproductiveViroPharma

Links with academia changing way Pharma does science, says Tufts CSDD

07-08-2012

Drug developers are forging new ways to work with academic medical centers to create the next generation…

PharmaceuticalRegulationResearch

GlaxoSmithKline files for EU and US approval for dabrafenib and trametinib

07-08-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) last week submitted regulatory filings in the European Union…

dabrafenibEuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationtrametinib

UK NICE draft guidance backs Servier's Procoralan for chronic heart failure

06-08-2012

The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in draft guidance…

Cardio-vascularEuropePharmaceuticalPricingProcoralanRegulationServier

Zaltrap gains US approval for metastatic colorectal cancer

06-08-2012

The US Food and Drug Administration on Friday approved French drug major Sanofi (Euronext: SAN) and US…

North AmericaOncologyPharmaceuticalRegeneronRegulationSanofiZaltrap

Positive outlook for Vectura, as Seebri Breezhaler closer to EU approval

02-08-2012

UK-based inhalation product development company Vectura (LSE: VEC) is a step closer to European approval…

FinancialNovartisPharmaceuticalRegulationRespiratory and PulmonarySeebri BreezhalerVectura

European Medicines Agency phasing out follow-up measures for MAs

02-08-2012

The European Medicines Agency this week issued a statement reminding marketing-authorization holders…

BiotechnologyEuropePharmaceuticalRegulation

USA's PDUFA V begins with relatively modest changes to user fee rates

01-08-2012

In two Federal Register notices published on August 1, the US Food and Drug Administration announced…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

US FDA rejects Regeneron's Arcalyst sBLA for gout flare prevention

01-08-2012

US drugmaker Regeneron Pharmaceuticals (Nasdaq: REGN) says that the US Food and Drug Administration issued…

Anti-Arthritics/RheumaticsArcalystBiotechnologyNorth AmericaPharmaceuticalRegeneronRegulation

Positive new data for Pfizer's tofacitinib; possible regulatory delay

01-08-2012

Pfizer (NYSE:PFE), the world's largest drugmaker by sales, yesterday released positive top-line results…

Anti-Arthritics/RheumaticsNorth AmericaPfizerPharmaceuticalRegulationResearchtofacitinib

EMA increases interaction with Japanese regulators

30-07-2012

The European Medicines Agency has increased its level of interaction and cooperation with medicines regulatory…

Asia-PacificBiotechnologyEuropePharmaceuticalRare diseasesRegulation

EU approval for Eisai's epilepsy drug Fycompa and Vertex' Kalydeco

30-07-2012

Japanese drug major Eisai (TYO: 4523) says that the European Commission has approved for marketing its…

EisaiEuropeFycompaKalydecoNeurologicalPharmaceuticalRare diseasesRegulationVertex

Genentech gains FDA panel backing for Lucentis to treat DME

30-07-2012

US biotech firm Genentech, a subsidiary of Swiss drug major Roche (ROG: SIX), revealed last week that…

BiotechnologyGenentechLucentisNorth AmericaOphthalmicsPharmaceuticalRegulationRoche

US FDA clears Amarin's Vascepa, a competitor for Lovaza

30-07-2012

The US Food and Drug Administration has approved biotech firm Amarin's (Nasdaq: AMRN) Vascepa (icosapent…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLovazaMergers & AcquisitionsNorth AmericaRegulationVascepa

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