Regulation - GlaxoSmithKline, Neurological

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Another stumbling block for Impax Pharma's Rytary

22-01-2013

Impax Pharmaceuticals, the branded products division of Impax Laboratories (Nasdaq: IPXL), revealed on…

GlaxoSmithKlineImpax LaboratoriesNeurologicalNorth AmericaPharmaceuticalProductionRegulationRytary

Pfizer's Quillivant XR oral suspension now available in USA; GlaxoSmithKline files BLA for albiglutide

15-01-2013

Confirming expectations announced when Pfizer (NYSE: PFE) revealed its $680 million acquisition of NextWave…

albiglutideDiabetesGlaxoSmithKlineMarkets & MarketingNeurologicalNorth AmericaPfizerPharmaceuticalQuillivantRegulation

EMA reviews hypothesis on Pandemrix hypothesis; finalizes on NSAIDs and CV events

21-10-2012

The European Medicines Agency's Committee on Human Medicinal Products (CHMP) said Friday that it has…

Anti-Arthritics/RheumaticsdiclofenacGlaxoSmithKlineibuprofenInflammatory diseasesNaproxenNeurologicalPandemrixPharmaceuticalRegulationVaccines

Teva/Impax generic Wellbutrin XL 300mg pulled from US market on non-bioequivalence grounds

04-10-2012

Following a review of new data, the US Food and Drug Administration says these indicate that Budeprion…

Bupropion HclGenericsGlaxoSmithKlineImpax LaboratoriesNeurologicalNorth AmericaRegulationTeva Pharmaceutical IndustriesWellbutrin XL

Research news: dolutegravir; TD-1211; and synaptic modulators

11-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and Japanese drugmaker Shionogi (TYO: 4507) have reported…

Anti-viralsdolutegravirGalenea CorpGastro-intestinalsGlaxoSmithKlineLicensingNeurologicalPharmaceuticalRegulationResearchShionogiTD-1211TheravanceZonegran

Final guidance from UK NICE on Tarceva, Tyverb, Herceptin, Zytiga and Botox

26-06-2012

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today published…

AllerganBotoxEuropeGlaxoSmithKlineHerceptinJanssenJohnson & JohnsonNeurologicalOncologyPharmaceuticalPricingRegulationRocheTarcevaTyverbZytiga

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

Warner Chilcott sues Watson over Lo Loestrin; Actavis debuts generic Requip

20-05-2012

Ireland-headquartered Warner Chilcott (Nasdaq: WCRX) has filed suit against USA-based Watson Pharmaceuticals…

ActavisGenericsGlaxoSmithKlineLegalLo LoestrinMarkets & MarketingNeurologicalNorth AmericaPatentsRegulationReproductiveRequip XLWarner ChilcottWatson Pharmaceuticals

Germany's IQWiG finds in favor of Yervoy but not Benlysta or Fampyra

09-05-2012

The German Institute for Quality and Efficiency in Health Care (IQWiG) in the past few days issued a…

BenlystaBiogen IdecBiotechnologyBristol-Myers SquibbEuropeFampyraGlaxoSmithKlineNeurologicalOncologyPharmaceuticalPricingRare diseasesRegulationYervoy

No proof of added benefit for GlaxoSmithKline’s Trobalt, says IQWiG

27-02-2012

In another warning to drugmakers trying to get approval of new drugs under Germany’s AMNOG reform…

EuropeGlaxoSmithKlineNeurologicalPharmaceuticalPricingRegulationTrobalt

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