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Pfizer and Bristol-Myers get first approval for blood thinner Eliquis, in EU


Following a positive recommendation from its drug advisory body (The Pharma Letter March 21), the European…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalRegulation

European Commission clears proposed DSM and Sinochem joint venture


The European Commission has cleared under the EU Merger Regulation the proposed joint venture between…

Antibiotics and Infectious diseasesAsia-PacificDSMGenericsMergers & AcquisitionsSinochem

Controversial NSAID nimesulide now banned in China for children below 12


The Chinese regulator, the State Food and Drug Administration (SFDA) has issued a notice banning the…


Fight over user fees underscores bigger questions about US FDA's mission, Burrill report finds


Industry frustration is growing over a failure to adequately fund the US Food and Drug Administration…

FinancialNorth AmericaPharmaceuticalRegulation

GlaxoSmithKline’s diabetes drug Avandia to be restricted on US market


As part of a US Food and Drug Administration re-assessment of UK drug giant GlaxoSmithKline’s troubled…

AvandiaDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

Sandoz files for generic of Shire’s Vyvanse; FDA warning


Ireland-headquartered biopharmaceutical company Shire (LSE: SHP) yesterday revealed that its US subsidiary…

GenericsMarkets & MarketingNeurologicalNorth AmericaNovartisPatentsPharmaceuticalRegulationSandozShireVyvanse

Pharma distribution in Central Europe in 2011: liberalization of non-pharmacy and on-line sales


Pharmaceutical distribution has been liberalized further in Central Europe in 2011, with Bulgaria making…

EuropeMarkets & MarketingPharmaceuticalRegulation

FDA advisory panel backs continued use of Abbott’s Trilipix with statins


The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee to review…

Abbott LaboratoriesCardio-vascularNorth AmericaPharmaceuticalRegulationTrilipix

Global pharma market will see just 3%-6% growth over next five years, reaching $1,100 billion in 2015


Global spending for medicines will reach nearly $1,100 billion by 2015, reflecting a slowing compound…

GenericsGlobalMarkets & MarketingPatentsPharmaceutical

Public Citizen says US FDA should immediately pull Eisai and Pfizer’s high-dose Aricept from market


US consumer watchdog Public Citizen has called for higher doses of Aricept (donepezil), marketed by originator…

AriceptEisaiNeurologicalNorth AmericaPfizerPharmaceuticalRegulation

Eisai gets Swiss approval for Halaven


Japanese drug major Eisai (TYO: 4532), says that its Halaven(eribulin) has been approved for use in…


Pfizer files for US and Japanese approval of crizotinib for NSCLC


US drug behemoth Pfizer (NYSE: PFE) says that its New Drug Application for crizotinib, an oral first-in-class…

Asia-PacificcrizotinibNorth AmericaOncologyPfizerPharmaceuticalRegulation

Israeli generics giant Teva wins largest share of German health insurance AOK tenders


Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA), the world’s biggest generic drugmaker,…

EuropeGenericsMarkets & MarketingTeva Pharmaceutical Industries

Australia’s TGA approves Biogen’s Fampyra to improve MS patients walking ability


The Australian Therapeutic Goods Administration (TGA) has granted approval for USA-based Biogen Idec’s…

AmpyraAsia-PacificBiogen IdecFampyraNeurologicalPharmaceuticalRegulation

Alimera resubmits eye drug Iluvien to US regulator


USA-based Alimera Sciences (Nasdaq: ALIM) says that it has resubmitted its New Drug Application for Iluvien…

Alimera SciencesIluvienNorth AmericaOphthalmicsPharmaceuticalpSividaRegulation

US FDA clears first hep C drug in a decade, Merck & Co’s Victrelis


In much awaited, though largely expected news, the US Food and Drug Administration on Friday approved…

Anti-viralsboceprevirMerck & CoNorth AmericaPharmaceuticalRegulationtelaprevirVertexVictrelis

US Medicare likely to run out of funds in 2024; Congressional Affordable Medicines Caucus


The US Trustees of the Social Security and Medicare trust funds report on the current and projected financial…

GenericsHealthcareNorth AmericaPharmaceuticalPoliticsPricing

Dr Reddy’s launches Neulastim copy in India; doubles 4th-qtr profit


Hyderabad, India-based generic drugmaker Dr Reddy’s Laboratories (NYSE: RDY) has launched its Peg-grafeel,…

Asia-PacificDr Reddy's LaboratoriesFinancialGenericsMarkets & MarketingNeulastimOncologyPeg-grafeelRoche

Australia clears way for increased access to generic medicines


Australian consumers and health professionals will have more ready access to generic medicines following…


Merck & Co debuts Simponi in the UK for RA, PsA and AS


US drug giant Merck & Co (NYSE: MRK), through its subsidiary MSD, yesterday announced the UK availability…

Anti-Arthritics/RheumaticsEuropeMarkets & MarketingMerck & CoPharmaceuticalRegulationSimponi Injection

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