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UK's NICE revokes NHS use of Novartis' Xolair for asthma in children and adults


The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in draft guidance…

EuropeNovartisPharmaceuticalPricingRegulationRespiratory and PulmonaryXolair

"New" CDER Exclusivity Board focuses on clarity and consistency of exclusivity decisions


The US Food and Drug Administration recently announced that the agency has established within the Center…

BiotechnologyLegalNorth AmericaPatentsPharmaceuticalRegulation

Health Council of Canada weighs in on drug safety in Canada


The Health Council of Canada, which appeared before the Standing Senate Committee on Social Affairs,…

North AmericaPharmaceuticalRegulationResearch

FDA approves Pfizer's Xeljanz for rheumatoid arthritis


Having in the summer put back its "action date" due to a request for additional analysis of the existing…

Anti-Arthritics/RheumaticsNorth AmericaPfizerPharmaceuticalRegulationtofacitinibXeljanz

FDA briefing papers for Novo Nordisk's insulin degludec note need to review cardiac risks


The US Food and Drug Administration yesterday published the briefing documents ahead of the Advisory…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

Extraneous clinical data collection costs drug developers $4-$6 billion a year, says Tufts CSDD


One out of every five procedures performed during later stage clinical trials collects extraneous data…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulationResearch

EU approves label change for Bristol-Myer's Baraclude


US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the European Commission has approved a Baraclude…

Anti-viralsBaracludeBristol-Myers SquibbEuropePharmaceuticalRegulation

Serious bleeding risk with Boehringer's Pradaxa no worse than warfarin, says FDA


In a follow up to a 2011 safety communication, the US Food and Drug Administration has evaluated new…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationResearch

"India Pharma Inc" gearing up for the next level of growth


Indian pharmaceutical companies will have to rethink business strategy in the light of several interventions…

Asia-PacificGenericsHealthcareMarkets & MarketingPharmaceuticalPricingProductionRegulation

Canadian Senate committee finds faults in current clinical trials system


The absence of a standardized approach to research ethics review significantly impacts the time required…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulationResearch

New Zealand decision on proposal for various Novartis products


Following a public consultation, New Zealand's Pharmaceutical Management Agency PHARMAC yesterday announced…


Novartis' Votubia cleared for non-cancerous kidney tumors in EU


Swiss drug major Novartis' (NOVN: VX) shares rose 1.1% this morning, as the company revealed it has received…

EuropeNephrology and HepatologyNovartisPharmaceuticalRegulationVotubia

European Commission OKs first gene therapy, uniQure's Glybera


After a somewhat rocky past, and a change of opinion by the European Medicines Agency's opinion in the…

BiotechnologyEuropeGlyberaRare diseasesRegulationuniQure

BioCryst withdraws BCX5191 lND following discussion with FDA


US biotech firm BioCryst Pharmaceuticals (Nasdaq: BCRX) says it is withdrawing its Investigational New…

Anti-viralsBCX5191BioCryst PharmaceuticalsBiotechnologyNorth AmericaRegulationResearch

UK's NICE plans to back NHS use of two breakthrough skin cancer treatments


The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) this morning…

Bristol-Myers SquibbEuropeOncologyPharmaceuticalPricingRegulationRocheYervoyZelboraf

Drug research in Asia goes native


High recruitment rates and a robust regulatory framework strongly favor the Asian clinical research industry…


2201 to 2225 of 2745 results



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