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2201 to 2225 of 2745 results

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

09-11-2012

The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in draft guidance…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

07-11-2012

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

07-11-2012

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

07-11-2012

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

06-11-2012

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

06-11-2012

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

06-11-2012

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

06-11-2012

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

05-11-2012

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

05-11-2012

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

05-11-2012

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

Asia-PacificNovartisPharmaceuticalPricingRegulation

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

05-11-2012

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

05-11-2012

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

04-11-2012

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

01-11-2012

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

01-11-2012

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

Asia-PacificPharmaceuticalRegulationResearch

2201 to 2225 of 2745 results

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