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CROMA and B&L’s eye drug Yellox approved by the European Commission


Austria-based CROMA Pharma GmbH, a private global specialty pharmaceutical and surgical company, and…

Bausch & LombCROMA PharmaEuropeOphthalmicsPharmaceuticalRegulationYellox

Pfizer files for EU approval of axitinib in advanced kidney cancer


The European Medicines Agency (EMA) has accepted US drugs behemoth Pfizer’s (NYSE: PFE) filing for…


European Medicines Agency and HMA propose measures on dossier transparency


A guidance document on the identification of commercially confidential information and protection of…


Tianyin granted production license for diabetes drug Gliclazide by China's SFDA


Tianyin Pharmaceutical (NYSE Amex: TPI), a China-based pharmaceutical company that specializes in patented…

Asia-PacificDiabetesGliclazidePharmaceuticalRegulationTianyin Pharma

European Commission to lift suspension of Octapharma MA for Octagam


The European Commission has adopted the European Medicines Agency’s recommendation 2011 to lift…

EuropeOctagamOctapharmaPharmaceuticalRare diseasesRegulation

CBO Director reviews potential effects of a ban on DTC advertising of new Rx drugs in USA


Direct-to-consumer (DTC) advertising of prescription drugs in the USA has elicited various concerns,…

Markets & MarketingNorth AmericaPharmaceuticalRegulation

Changing the Indian culture in reporting adverse drug reactions


Adverse drug reactions (ADRs) are the sixth global leading cause of death among hospitalized patients…

Asia-PacificBoehringer IngelheimPharmaceuticalRegulationResearch

Recommendations for European Medicines Agency communication on medicines; 40 years of PIC/S


A report written by an independent expert has highlighted a number of recommendations to help improve…


MAP Pharma files NDA with US regulator for Levadex in migraine


MAP Pharmaceuticals (Nasdaq: MAPP) has submitted a New Drug Application to the US Food and Drug Administration…

LevadexMAP PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulation

New legislation to fight against falsified medicines adopted by EU


The European Union Council on Friday formally adopted new legislation aimed at protecting patients against…


Chiesi, Eli Lilly and Bayer named for breaches of the ABPI Code of Practice


The UK subsidiaries of Italy’s Chiesi, US drug major Eli Lilly (NYSE: LLY) and Germany’s Bayer…

BayerChiesi FarmaceuticiEli LillyEuropeLevitraNeurologicalPharmaceuticalRegulationReproductiveYasmin

US GPhA calls on House Appropriations Committee to protect funding for FDA; welcomes Solicitor General’s action


The USA’s Generic Pharmaceutical Association (GPhA) has written to House Appropriations Committee…

FinancialGenericsLegalNorth AmericaRegulation

Canada’s Quebec Province overhauls cancer drug evaluation


The Canadian Province of Quebec, which has the highest incidence of new cancer cases in the country,…

North AmericaPharmaceuticalRegulation

German approval for GW and Almirall’s Sativex for spasticity due to MS


Spain’s leading drugmaker Almirall (ALM) and UK-based originator of the cannabis based product GW…

AlmirallEuropeGW PharmaceuticalsNeurologicalPharmaceuticalRegulationSativex

Two more product approvals in Russia for India’s Claris


Claris Lifesciences (CLAR: IN), one of the largest sterile injectables pharmaceutical companies in India,…

Antibiotics and Infectious diseasesClaris LifesciencesEuropeFluconazoleGenericsLevofloxacinRegulation

US Senators accuse Sanofi over lobbying FDA on generic Lovenox


US Senate Finance Committee Chairman Max Baucus (Democrat, Montana) and senior Committee Member Chuck…

Cardio-vascularGenericsLovenoxNorth AmericaPharmaceuticalRegulationSanofi

Vaccine side effects under the microscope in Australia


Australia’s Gillard government yesterday released an independent assessment of the nation's management…


UK’s NICE recommends naftidrofuryl oxalate for symptoms of peripheral arterial disease


The National Institute for Health and Clinical Excellence (NICE) has today issued final guidance recommending…

Cardio-vascularEuropeMerck SerononaftidrofurylPharmaceuticalPraxilenePricingRegulation

Information overload in drug side effect labeling


The lists of potential side effects that accompany prescription drugs have ballooned in size, averaging…

North AmericaPharmaceuticalRegulation

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