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NICE consulting again on Celgene's Revlimid for multiple myeloma

NICE consulting again on Celgene's Revlimid for multiple myeloma

31-07-2014

The UK clinical guidance body, the National Institute for Health and Care Excellence (NICE), is again…

Celgene Corp.ImmunosuppressantslenalidomideOncologyPharmaceuticalRegulationRevlimidUK

Regeneron’s Eylea gains FDA approval for DME

Regeneron’s Eylea gains FDA approval for DME

30-07-2014

The Food and Drug Administration has approved US biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept)…

BayerBiotechnologyEyleaOphthalmicsRegeneronRegulationUSA

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

30-07-2014

The European Commission has approved US pharma majors Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban)…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalRegulation

FDA performs inspection of Impax's Taiwan facility

FDA performs inspection of Impax's Taiwan facility

30-07-2014

The US Food and Drug Administration has performed a general Good Manufacturing Practices (GMP) inspection…

Impax LaboratoriesNeurologicalPharmaceuticalRegulationRytaryUSA

Canada’s Health Minister moves on safe prescribing practices for drugs prone to abuse

Canada’s Health Minister moves on safe prescribing practices for drugs prone to abuse

29-07-2014

Canada’s Minister of Health, Rona Ambrose, has issued a national Call for Proposals to improve the…

CanadaNeurologicalPharmaceuticalRegulation

pSivida’s Iluvien given marketing authorization in Norway and reimbursement approval in Portugal

pSivida’s Iluvien given marketing authorization in Norway and reimbursement approval in Portugal

29-07-2014

Eye disease specialist pSivida has been granted marketing authorization in Norway for its treatment Iluvien,…

IluvienNorwayOphthalmicsPharmaceuticalPortugalpSividaRegulation

Antiviral gel in condoms to kill HIV approved in Australia

Antiviral gel in condoms to kill HIV approved in Australia

28-07-2014

Australian biotech firm Starpharma says it has achieved a major milestone with the receipt of Conformity…

AnsellAnti-viralsAntibiotics and Infectious diseasesAustraliaBiotechnologyRegulationStarpharmaVivaGel

Alcon’s Simbrinza approved for glaucoma in the EU

Alcon’s Simbrinza approved for glaucoma in the EU

28-07-2014

Eyecare specialist Alcon, a division of Swiss drug major Novartis, says its Simbrinza eye drops suspension…

AlconEuropeEuropean CommissionGlaucomaOphthalmicsPharmaceuticalRegulationSimbrinza

AcelRx Pharma’s Zalviso approval delayed by FDA

AcelRx Pharma’s Zalviso approval delayed by FDA

28-07-2014

USA-based specialty pharma firm AcelRx Pharmaceuticals says that the US Food and Drug Administration…

AcelRxFood and Drug AdministrationNeurologicalPharmaceuticalRegulationUSAZalviso

Is Europe putting cancer research at risk?

25-07-2014

The European Society for Medical Oncology (ESMO) has expressed concern that the proposed European Union…

EuropeOncologyPharmaceuticalRegulationResearch

FDA approves Purdue’s abuse-deterrent opioid Targiniq ER for pain-management

FDA approves Purdue’s abuse-deterrent opioid Targiniq ER for pain-management

25-07-2014

The US Food and Drug Administration has approved privately-held USA-based Purdue Pharma’s abuse-deterrent…

AlcoholsAnalgesiaChemistryNaloxonePharmaceuticalPurdue PharmaRegulationTarginiqUSA

Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

GSK files EU regulatory submission for RTS,S malaria vaccine candidate

24-07-2014

UK pharma giant GlaxoSmithKline announced today that it has submitted a regulatory application to the…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRest of the WorldRTS,STropical diseasesVaccines

Levonorgestrel and ulipristal remain suitable emergency contraceptives, says EMA

24-07-2014

The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel…

EuropeLevonorgestrelNorLevoPharmaceuticalRegulationReproductiveulipristalWomen's Health

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

24-07-2014

US biotech firm Biogen Idec said that the European Commission has approved its subcutaneous injectable…

Biogen IdecCytokinesMultiple sclerosisNeurologicalPharmaceuticalPlegridyRegulationUSA

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