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FDA approves Eisai’s Akynzeo for CINV

13-10-2014

The US Food and Drug Administration has approved Japanese pharma major Eisai’s Akynzeo (netupitant…

AkynzeoEisaiHelsinnnetupitantOncologypalonosetronPharmaceuticalRegulationUSA

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

12-10-2014

As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationSovaldiUSA

Highlights from EMA Pharmacovigilance October meeting

10-10-2014

At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee…

Ariad PharmaceuticalsEuropeIclusigMen's HealthNeurologicalOncologyPharmaceuticalRegulationTestosteronevalproate

New Zealand approval of Novartis multiproduct proposal

10-10-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with…

NeurologicalNew ZealandOncologyPharmaceuticalRegulationRespiratory and Pulmonary

IQWiG finds added benefit of Novartis’ Gilenya not proven

IQWiG finds added benefit of Novartis’ Gilenya not proven

10-10-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

GermanyGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

Biogen Idec files for Elocta approval in Europe

Biogen Idec files for Elocta approval in Europe

10-10-2014

US biotech firm Biogen Idec has submitted a Marketing Authorization Application (MAA) for Elocta (rFVIIIFc;…

Biogen IdecBiotechnologyEloctaEloctateEuropeHematologyRegulationSwedish Orphan Biovitrum

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

09-10-2014

US privately-held oncolytic virus expert DNAtrix says that the US Food and Drug Administration has granted…

BiotechnologyDNAtrixDNX-2401OncologyRegulationUSA

NICE updates guidance for management of multiple sclerosis but does not recommend Bayer's Sativex

NICE updates guidance for management of multiple sclerosis but does not recommend Bayer's Sativex

09-10-2014

The UK’s National Institute for Health and Care Excellence (NICE) has updated its guidance for the…

BayerNeurologicalPharmaceuticalRegulationSativexUK

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

08-10-2014

One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive…

BiotechnologyLegalLicensingPatents & Trade marksProductionRegulationResearchSocial IssuesUK

Australia’s TGA completes review of NSAIDs safety

Australia’s TGA completes review of NSAIDs safety

08-10-2014

Australian regulator the Therapeutic Goods Administration (TGA) has completed a review of the cardiovascular…

AustraliacelecoxibdiclofenacetoricoxibibuprofenIndomethacinMeloxicamNaproxenNeurologicalPharmaceuticalPiroxicamRegulation

US FDA grants Fast Track status to BrainStorm Cell Therapeutics for ALS treatment NurOwn

US FDA grants Fast Track status to BrainStorm Cell Therapeutics for ALS treatment NurOwn

07-10-2014

The US Food and Drug Administration has designated a product from stem cell treatment developer BrainStorm…

BiotechnologyBrainStorm Cell TherapeuticsNeurologicalNurOwnRegulationUSA

Regeneron gains further FDA indications for Eylea

Regeneron gains further FDA indications for Eylea

07-10-2014

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

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

AbbVie gains expanded approval for Humira by FDA

AbbVie gains expanded approval for Humira by FDA

06-10-2014

US drugmaker AbbVie has received approval from the US Food and Drug Administration for an extension of…

AbbVieAnti-Arthritics/RheumaticsHumiraPharmaceuticalRegulationUSA

French Transparency Commission recognizes efficacy of Eisai’s Zonegran monotherapy

French Transparency Commission recognizes efficacy of Eisai’s Zonegran monotherapy

06-10-2014

Transparency advice for Japanese pharma major Eisai’s Zonegran (zonisamide) monotherapy in the treatment…

EisaiFranceNeurologicalPharmaceuticalRegulationZonegran

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

06-10-2014

When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar…

BiosimilarsBiotechnologyDenmarkPharmacologyRegulation

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

04-10-2014

The US Food and Drug Administration has granted orphan drug designation for Ireland-headquartered specialty…

ActimmuneBiotechnologyHorizon PharmaRare diseasesRegulationUSA

Daiichi Sankyo seeks wider indication for Cravit in Japan

Daiichi Sankyo seeks wider indication for Cravit in Japan

03-10-2014

Japanese drug major Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) in Japan…

Antibiotics and Infectious diseasesCravitDaiichi SankyoJapanPharmaceuticalRegulation

Eli Lilly's Humalog KwikPen approved in Europe for new 200 units/ml version

Eli Lilly's Humalog KwikPen approved in Europe for new 200 units/ml version

03-10-2014

US drug major Eli Lilly has received marketing authorization from the European Commission for its Humalog…

DiabetesEli LillyEuropeHumalogPharmaceuticalRegulation

FDA Breakthrough designation for Ariad’s AP26113

FDA Breakthrough designation for Ariad’s AP26113

03-10-2014

US specialty pharma firm Ariad Pharmaceuticals says that its investigational cancer drug AP26113 has…

AP26113Ariad PharmaceuticalsOncologyPharmaceuticalRegulationResearchUSA

International Society for Pharmaceutical Engineering launches prevention plan to tackle drug shortages

International Society for Pharmaceutical Engineering launches prevention plan to tackle drug shortages

03-10-2014

The International Society for Pharmaceutical Engineering (ISPE) is to release its Drug Shortages Prevention…

GlobalISPEISPE Drug Shortages Task TeamPharmaceuticalRegulation

EMA adopts landmark policy to take effect January 2015

EMA adopts landmark policy to take effect January 2015

03-10-2014

In a bid toward greater transparency, the European Medicines Agency has decided to publish the clinical…

EMAEuropePharmaceuticalRegulationResearch

Data uncertainties mean NICE does not recommend Roche leukemia drug

Data uncertainties mean NICE does not recommend Roche leukemia drug

03-10-2014

In yet another rejection of the company’s cancer drugs, the UK drugs watchdog, the National Institute…

GazyvaroOncologyPharmaceuticalPricingRegulationRocheUK

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