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Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

09-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published new draft…

AbraxaneBiotechnologyCelgene Corp.OncologyPaclitaxelPricingRegulationUK

Roche’s RoActemra gains EU approval for use in early RA

Roche’s RoActemra gains EU approval for use in early RA

08-09-2014

The European Commission has approved Swiss pharma major Roche’s RoActemra (tocilizumab) for use in…

ActemraAnti-Arthritics/RheumaticsEuropeInterleukin 6PharmaceuticalRegulationRoActemraRoche

Astellas' isavuconazole NDA accepted by US FDA

Astellas' isavuconazole NDA accepted by US FDA

08-09-2014

The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major…

Astellas PharmaFungal diseasesInvasive aspergillosisInvasive mucormycosisisavuconazoleOncologyPharmaceuticalRegulationUSA

New report debunks some common perceptions of R&D productivity

New report debunks some common perceptions of R&D productivity

08-09-2014

The 2014 edition of the Thomson Reuters CMR Pharmaceutical R&D Factbook, published today, contains some…

GlobalMarkets & MarketingPharmaceuticalRegulationResearch

FDA accepts Actavis’ NDA for ceftazidime-avibactam

FDA accepts Actavis’ NDA for ceftazidime-avibactam

05-09-2014

Ireland-headquartered generic drugs major Actavis today confirmed that the US Food and Drug Administration…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamPharmaceuticalRegulationResearchUSA

FDA lifts partial clinical hold on OncoMed's ipafricept

05-09-2014

Shares of US biotech companies OncoMed Pharmaceuticals rose 5.6% to $17.68 on news that the US Food and…

BayerBiotechnologyipafriceptOncologyOncoMed PharmaceuticalsRegulationResearchUSA

Australia's federal court rules that companies can patent genetic material

Australia's federal court rules that companies can patent genetic material

05-09-2014

The Full Bench of the Federal Court of Australia has decided a private company may hold a patent on a…

AustraliaBiotechnologyIntellectual propertyLegalPatentsPharmaceutical sciencesRegulation

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

05-09-2014

The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s…

KeytrudaMerck & CoOncologypembrolizumabPharmaceuticalRegulationUSA

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

FDA accepts Actavis NDA for eluxadoline

FDA accepts Actavis NDA for eluxadoline

03-09-2014

Ireland-headquartered generic drug major Actavis says that the US Food and Drug Administration has accepted…

ActaviseluxadolineForest LaboratoriesFuriex PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

FDA Breakthrough designation for ACADIA’s Nuplazid for Parkinson’s disease psychosis

FDA Breakthrough designation for ACADIA’s Nuplazid for Parkinson’s disease psychosis

03-09-2014

US biotech firm ACADIA Pharmaceuticals says that the US Food and Drug Administration has granted Breakthrough…

ACADIA PharmaceuticalsBiotechnologyNeurologicalNuplazidpimavanserinRegulationUSA

Bristol-Myers Squibb launches Daklinza in the UK for chronic hepatitis C

Bristol-Myers Squibb launches Daklinza in the UK for chronic hepatitis C

03-09-2014

US drug major Bristol-Myers Squibb has launched Daklinza (daclastavir) in the UK for chronic hepatitis…

AntiviralsBristol-Myers SquibbDaklinzaHepatitis CNephrology and HepatologyPharmaceuticalRegulationUK

Allergan’s Ozurdex approved for DME in Europe

Allergan’s Ozurdex approved for DME in Europe

02-09-2014

Allergan revealed today that the European Commission has extended the marketing authorization for Ozurdex…

AllerganEuropeOphthalmicsOzurdexPharmaceuticalRegulation

Australia participating in EU DCP for evaluation of generic drugs

Australia participating in EU DCP for evaluation of generic drugs

02-09-2014

Under the auspices of the International Generic Drug Regulators Pilot , Australia’s Therapeutic Goods…

AustraliaGenericsRegulation

New EMA guidance on EU periodic-safety-update-report single assessment for nationally authorized medicines

01-09-2014

The European Medicines Agency has updated its procedural guidance to ensure that marketing-authorization…

EuropePharmaceuticalRegulation

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