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Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

06-03-2015

Sandoz, the generics unit of Swiss pharma giant Novartis, today received approval from the US Food and…

AmgenBiosimilarsBiotechnologyNeupogenNovartisOncologyRegulationSandozUSAZarxioZarzio

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

New analysis of potential savings from Biosimilars in USA

New analysis of potential savings from Biosimilars in USA

04-11-2014

Introducing competing “biosimilar” versions of complex biologic drugs used to treat illnesses such…

Anti-Arthritics/RheumaticsBiosimilarsFinancialGenericsOncologyRegulationSandozUSA

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

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

07-04-2014

Uptake of biosimilars in Europe has increased as a result of member states’ policies, according to…

BiosimilarsEuropeFilgrastimInterviewsMarkets & MarketingRegulationSandoz

Sandoz receives Danish approval for AirFluSal Forspiro inhaler

Sandoz receives Danish approval for AirFluSal Forspiro inhaler

19-12-2013

Swiss drug major Novartis' (NOVN: VX) generics unit Sandoz has received Danish marketing authorization…

DenmarkPharmaceuticalRegulationRespiratory and PulmonarySandozVectura

Apricus ED drug gains national phase approval in Germany

09-10-2013

Germany's Federal Institute for Drugs and Medical Devices has granted national phase approval for USA-based…

Apricus BioscienceEuropeMen's HealthPharmaceuticalRegulationSandozVitaros

Proposal for a sole supply arrangement for fentanyl patches in New Zealand

08-07-2013

New Zealand's Pharmaceutical Management Agency, PHARMAC, is seeking feedback on a proposal to list a…

Asia-PacificfentanylFentanyl SandozNeurologicalNovartisPharmaceuticalPricingRegulationSandoz

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