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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

Pharma giants included in China's investigation into pricing of foreign imports

05-07-2013

China's National Development and Reform Commission (NDRC) has launched an investigation into UK pharma…

Astellas PharmaBaxterBoehringer IngelheimGlaxoSmithKlineJiangsu Hengrui MedicinePharmaceuticalPricingRegulationSandozSinopharm Group

FDA warns Novartis on Austrian generic manufacturing plant cGMP failures

07-06-2013

The US Food and Drug Administration has written to Joseph Jimenez, chief executive of Swiss drug major…

Ebewe PharmaGenericsNovartisProductionRegulationSandoz

Sandoz to emphasize need for consistent regulatory standards across all biologics at FDA hearings

10-05-2012

Germany-based Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX) announced that Mark McCamish,…

BiotechnologyGeneralNorth AmericaNovartisRegulationResearchSandoz

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