Regulation - Janssen, Oncology

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UK NICE backs Janssen’s Velcade for multiple myeloma

UK NICE backs Janssen’s Velcade for multiple myeloma

21-03-2014

In new draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence…

JanssenJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

Janssen files for simultaneous US and EU approval for Castleman disease drug

04-09-2013

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), yesterday…

EuropeJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRare diseasesRegulationsiltuximab

J&J's daratumumab gets "Breakthrough" status; GSK's trametinib delayed by FDA

02-05-2013

The US Food and Drug Administration has granted "Breakthrough Therapy Designation" for health care giant…

daratumumabGenmabGlaxoSmithKlineJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationtrametinib

Pharmacyclics and Janssen gain third FDA "Breakthrough" designation for ibrutinib; new Ph II data

09-04-2013

Pharmacyclics (Nasdaq: PCYC) saw its shares gain 4.5% to $78.96 in early trading Monday, after it revealed…

ibrutinibJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationResearch

Zeltia's Yondelis approved for sale in 10 new countries

04-12-2012

Pharma Mar, a subsidiary of Spain's Grupo Zeltia (ZEL: MC), says it has been advised by its licensee…

GlobalJanssenJohnson & JohnsonOncologyPharmaceuticalPharmaMarRegulationYondelisZeltia

FDA OKs new indication for Janssen's Nucynta and fast tracks Zytiga sNDA

30-08-2012

There were two pieces of good news for US health care giant Johnson & Johnson (NYSE: JNJ) subsidiaries…

BiotechnologyJanssenJohnson & JohnsonNeurologicalNorth AmericaNucyntaOncologyPharmaceuticalRegulationZytiga

Johnson & Johnson units file for new Zytiga use in USA and EU

18-06-2012

Janssen Research & Development, a subsidiary of US drugs giant Johnson & Johnson (NYSE: JNJ), has submitted…

EuropeJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationZytiga

UK's NICE does U-turn, recommending Zytiga as Janssen cuts price

16-05-2012

UK drugs watch dog the National Institute for Health and Clinical Excellence (NICE) has reversed an earlier…

EuropeJanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationZytiga

NICE issues negative guidance for Zytiga

02-02-2012

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

EuropeJanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationZytiga

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