Pharmaceutical - Johnson & Johnson, Janssen-Cilag

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EU approval for Janssen's Sylvant to treat patients with MCD

EU approval for Janssen's Sylvant to treat patients with MCD

08-06-2014

The European Commission (EC) has approved the use of Janssen-Cilag International's Sylvant (siltuximab)…

EuropeJanssen-CilagJohnson & JohnsonPharmaceuticalRare diseasesRegulationSylvant

Janssen’s Sirturo gets conditional EU approval for multi-resistant TB

Janssen’s Sirturo gets conditional EU approval for multi-resistant TB

10-03-2014

US health care giant Johnson & Johnson’s European subsidiary Janssen-Cilag has been granted conditional…

Antibiotics and Infectious diseasesEuropeJanssen-CilagJohnson & JohnsonPharmaceuticalRegulationSirturo

NICE consults on draft guidance backing Invokana, as drug debuts in the UK

24-02-2014

UK drugs watchdog the National Institute for Health and Care Excellence is currently appraising Invokana…

DiabetesInvokanaJanssen-CilagJohnson & JohnsonMarkets & MarketingNorthern EuropePharmaceuticalPricingRegulationUK

Four medicines recommended for approval by EMA/CHMP

Four medicines recommended for approval by EMA/CHMP

22-12-2013

Following regular monthly meeting of the European Medicines Agency’s Committee for Medicinal Products…

AlconAntibiotics and Infectious diseasesComtriqDermatologicalsEuropeGaldermaJanssen-CilagJohnson & JohnsonMirvasoNovartisOncologyOphthalmicsPharmaceuticalRegulationSirturoTMC Pharma Services

NICE seeks more data on J&J’s Velcade for multiple myeloma

NICE seeks more data on J&J’s Velcade for multiple myeloma

12-11-2013

In draft guidance published today, the UK’s drugs watchdog the National Institute of Health and Care…

EuropeJanssen-CilagJohnson & JohnsonOncologyPharmaceuticalPricingRegulationVelcade

Janssen-Cilag files European approval of combination medicine for HIV-1

16-10-2013

US health care giant Johnson & Johnson subsidiary Janssen-Cilag International NV has submitted a Marketing…

Anti-viralsBiotechnologycobicistatDarunavirEuropeGilead SciencesJanssen-CilagJohnson & JohnsonPharmaceuticalRegulation

EU backs wider use of Velcade

09-08-2013

The European Commission has approved the use of Johnson & Johnson (NYSE: JNJ) European subsidiary Janssen-Cilag's…

EuropeJanssen-CilagJohnson & JohnsonOncologyPharmaceuticalRegulationVelcade

Janssen files for European approval of hep C candidate simeprevir

25-04-2013

Janssen-Cilag International, a European subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ),…

Anti-viralsBiotechnologyEuropeJanssen-CilagJohnson & JohnsonPharmaceuticalRegulationsimeprevir

EU Commission sends antitrust complaint to Johnson & Johnson and Novartis

01-02-2013

The European Commission has informed US health care giant Johnson & Johnson (NYSE: JNJ) and Swiss drug…

DuragesicEuropefentanylGenericsJanssen-CilagJohnson & JohnsonLegalMarkets & MarketingNeurologicalNovartisPatentsPharmaceuticalSandoz

Expanded indication for Janssen's Zytiga cleared in EU

14-01-2013

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International said Friday…

EuropeJanssen-CilagJohnson & JohnsonOncologyPharmaceuticalRegulationZytiga

Regulatory briefs from Ipsen/Inspiration, Janssen and Astellas

20-11-2012

French drugmaker Ipsen (Euronext: IPN) and partner USA-based privately-held Inspiration Biopharmaceuticals…

Astellas PharmaBiotechnologyEuropeInspiration BiopharmaceuticalsIpsenJanssen-CilagJohnson & JohnsonNorth AmericaOBI-1OncologyPharmaceuticalRegulationTarcevaZytiga

EU approval for Janssen-Cilag's Dacogen and Novartis/Vectura's Seebri Breezhealer

01-10-2012

The European Commission on Friday approved the marketing authorization for Janssen-Cilag's (a unit of…

Astex PharmaceuticalsDacogenEuropeJanssen-CilagJohnson & JohnsonNovartisOncologyPharmaceuticalRegulationRespiratory and PulmonarySeebri BreezhalerVectura

Janssen-Cilag files for EU approval of bedaquiline in MDR-TB

02-09-2012

Johnson & Johnson (NYSE: JNJ) Belgium-based subsidiary Janssen-Cilag International submitted a Marketing…

Antibiotics and Infectious diseasesbedaquilinedelamanidEuropeJanssen-CilagJohnson & JohnsonOtsukaPharmaceuticalRegulation

CHMP positive on first gene therapy, Glybera; and more opinions

23-07-2012

Reversing an earlier negative opinion (The Pharma Letter April 22), the European Medicines Agency's Committee…

AdcetrisBiotechnologyCelgeneDacogenEuropeGlyberaIstodaxJanssen-CilagJohnson & JohnsonOncologyPfizerPharmaceuticalRare diseasesRegulationTakeda PharmaceuticalsuniQureXalkori

Johnson & Johnson pulls EU submission for Velcade use in NHL

05-07-2012

The European Medicines Agency has been formally notified by US health care giant Johnson & Johnson's…

EuropeJanssen-CilagJohnson & JohnsonOncologyPharmaceuticalRegulationVelcade

UK NICE issues final guidance for Tasigna, Glivec, Sprycel, Victrelis and Incivo

25-04-2012

In final guidance issued this morning, UK drugs watchdog the National Institute for Health and Clinical…

Anti-viralsBristol-Myers SquibbEuropeGlivecIncivoJanssen-CilagJohnson & JohnsonMerck & CoNovartisOncologyPharmaceuticalPricingRegulationSprycelTasignaVictrelis

Caelyx and Ceplene manufacturing should be moved, says EMA

18-03-2012

The European Medicines Agency has recommended that the manufacturing processes for the anticancer medicines…

Boehringer IngelheimCaelyxCepleneEpiCeptJanssen-CilagJohnson & JohnsonOncologyPharmaceuticalRegulationRespiratory and Pulmonary

Positive NICE news for Gilenya for MS and Incivo for hep C

16-03-2012

There was good news from the UK drugs watchdog the Institute for Health and Clinical Excellence (NICE)…

Anti-viralsEuropeGilenyaIncivoJanssen-CilagJohnson & JohnsonNeurologicalNovartisPharmaceuticalPricingRegulation

Gilead and Johnson & Johnson get EU backing for HIV drugs Eviplera and Edurant, respectively

29-11-2011

In the first of two pieces of good news for HIV/AIDS drug developers, US biotech firm Gilead Sciences…

Anti-viralsEdurantEuropeEvipleraGilead SciencesJanssen-CilagJohnson & JohnsonPharmaceuticalRegulationTibotec

EU approval for Janssen-Cilag’s Zytiga in prostate cancer and Novartis’ Votubia for SEGA

08-09-2011

Belgium-based Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson (NYSE:…

AfinitorEuropeJanssen-CilagJohnson & JohnsonNovartisOncologyPharmaceuticalRegulationVotubiaZytiga

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