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UK NICE recommends hepatitis C drugs Sovaldi and Olysio

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

16-01-2015

In final draft guidance issued today, England health costs watchdog the National Institute for Health…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioPricingRegulationSovaldiUK

Hospira submits new BLA for epoetin alfa biosimilar In USA

12-01-2015

US injectable drugs and infusion technologies and biosimilars developer Hospira has submitted a Biologics…

AmgenBiosimilarsBiotechnologyepoetinEpogenHematologyHospiraJanssenJohnson & JohnsonProcritRegulationRetacritUSA

NICE now proposes to recommend Stelara for psoriatic arthritis

NICE now proposes to recommend Stelara for psoriatic arthritis

09-12-2014

UK health cost watchdog, the National Institute for Health and Care Excellence (NICE) has opened a consultation…

Anti-Arthritics/RheumaticsBiotechnologyInflammatory diseasesJanssenJohnson & JohnsonPricingRegulationStelaraUK

Astellas Xtandi approved in Europe for new indication; Janssen deal update

03-12-2014

Japanese pharma major Astellas Pharma has received European Commission approval for a variation to amend…

Anti-Arthritics/RheumaticsASP015KAstellas PharmaEuropeJanssen BiotechJohnson & JohnsonLicensingMedivationOncologyPharmaceuticalRegulationXtandi

Mallinckrodt questions FDA reasoning on methylphenidate ER reclassification

13-11-2014

US drugmaker Mallinckrodt says it has been informed by the Food and Drug Administration that the agency…

ConcertaGenericsJohnson & JohnsonMallinckrodtMethylphenidate Extended-Release TabletsNeurologicalRegulationUSA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

06-11-2014

The Food and Drug Administration has approved US health care giant Johnson & Johnson's Olysio (simeprevir)…

Anti-viralsBiotechnologyJohnson & JohnsonMedivirOlysioRegulationsofosbuvirUSA

Medivir concludes Swedish agreement on Olysio-based treatment for hepatitis C

Medivir concludes Swedish agreement on Olysio-based treatment for hepatitis C

31-10-2014

Swedish drugmaker Medivir says it has entered into an agreement with Swedish county councils regarding…

Anti-viralsJanssenJohnson & JohnsonMedivirOlysioPharmaceuticalPricingRegulationSweden

Pharmacyclics files Imbruvica sNDA for Waldenstrom’s macroglobulinemia

20-10-2014

US drugmaker Pharmacyclics has submitted a supplemental New Drug Application to the US Food and Drug…

ImbruvicaJanssen BiotechJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulationUSA

Pharmacyclics’ Imbruvica gains EU approval for two blood cancers

17-10-2014

US drugmaker Pharmacyclics has received marketing approval from the European Commission for Imbruvica…

EuropeImbruvicaJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulation

Janssen files for EU approval of Stelara in pediatric plaque psoriasis

13-10-2014

Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines…

BiotechnologyDermatologicalsEuropeInflammatory diseasesJanssen-CilagJohnson & JohnsonRegulationStelara

UK NICE consults on draft guidance for hepatitis C drug Olysio

UK NICE consults on draft guidance for hepatitis C drug Olysio

18-09-2014

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

Anti-viralsJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulationUK

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

15-09-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsGermanyJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulation

Celltrion files for US FDA approval of Remsima biosimilar

Celltrion files for US FDA approval of Remsima biosimilar

13-08-2014

South Korean biopharmaceutical firm Celltrion says it has completed the filing procedure to obtain US…

BiosimilarsBiotechnologyCellTrionClinical researchInflammatory diseasesinfliximabJanssen BiotechJohnson & JohnsonPatentsRegulationRemicadeRemsimaUSA

FDA approves Janssen’s Invokamet for diabetes

09-08-2014

The US Food and Drug Administration has approved US health care giant Johnson & Johnson subsidiary Janssen…

DiabetesInvokametInvokanaJanssenJohnson & JohnsonPharmaceuticalRegulationUSA

EMA’s CHMP backs approval of two new treatment options for rare cancers

EMA’s CHMP backs approval of two new treatment options for rare cancers

26-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting,…

BiotechnologyEuropeFinancialGilead SciencesImbruvicaJanssen BiotechJohnson & JohnsonOncologyRegulationZydelig

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

17-06-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

DiabetesGermanyInvokanaJanssen-CilagJohnson & JohnsonPharmaceuticalPricingRegulation

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

NICE gives negative guidance on Janssen’s Stelara for psoriatic arthritis

NICE gives negative guidance on Janssen’s Stelara for psoriatic arthritis

28-05-2014

US health care giant Johnson & Johnson subsidiary Janssen today received a negative opinion from UK watchdog…

DermatologicalsInflammatory diseasesJanssenJohnson & JohnsonPharmaceuticalPricingRegulationStelaraUK

Janssen pulls EU application for IV Simponi

19-05-2014

Janssen Biologics, a European subsidiary of US health care giant Johnson & Johnson, says it has withdrawn…

Anti-Arthritics/RheumaticsBiotechnologyEuropeJanssenJohnson & JohnsonRegulationSimponi Injection

Janssen’s hepatitis C drug Olysio cleared in EU

16-05-2014

Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson, says that its next…

Anti-viralsBiotechnologyEuropeJanssen-CilagJohnson & JohnsonOlysioRegulation

UK’s NICE backs Janssen’s Invokana for type 2 diabetes

16-05-2014

Janssen, a subsidiary of US health care giant Johnson & Johnson, said today that it welcomes the publication…

DiabetesInvokanaJanssenJohnson & JohnsonPharmaceuticalPricingRegulationUK

Negative NICE draft guidance on Janssen’s Zytiga for prostate cancer

Negative NICE draft guidance on Janssen’s Zytiga for prostate cancer

14-05-2014

In draft guidance published this morning, the UK drugs watchdog the National Institute for Health and…

JanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationUKZytiga

Janssen submits sNDA for Olysio in combination with sofosbuvir

Janssen submits sNDA for Olysio in combination with sofosbuvir

08-05-2014

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson, has submitted…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioRegulationSovaldiUSA

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