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Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Strong pipeline of MAbs biosimilars in the USA and Europe lends impetus to global market

Strong pipeline of MAbs biosimilars in the USA and Europe lends impetus to global market

30-01-2014

The imminent entry of several companies, including big pharma, small biotech and generic participants,…

BioconBiosimilarsCellTrionDr Reddy's LaboratoriesEuropeHospiraJohnson & JohnsonMarkets & MarketingNorth AmericaRemicadeUSA

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

09-01-2014

Health care giant Johnson & Johnson’s Janssen Pharmaceutical companies have submitted a Citizen Petition…

BiosimilarsGenericsJanssenJohnson & JohnsonNorth AmericaRegulationUSA

US FDA calls for more data on Janssen’s fixed dose diabetes drug

US FDA calls for more data on Janssen’s fixed dose diabetes drug

16-12-2013

US health care giant Johnson & Johnson has received a complete response letter from the Food and Drug…

canagliflozinDiabetesJanssenJohnson & JohnsonmetforminNorth AmericaPharmaceuticalRegulation

J&J’s Invokana approved in Europe and Olysio cleared in USA

J&J’s Invokana approved in Europe and Olysio cleared in USA

25-11-2013

It was a good news day for US health care giant Johnson & Johnson, with two of its Janssen subsidiaries…

Anti-viralsDiabetesEuropeInvokanaJanssenJohnson & JohnsonMedivirNorth AmericaOlysioPharmaceuticalRegulation

J&J unit DePuy in $2.5 billion US settlement relating to ASR Hip System

20-11-2013

US health care giant Johnson & Johnson’s subsidiary DePuy Orthopaedics and the Court-appointed committee…

DePuyFinancialJohnson & JohnsonLegalNorth AmericaPharmaceutical

Pharma figures high in EU R&D Investment Scoreboard, but led by US firms

19-11-2013

Though not topping the league table, the pharmaceutical industry had a number of drugmakers among the…

EuropeFinancialGlaxoSmithKlineJohnson & JohnsonMerck & CoNorth AmericaNovartisPfizerPharmaceuticalResearchRocheSanofi

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

14-11-2013

The US Food and Drug Administration yesterday approved US health care giant Johnson & Johnson’s Imbruvica…

ibrutinibImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclics

Johnson & Johnson to pay over $2.2 billion to settle DoJ probe

Johnson & Johnson to pay over $2.2 billion to settle DoJ probe

05-11-2013

Global health care giant Johnson & Johnson and its subsidiaries will pay more than $2.2 billion to resolve…

FinancialInvegaJanssenJohnson & JohnsonLegalMarkets & MarketingNatrecorNorth AmericaPharmaceuticalRisperdalScios

AHF sues Johnson & Johnson over AIDS drug pricing

AHF sues Johnson & Johnson over AIDS drug pricing

01-11-2013

The Washington DC, USA-based AIDS Healthcare Foundation (AHF) has filed a law suit in the Superior Court…

Anti-viralsJanssenJohnson & JohnsonLegalNorth AmericaPharmaceuticalPricing

Unanimous FDA panel backing for Janssen’s simeprevir for hep C

Unanimous FDA panel backing for Janssen’s simeprevir for hep C

25-10-2013

Janssen announced yesterday that the FDA's Antiviral Drugs Advisory Committee unanimously recommended…

Anti-viralsJanssenJohnson & JohnsonMedivirNorth AmericaPharmaceuticalRegulationsimeprevir

Prostate cancer market set to grow 50% by 2021: report

06-09-2013

The increasing number of sufferers and the uptake of new drugs will see the prostate cancer market grow…

Asia-PacificAstellas PharmaEuropeJohnson & JohnsonMarkets & MarketingNorth AmericaOncologyPharmaceuticalXtandiZytiga

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

FDA acceptance of ibrutinib NDA triggers milestone for Pharmacyclics

30-08-2013

California, USA-based Pharmacyclics (Nasdaq: PCYC) said yesterday (August 29, 2013) that the US Food…

BiotechnologyibrutinibJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulation

Simponi ARIA cleared by US FDA

19-07-2013

US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Biotech subsidiary has received US Food…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi ARIA

Janssen submits NDA for "breakthrough" leukemia and lymphoma drug ibrutinib

11-07-2013

Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted…

ibrutinibJanssen PharmaceuticaJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulation

Setback for Janssen and Bayer's Xarelto as FDA calls for more info in stent thrombosis setting for ACS patients

01-07-2013

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

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

US FDA approves Janssen's Simponi to treat ulcerative colitis

16-05-2013

The US Food and Drug Administration late yesterday (May 15) approved a new use for Johnson & Johnson…

BiotechnologyGastro-intestinalsInflammatory diseasesJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

Six months post launch, US prescribing trends for Xtandi

07-05-2013

At six months following launch of Xtandi (Astellas Pharma/Medivation's enzalutamide), surveyed urologists…

3MAstellas PharmaJevtanaJohnson & JohnsonMarkets & MarketingMedivationNorth AmericaOncologyPharmaceuticalSanofiXtandiZytiga

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