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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

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

UK lags behind some European countries in biosimilars uptake, new study finds

12-09-2013

New research has shown that the UK lags behind some European countries in terms of biosimilars uptake,…

CellTrionepoetinEuropeFilgrastimGenericsHealthcareinfliximabJohnson & JohnsonRemsima

Shire settles with Actavis/Watson over Intuniv; Lilly sues J&J

26-04-2013

Ireland-headquartered Shire (LSE: SHP) says it has settled all pending litigation with Actavis (NYSE:…

ActavisEli LillyGenericsIntunivJohnson & JohnsonNeurologicalNorth AmericaPatentsPharmaceuticalShiresolanezumabWatson Pharmaceuticals

FDA approval of generic cancer drug Doxil is expected to help resolve shortage

06-02-2013

The US Food and Drug Administration has approved the first generic version of the cancer drug Doxil (doxorubicin…

DoxilGenericsJohnson & JohnsonLipodoxNorth AmericaOncologyRegulationSun Pharmaceutical Industries

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

European Commission enforcement action in pharmaceutical sector following sector inquiry

31-01-2013

Following its competition inquiry into the pharmaceutical sector of 2008/2009, the European Commission…

DuragesicEuropeGenericsJohnson & JohnsonLundbeckMarkets & MarketingPatentsPharmaceuticalServier

Impax Labs and Teva settle Concerta litigation with J&J units

17-09-2012

USA-based Impax Laboratories (Nasdaq: IPXL) and the US unit of Israel generics giant Teva Pharmaceutical…

ALZA CorpConcertaGenericsImpax LaboratoriesJanssenJohnson & JohnsonNeurologicalNorth AmericaPatentsTeva Pharmaceutical Industries

Senior appointments at Teva and Johnson & Johnson

14-09-2012

Israel's Teva Pharmaceutical Industries (NYSE: TEVA) has announced the appointment of Itzhak Krinsky…

GenericsJohnson & JohnsonManagementPharmaceuticalTeva Pharmaceutical Industries

World's first (official) biosimilar antibody goes to reumatoid arthritis

09-08-2012

The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory…

BiotechnologyCellTrionGenericsGlobalinfliximabJohnson & JohnsonMarkets & MarketingRegulationRemicadeRemsima

Watson settles with Janssen over Ortho Tri-Cyclen LO

08-02-2012

US generic drugmaker Watson Pharmaceutical (NYSE: WPI) says that its subsidiary, Watson Laboratories,…

GenericsJanssenJohnson & JohnsonLegalNorth AmericaPatentsReproductiveWatson PharmaceuticalsWomen's Health

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