Regulation - Xarelto

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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 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

Bayer's Xarelto gains EU clearance for secondary prevention after ACS

28-05-2013

German chemical and pharma group Bayer (BAYN: DE) says that its novel oral anticoagulant Xarelto (rivaroxaban)…

BayerCardio-vascularEuropeJohnson & JohnsonPharmaceuticalRegulationXarelto

Draft guidance from NICE recommends Bayer's Xarelto for PE and DVT

19-04-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) this morning (April 19)…

BayerCardio-vascularEuropePharmaceuticalPricingRegulationXarelto

FDA expands Bayer/Janssen's Xarelto use to treat, reduce recurrence of blood clots

05-11-2012

The US Food and Drug Administration (FDA) late Friday approved German drug major Bayer's (BAYN: DE) oral…

BayerBiotechnologyCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Janssen responds to FDA's Xarelto CRL; resubmits sNDA

10-09-2012

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, German drug major Bayer's (BAYN:…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

UK NICE says final "yes" for Bayer's Xarelto to treat blood clots

24-07-2012

Confirming its final draft guidance last month (The Pharma Letter June 1), in final guidance published…

BayerCardio-vascularEuropePharmaceuticalPricingRegulationXarelto

US priority review for two Xarelto sNDAs; one dropped

10-07-2012

The US Food and Drug Administration has assigned a priority review designation to the supplemental New…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Disappointing FDA views for Bayer's Xarelto and Pozen ulcer drug

22-06-2012

Bayer HealthCare, a unit of Germany's Bayer (BAYN: DE) says that it has received a complete response…

BayerCardio-vascularGastro-intestinalsJohnson & JohnsonNorth AmericaPA32540PharmaceuticalPozenRegulationXarelto

US FDA advisory panel votes against added indication for Bayer's Xarelto

24-05-2012

Despite relatively positive briefing papers earlier this week (The Pharma Letter May 22), the US Food…

BayerCardio-vascularJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

"NICE" news for Bayer, as UK watchdog backs Xarelto for AF

23-05-2012

There was good news today (May 23) for German drug major Bayer (BAYN: DE), when the UK's drug watchdog,…

BayerCardio-vascularEuropePharmaceuticalPricingRegulationXarelto

FDA staffers basically back Xarelto for ACS but identify missing data in study

22-05-2012

The US Food and Drug Administration advisory panelists due to revue Johnson & Johnson (NYSE: JNJ) and…

BayerCardio-vascularJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Bayer's Xarelto reimbursement backed in Canada; EMA concludes Yvidually arbitration

24-04-2012

The Canadian Agency for Drugs and Technologies in Health (CADTH) through the Common Drug Review (CDR),…

BayerCardio-vascularEuropeNorth AmericaPharmaceuticalPricingRegulationReproductiveXareltoYvidually

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