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KYTHERA regains rights to ATX-101 outside USA and Canada from Bayer

KYTHERA regains rights to ATX-101 outside USA and Canada from Bayer

11-03-2014

US biotech firm KYTHERA Biopharmaceuticals says it has re-acquired all rights outside of the USA and…

ATX-101BayerDermatologicalsKYTHERA BiopharmaceuticalsLicensingNorth AmericaPharmaceutical

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 ambivalent on NSAID cardiovascular risk

FDA advisory panel ambivalent on NSAID cardiovascular risk

12-02-2014

The US Food and Drug Administration’s joint Arthritis Advisory Committee and Drug Safety and Risk Management…

Anti-Arthritics/RheumaticsBayerNaproxenNeurologicalNorth AmericaPfizerPharmaceuticalUSA

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

Cubist’s tedizolid NDA accepted for priority review in USA

Cubist’s tedizolid NDA accepted for priority review in USA

31-12-2013

The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ New Drug Application for its…

Antibiotics and Infectious diseasesBayerCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationtedizolidTrius TherapeuticsUSA

US FDA calls for more trials on Genzyme’s Lemtrada

US FDA calls for more trials on Genzyme’s Lemtrada

30-12-2013

There was a significant disappointment this morning for French drug major Sanofi, when it revealed that…

BayerGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofiUSA

“Breakthrough Therapy” status for Portola’s andexanet alfa

25-11-2013

USA-based Portola Pharmaceuticals has been granted “Breakthrough Therapy” designation by the US Food…

andexanet alfaBayerBristol-Myers SquibbCardio-vascularEliquisNorth AmericaPharmaceuticalPortola PharmaceuticalsRegulationResearchXarelto

Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan

23-11-2013

There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

Liver cancer market to nearly treble in size to $1.4 billion by 2019

Liver cancer market to nearly treble in size to $1.4 billion by 2019

13-11-2013

The value of the hepatocellular cancer (HCC) market is set to grow by a massive 172% and hit $1.4 billion…

BayerEuropeMarkets & MarketingNexavarNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalResearchUSA

Eylea filed for EU and US approval in diabetic macular edema

Eylea filed for EU and US approval in diabetic macular edema

07-11-2013

US biotech firm Regeneron Pharmaceuticals says its partner German drug major Bayer has submitted an application…

BayerDiabetesEuropeEyleaNorth AmericaOphthalmicsPharmaceuticalRegeneronRegulation

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

Bayer gains two orphan drug designations for riociguat

Bayer gains two orphan drug designations for riociguat

26-09-2013

Bayer’s investigational drug riociguat has been granted two orphan drug designations by the US Food…

BayerNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

MSF warns of US/Indian tension over generic policy discussion

MSF warns of US/Indian tension over generic policy discussion

25-09-2013

Humanitarian group Médecins Sans Frontières has warned that India is facing political pressure from…

Anti-viralsAsia-PacificBayerGenericsGleevecHealthcareNexavarNorth AmericaNovartisPolitics

Bayer in settlement over Cipro pricing

04-09-2013

A partial settlement has been reached in a US class action law suit involving the prescription antibiotic…

Antibiotics and Infectious diseasesBayerCiproGenericsLegalNorth AmericaPharmaceuticalPricing

Nexavar gains FDA priority review for thyroid cancer sNDA

27-08-2013

German drug major Bayer (BAYN: DE) and partner Onyx Pharmaceuticals (Nasdaq: ONXX), which has just agreed…

BayerBiotechnologyNexavarNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

Bayer's PAH/CTEPH drug gets unanimous backing from FDA advisory panel

07-08-2013

In what was largely expected following this week's briefing papers from US Food and Drug Administration…

AdempasBayerNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

FDA staffers back riociguat approval, but with modified dose

05-08-2013

On Tuesday (August 6), the US Food and Drug Administration's Renal Drugs Advisory Committee will discuss…

ActelionAdempasBayerNorth AmericaOpsumitPharmaceuticalRegulationRespiratory and PulmonaryriociguatTracleer

US pulmonologists views on PAH prescribing options

19-07-2013

US pulmonologists surveyed by health care advisory firm Decision Resources consider a drug's effect on…

ActelionBayerMarkets & MarketingNorth AmericaOpsumitPharmaceuticalRespiratory and Pulmonaryriociguat

US and European Rxing decisions on metastatic colorectal cancer

15-07-2013

The effect of a therapy on overall survival and progression-free survival are attributes that most influence…

AvastinBayerEli LillyEuropeMarkets & MarketingNorth AmericaOncologyPharmaceuticalramucirumabRegeneronRocheSanofiStivargaZaltrap

Strong uptake of Regeneron/Bayer wet AMD drug Eylea in USA, but Avastin still leads

11-07-2013

The majority of wet age-related macular degeneration (AMD) patients are administered their first intravitreal…

AllerganAvastinBayerBiotechnologyEyleaFovistaLucentisMarkets & MarketingNorth AmericaOphthalmicsOphthotechPharmaceuticalRegeneronRoche

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

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