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Amgen’s Vectibix approved for colorectal cancer by FDA

Amgen’s Vectibix approved for colorectal cancer by FDA

27-05-2014

USA-based Amgen, the world's leading independent biotech firm, has announced that the US Food and Drug…

AmgenBiotechnologyChemotherapy regimensMetastatic colorectal cancerOncologyRegulationUSAVectibix

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

Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan

29-08-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) has filed an application for approval in Japan to manufacture…

AmgenAsia-PacificDaiichi SankyoOncologyPharmaceuticalPraliaRanmarkRegulation

European Commission OK for Lonquex

09-08-2013

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA|), the world's leading generics drugmaker, says…

AmgenEuropeLonquexOncologyPharmaceuticalRegulationTeva Pharmaceutical Industries

FDA backs Amgen's Xgeva for new use, to treat giant cell tumor of the bone

14-06-2013

The US Food and Drug Administration late yesterday (June 13) expanded the approved use of biotech major…

AmgenBiotechnologyNorth AmericaOncologyRegulationXgeva

Briefs: Elan tender offer; German drug price review; Daiichi Sankyo pays milestone

19-04-2013

Ireland-based drugmaker Elan (NYSE: ELN) yesterday reported final results of its modified Dutch auction…

ActemraAmgenAnticalinBayerElanFinancialNovo NordiskPharmaceuticalPradaxaPricingProliaRegulationResearchRocheVictozaXarelto

FDA suspends pediatric trial of Amgen's Sensipar after patient death

27-02-2013

The US Food and Drug Administration revealed yesterday that it has stopped all pediatric clinical trials…

AmgenBiotechnologyRegulationResearchSensipar

US biotech giants lobbying to block biosimilars, NTY claims

31-01-2013

Some of the USA's biggest biotechnology companies are lobbying intensively to limit generic competition…

AmgenBiotechnologyGenentechGenericsNorth AmericaPoliticsRegulation

FDA approves SOBI's Kineret for the treatment of NOMID

08-01-2013

Biotech firm Swedish Orphan Biovitrum (STO: SOBI) today announced that the US Food and Drug Administration…

AmgenBiotechnologyInflammatory diseasesKineretNorth AmericaRegulationSobiSwedish Orphan Biovitrum

Amgen's Xgeva gets NICE backing for bone metastasis

24-10-2012

New guidance published today (October 24) by the UK's drugs watchdog the National Institute for Health…

AmgenBiotechnologyEuropeOncologyPricingRegulationXgeva

Amgen's Prolia gets FDA nod for men with osteoporosis

24-09-2012

The US Food and Drug Administration last week approved a new indication for world biotech leader Amgen's…

AmgenAnti-Arthritics/RheumaticsBiotechnologyMen's HealthNorth AmericaProliaRegulation

UK's NICE continues to back Amgen's Xgeva for most cancer patients with bone metastases

17-08-2012

In a final draft guidance issued today, (August 17), the National Institute for Health and Clinical Excellence…

AmgenBiotechnologyEuropePricingRegulationXgeva

UK's NICE takes second look at Amgen's Xgeva

12-06-2012

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) today launched a second…

AmgenBiotechnologyEuropeOncologyPricingRegulationXgeva

FDA stalls Amgen's Xgeva sBLA for prevention of bone metastases

30-04-2012

USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued…

AmgenBiotechnologyNorth AmericaOncologyRegulationXgeva

NICE recommendations on Bayer's Xarelto and Amgen Xgeva's for UK NHS use

30-03-2012

Following the receipt of further evidence from Bayer HealthCare, a unit of German drugmaker Bayer (BAY:…

AmgenBayerCardio-vascularEuropeOncologyPharmaceuticalPricingRegulationXareltoXgeva

Daiichi Sankyo files denosumab in Japan for osteoporosis

26-03-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) revealed on Friday that it has filed for approval in Japan…

AmgenAnti-Arthritics/RheumaticsAsia-PacificDaiichi SankyodenosumabPharmaceuticalRegulation

Amgen fails to get FDA advisory backing for extended use of Xgeva

09-02-2012

The world’s largest independent biotech firm, Amgen (Nasdaq: AMGN), has failed to convince a Food…

AmgenBiotechnologyNorth AmericaOncologyPharmaceuticalRegulationXgeva

Japanese approval for Regnite and Ranmark

18-01-2012

Japanese drug major Astellas Pharma (TYO: 4503) and USA-based XenoPort (Nasdaq: XNPT) revealed yesterday…

AmgenAsia-PacificAstellas PharmaAstraZenecaBiotechnologyDaiichi SankyodenosumabFinancialNeurologicalOncologyPharmaceuticalRanmarkRegniteRegulationXenoPort

Janssen files Xarelto sNDA for ACS; FDA to review Amgen’s Xgeva for CRPC

30-12-2011

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Research & Development, has submitted…

AmgenBayerBiotechnologyCardio-vascularJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationXareltoXgeva

FDA eases REMS requirements for Amgen’s Nplate and GSK’s Promacta

07-12-2011

The US Food and Drug Administration says that an agency initiated review of the current information has…

AmgenBiotechnologyGlaxoSmithKlineNorth AmericaNplatePharmaceuticalPromactaRare diseasesRegulation

More cancer and HIV drugs added to Australian PBS

07-12-2011

More than 160,000 patients will benefit directly from changes to Australia’s Pharmaceutical Benefits…

AmgenAnti-viralsAsia-PacificGilead SciencesOncologyPharmaceuticalPrezistaPricingRegulationXgeva

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