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Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

Invasive meningococcal diseaseLP2086PfizerPharmaceuticalRegulationrLP2086USAVaccines

Pfizer granted European approval for Enbrel in early-stage inflammatory joint disease

Pfizer granted European approval for Enbrel in early-stage inflammatory joint disease

06-08-2014

US pharma giant Pfizer has been granted a license extension by the European Commission for Enbrel (etanercept)…

Anti-Arthritics/RheumaticsArthritisChronic, lifelong inflammatory diseaseEnbrelPfizerPharmaceuticalRegulationSpondyloarthropathyUSA

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

30-07-2014

The European Commission has approved US pharma majors Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban)…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalRegulation

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

Pfizer to submit NDA for breast cancer drug palbociclib later this year

18-05-2014

US pharma giant Pfizer says that it will submit a New Drug Application with the US Food and Drug Administration…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

EMA advisory committee backs addition for Eliquis SmPC

EMA advisory committee backs addition for Eliquis SmPC

02-05-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

Bristol-Myers SquibbCardio-vascularEliquisPfizerPharmaceuticalRegulation

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

North AmericaPfizerPharmaceuticalRegulationrLP2086USAVaccines

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

03-01-2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers…

Anti-viralsAntibiotics and Infectious diseasesAsia-PacificBioKangtaiChinaFluconazolePfizerPharmaceuticalRegulationVaccines

Negative NICE appraisal of Pfizer’s Bosulif for CML

Negative NICE appraisal of Pfizer’s Bosulif for CML

27-11-2013

UK drug watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance…

BosulifEuropeOncologyPfizerPharmaceuticalPricingRare diseasesRegulation

Pfizer’s Xalkori gains regular FDA approval for NSCLC

Pfizer’s Xalkori gains regular FDA approval for NSCLC

22-11-2013

The US Food and Drug Administration yesterday (November 21) granted pharma behemoth Pfizer’s Xalkori…

North AmericaOncologyPfizerPharmaceuticalRegulationXalkori

Regulator backs Inlyta, Lucentis and Xtandi for NHS Scotland, but not Bosulif

12-11-2013

The Scottish Medicines Consortium (SMC) revealed this morning (November 12) that it has accepted US drug…

Astellas PharmaBosulifEuropeInlytaLucentisNovartisOncologyOphthalmicsPfizerPharmaceuticalRegulationXtandi

ViiV Healthcare’s Tivicay approved in Canada for HIV

04-11-2013

ViiV Healthcare, the HIV/AIDS joint venture set up by UK pharma giant GlaxoSmithKline with US behemoth…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

Report: Tarceva and Iressa favored by European oncologists for NSCLC

Report: Tarceva and Iressa favored by European oncologists for NSCLC

04-11-2013

Oncologists across the top five European countries are prescribing Roche's Tarceva or AstraZeneca's Iressa…

AstraZenecaEuropeIressaOncologyPfizerPharmaceuticalPricingRegulationRocheTarcevaXalkori

Updated EU labeling for Pfizer’s Prevenar 13

Updated EU labeling for Pfizer’s Prevenar 13

17-10-2013

The European Commission has approved updates to the Summary of Product Characteristics for US pharma…

EuropePfizerPharmaceuticalPrevenarRegulationVaccines

US FDA backs Pfizer’s hot flashes drug Duavee

US FDA backs Pfizer’s hot flashes drug Duavee

04-10-2013

Pfizer and partner Ligand Pharmaceuticals say that the US Food and Drug Administration has approved Duavee,…

bazedoxifeneDuaveeLigand PharmaceuticalsNorth AmericaPfizerPharmaceuticalRegulationWomen's Health

FDA issues new Boxed Warning on Pfizer antibacterial

FDA issues new Boxed Warning on Pfizer antibacterial

28-09-2013

The US Food and Drug Administration is warning that an additional analysis shows an increased risk of…

Antibiotics and Infectious diseasesNorth AmericaPfizerPharmaceuticalRegulationTygacil

NICE says Xalkori is not cost effective in ALK-positive NSCLC

20-08-2013

US pharma behemoth Pfizer (NYSE: PFE) has today (August 16) expressed concern and disappointment that…

EuropeOncologyPfizerPharmaceuticalPricingRegulationXalkori

FDA approves new ViiV Healthcare HIV drug

13-08-2013

The US Food and Drug Administration yesterday (August 12) approved Tivicay (dolutegravir), a new drug…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

Disappointment for Pfizer on negative CHMP view for Xeljanz

26-07-2013

There was disappointment for US pharma behemoth Pfizer (NNYSE: PFE), when the European Medicines Agency's…

Anti-Arthritics/RheumaticsEuropePfizerPharmaceuticalRegulationXeljanz

Negative NICE news for Pfizer leukemia drug

16-07-2013

There was disappointment for global drugs behemoth Pfizer (NYSE: OFE) when the UK drugs watchdog the…

BosulifEuropeOncologyPfizerPharmaceuticalPricingRegulation

Pfizer gets Swiss nod for Xeljanz for rheumatoid arthritis

16-07-2013

US drug giant Pfizer (NYSE: PFE) said its rheumatoid arthritis (RA) therapy Xeljanz (tofacitinib) has…

Anti-Arthritics/RheumaticsEuropePfizerPharmaceuticalRegulationTakeda NycomedXeljanz

US FDA accepts Bristol-Myers/Pfizer' Eliquis sNDA

12-07-2013

US pharma major Bristol-Myers Squibb (NYSE: BMY) and behemoth Pfizer (NYSE: PFE) announced that the US…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

Pfizer gets EU approval for Prevenar 13 for adults aged 18-49

10-07-2013

US drug giant Pfizer (NYSE: PFE) has today received European approval for an expanded indication of its…

EuropePfizerPharmaceuticalPrevenarRegulationVaccines

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