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Negative NICE appraisal of Pfizer’s Bosulif for CML

Negative NICE appraisal of Pfizer’s Bosulif for CML


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

BosulifEuropeOncologyPfizerPharmaceuticalPricingRare diseasesRegulation

Repligen gets first milestone under SMA deal with Pfizer


USA-based Repligen (Nasdaq: RGEN) says it has received a $1 million milestone payment from global drugs…

FinancialLicensingPfizerPharmaceuticalRare diseasesRepligen

Protalix BioTherapeutics enters Gaucher drug Uplyso deal with Brazil's Ministry of Health


Israel-based Protalix BioTherapeutics (TASE:PLX) has entered into a supply and technology transfer agreement…

FiocruzMarkets & MarketingPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesSouth AmericaUplyso

Pfizer and Protalix' Gaucher drug Uplyso approved in Brazil


US drugs behemoth Pfizer (NYSE: PFE) and Israel-based Protalix BioTherapeutics (NYSE MKT:PLX) said that…

BiotechnologyElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationSouth AmericaUplyso

Repligen in $70 million deal with Pfizer for SMA program


USA-based Repligen (Nasdaq: RGEN) saw its share jump 5.6% to $6.63, after the company revealed it has…

BiotechnologyLicensingNeurologicalPfizerPharmaceuticalRare diseasesRepligenRG3039

Protalix and Pfizer expand Elelyso agreement


Israeli drug developer Protalix BioTherapeutics (NYSE-AMEX: OLX) said yesterday that it has entered into…

ElelysoLicensingPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesResearch

Pfizer in $58 million drug discovery accord on cystic fibrosis


The USA-based Cystic Fibrosis Foundation Therapeutics (CFFT), the non-profit drug discovery and development…

PfizerPharmaceuticalRare diseasesResearch

Pfizer 3rd-qtr profits slump on lower than expected sales; EU says "no" to Gaucher drug


US pharma behemoth Pfizer (NYSE: PFE) saw it shares fall 1.1% to $24.59 in morning trading yesterday,…

EuropeFinancialPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationtaliglucerase

FDA nod for Pfizer's rare leukemia drug Bosulif


In a third cancer drug approval in just over a year for drugs behemoth Pfizer (NYSE: PFE), the US Food…

BosulifbosutinibNorth AmericaOncologyPfizerPharmaceuticalRare diseasesRegulation

US FDA calls for more efficacy data on Pfizer's tafamidis NDA


The US Food and Drug Administration yesterday issued a complete response letter regarding drugs behemoth…

North AmericaPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

$25 million milestone for Protalix following US approval of Elelyso


Israel-based Protalix BioTherapeutics (TASE:PLX) has received a $25 million milestone payment from global…

ElelysoFinancialPfizerPharmaceuticalProtalix BioTherapeuticsRare diseases

FDA advisory panel gives mixed views on Pfizer's tafamidis


The US Food and Drug Administration's peripheral and Central Nervous System Drugs Advisory Committee…

North AmericaPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

FDA expands Levemir use to young children; negative on tafamidis


Denmark-based global insulin giant Novo Nordisk (NOV: N) says that the US Food and Drug Administration…

DiabetesLevemirNorth AmericaNovo NordiskPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

Complete responses in Phase I trial of crizotinib in rare childhood cancer


A pill designed to zero in on abnormal genes that drive specific cancers has produced encouraging early…

crizotinibKalkoriOncologyPfizerPharmaceuticalRare diseasesResearch

Elelyso: a new therapeutic option for patients with Gaucher disease


The US Food and Drug Administration recently approved Protalix BioTherapeutic's (NYSE-AMEX: OLX) Elelyso…

CerezymeElelysoGenzymeMarkets & MarketingPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesShireVpriv

Pfizer's Elelyso approved in USA for Gaucher disease; Celebrex settlement


The US Food and Drug Administration yesterday approved Elelyso (taliglucerase alfa) for injection, an…

Anti-Arthritics/RheumaticsCelebrexElelysoLegalNorth AmericaPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationtaliglucerase

Germany's IQWiG finds some benefit for Pfizer orphan drug Vyndaqel


The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Vyndaqel (tafamidis),…

EuropePfizerPharmaceuticalPricingRare diseasesRegulationVyndaqel

FDA now accepts Pfizer’s tafamidis NDA


Having around a year ago issued a refuse to file letter (The Pharma Letter April 5, 2011), the US Food…

North AmericaPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

Pfizer’s Vyndaqel, first drug to treat rare and fatal disease TTR-FAP, approved in Europe


Following a positive opinion from an advisory committee in the summer (The Pharma Letter July 23), the…

EuropePfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

FDA approves Incytes’ Jakafi, first drug to treat MF; advisory panel backs Pfizer’s Prevnar 13 for adults


USA-based Incyte (Nasdaq: INCY) saw its shares rise 10% to$13.90 on the news that the Food and Drug Administration…

BiotechnologyIncyteJakafiNorth AmericaNovartisPfizerPharmaceuticalPrevnarRare diseasesRegulationruxolitinibVaccines

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