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Egalet to file NDA for abuse-deterrent morphine in 4th-qtr

Egalet to file NDA for abuse-deterrent morphine in 4th-qtr

11-03-2015

Shares of US biotech firm Egalet Corp rose 3.65% to $14.48 after it said it plans to file a New Drug…

BiotechnologyEgalet CorpEgalet-001NeurologicalRegulationResearchUSA

EMA publishes document accounting for its pharmacovigilance fees

EMA publishes document accounting for its pharmacovigilance fees

11-03-2015

The European Medicines Agency has published a document accounting for its pharmacovigilance fees.

EMAEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

11-03-2015

Japanese drug major Eisai has announced that its drug Halaven (eribulin) will remain on the UK's National…

EisaiHalavenOncologyPharmaceuticalRegulationUK

NICE says ‘yes’ to new blood cancer drug from Roche

NICE says ‘yes’ to new blood cancer drug from Roche

11-03-2015

Patients in England and Wales with chronic lymphocytic leukemia (CLL) could soon benefit from Gazyvaro…

BiotechnologyGazyvaroOncologyPricingRegulationRocheUK

NICE gives go ahead for Xolair to treat potentially disabling skin condition

NICE gives go ahead for Xolair to treat potentially disabling skin condition

11-03-2015

The medicines cost watchdog the National Institute of Health and Care Excellence (NICE) has recommended…

DermatologicalsNovartisPharmaceuticalPricingRegulationUKXolair

FDA approves Unituxin for high-risk neuroblastoma

FDA approves Unituxin for high-risk neuroblastoma

10-03-2015

The US Food and Drug Administration today approved US biotech firm United Therapeutics’ Unituxin (dinutuximab)…

BiotechnologyOncologyRegulationUnited TherapeuticsUnituxinUSA

FDA updates label on Pfizer's Chantix to warn of interaction with alcohol

FDA updates label on Pfizer's Chantix to warn of interaction with alcohol

10-03-2015

The US Food and Drug Administration has updated the label on Chantix (varenicline), marketed by Pfizer,…

ChantixNeurologicalPfizerPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for KYTHERA’s ATX-101

Unanimous FDA advisory panel backing for KYTHERA’s ATX-101

10-03-2015

US biotech firm KYTHERA Biopharmaceuticals said yesterday that the US Food and Drug Administration's…

ATX-101BayerBiotechnologyDermatologicalsKYTHERA BiopharmaceuticalsRegulationUSA

Germany’s IQWiG finds no added benefit for Novartis’ Galvus

Germany’s IQWiG finds no added benefit for Novartis’ Galvus

09-03-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a new dossier…

DiabetesGalvusGermanyNovartisPharmaceuticalPricingRegulation

Scottish Medicines Consortium approves Gilead's Zydelig and B-MS/Pfizer's Eliquis

Scottish Medicines Consortium approves Gilead's Zydelig and B-MS/Pfizer's Eliquis

09-03-2015

The Scottish Medicines Consortium has approved Zydelig (idelalisib) from Gilead for adult chronic lymphocytic…

EliquisGileadHematologyOncologyPharmaceuticalRegulationUKZydelig

EFPIA and APRaD sign letter of intent to advance Ukraine’s health care

EFPIA and APRaD sign letter of intent to advance Ukraine’s health care

09-03-2015

On March 3, the Ministry of Health of Ukraine and international research-based pharmaceutical industry…

HealthcarePharmaceuticalPoliticsProductionRegulationUkraine

GSK dismisses 110 employees in Chinese bribery scandal

GSK dismisses 110 employees in Chinese bribery scandal

09-03-2015

UK pharma major GlaxoSmithKline has reportedly sacked more than 100 employees in China due to misconduct…

BloombergChinaGSKPharmaceuticalRegulation

US FTC calls for divestitures for Impax buy of CorePharma to proceed

US FTC calls for divestitures for Impax buy of CorePharma to proceed

09-03-2015

US Federal Trade Commission imposes divestiture conditions on proposed acquisition by generic drugmaker…

CorePharmaGenericsImpax LaboratoriesMergers & AcquisitionsPerrigoPilocarpineRegulationUrsodiolUSA

FDA approves Astellas’ new antifungal drug Cresemba

FDA approves Astellas’ new antifungal drug Cresemba

07-03-2015

The US Food and Drug Administration on Friday approved Cresemba (isavuconazonium sulfate), a new antifungal…

Antibiotics and Infectious diseasesAstellas PharmaBasilea PharmaceuticaCresembaPharmaceuticalRegulationUSA

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

06-03-2015

Sandoz, the generics unit of Swiss pharma giant Novartis, today received approval from the US Food and…

AmgenBiosimilarsBiotechnologyNeupogenNovartisOncologyRegulationSandozUSAZarxioZarzio

US biosimilar approvals poised to grow, but market uptake faces challenges, says Tufts CSDD

05-03-2015

Biosimilar approvals in the USA are expected to increase during the next five years, but safety concerns…

BiosimilarsBiotechnologyFinancialMarkets & MarketingRegulationUSA

European generics group launches Code of Conduct

05-03-2015

Following the adoption of the European Commission Guiding Principles Promoting Good Governance in the…

BiosimilarsEuropeGenericsMarkets & MarketingRegulation

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

05-03-2015

The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers…

BiotechnologyBristol-Myers SquibbOncologyOpdivoRegulationUSA

Positive EMA/CHMP opinion for a label update of Brintellix

Positive EMA/CHMP opinion for a label update of Brintellix

05-03-2015

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

BrintellixEuropeLundbeckNeurologicalPharmaceuticalRegulation

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

04-03-2015

The US Food and Drug Administration has accepted German pharma major Bayer’s Biologics License Application…

BAY 81-8973BayerBiotechnologyHematologyKovaltryRegulationUSA

US FDA warns on over-prescribing of testosterone products

US FDA warns on over-prescribing of testosterone products

04-03-2015

The US Food and Drug Administration is requiring that the manufacturers of all approved prescription…

AbbVieAndroGelAxironEli LillyMen's HealthPharmaceuticalRegulationUSA

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