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GSK receives positive CHMP opinion for COPD drug Incruse

GSK receives positive CHMP opinion for COPD drug Incruse

21-02-2014

GlaxoSmithKline has announced that the European Medicines Agency’s Committee for Medicinal Products…

GlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUKumeclidinium

NICE asks Biogen Idec for more information on Tecfidera

NICE asks Biogen Idec for more information on Tecfidera

21-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is calling on US biotech firm Biogen…

Biogen IdecBiotechnologyCNS DiseasesRegulationTecfideraUK

Scancell granted orphan drug designation for melanoma drug

Scancell granted orphan drug designation for melanoma drug

17-02-2014

UK-based immunotherapy company Scancell has been granted orphan drug designation for its SCIB1 ImmunoBody…

ImmunologicalsOncologyPharmaceuticalRegulationScancellSCIB1UKUSA

UK’s NICE calls for more people at risk of CVD to be prescribed statins

UK’s NICE calls for more people at risk of CVD to be prescribed statins

12-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is recommending that many more people…

Cardio-vascularHealthcarePharmaceuticalRegulationUK

UK’s MHRA approves Botox for treatment of ankle disability in stroke survivors

04-02-2014

Allergan says that Botox has been approved by the UK’s Medicines and Healthcare Products Regulatory…

AllerganBotoxPharmaceuticalRegulationUK

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

04-02-2014

GlaxoSmithKline’s Tafinlar (dabrafenib) is now available for metastatic melanoma patients in England…

FinancialGSKOncologyPharmaceuticalRegulationTafinlarUK

UK’s NICE consults on updating guidance for Tarceva and Iressa

UK’s NICE consults on updating guidance for Tarceva and Iressa

04-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) said this morning that it is reviewing…

AstraZenecadocetaxelIressaOncologyPharmaceuticalRegulationRocheTarcevaUK

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

28-01-2014

UK drugs watchdog the National Institute of Health and Care Excellence (NICE) has issued new draft guidance…

Astellas PharmaEuropeOncologyPharmaceuticalPricingRegulationUKXtandi

UK’s NICE gives green light to Roche’s MabThera for GPA and MPA

UK’s NICE gives green light to Roche’s MabThera for GPA and MPA

24-01-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today approved the use…

EuropeImmunologicalsMabTheraPharmaceuticalPricingRegulationRocheUK

NICE recommends Sanofi’s Aubagio as new treatment option for MS

NICE recommends Sanofi’s Aubagio as new treatment option for MS

22-01-2014

In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has…

AubagioBiotechnologyGenzymeNeurologicalNorthern EuropePricingRegulationSanofiUK

New data reveals substantial variation in patients’ access to medicines across England

New data reveals substantial variation in patients’ access to medicines across England

21-01-2014

Analysis showing the extent to which the UK National Health Service (NHS) is prescribing National Institute…

HealthcarePharmaceuticalRegulationUK

Allergan closes $65 million deal with Medytox

Allergan closes $65 million deal with Medytox

09-01-2014

This week US drugmaker Allergan (NYSE: AGN) announced that it has closed a $65 million license agreement…

AllerganAsia-PacificBotoxDermatologicalsLicensingMedytoxPharmaceuticalRegulationUKUSA

GSK gains accelerated FDA approval for combination use of Mekinist and Tafinlar

GSK gains accelerated FDA approval for combination use of Mekinist and Tafinlar

09-01-2014

GlaxoSmithKline (LSE: GSK) says that the US Food and Drug Administration has approved Mekinist (trametinib)…

GlaxoSmithKlineMekinistOncologyPharmaceuticalRegulationTafinlarUKUSA

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

06-01-2014

The UK House of Commons Public Accounts Committee is calling for all data on drugs being prescribed in…

Anti-viralsNorthern EuropePharmaceuticalRegulationResearchRocheTamifluUK

UK NICE draft guidance recommends Ferring’s Firmagon for prostate cancer

UK NICE draft guidance recommends Ferring’s Firmagon for prostate cancer

27-12-2013

UK drugs watchdog the National Institute for Health and Care Excellence has issued new draft guidance…

EuropeFerring PharmaceuticalsFirmagonOncologyPharmaceuticalPricingRegulationUK

UK’s NICE draft guidance negative on Stelara for psoriatic arthritis

UK’s NICE draft guidance negative on Stelara for psoriatic arthritis

27-12-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has opened a consultation…

Anti-Arthritics/RheumaticsEuropeJanssenJohnson & JohnsonPharmaceuticalPricingRegulationStelara InjectionUK

EU Clinical Trials Regulation must put all EU patients first, says BIA

EU Clinical Trials Regulation must put all EU patients first, says BIA

19-12-2013

Commenting in advance of the European Union Committee of Permanent Representatives (COREPER) agreement…

Northern EuropePharmaceuticalRegulationUK

Pediatric indication for SOBI’s Kineret from UK’s MHRA

Pediatric indication for SOBI’s Kineret from UK’s MHRA

18-12-2013

Kineret (anakinra), from Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI), has been licensed…

BiotechnologyImmunologicalsKineretRegulationSobiUK

Sanofi’s Aubagio gains backing from UK’s NICE

Sanofi’s Aubagio gains backing from UK’s NICE

08-12-2013

In final draft guidance issued on Friday, the UK drugs watchdog the National Institute for Health and…

AubagioEuropeGenzymeNeurologicalPharmaceuticalPricingRegulationSanofiUK

EMA approves fortnightly dosing option for CSL’s Hizentra

EMA approves fortnightly dosing option for CSL’s Hizentra

05-12-2013

Plasma-protein specialists CSL Behring, a subsidiary of Australia’s CSL Ltd (CSL: AX), announced today…

CSL BehringEuropeHizentraImmunologicalsPharmaceuticalRegulationUK

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

05-12-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme,…

BiotechnologyEuropeGenzymeLemtradaNeurologicalPricingRegulationSanofiUK

FT Pharma 2013: NICE chair David Haslam says “I want as many yeses as possible”

FT Pharma 2013: NICE chair David Haslam says “I want as many yeses as possible”

04-12-2013

The chair of the UK’s regulatory body the National Institute for Health and Care Excellence shared…

InterviewsPharmaceuticalRegulationUK

Third NICE consultation on Eli Lilly’s Alimta in the UK

Third NICE consultation on Eli Lilly’s Alimta in the UK

27-11-2013

The UK’s drugs watchdog the National Institute of Health and Care Excellence (NICE) is holding a third…

AlimtaEli LillyOncologyPharmaceuticalRegulationUK

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