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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In final draft guidance issued on Friday, the UK drugs watchdog the National Institute for Health and…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UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance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

BTG’s varicose vein treatment Varithena gets FDA approval

BTG’s varicose vein treatment Varithena gets FDA approval

27-11-2013

UK specialist health care company BTG (LSE: BTG) has received approval from the US Food and Drug Administration…

BTGPharmaceuticalRegulationUKUSAVarithena

GW Pharma receives FDA orphan drug designation for cannaboid-based agent

GW Pharma receives FDA orphan drug designation for cannaboid-based agent

15-11-2013

GW Pharmaceuticals (Nasdaq: GWPH) has been granted orphan drug designation by the US Food and Drug Administration…

EuropeGW PharmaceuticalsNorth AmericaPharmaceuticalRare diseasesRegulationUKUSA

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