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Beike receives approval from Chinese FDA for umbilical stem cells in lupus

Beike receives approval from Chinese FDA for umbilical stem cells in lupus

10-07-2014

China-based stem cell research company Beike Biotechnology has been accepted into the approval process…

beikeBeike BiotechnologyBiotechnologyChinaGuangdong Food and Drug AdministrationImmunologicalsRegulationStem cells

Positive opinion from CHMP for Veloxis’ Envarsus

22-05-2014

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

EnvarsusEuropeImmunologicalsPharmaceuticalRegulationVeloxis Pharmaceuticals

FDA extends PDUFA date for Baxter and Halozyme’s HyQvia

21-05-2014

US drugmakers Baxter International and Halozyme Therapeutics revealed that the US Food and Drug Administration…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQviaImmunologicalsRegulationUSA

FDA approves Merck’s Ragwitek for short ragweed pollen allergies

18-04-2014

The US Food and Drug Administration has approved US pharma giant Merck & Co’s Biological License Application…

ALK AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

US FDA approves Stallergenes’ allergy tablet Oralair

US FDA approves Stallergenes’ allergy tablet Oralair

02-04-2014

The US Food and Drug Administration has approved Oralair immunotherapy tablet from French allergen specialist…

ImmunologicalsOralairPharmaceuticalRegulationStallergenesUSA

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

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

28-01-2014

The US Food and Drug Administration’s Allergenic Products Advisory Committee has voted that the available…

Alk-AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

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

Veloxis Pharma submits NDA for Envarsus in kidney transplant recipients

30-12-2013

Denmark’s Veloxis Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration…

EnvarsusImmunologicalsLCP-TacroNorth AmericaPharmaceuticalRegulationUSAVeloxis Pharmaceuticals

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

Unanimous FDA panel support for Merck & Co’s Grastek

Unanimous FDA panel support for Merck & Co’s Grastek

13-12-2013

The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted…

Alk-AbelloGrastekGrazaxImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Stallergenes' Oralair gains US FDA panel backing

Stallergenes' Oralair gains US FDA panel backing

12-12-2013

France’s Stallergenes said late yesterday that the Allergenic Products Advisory Committee (APAC) of…

GREER LaboratoriesImmunologicalsNorth AmericaOralairPharmaceuticalRegulationStallergenes

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

10-12-2013

The US Food and Drug Administration Allergenic Products Advisory Committee will review US pharma giant…

ALK AbelloImmunologicalsMerck & CoPharmaceuticalRegulationUSA

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

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

02-12-2013

USA-based Baxter International has completed submission of an amended biologics license application to…

Baxter InternationalHalozyme TherapeuticsHyQviaImmunologicalsNorth AmericaPharmaceuticalRegulationUSA

Rigel sees clear forward path for fostamatinib but will drop R333

25-10-2013

Clinical-stage US drug developer Rigel Pharmaceuticals has announced mixed updates on two of its pipeline…

BiotechnologyDermatologicalsfostamatinibImmunologicalsR333RegulationResearchRigel Pharmaceuticals

ALK’s allergy tablet falls victim to US government shutdown

ALK’s allergy tablet falls victim to US government shutdown

08-10-2013

ALK Abello is the first pharma casualty of the US government shutdown.

ALK AbelloImmunologicalsMerk & CoNorth AmericaPharmaceuticalRegulation

CSL Behring’s Hizentra approved in Japan for PID and SID

CSL Behring’s Hizentra approved in Japan for PID and SID

27-09-2013

The Japanese Ministry of Health, Labor and Welfare has approved Hizentra for the treatment of primary…

Asia-PacificCSL BehringHizentraImmunologicalsPharmaceuticalRare diseasesRegulation

FDA backs Astellas' Astragraf XL for kidney transplant rejection prophylaxis

22-07-2013

The US Food and Drug Administration has approved Japanese drug major Astellas Pharma's (TYO: 4503) Astragraf…

Astellas PharmaAstragraf XLImmunologicalsNorth AmericaPharmaceuticalRegulationtacrolimus

Positive Ph III findings on ALK's new house dust mite allergy immunotherapy; EU filing expected in 2014

20-06-2013

Denmark-based allergy specialist ALK Abello (ALKB: DC) has announced positive outcome of the first of…

ALK AbelloImmunologicalsPharmaceuticalRegulationResearchRespiratory and Pulmonary

Additional indications in Japan for Roche's Avastin and Astellas' Prograf

17-06-2013

Swiss drug major Roche (ROG: SIX) says that the Japanese Ministry of Health, Labor and Welfare (MHLW)…

Asia-PacificAstellas PharmaAvastinBiotechnologyImmunologicalsOncologyPharmaceuticalPrografRegulationRoche

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