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Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

28-02-2015

US biotech major Biogen Idec and Nordic drugmaker Swedish Orphan Biovitrum have announced positive top-line…

AlprolixBiogen IdecBiotechnologyEuropeHematologyRegulationResearchSobiSwedish Orphan Biovitrum

UK doctors call for approval of off-label use of Avastin for wet-AMD

UK doctors call for approval of off-label use of Avastin for wet-AMD

25-02-2015

Doctors in the UK are calling on health ministers and NHS England to intervene to make Swiss pharma giant…

AvastinBiotechnologyHealthcareLucentisNovartisOphthalmicsPricingRegulationRocheUK

Health care is up for a revolution with the rise of personal genomic tests; report

24-02-2015

As the era of personalized medicine dawns on health care, the need to understand an individual’s genetic…

BiotechnologyGlobalRegulationResearch

Intas becomes first Indian company to launch biosimilar in the EU

Intas becomes first Indian company to launch biosimilar in the EU

23-02-2015

Indian biopharma company Intas has become the first Indian company to launch a biosimilar in highly regulated…

BiosimilarsBiotechnologyFilgrastimHematologyImmunologicalsIndiaIntas PharmaceuticalsMarkets & MarketingRegulation

FDA accepts for review Synageva's Biologics License Application for Kanuma

FDA accepts for review Synageva's Biologics License Application for Kanuma

23-02-2015

The US Food and Drug Administration has accepted for review the Biologics License Application for Kanuma…

BiotechnologyGeneticsKanumaRegulationSynageva BioPharmaUSA

Holoclar, the first stem cell-based medicinal product approved in Europe

Holoclar, the first stem cell-based medicinal product approved in Europe

22-02-2015

The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004,…

BiotechnologyChiesi FarmaceuticiEuropeHoloclarHolostem Terapie AvanzateOphthalmicsRegulation

European approval for expanded use of Celgene’s Revlimid

20-02-2015

US biotech firm Celgene’s European subsidiary has received approval from the European Commission for…

BiotechnologyCelgene CorpEuropeOncologyRegulationRevlimid

IQWiG says Octapharma provided no suitable data on Nuwiq to show added benefit

IQWiG says Octapharma provided no suitable data on Nuwiq to show added benefit

20-02-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined data on independent…

BiotechnologyGermanyHematologyNuwiqOctapharmaPricingRegulation

US FDA expands use of Celgene’s Revlimid

18-02-2015

US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication…

BiotechnologyCelgene CorpOncologyRegulationRevlimidUSA

EMA Orphan Drug status for aTyr’s Resolaris in FSHD

18-02-2015

Privately-held US biotech firm aTyr Pharma says that the European Commission has granted Orphan Drug…

ATyr PharmaBiotechnologyEuropeRare diseasesRegulationResolaris

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

17-02-2015

Privately-held US biotech firm Bexion Pharmaceuticals has received Orphan Drug designation for the US…

Bexion PharmaceuticalsBiotechnologyBXQ-350OncologyRegulationSaposin CUSA

Biotie receives positive opinion on orphan drug status for BTT1023 from EMA

Biotie receives positive opinion on orphan drug status for BTT1023 from EMA

17-02-2015

Finnish biotech and pharma company Biotie has received a positive opinion from the European Medicines…

BiotechnologyBiotie TherapiesFinlandNephrology and HepatologyRegulation

Tecfidera, first-line oral treatment for multiple sclerosis, approved in India

13-02-2015

US biotech major Biogen Idec’s Indian subsidiary has received approval of the first oral therapy for…

Biogen IdecBiotechnologyIndiaNeurologicalRegulationTecfidera

NICE final draft guidance does not recommend pomalidomide for blood cancer

NICE final draft guidance does not recommend pomalidomide for blood cancer

13-02-2015

The England medical costs watchdog the National Institute for Health and Care excellence (NICE) has issued…

BiotechnologyCelgene CorpImnovidOncologypomalidomidePricingRegulationUK

Further approvals for ThromboGenics’ Jetrea

12-02-2015

Belgian biotech company ThromboGenics, which is focused on developing and commercializing innovative…

AlconArgentinaBiotechnologyIsraelJetreaNovartisOphthalmicsRegulationThromboGenics

Celgene's Abraxane recommended by Scottish Medicines Consortium

Celgene's Abraxane recommended by Scottish Medicines Consortium

10-02-2015

The Scottish Medicines Consortium has decided to recommend Abraxane (paclitaxel) in combination with…

AbraxaneBiotechnologyCelgene CorpOncologyRegulationUK

FDA approves added indication for Genentech’s Lucentis

FDA approves added indication for Genentech’s Lucentis

08-02-2015

The US Food and Drug Administration on Friday approved Swiss pharma giant Roche subsidiary Genentech’s…

BiotechnologyGenentechLucentisNovartisOphthalmicsRegulationRocheUSA

European Commission approves added indication for Janssen’s Velcade, in MCL

European Commission approves added indication for Janssen’s Velcade, in MCL

06-02-2015

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International NV (Janssen)…

BiotechnologyEuropeJanssen-Cilag InternationalJohnson & JohnsonOncologyRegulationVelcade

First UK NICE highly specialized technologies guidance recommends Soliris

First UK NICE highly specialized technologies guidance recommends Soliris

28-01-2015

England’s health costs watchdog the National Institute for Health and care Excellence has today issued…

Alexion PharmaceuticalsBiotechnologyHematologyPricingRare diseasesRegulationSolarisUK

Sanofi and Regeneron’s Praluent BLA gains priority review from US FDA

26-01-2015

The US Food and Drug Administration has accepted for priority review the Biologics License Application…

alirocumabAmgenBiotechnologyCardio-vascularevolocumabPraluentRegeneron PharmaceuticalsRegulationSanofiUSA

US FDA approves NPS Pharma’s Natpara

US FDA approves NPS Pharma’s Natpara

24-01-2015

The US Food and Drug Administration on Friday approved NPS Pharmaceuticals’ Natpara (parathyroid hormone)…

BiotechnologyNatparaNPS PharmaceuticalsRare diseasesRegulationShireUSA

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

22-01-2015

French drug major Sanofi and its subsidiary Genzyme have been granted marketing authorization by the…

BiotechnologyCerdelgaGeneticsGenzymeRegulationSanofi

Latest approval for Novartis’ Cosentyx, from US FDA

Latest approval for Novartis’ Cosentyx, from US FDA

22-01-2015

Adding to recent marketing clearances in Japan and the European Union, the US Food and Drug Administration…

BiotechnologyCosentyxDermatologicalsNovartisRegulationUSA

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

21-01-2015

South Korea’s Samsung Bioepis says that the Marketing Authorization Application for its Enbrel (etanercept)…

AmgenAnti-Arthritics/RheumaticsBiogen IdecBiosimilarsBiotechnologyEnbrelEuropePfizerRegulationSamsung Bioepis

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