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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

Naming conventions for biosimilars in Australia

Naming conventions for biosimilars in Australia

21-01-2015

Following recent international developments in the area of biosimilar naming, Australian regulator the…

AustraliaBiosimilarsBiotechnologyRegulationTherapeutic Goods Administration

FDA removes hold on CytRx's aldoxorubicin Phase III trials

FDA removes hold on CytRx's aldoxorubicin Phase III trials

20-01-2015

The US Food and Drug Administration has removed the partial clinical hold on biopharma oncology company…

aldoxorubicinBiotechnologyCytRxOncologyRegulationResearchUSA

Novartis’ Cosentyx gets third approval, now in Europe

19-01-2015

The European Commission (EC) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab, formerly…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulation

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

18-01-2015

US biotech firm Celgene’s European subsidiary has received marketing authorization from the European…

Anti-Arthritics/RheumaticsBiotechnologyCelgene CorpDermatologicalsEuropeOtezlaRegulation

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

16-01-2015

In final draft guidance issued today, England health costs watchdog the National Institute for Health…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioPricingRegulationSovaldiUK

Cost to NHS of Provenge too high to be recommended, says NICE

13-01-2015

England’s health care cost watchdog the National Institute for Health and Care Excellence (NICE) has…

BiotechnologyDendreonOncologyPricingProvengeRegulationUK

Hospira submits new BLA for epoetin alfa biosimilar In USA

12-01-2015

US injectable drugs and infusion technologies and biosimilars developer Hospira has submitted a Biologics…

AmgenBiosimilarsBiotechnologyepoetinEpogenHematologyHospiraJanssenJohnson & JohnsonProcritRegulationRetacritUSA

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

12-01-2015

French drug major Sanofi and US biotech company Regeneron have announced that the European Medicines…

alirocumabBiotechnologyCardio-vascularEuropeRegeneronRegulationSanofi

China’s FDA approves Chipscreen’s Epidaza

China’s FDA approves Chipscreen’s Epidaza

12-01-2015

Chinese biotech firm Chipscreen Biosciences has received regulatory approval of Epidaza (chidamide),…

BiotechnologychidamideChinaChipscreen BiosciencesEpidazaOncologyRegulation

BIO urges US FDA to release guidance on biosimilars

BIO urges US FDA to release guidance on biosimilars

08-01-2015

The US trade group the Biotechnology Industry Organization (BIO) has called on the Food and Drug Administration…

BiosimilarsBiotechnologyRegulationUSA

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

06-01-2015

In briefing papers ahead of an advisory committee meeting, agency staff at the US Food and Drug Administration…

AmgenBiosimilarsBiotechnologyImmunologicalsNeupogenNovartisRegulationUSA

US FDA approves wider use for Vertex’ Kalydeco

US FDA approves wider use for Vertex’ Kalydeco

30-12-2014

US biotech firm Vertex Pharmaceuticals says the US Food and Drug Administration has approved a supplemental…

BiotechnologyKalydecoRare diseasesRegulationUSAVertex Pharmaceuticals

BioMarin’s Vimizim approved in Japan for Morquio A syndrome

BioMarin’s Vimizim approved in Japan for Morquio A syndrome

29-12-2014

US biotech firm BioMarin Pharmaceutical has received approval from Japan’s Ministry of Health, Labor…

BioMarin PharmaceuticalBiotechnologyJapanRare diseasesRegulationVimizim

First ever regulatory approval of Novartis' Cosentyx, in Japan

First ever regulatory approval of Novartis' Cosentyx, in Japan

26-12-2014

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Swiss pharma giant Novartis’…

Anti-Arthritics/RheumaticsBiotechnologyCosentyxDermatologicalsJapanNovartisRegulation

US health care predictions from Steven Burrill

US health care predictions from Steven Burrill

24-12-2014

US politics will continue to be characterized by partisanship as the Republican majorities in the House…

BiosimilarsBiotechnologyHealthcarePoliticsRegulationUSA

NICE opens consultation on Millennium’s Crohn’s drug Entyvio

23-12-2014

In draft guidance issued today, UK health costs watchdog the National Institute for Health and Care Excellence…

BiotechnologyEntyvioGastro-intestinalsMillennium PharmaceuticalsPricingRegulationTakeda PharmaceuticalUK

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

15-12-2014

Genentech, the US biotech subsidiary of Swiss Pharma major Roche Group, has submitted a New Drug Application…

BiotechnologycobimetinibExelixisGenentechOncologyRegulationRocheUSAZelboraf

NICE now proposes to recommend Stelara for psoriatic arthritis

NICE now proposes to recommend Stelara for psoriatic arthritis

09-12-2014

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

Anti-Arthritics/RheumaticsBiotechnologyInflammatory diseasesJanssenJohnson & JohnsonPricingRegulationStelaraUK

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