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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

FDA approves new indication for Amgen's Xgeva

FDA approves new indication for Amgen's Xgeva

08-12-2014

USA-based Amgen says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab),…

AmgenBiotechnologyOncologyRare diseasesRegulationUSAXgeva

Credit Suisse sees PTC Therapeutics as a top stock pick

05-12-2014

Credit Suisse has released a biotech research report from analysts Jason Kantor and Jeremiah Shepard…

BiotechnologyFinancialNeurologicalPTC TherapeuticsRare diseasesRegulationTranslarna

US FDA approves new indication for Incyte’s Jakafi

US FDA approves new indication for Incyte’s Jakafi

05-12-2014

The US Food and Drug Administration yesterday approved a new use for Incyte Corp’s Jakafi (ruxolitinib)…

BiotechnologyIncyteJakafiOncologyRegulationUSA

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

04-12-2014

Ahead of the anticipated decision date, the US Food and Drug Administration yesterday approved Blincyto…

AmgenBiotechnologyblinatumomabBlincytoOncologyRegulationUSA

Puma shares plummet as it delays NDA filing

Puma shares plummet as it delays NDA filing

03-12-2014

Puma Biotechnology will delay the filing of its New Drug Application (NDA) for the approval of PB272…

BiotechnologyneratinibOncologyPuma BiotechnologyRegulationUSA

NICE final draft guidance recommends Soliris, but saying it is “very expensive”

NICE final draft guidance recommends Soliris, but saying it is “very expensive”

27-11-2014

The UK National Institute for Health and Care Excellence (NICE) has today issued final draft guidance…

Alexion PharmaceuticalsBiotechnologyPricingRare diseasesRegulationSolirisUK

Takeda's Entyvio given provisional approval by UK's NICE

Takeda's Entyvio given provisional approval by UK's NICE

26-11-2014

The UK’s National Institute for Health and Care Excellence (NICE) has given a provisional approval…

BiotechnologyEntyvioGastro-intestinalsRegulationTakeda PharmaceuticalUK

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

26-11-2014

The chief executive of Medicines Australia has called for a strengthening of Australia’s intellectual…

AustraliaBiotechnologyLegalMedicines AustraliaRegulationResearch

Regeneron and Sanofi granted breakthrough designation for dupilumab

Regeneron and Sanofi granted breakthrough designation for dupilumab

25-11-2014

US biotech Regeneron Pharmaceuticals and French pharma major Sanofi have said that the US Food and Drug…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

21-11-2014

Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulationsecukinumab

UK government looks to speed up access to new medicines

UK government looks to speed up access to new medicines

20-11-2014

The UK government has announced a substantial investment package from industry, and that it is to carry…

BiotechnologyPoliticsRegulationUKUnited Kingdom

Sanofi and Regeneron’s dupilumab gets Breakthrough designation from FDA

20-11-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

Gilead Sciences’ Harvoni gains EU approval

Gilead Sciences’ Harvoni gains EU approval

19-11-2014

The European Commission yesterday granted marketing authorization for US biotech antiviral specialists…

Anti-viralsBiotechnologyEuropeGilead SciencesHarvoniRegulationSovaldi

Bayer/Regeneron’s Eylea approved in Japan for DME

18-11-2014

German pharma major Bayer’s Japanese subsidiary, Bayer Yakuhin, has received approval from the Ministry…

BayerBiotechnologyEyleaJapanOphthalmicsRegeneronRegulation

Yet another indication for Roche’s blockbuster Avastin from FDA

16-11-2014

The US Food and Drug Administration on Friday approved Avastin (bevacizumab) solution for intravenous…

AvastinBiotechnologyEli LillyGemzarGenentechOncologyRegulationRocheUSA

FDA at last approves Genzyme’s Lemtrada

FDA at last approves Genzyme’s Lemtrada

15-11-2014

The US Food and Drug Administration on Friday approved French pharma major Sanofi subsidiary Genzyme’s…

BayerBiotechnologyGenzymeLemtradaNeurologicalRegulationSanofiUSA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

06-11-2014

The Food and Drug Administration has approved US health care giant Johnson & Johnson's Olysio (simeprevir)…

Anti-viralsBiotechnologyJohnson & JohnsonMedivirOlysioRegulationsofosbuvirUSA

GlaxoSmithKline files for US and EU approval of mepolizumab

GlaxoSmithKline files for US and EU approval of mepolizumab

05-11-2014

UK pharma major GlaxoSmithKline says it has filed regulatory submissions in the USA and Europe for mepolizumab…

BarclaysBiotechnologyBosatriaEuropeGlaxoSmithKlineImmunosuppressantsmepolizumabRegulationRespiratory and PulmonaryUnited StatesUSA

Vertex seeks regulatory approval for lumacaftor/ivacaftor combination for CF

05-11-2014

US biotech firm Vertex Pharmaceuticals has filed for marketing approval for a fully co-formulated combination…

BiotechnologyEuropeivacaftorlumacaftorRare diseasesRegulationUSAVertex Pharmaceuticals

Biogen Idec and SOBI’s Elocta MAA validated in Europe

01-11-2014

Biotechnology companies Biogen Idec of the USA and Swedish Orphan Biovitrum said on Friday that the European…

Biogen IdecBiotechnologyEloctaEloctateEuropeHematologyRegulationSwedish Orphan Biovitrum

Specialised Therapeutics' Abraxane to be reimbursed via Australian PBS

Specialised Therapeutics' Abraxane to be reimbursed via Australian PBS

31-10-2014

Australian biopharma company Specialised Therapeutics is to have its Abraxane (nanoparticle albumin-bound…

AbraxaneAustraliaBiotechnologyOncologyRegulationSpecialised Therapeutics Australia

EMA guidance on facilitating global development of biosimilars

EMA guidance on facilitating global development of biosimilars

30-10-2014

The European Medicines Agency has published its revised overarching guideline on biosimilars, or follow-on…

BiosimilarsBiotechnologyEuropeRegulation

EuropaBio’s new White Paper 'Realising the Potential of Personalized Medicine in Europe'

27-10-2014

Biotechnology trade group EuropaBio has issued a new White Paper, aiming to identify the required adaptations…

BiotechnologyEuropeRegulationResearch

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