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NICE reverses guidance on Novartis’ Glivec for GIST

NICE reverses guidance on Novartis’ Glivec for GIST

17-10-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new…

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

Dendreon’s Provenge too expensive to be recommended, says NICE in draft guidance

Dendreon’s Provenge too expensive to be recommended, says NICE in draft guidance

16-10-2014

In preliminary draft guidance issued this morning the UK health costs watchdog the National Institute…

BiotechnologyDendreonOncologyPricingProvengeRegulationUK

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

15-10-2014

There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted…

BanzelEisailenvatinibNeurologicalOncologyPharmaceuticalRegulationRufinamide TabletsUSA

Northwest Bio says DCVax-L hospital exemption program under way in Germany

Northwest Bio says DCVax-L hospital exemption program under way in Germany

15-10-2014

US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for…

BiotechnologyDCVax-LGermanyNorthwest BiotherapeuticsOncologyRegulationResearch

NICE preliminary guidance negative on Celgene’s pomalidomide for multiple myeloma

NICE preliminary guidance negative on Celgene’s pomalidomide for multiple myeloma

15-10-2014

UK medical costs watchdog the National Institute for Health and Care Excellence (NICE) has issued preliminary…

BiotechnologyCelgene Corp.ImnovidOncologyPricingRegulationUK

Pfizer’s palbociclib gains FDA Priority Review

13-10-2014

Pfizer says that the New Drug Application for its investigational breast cancer treatment palbociclib…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

FDA approves Eisai’s Akynzeo for CINV

13-10-2014

The US Food and Drug Administration has approved Japanese pharma major Eisai’s Akynzeo (netupitant…

AkynzeoEisaiHelsinnnetupitantOncologypalonosetronPharmaceuticalRegulationUSA

Highlights from EMA Pharmacovigilance October meeting

10-10-2014

At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee…

Ariad PharmaceuticalsEuropeIclusigMen's HealthNeurologicalOncologyPharmaceuticalRegulationTestosteronevalproate

New Zealand approval of Novartis multiproduct proposal

10-10-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with…

NeurologicalNew ZealandOncologyPharmaceuticalRegulationRespiratory and Pulmonary

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

09-10-2014

US privately-held oncolytic virus expert DNAtrix says that the US Food and Drug Administration has granted…

BiotechnologyDNAtrixDNX-2401OncologyRegulationUSA

FDA Breakthrough designation for Ariad’s AP26113

FDA Breakthrough designation for Ariad’s AP26113

03-10-2014

US specialty pharma firm Ariad Pharmaceuticals says that its investigational cancer drug AP26113 has…

AP26113Ariad PharmaceuticalsOncologyPharmaceuticalRegulationResearchUSA

Data uncertainties mean NICE does not recommend Roche leukemia drug

Data uncertainties mean NICE does not recommend Roche leukemia drug

03-10-2014

In yet another rejection of the company’s cancer drugs, the UK drugs watchdog, the National Institute…

GazyvaroOncologyPharmaceuticalPricingRegulationRocheUK

FDA grants approval for Xtandi in metastatic prostate cancer

FDA grants approval for Xtandi in metastatic prostate cancer

01-10-2014

Japanese drug major Astellas Pharma and Medivation has received extended approval for Xtandi (enzalutamide)…

Astellas PharmaDiplomatMedivationOncologyPharmaceuticalRegulationUSAXtandi

Bristol-Myers Squibb updates on Opdivo regulatory milestones

Bristol-Myers Squibb updates on Opdivo regulatory milestones

30-09-2014

US pharma major Bristol-Myers Squibb has announced multiple regulatory milestones for Opdivo (nivolumab),…

Bristol-Myers SquibbEuropeOncologyOno PharmaceuticalOpdivoPharmaceuticalRegulationUSA

ESMO 2014: Canada and Europe sometimes years slower than USA in approving cancer

ESMO 2014: Canada and Europe sometimes years slower than USA in approving cancer

29-09-2014

Access to potentially life-extending cancer drugs varies significantly in different regions of the world,…

CanadaEastern EuropeEuropeOncologyPharmaceuticalRegulationUSA

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

25-09-2014

Switzerland-based Celgene International, a wholly-owned subsidiary of US biotech major Celgene, say that…

AbraxaneBiotechnologyCelgene Corp.OncologyRegulationSwitzerland

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

24-09-2014

The UK’s drug watchdog the National Institute for Health and Care Excellence (NICE) has today issued…

BiotechnologyCelgene Corp.OncologyPricingRegulationRevlimidUK

Amgen files BLA for BiTE immunotherapy blinatumomab

Amgen files BLA for BiTE immunotherapy blinatumomab

22-09-2014

USA-based Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

22-09-2014

US biotech firm Halozyme Therapeutics says the US Food and Drug Administration has removed the clinical…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

European Commission approves Gilead’s Zydelig for blood cancer

European Commission approves Gilead’s Zydelig for blood cancer

19-09-2014

The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig…

BiotechnologyEuropeGilead SciencesLymphomaMedicineOncologyRegulationZydelig

Orphan status for Navidea’s Lymphoseek in head and neck cancers

Orphan status for Navidea’s Lymphoseek in head and neck cancers

19-09-2014

US biotech company Navidea Biopharmaceuticals that its Lymphoseek (technetium Tc 99m tilmanocept) Injection…

BiotechnologyLymphoseekNavidea BiopharmaceuticalsOncologyRegulationUSA

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

18-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft…

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationRocheTafinlarUKZelboraf

First therapy under UK’s early access scheme to be Northwest Biotherapeutics’ DCVax-L

First therapy under UK’s early access scheme to be Northwest Biotherapeutics’ DCVax-L

17-09-2014

The UK’s Department of Health announced that DCVax-L, the dendritic cell-based vaccine from US company…

BiotechnologyDCVaxNorthwest BiotherapeuticsOncologyRegulationUK

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