Regulation - Pharmaceutical, Oncology

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Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

22-07-2014

US-based pharmaceutical company Halozyme Therapeutics has said it is once again enrolling and dosing…

Halozyme TherapeuticsHyaluronidaseOncologyPancreatic cancerPEGylationPharmaceuticalRegulationUSA

New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review

New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review

21-07-2014

The organization that reviews oncology medicines in Canada may unnecessarily delay approvals while cancer…

BevacizumabCanadaFraser InstituteOncologyPharmaceuticalRegulation

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

16-07-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has today published the results…

Breast cancerGermanyInstitute for Quality and Efficiency in Health CareOncologyPharmaceuticalRegulation

CellAct Pharma receives orphan drug designation in EU for cancer drug

CellAct Pharma receives orphan drug designation in EU for cancer drug

16-07-2014

The European Medicines Agency’s Committee for Orphan Medicinal Products has granted German cancer specialists…

CAP7.1CellAct PharmaEuropeGermanyHepatologyOncologyPharmaceuticalRegulationTreatment of biliary tract cancers

Breakthrough therapy designation likely to positively influence oncologists

Breakthrough therapy designation likely to positively influence oncologists

15-07-2014

Breakthrough therapy designation is likely to positively influence perceptions of the drug for both oncologists…

Decision Resources GroupOncologyPharmaceuticalRegulationUSA

Ariad says PRAC requires additional data on Iclusig

Ariad says PRAC requires additional data on Iclusig

15-07-2014

US specialty pharma firm Ariad Pharmaceuticals says that the Pharmacovigilance Risk Assessment Committee…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalPharmacovigilance Risk Assessment CommitteeRegulation

UK cancer patients face increasing coverage restriction, US report shows

UK cancer patients face increasing coverage restriction, US report shows

11-07-2014

New US research released yesterday quantifies the extent to which centralized value assessments by the…

OncologyPharmaceuticalPricingRegulationUK

Bristol-Myers to file Opdivo BLA earlier than expected

Bristol-Myers to file Opdivo BLA earlier than expected

10-07-2014

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third…

Bristol-Myers SquibbnivolumabOncologyOpdivoPharmaceuticalRegulationUSA

Novartis receives fifth Breakthrough Therapy designation with CTL019 for leukemia

Novartis receives fifth Breakthrough Therapy designation with CTL019 for leukemia

08-07-2014

Swiss drug major Novartis has been granted Breakthrough Therapy designation for its leukemia treatment…

CancerCTL019LeukemiaNovartisOncologyPharmaceuticalRefractory acute lymphoblastic leukemiaRegulationUSA

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

07-07-2014

US-based pharmaceutical company CASI, which develops therapeutics for the treatment of cancer and other…

CASIENMD-2076Hepatocellular carcinomaOncologyPharmaceuticalRegulationUSA

GSK receives EU approval for Mekinist for melanoma

GSK receives EU approval for Mekinist for melanoma

04-07-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s Mekinist…

EuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulation

Japan first to approve Roche’s lung cancer drug alectinib

Japan first to approve Roche’s lung cancer drug alectinib

04-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Swiss pharma major Roche’s alectinib…

alectinibJapanOncologyPharmaceuticalRegulationRoche

FDA approves Spectrum’s Beleodaq for PTCL

FDA approves Spectrum’s Beleodaq for PTCL

04-07-2014

Under its accelerated approval program, the US Food and Drug Administration late yesterday cleared Spectrum…

BeleodaqbelinostatOncologyPharmaceuticalRegulationSpectrum PharmaceuticalsTopotargetUSA

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

03-07-2014

The European Commission has granted marketing authorization for a new indication for the use of UK pharma…

ArzerraEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

Eisai’s breast cancer drug Halaven receives MAA in Europe

Eisai’s breast cancer drug Halaven receives MAA in Europe

03-07-2014

The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from…

EisaiEuropeHalavenOncologyPharmaceuticalRegulation

Ipsen files sNDA for Somatuline for GEP-NETs

Ipsen files sNDA for Somatuline for GEP-NETs

01-07-2014

French drugmaker Ipsen has submitted a Supplemental New Drug Application to the US Food and Drug Administration…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

EMA accepts Merck’s pembrolizumab MAA for review

EMA accepts Merck’s pembrolizumab MAA for review

01-07-2014

US pharma giant Merck & Co says that the European Medicines Agency has accepted for review a Marketing…

EuropeMerck & CoOncologypembrolizumabPharmaceuticalRegulation

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

30-06-2014

Positive results have been announced by US pharma giant Merck & Co from a global, investigational Phase…

EmendMerck & CoOncologyPharmaceuticalRegulationResearch

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

UK’s NICE draft guidance backs Novartis’ Glivec for GISTs

UK’s NICE draft guidance backs Novartis’ Glivec for GISTs

27-06-2014

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

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

Eisai files first marketing application for lenvatinib in Japan

Eisai files first marketing application for lenvatinib in Japan

26-06-2014

Japanese pharma major Eisai said today that it has submitted its first marketing authorization application…

EisaiJapanlenvatinibOncologyPharmaceuticalRegulation

Negative view from FDA advisory for AstraZeneca’s olaparib

Negative view from FDA advisory for AstraZeneca’s olaparib

26-06-2014

There was disappointment for Anglo-Swedish pharma major AstraZeneca yesterday when a US Food and Drug…

AstraZenecaLynparzaolaparibOncologyPharmaceuticalRegulationUSA

FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication

FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication

23-06-2014

The US Food and Drug Administration is warning that the intravenous chemotherapy drug docetaxel contains…

docetaxelOncologyPharmaceuticalRegulationUSA

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

20-06-2014

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s oral…

BayerJapanNexavarOncologyPharmaceuticalRegulation

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