Regulation - Vaccines, Oncology


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CHMP positive opinion for GSK’s Cervarix two-dose schedule

CHMP positive opinion for GSK’s Cervarix two-dose schedule


UK pharma giant GlaxoSmithKline says that the European Medicines Agency's Committee for Medicinal Products…


Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine


US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from…

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

Positive CHMP recommendations for Sanofi and Novartis, but not for Celgene


There was a batch of good news for two pharma companies and a negative opinion for one last Friday coming…


News briefs from Threshold, Merck KGaA and GSK


US biotech firm Threshold Pharmaceuticals (Nasdaq: THLD) said yesterday that data from a Phase IIb trial…

BiotechnologyErbituxEuropeGlaxoSmithKlineMerck KGaAMerck SeronoOncologyPharmaceuticalRegulationResearchSynflorixTH-302Threshold PharmaceuticalsVaccines

PDUFA Action Date for Astellas enzalutamide; Urogenix facility to close


The US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date…

Astellas PharmaenzalutamideGenito-urinaryMedivationOncologyPharmaceuticalRegulationResearchUrogenixVaccines

Batch of mixed opinions from FDA advisory panels


Advisory panels of the US Food and Drug Administration meeting yesterday came back with a mixture of…

carfilzomibKyprolisMerck & CoNorth AmericaOncologyOnyx PharmaceuticalsPfizerPharmaceuticalPneumovaxPrevnarRegulationSanofisemuloparinVaccines

Biovest to file for EU approval of BiovaxID, a personalized cancer vaccine


USA-based Biovest International (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals…

BiovaxIDBiovest InternationalEuropeOncologyPharmaceuticalRegulationVaccines

GSK and Novartis withdraw EU extended use applications for Tyverb and Fluad, respectively


The European Medicines Agency has been formally notified by UK pharma giant GlaxoSmithKline (LSE: GSK)…


FDA wants more info on Menveo; advisory negative on Dacogen


Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter…

Astex PharmaceuticalsDacogenEisaiMenveoNorth AmericaNovartisOncologyPharmaceuticalRegulationVaccines

Daiichi Sankyo admits supply problem with flu vaccine; gains approval for silodosin in China


Japanese drug major Daiichi Sankyo (TYO: 4568) announced this week that its domestic subsidiary, Kitasato…

Asia-PacificDaiichi SankyoMarkets & MarketingOncologyPharmaceuticalRegulationsilodosinVaccines

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