Regulation - Vaccines, Novartis


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FDA licenses Novartis facility to produce cell-culture influenza vaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines


The US Food and Drug Administration has licensed Swiss pharma major Novartis’ manufacturing facility…


UK about turn, as JCVI now recommends meningitis B vaccination for infants


The UK’s Joint Committee on Vaccination and Immunization has recommended that the meningitis B vaccine…

BexseroNorthern EuropeNovartisPharmaceuticalRegulationUKVaccines

Novartis MenB vaccine approved in Australia


Swiss drug major Novartis (NOVN: VX) revealed this morning (August 15) that the Australian Therapeutic…


FDA expands age indication for Menveo, quadrivalent meningococcal vaccine


The US Food and Drug Administration late yesterday (August 1) approved Swiss drug major Novartis' (NOVN:…

MenveoNorth AmericaNovartisPharmaceuticalRegulationVaccines

EU approval for Novo Nordisk's Tresiba and Ryzodeg and for Novartis' for Bexsero


Following positive recommendations from the European Medicines Agency's advisory committee, the European…

BexseroDiabetesEuropeNovartisNovo NordiskPharmaceuticalRegulationRyzodegTresibaVaccines

FDA approves Novartis' Flucelvax, first seasonal flu vaccine using cell culture technology


The US Food and Drug Administration yesterday approved Swiss drug major Novartis' (NOVN: VX) Flucelvax,…

FlucelvaxNorth AmericaNovartisPharmaceuticalProductionRegulationVaccines

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 Sanofi, Biogen/SOBI and Novartis


French drug major Sanofi (Euronext: SAN) and subsidiary Genzyme have reported results from pivotal studies…

AgrippalBiogen IdecBiotechnologyFluadLemtradaNeurologicalNovartisPharmaceuticalRegulationResearchSanofiSwedish Orphan BiovitrumVaccines

Novartis' flu vaccines suspended in several countries on suspected quality issues


A number of European Union member states have halted the use, as a precautionary measure, of some anti-influenza…

AgrifluAgrippalEuropeFluadMarkets & MarketingNorth AmericaNovartisPharmaceuticalRegulationVaccines

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

FDA approves Incytes’ Jakafi, first drug to treat MF; advisory panel backs Pfizer’s Prevnar 13 for adults


USA-based Incyte (Nasdaq: INCY) saw its shares rise 10% to$13.90 on the news that the Food and Drug Administration…

BiotechnologyIncyteJakafiNorth AmericaNovartisPfizerPharmaceuticalPrevnarRare diseasesRegulationruxolitinibVaccines

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