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

16-06-2014

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

FlucelvaxNovartisPharmaceuticalProductionRegulationUSAVaccines

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

21-03-2014

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

BexseroNorthern EuropeNovartisPharmaceuticalRegulationUKVaccines

Novartis MenB vaccine approved in Australia

15-08-2013

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

Asia-PacificBexseroNovartisPharmaceuticalRegulationVaccines

FDA expands age indication for Menveo, quadrivalent meningococcal vaccine

02-08-2013

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

22-01-2013

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

21-11-2012

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

19-11-2012

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

BexseroBiotechnologyCelgeneDiabetesEuropeIstodaxLyxumiaNovartisOncologyPharmaceuticalRegulationSanofiVaccinesZaltrap

News briefs from Sanofi, Biogen/SOBI and Novartis

01-11-2012

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

29-10-2012

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

16-02-2012

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

EuropeFluadGlaxoSmithKlineNovartisOncologyPharmaceuticalRegulationTyverbVaccines

FDA wants more info on Menveo; advisory negative on Dacogen

13-02-2012

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

17-11-2011

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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