Regulation - Vaccines, North America

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US FDA clears GlaxoSmithKline’s H5N1 flu vaccine

26-11-2013

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s pandemic Influenza…

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

25-10-2013

Merck & Co yesterday provided an overview of the clinical trial program for V503, the company’s investigational…

Merck & CoNorth AmericaPharmaceuticalRegulationResearchV503Vaccines

GSK's Flulaval vaccine approved by US FDA

16-08-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has had its Flulaval quadrivalent intramuscular influenza…

FluarixFlulavalGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

US FDA approves shipment of quadrivalent flu vaccine to health care providers

06-08-2013

The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

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

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

11-06-2013

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

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

GlaxoSmithKline cleared for $91M flu vaccine plant in USA; Gets CRL on Q-Plan H5N1

27-03-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and The Texas A&M University System (TAMUS) say that the US…

GlaxoSmithKlineNorth AmericaPharmaceuticalProductionQ-Plan H5N1RegulationVaccines

FDA delays approval of Dynavax' Heplisav, issuing CRL

26-02-2013

Dynavax Technologies ( Nasdaq: DVAX) saw its shares plunge as much as 38% to $1.84 in pre-market trading…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavNorth AmericaRegulationVaccines

FDA approves Protein Sciences egg-free flu vaccine Flublok; and Octapharma's Octaplas

18-01-2013

The US Food and Drug Administration revealed it has approved privately-held US biotech firm Protein Sciences…

Anti-viralsBiotechnologyFlublokMergers & AcquisitionsNorth AmericaOctapharmaOctaplasPanblokPharmaceuticalProtein Sciences CorpRegulationVaccines

GlaxoSmithKline gains FDA approval of four-strain seasonal influenza vaccine

17-12-2012

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline's (LSE: GSK) Fluarix…

FluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Health Canada approves Vertex' Kalydeco; and Sanofi Pasteur's Menactra

03-12-2012

Vertex Pharmaceuticals (Nasdaq: VRTX) says that Health Canada has approved Kalydeco (ivacaftor), the…

BiotechnologyKalydecoMenactraNorth AmericaPharmaceuticalRare diseasesRegulationSanofiSanofi PasteurVaccinesVertex

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

FDA advisory panel backs GlaxoSmithKline H5N1 influenza vaccine candidate

15-11-2012

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC)…

GlaxoSmithKlineNorth AmericaPharmaceuticalPumarixRegulationVaccines

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

US FDA agrees to review Sanofi Pasteur's new quadrivalent influenza vaccine

18-10-2012

Sanofi Pasteur, the vaccines division of Sanofi (Euronext: SAN) says it has filed a supplemental Biologics…

Anti-viralsNorth AmericaPharmaceuticalRegulationSanofiSanofi PasteurVaccines

Batch of mixed opinions from FDA advisory panels

21-06-2012

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

carfilzomibKyprolisMerck & CoNorth AmericaOncologyOnyx PharmaceuticalsPfizerPharmaceuticalPneumovaxPrevnarRegulationSanofisemuloparinVaccines

FDA approves GlaxoSmithKline's new combo vaccine MenHibrix

18-06-2012

The US Food and Drug Administration has approved US pharma giant GlaxoSmithKline's (LSE: GSK) MenHibrix…

GlaxoSmithKlineMenHibrixNorth AmericaPharmaceuticalRegulationVaccines

FDA OKs first quadrivalent flu vaccine; and lower dose Angeliq

01-03-2012

Anglo-Swedish drug major AstraZeneca (LSE: AZN) US unit MedImmune's FluMist Quadrivalent, a vaccine to…

Anti-viralsNorth AmericaPharmaceuticalRegulationVaccinesWomen's Health

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

Expanded use for Pfizer’s Prevnar 13

03-01-2012

Following a previous US Food and Drug Administration advisory panel recommendation (The Pharma Letter…

North AmericaPfizerPharmaceuticalPrevnarRegulationVaccines

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