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EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

17-03-2014

The president of pharma giant Merck & Co’s (NYSE: MRK) operations in Europe and Canada Bruno Strigini…

Anti-viralsCanadaDiabetesEuropeInterviewsMerck & CoMK-3475OncologyPharmaceuticalRegulationUKVaccines

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

Dynavax withdraws European MAA for Heplisav

18-02-2014

US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

03-01-2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers…

Anti-viralsAntibiotics and Infectious diseasesAsia-PacificBioKangtaiChinaFluconazolePfizerPharmaceuticalRegulationVaccines

China bans BioKangtai hepatitis B vaccine

26-12-2013

Chinese authorities on Friday issued a circular to ban the use of the recombinant hepatitis B vaccine…

Anti-viralsAsia-PacificBioKangtaiChinaHealthcarePharmaceuticalRegulationVaccines

AstraZeneca’s Fluenz Tetra cleared in EU

AstraZeneca’s Fluenz Tetra cleared in EU

06-12-2013

The European Commission has granted Marketing Authorization to Fluenz Tetra, the product’s maker Anglo-Swedish…

Anti-viralsAstraZenecaEuropeFluenz TetraPharmaceuticalRegulationVaccines

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

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

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

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

EMA accepts Dynavax' filing for hep B drug Heplisav

23-08-2012

US biotech firm Dynavax Technologies (Nasdaq: DVAX) revealed yesterday that the European Medicines Agency…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

EU Commission OKs Baxter Avian flu vaccine Vepacel; drops GSK probe

05-03-2012

US drugmaker Baxter International (NYSE:BAX) says that the European Commission has granted marketing…

Anti-viralsBaxter InternationalEuropeGlaxoSmithKlineLegalPharmaceuticalRegulationSynthonVaccinesVepacel

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

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