Regulation - Anti-virals, Vaccines


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

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


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


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


US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…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


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


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


AstraZeneca’s Fluenz Tetra cleared in EU

AstraZeneca’s Fluenz Tetra cleared in EU


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


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


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


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


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


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


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


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


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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