BioCentury | Mar 7, 2020
Product Development

Haste plus speed: the need to ensure COVID-19 vaccines don’t make infections worse

...cautioned. In Dengue, the phenomenon has held up vaccine development for several drug developers (see “Dengvaxia’s...
BioCentury | Jan 1, 2020
Company News

Fewer FDA approvals in 2019, but a basket of firsts

...FDA granted its first approvals of vaccines for two tropical viruses this year: Dengue vaccine Dengvaxia...
...golodirsen (SRP-4053) Zolgensma, onasemnogene abeparvovec-xioi, ScAAV9.CB.SMN (AVXS-101, charisma) crizanlizumab (SEG101, selg1) Piqray, alpelisib (BYL719) Zulresso, brexanolone (sage-547) Dengvaxia (Tetravalent dengue vaccine, cyd-tdv, ChimeriVax-Dengue) Recombinant...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

...NASDAQ:SNY) EC approves Zynquista sotagliflozin to treat Type I diabetes Sanofi (Euronext:SAN; NASDAQ:SNY) FDA approves Dengvaxia...
BioCentury | May 2, 2019
Company News

Competition looms as Sanofi vaccine gets FDA's first dengue approval in narrow population

...FDA approved Sanofi's dengue fever vaccine Dengvaxia in a narrower population than the pharma had sought...
...tropical disease voucher program. Dengvaxia was itself reviewed under Priority Review. The European Commission approved Dengvaxia...
...Officials Face Criminal Charges in Philippines for Dengvaxia Deaths" ). Paul Bonanos, Assistant Editor Dengvaxia (Tetravalent dengue vaccine, cyd-tdv, ChimeriVax-Dengue) TAK-003...
BioCentury | Apr 6, 2019
Finance

Big caps under pressure

...Products S.A. de C.V. Tesofensine Treat obesity Submit Mexican NDA 2Q19 Sanofi (Euronext:SAN; NASDAQ:SNY) Dengvaxia tetravalent dengue vaccine...
BioCentury | Mar 8, 2019
Company News

FDA panel does not back broad reach of Sanofi's dengue vaccine

...Charges in Philippines for Dengvaxia Deaths" ). A series of long-term studies in 2017 found Dengvaxia...
...dengue-naïve or seronegative children. Sanofi took the findings into account in its BLA, which seeks Dengvaxia's...
...vaccination should not be recommended (see “Dengvaxia’s Warning” ). Elizabeth S. Eaton, Staff Writer Dengvaxia (Tetravalent dengue vaccine, cyd-tdv, ChimeriVax-Dengue) Sanofi...
BioCentury | Mar 8, 2019
Company News

Sanofi, government officials face criminal charges in Philippines for Dengvaxia deaths

...criminal charges related to the deaths of 10 children allegedly linked to Sanofi's dengue vaccine Dengvaxia...
...Sanofi said vaccination should not be recommended (see “Dengvaxia’s Warning” ). The European Commission approved Dengvaxia...
...under Priority Review; its PDUFA date is May 1. Elizabeth S. Eaton, Staff Writer Dengvaxia (Tetravalent dengue vaccine, cyd-tdv, ChimeriVax-Dengue) Sanofi Dengue...
BioCentury | Mar 1, 2019
Politics & Policy

Sanofi, government officials face criminal charges in Philippines for Dengvaxia deaths

...criminal charges related to the deaths of 10 children allegedly linked to Sanofi's dengue vaccine Dengvaxia...
...Sanofi said vaccination should not be recommended (see “Dengvaxia’s Warning” ). The European Commission approved Dengvaxia...
...the vaccine under Priority Review; its PDUFA date is May 1. Elizabeth S. Eaton Dengvaxia (Tetravalent dengue vaccine, cyd-tdv, ChimeriVax-Dengue) Sanofi...
BioCentury | Feb 1, 2019
Clinical News

Takeda's tetravalent dengue vaccine meets in Phase III

...dengue fever caused by any of the four serotypes of the virus. TAK-003 is a tetravalent dengue vaccine...
...is May 1. The European Commission approved Dengvaxia in December. In 2017, long-term studies of Dengvaxia...
...and exacerbated dengue infection in some dengue-naïve or seronegative children instead of protecting them (see "Dengvaxia’s...
BioCentury | Jan 12, 2019
Finance

We all fall down

...talazoparib to treat breast cancer with a germline BRCA mutation Sanofi (Euronext:SAN; NASDAQ:SNY) EC approves Dengvaxia...
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