BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | 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, reflecting an advisory panel's conclusions in March and leaving the door open to vaccines in Phase III testing to...
BioCentury | Apr 6, 2019
Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
BC Extra | Mar 8, 2019
Company News

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

Sanofi's dengue vaccine did not win the support of an FDA panel for its proposed population of individuals ages 9-45 Thursday, but the panel did back the vaccine's use in adolescents. The vote came as...
BC Week In Review | Mar 8, 2019
Company News

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

The Philippines Department of Justice found probable cause to indict 20 people, including Sanofi (Euronext:SAN; NASDAQ:SNY) employees and government officials, on criminal charges related to the deaths of 10 children allegedly linked to Sanofi's dengue...
BC Extra | Mar 1, 2019
Politics & Policy

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

The Philippines Department of Justice found probable cause to indict 20 people, including Sanofi (Euronext:SAN; NASDAQ:SNY) employees and government officials, on criminal charges related to the deaths of 10 children allegedly linked to Sanofi's dengue...
BC Week In Review | Feb 1, 2019
Clinical News

Takeda's tetravalent dengue vaccine meets in Phase III

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) said TAK-003 met the primary endpoint in Part 1 of the Phase III TIDES (DEN-301) trial to prevent dengue fever caused by any of the four serotypes of the...
BC Week In Review | Nov 2, 2018
Clinical News

Sanofi gets Priority Review for dengue vaccine

Sanofi (Euronext:SAN; NYSE:SNY) said FDA accepted and granted Priority Review to a BLA for Dengvaxia dengue tetravalent vaccine. The PDUFA date is May 1, 2019. If approved, Dengvaxia "would represent the first and only medical...
BC Extra | Oct 30, 2018
Company News

Sanofi gets Priority Review for dengue vaccine

Sanofi (Euronext:SAN; NYSE:SNY) said FDA accepted and granted Priority Review to a BLA for Dengvaxia dengue tetravalent vaccine. The PDUFA date is May 1, 2019. If approved, Dengvaxia "would represent the first and only medical...
BC Week In Review | Oct 26, 2018
Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks...
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