BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

BioMarin's hemophilia gene therapy gets Priority Review BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) could become the first company to have a hemophilia gene therapy approved in the U.S. FDA accepted and granted Priority Review to a BLA...
BioCentury | Feb 8, 2020
Product Development

Coronavirus biology: where products in clinical testing intervene

The 13 therapies in clinical trials to treat coronavirus map to at least half a dozen mechanisms, intervening at three different steps in the viral cycle or manipulating different aspects of the host immune response....
BioCentury | Oct 4, 2019
Company News

Narrower Descovy label for PrEP unlikely to hamper Gilead

While FDA's approval of Gilead’s Descovy to reduce the risk of HIV-1 infection does not include the cisgender women population as expected, the narrower label is unlikely to significantly affect sales. The agency approved Thursday...
BioCentury | Aug 5, 2019
Company News

Aug. 5 Company Quick Takes: Briefing docs for Descovy cast doubt on full PrEP approval; plus Alnylam, Provention and more

FDA questions Descovy as PrEP in cis women Briefing documents released ahead of the Aug. 7 Antimicrobial Drugs Advisory Committee meeting for Descovy emtricitabine/tenofovir alafenamide from Gilead Sciences Inc. (NASDAQ:GILD) indicate that FDA is uncertain...
BioCentury | Jun 21, 2019
Company News

June 21 Company Quick Takes: FDA rejects Daiichi's AML candidate; plus Sanofi, Novartis and more

Complete response letter for Daiichi's quizartinib Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory...
BioCentury | May 10, 2019
Company News

May 10 Company Quick Takes: Red flags for Daiichi ahead of ODAC; plus JHL/Genentech, J&J, Gilead

FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib Despite both pexidartinib and quizartinib meeting the primary endpoints in their pivotal trials, FDA reviewers raised concerns about each agent from Daiichi Sankyo Co. Ltd. (Tokyo:4568) in...
BioCentury | Apr 5, 2019
Company News

Gilead sees Descovy as successor to Truvada for HIV PrEP

With Truvada’s patent expiration imminent, Gilead is looking to Descovy to extend its hold on the HIV prevention market. Gilead Sciences Inc. (NASDAQ:GILD) said Friday it submitted an sNDA to FDA for Descovy emtricitabine/tenofovir alafenamide...
BioCentury | Mar 22, 2019
Clinical News

Descovy non-inferior to Truvada for HIV prevention

Gilead reported on March 6 that once-daily Descovy emtricitabine/tenofovir alafenamide met the primary endpoint of non-inferiority to once-daily Truvada emtricitabine/tenofovir in the Phase III DISCOVER trial to prevent HIV infection. Gilead Sciences Inc. (NASDAQ:GILD) said...
BioCentury | Dec 7, 2018
Clinical News

China approves Descovy, Harvoni, Hemlibra

China's National Medical Products Administration (NMPA) has issued new approvals for three drugs marketed in the U.S. and EU: Descovy emtricitabine/tenofovir alafenamide and Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), and Hemlibra emicizumab-kxwh from Roche...
BioCentury | Dec 4, 2018
Company News

China approves Descovy, Harvoni, Hemlibra

China's National Medical Products Administration (NMPA) has issued new approvals for three drugs marketed in the U.S. and EU: Descovy emtricitabine/tenofovir alafenamide and Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), and Hemlibra emicizumab-kxwh from Roche...
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