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

...of all four of the CDC's PrEP patents covering HIV drugs Truvada emtricitabine/tenofovir and Descovy emtricitabine/tenofovir alafenamide...
...CDC filed suit in November seeking royalties and damages from Gilead, asserting that Truvada and Descovy...
...SLC18A2) - Vesicular monoamine transporter 2 BioCentury Staff valoctocogene roxaparvovec (bmn 270) Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy...
BioCentury | Feb 8, 2020
Product Development

Coronavirus biology: where products in clinical testing intervene

...GS-5734 Tamiflu, oseltamivir (GS 4104, Ro 64-0796) Kaletra, lopinavir/ritonavir (ABT-378/r) Avigan, favipiravir (T-705) Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy...
BioCentury | Jan 25, 2020
Company News

Jan. 24 Company Quick Takes: Tecentriq misses in bladder cancer; plus Gilead-CDC and PureTech

...in documents filed Thursday that CDC’s four patents for HIV drugs Truvada emtricitabine/tenofovir and Descovy emtricitabine/tenofovir alafenamide...
BioCentury | Nov 7, 2019
Politics & Policy

Gilead to seek pause in U.S. government HIV PrEP suit until patent office rules on patent validity

...to pause a patent infringement lawsuit the federal government filed against the company’s Truvada and Descovy...
...the U.S. District Court for the District of Delaware, asserts that in marketing Truvada and Descovy...
...filed by the CDC. It seeks royalties and payments for damages from Gilead. Truvada and Descovy...
BioCentury | Oct 9, 2019
Politics, Policy & Law

Long-term data help two drugs sway ICER in drug price report

...was new evidence of added benefit over existing treatments based on long-term data. For Genvoya elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...
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...
...consensus sales for Descovy at $1.5 billion this year and $3 billion in 2023, assuming Descovy...
...about 10% of PrEP patients on Truvada. Jonathan Block, Associate Editor Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy...
BioCentury | Aug 23, 2019
Company News

Aug. 22 Company Quick Takes: Innovent, Lilly in biologics deal; plus Sobi, Gilead, Themis-Merck, Iconic-Novartis, GW, BeiGene, Clearside, Inex Innovations

...the infection; two weeks ago FDA’s Antimicrobial Drugs Advisory Committee backed Gilead's HIV therapy Descovy emtricitabine/tenofovir alafenamide...
BioCentury | Aug 10, 2019
Company News

Aug. 9 Company Quick Takes: Nektar, Novo, Biktarvy, Autolus and more

...HIV drug Biktarvy Gilead Sciences Inc. (NASDAQ:GILD) said China's National Medical Products Administration approved Biktarvy bictegravir/emtricitabine/tenofovir alafenamide...
...to for a U.S. launch in 1Q20. Val Kennedy, Associate Editor and Mary Romeo, Assistant Editor Biktarvy, bictegravir/emtricitabine/tenofovir alafenamide Ozempic...
BioCentury | Aug 8, 2019
Company News

Aug. 7 Company Quick Takes: Panel backs narrower PrEP label for Descovy; plus Teva, Blueprint, DBV and more

...FDA panel backs narrower PrEP label for Descovy FDA’s Antimicrobial Drugs Advisory Committee voted 16 to...
...voted 16 to 2 that Gilead Sciences Inc. (NASDAQ:GILD) has provided sufficient evidence that Descovy emtricitabine/tenofovir alafenamide...
...were uncertain whether data supported the candidate's efficacy in the population (see “ Gilead Sees Descovy...
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...
...Briefing documents released ahead of the Aug. 7 Antimicrobial Drugs Advisory Committee meeting for Descovy emtricitabine/tenofovir alafenamide...
...undisclosed. Targets: ALAS-1 - Aminolevulinate synthase-1 Elizabeth S. Eaton, Staff Writer Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy...
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