BioCentury | May 19, 2020
Product Development

May 18 Quick Takes: ChemoCentryx’s Phase II miss; plus Teva, Zai-Novocure, Lava-J&J, Sanofi, Rhythm, ViiV

...not expect an advisory committee meeting (see “Data Set Up Submissions” ). Cabotegravir non-inferior to Truvada...
...Healthcare Ltd. said long-acting, injectable cabotegravir met the primary endpoint of non-inferiority to SOC Truvada emtricitabine/tenofovir...
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...
...invalid. Separately, CDC filed suit in November seeking royalties and damages from Gilead, asserting that Truvada...
...monoamine transporter 2 BioCentury Staff valoctocogene roxaparvovec (bmn 270) Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy (Other) Truvada, emtricitabine/tenofovir elafibranor...
BioCentury | Feb 8, 2020
Product Development

Coronavirus biology: where products in clinical testing intervene

...9 Sandi Wong, Assistant Editor remdesivir, GS-5734 Tamiflu, oseltamivir (GS 4104, Ro 64-0796) Kaletra, lopinavir/ritonavir (ABT-378/r) Avigan, favipiravir (T-705) Descovy (Brand), emtricitabine/tenofovir...
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...
...in patients while avoiding side effects (see “Schizophrenia Combo Clears Phase II Bar” ). BioCentury Staff Truvada, emtricitabine/tenofovir Tecentriq...
BioCentury | Nov 7, 2019
Politics & Policy

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

...federal court to pause a patent infringement lawsuit the federal government filed against the company’s Truvada...
...government in the U.S. District Court for the District of Delaware, asserts that in marketing Truvada...
...studies on emtricitabine/tenofovir as PrEP. The government’s suit contends that prior to FDA approval of Truvada...
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...
...data from randomized controlled trials to ICER that showed that Genvoya was superior to Stribild elvitegravir/cobicistat/emtricitabine/tenofovir...
...price increase, $688 million total cost increase) and Cialis tadalafil (33%, $403 million); Gilead’s Truvada emtricitabine/tenofovir...
BioCentury | Oct 4, 2019
Company News

Narrower Descovy label for PrEP unlikely to hamper Gilead

...follow-on to Truvada for PrEP as Truvada's patent expires in 2021. An authorized generic of Truvada...
...market next September (see "Gilead sees Descovy as Successor to Truvada for HIV PrEP" ). Truvada’s...
...PrEP patients on Truvada. Jonathan Block, Associate Editor Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy (Other) Truvada, emtricitabine/tenofovir Gilead...
BioCentury | Aug 29, 2019
Translation in Brief

Cytomegalovirus vectors for a prophylactic HIV vaccine

...virus postinfection, they are also looking at ways to prevent HIV infection. Antiretroviral drug Truvada emtricitabine/tenofovir...
...is dependent on a patient’s adherence to daily dosing, and is associated with safety issues. Truvada's...
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

...2015. Gilead said published materials describe the invention as early as 2004. The company's Truvada emtricitabine/tenofovir...
...the infection; two weeks ago FDA’s Antimicrobial Drugs Advisory Committee backed Gilead's HIV therapy Descovy emtricitabine/tenofovir...
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...
...to for a U.S. launch in 1Q20. Val Kennedy, Associate Editor and Mary Romeo, Assistant Editor Biktarvy, bictegravir/emtricitabine/tenofovir...
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