22:28 , Jul 2, 2019 |  BC Extra  |  Company News

July 2 Company Quick Takes: Gilead's Truvada REMS removed; plus UC, Amicus/Paragon and Iovance

FDA removes REMS for Truvada  FDA said it is eliminating the REMS for Truvada emtricitabine/tenofovir from Gilead Sciences Inc. (NASDAQ:GILD) and its four generics approved for pre-exposure prophylaxis (PrEP), which required manufacturers to provide educational...
23:16 , Jun 21, 2019 |  BC Extra  |  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...
21:57 , May 16, 2019 |  BC Extra  |  Company News

Gilead defends Truvada pricing during House hearing

Chairman and CEO Daniel O'Day defended Gilead's pricing of HIV PrEP drug Truvada at a congressional hearing Thursday. Democrats led by House Oversight and Reform Committee Chair Elijah Cummings (D-Md.) pressed O'Day on the price...
23:56 , May 14, 2019 |  BC Extra  |  Tools & Techniques

May 14 P&P Quick Takes: German council weighs in on germline editing; plus Gilead’s Truvada, U.K. R&D tax

German committee outlines recs for human germline editing  The German Ethics Council took a positive stand towards eventual use of germline editing, with a report that starts to map a path forward; however, the council...
21:57 , May 10, 2019 |  BC Extra  |  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...
00:06 , May 3, 2019 |  BC Extra  |  Company News

O’Day touts cell therapies as Gilead beats on EPS

On his first earnings call as CEO of Gilead, Daniel O'Day said more M&A and deals by the bellwether within cell therapy are "fundamental and essential" as the company reported 1Q19 earnings Thursday that beat...
18:55 , Apr 12, 2019 |  BC Week In Review  |  Company News

FDA approves ViiV's two-drug HIV regimen

FDA approved Viiv's Dovato dolutegravir/lamivudine for HIV-1 infection in treatment-naïve adults. The product is a once-daily, single-tablet regimen of dolutegravir and lamivudine that the company plans to launch in 2-3 weeks at a wholesale acquisition...
00:04 , Apr 6, 2019 |  BioCentury  |  Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
21:39 , Apr 5, 2019 |  BC Extra  |  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...
21:38 , Mar 28, 2019 |  BC Extra  |  Politics & Policy

China lists 30 more overseas drugs eligible for Priority Review

China’s Drug Evaluation Center posted a second batch of drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China. Fourteen of the 30 drugs on the list...