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....
BC Extra | Jan 25, 2020
Company News

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

Phase III miss for Tecentriq as adjuvant for bladder cancer   Genentech Inc. said Tecentriq atezolizumab as post-surgery adjuvant monotherapy vs. no intervention failed to improve disease-free survival, the primary endpoint in the Phase III...
BC Extra | Nov 7, 2019
Politics & Policy

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

Gilead plans to ask a federal court to pause a patent infringement lawsuit the federal government filed against the company’s Truvada and Descovy HIV pre-exposure prophylaxis (PrEP) drugs pending resolution of Gilead’s patent challenges by...
BioCentury | Oct 9, 2019
Politics, Policy & Law

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

An analysis by the Institute for Clinical and Economic Review of price increases for some of the costliest drugs in the U.S. has found that seven of nine were not supported by new clinical evidence,...
BC Extra | 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...
BC Innovations | Aug 29, 2019
Translation in Brief

Cytomegalovirus vectors for a prophylactic HIV vaccine

A spread-deficient cytomegalovirus carrying SIV antigens evoked long-term protective immunity against successive SIV infections in monkeys, suggesting that a prophylactic HIV vaccine can be developed in humans using a similar strategy. While academics and companies...
BC Extra | 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

Innovent, Lilly in third biologics deal  Innovent Biologics Inc. (HKEX:1801) in-licensed Chinese rights to OXM3 from Eli Lilly and Co. (NYSE:LLY) to treat diabetes. The oxyntomodulin analog -- a dual agonist of GLP-1R and GCGR...
BC Extra | Aug 10, 2019
Company News

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

Nektar tumbles on bempegaldesleukin revelation   Nektar Therapeutics (NASDAQ:NKTR) fell $8.65 (29%) to close at $20.92 after reporting during its 2Q19 earnings call late Thursday that it had connected decreasing responses seen in a trial...
BC Extra | 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 2 that Gilead Sciences Inc. (NASDAQ:GILD) has provided sufficient evidence that Descovy emtricitabine/tenofovir alafenamide is safe and effective for...
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