BioCentury | Apr 21, 2020
Product Development

Cara’s pruritus therapy headed for submission after second Phase III readout

New Phase III data for its lead program will be part of Cara’s planned NDA submission this year of Korsuva to treat pruritus associated with chronic kidney disease. President and CEO Derek Chalmers said on...
BioCentury | Mar 10, 2020
Product Development

March 9 Quick Takes: A first for Boehringer’s Ofev; plus Cel-Sci’s COVID-19 therapy, Sinopharm, AZ, Urovant, Hengrui, Trevena, and Tetra-Shionogi

Boehringer’s Ofev approved as first therapy for lung scarring disease  FDA approved Ofev nintedanib from Boehringer Ingelheim GmbH as the first therapy for chronic fibrosing interstitial lung diseases; the NDA had received Priority Review. The...
BioCentury | Feb 22, 2020
Translation in Brief

Storm's open-access algorithm for RNA epigenetics; plus Duke studies show checkpoint blockers promote anti-HIV bNAbs and reduce opioid efficacy

Algorithm from Storm and academic collaborators for high-throughput analysis of RNA epigenetics  Storm Therapeutics Ltd. and collaborators at the University of Pennsylvania and the University of Tübingen have created a computational algorithm, Nucleic Acid Search...
BC Extra | Jan 29, 2020
Company News

Jan. 28 Company Quick Takes: Kite, Alkermes, Regeneron-Sanofi, Incyte, NantHealth-NantOmics, Sorrento, MicroCures, Paion-Mundipharma

Kite’s KTE-X19 under review in Europe   EMA has accepted an MAA for KTE-X19 from Kite, positioning the CAR T cell therapy from the Gilead Sciences Inc. (NASDAQ:GILD) unit to become the first CAR T...
BC Extra | Jan 15, 2020
Company News

Nektar to wind down subsidiary after withdrawing opioid NDA

Nektar's decision to withdraw its NDA for oxycodegol will spell the end of its Inheris subsidiary, which it created last year ahead of the therapy's planned launch. The company will not invest further in the...
BC Extra | Jan 14, 2020
Company News

Amid need for new pain options, FDA panel rebuffs Nektar’s ‘safer’ opioid

Regulators and physicians are urgently seeking novel pain therapeutics to combat the opioid crisis without compromising treatment availability for chronic pain patients, but according to an FDA panel, Nektar’s oxycodegol shouldn’t make the cut based...
BC Extra | Dec 4, 2019
Company News

Dec. 3 Company Quick Takes: Brii adds neuroscience focus; plus Immunomedics, Hanmi-Rapt, Luye-Boan and Cara

Brii steps into neuroscience  Cross-border biotech Brii Biosciences said it will begin developing neuroscience programs as its second therapeutic area of interest, adding to its original focus on infectious diseases. The Beijing, China, and Durham,...
BC Extra | Oct 23, 2019
Company News

With MS approval looming, Alkermes restructures to seek sustainable profits

Alkermes expects cost savings from a newly announced restructuring, combined with payments due to the company upon the anticipated approval of a new MS therapy, will allow it to maintain profitability in the coming years....
BC Innovations | Aug 22, 2019
Tools & Techniques

Digital makes its mark on cognition

Digital biomarkers of cognitive decline could be the antidote to the slop in the subjective tests on which clinical neurology programs often hinge. With proof of concept established in small clinical trials and bigger readouts...
BC Extra | Jul 25, 2019
Financial News

July 25 Financial Quick Takes: Livongo, Castle pop after IPOs; plus a K2HV-Evelo deal, earnings beats for AZ & Roche, and more

Livongo, Castle rise in first trading day  Livongo Health inc. (NASDAQ:LVGO) and Castle Biosciences Inc. (NASDAQ:CSTL) each posted gains in their first day of trading Thursday after pricing upsized IPOs. Digital health play Livongo added...
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