BioCentury | Nov 17, 2020
Regulation

Alkermes expects quick resolution to FDA setback for antipsychotic

Alkermes expects a swift resolution to a manufacturing issue that led to FDA’s issuance of a complete response letter for ALKS 3831, but the company isn’t yet committing to a launch timeline for the antipsychotic...
BioCentury | Oct 13, 2020
Product Development

Oct. 13 Quick Takes: J&J pauses dosing in COVID-19 vaccine trials; plus Voyager, Avenue and Surface Oncology

J&J pauses COVID-19 vaccine trial dosing Johnson & Johnson (NYSE:JNJ) said it has temporarily paused dosing on its COVID-19 vaccine trials, including the Phase III ENSEMBLE trial, due to “an unexplained illness in a study participant,”...
BioCentury | Oct 8, 2020
Product Development

COVAX nears $2B fund-raising goal for equitable vaccine distribution; plus Novartis-Merck KGaA, 10x Genomics, Alkermes, UCB-Aetion, Janpix, BeiGene-BioAtla, Phenomic AI

COVAX nearing $2B fund-raising goal for equitable vaccine distributionThe U.K., Canada, Germany, Italy and Sweden pledged $958 million to Gavi’s COVID-19 Vaccines Advance Market Commitment (COVAX AMC), which seeks to ensure equitable access to COVID-19...
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...
BioCentury | Feb 1, 2020
Preclinical News

Cellular fluorescence assay to assess allosteric modulator potency in drug discovery

...developers applying the technique to identify compounds that interfere with protein-protein interactions, including dimers of opioid receptors...
BioCentury | 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 cell...
BioCentury | 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...
BioCentury | 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...
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