BioCentury | Feb 22, 2020
Product Development

Regenerative medicine for hearing loss makes quiet progress

While the late-stage programs for hearing loss are designed to protect cells in the inner ear, or help them recover from trauma, a growing number of early-stage therapies is aiming for a more dramatic outcome...
BioCentury | Nov 14, 2019
Company News

Nov. 13 Company Quick Takes: FDA panel rebuffs Jardiance; plus Nucala, Cellular Biomedicine, BeiGene, Autolus and Noile-Immune

Panel rebuffs Jardiance for Type I diabetes FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 Wednesday that available data do not support approval of Jardiance empagliflozin from Boehringer Ingelheim GmbH. The panel was asked...
BioCentury | Dec 5, 2018
Distillery Therapeutics

Hepatic

INDICATION: Non-alcoholic steatohepatitis (NASH) Patient sample and mouse studies suggest inhibiting the Notch pathway components HES1, γ secretase, MAML1 and NCSTN could help treat NASH. In NASH patient liver tissue samples, hepatocyte levels of HES1...
BioCentury | Sep 19, 2018
Distillery Techniques

Drug platforms

TECHNOLOGY: Cell therapy A method for differentiating HSPCs into megakaryocytes by overexpressing or activating one of 15 genes could help generate platelet-producing megakaryocyte colonies for thrombocytopenia. The method involves two steps: generating megakaryocyte progenitor cells...
BioCentury | Jun 2, 2017
Product Development

Ears wide open

Based on unmet need alone, hearing loss should have been every bit as attractive to investors and drug developers as ophthalmic diseases, which entered a renaissance in the mid-2000s resulting in a multibillion-dollar market for...
BioCentury | Apr 13, 2017
Clinical News

Nucala: Ph III started

GlaxoSmithKline began a double-blind, placebo-controlled, international Phase III trial to compare 300 mg subcutaneous Nucala every 4 weeks plus standard of care (SOC) vs. SOC alone in about 80-120 patients ages ≥12. GSK markets Nucala...
BioCentury | Apr 7, 2017
Emerging Company Profile

Up a notch

By targeting a protein all Notch receptors use to turn on oncogenes, Cellestia Biotech AG ’s molecules could treat more patients than therapies against individual Notch receptors or ligands, with less toxicity than other pan-Notch...
BioCentury | Sep 22, 2016
Distillery Therapeutics

Therapeutics: Notch signaling pathway; hairy and enhancer of split1 (HES1)

Cancer INDICATION: Sarcoma In vitro and mouse studies suggest inhibiting Notch signaling could help treat dedifferentiated liposarcoma. In patient tissue samples, levels of the Notch pathway ligand HES1 were higher in tumors than in normal...
BioCentury | Mar 3, 2016
Translation in Brief

Notching up differences

A study in Cancer Research from the University of Queensland suggests that Notch 4 might be an outlier in the Notch family of proteins that are commonly thought of as oncogenes. By showing Notch 4...
BioCentury | Nov 10, 2014
Clinical News

Mepolizumab regulatory update

GlaxoSmithKline submitted a BLA to FDA and an MAA to EMA for mepolizumab as a maintenance treatment for severe eosinophilic asthma in patients with a history of exacerbations. The BLA covers patients ages >=12 years...
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