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49943 items
2:55 PM, Feb 13, 2018  |  BC Extra | Clinical News

Catabasis gains on 60-week DMD data

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) was up $0.31 (25%) to $1.56 on Tuesday after reporting that edasalonexent (CAT-1004) preserved muscle function and slowed disease progression through 60 weeks of treatment in an open-label extension of the...
2:53 PM, Feb 13, 2018  |  BC Extra | Company News

Cytobank, FDA using machine learning to classify MSCs

Cytobank Inc. (Santa Clara, Calif.) partnered with FDA to develop machine learning-based methods for characterization of mesenchymal stromal cell morphology that could be used to improve cellular manufacturing. The collaboration is based on experiments by...
2:52 PM, Feb 13, 2018  |  BC Extra | Company News

FDA approves second generic of thrice-weekly Copaxone

The Sandoz Ltd. unit of Novartis AG (NYSE:NVS; SIX:NOVN) and partner Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said FDA approved an ANDA for thrice-weekly 40 mg/mL Glatopa glatiramer acetate injection as a generic version of multiple sclerosis...
2:37 PM, Feb 13, 2018  |  BC Extra | Politics & Policy

FDA to hold rare disease workshop

FDA said it will hold a one-day public workshop on March 19 to solicit feedback on issues facing rare disease therapeutics developers, including best practices for adaptive study designs and analytic tools for trials with...
2:28 PM, Feb 13, 2018  |  BC Extra | Financial News

Catalyst prices $100M follow-on

Catalyst Biosciences Inc. (NASDAQ:CBIO) raised $100 million through the sale of 2.9 million shares at $34 in a follow-on underwritten by JonesTrading Institutional Services, Ladenburg Thalmann, LifeSci Capital and B. Riley FBR. The price is...
1:15 PM, Feb 13, 2018  |  BC Extra | Company News

EC approves Diurnal's Alkindi

Diurnal Group plc (LSE:DNL) said the European Commission approved Alkindi (Infacort) as a replacement therapy to treat adrenal insufficiency in individuals less than 18 years old. Diurnal plans to launch Alkindi in 2Q18, but told...
5:07 PM, Feb 12, 2018  |  BC Extra | Preclinical News

Study counters CRISPR-Cas9 variant concerns

A study by Wellcome Sanger Institute researchers showed CRISPR-Cas9 (CRISPR-associated protein 9) produced no unexpected off-target edits in mice, countering a 2017 report of high off-target activity and confirming doubts about that study's results from...
5:04 PM, Feb 12, 2018  |  BC Extra | Preclinical News

Vascular endothelial stem cells could enable regenerative therapy

In a study published in Cell Stem Cell, researchers at Osaka University and colleagues discovered a population of vascular endothelial cells that could be used as a regenerative therapy for vascular injury and hemophilia. The existence...
5:03 PM, Feb 12, 2018  |  BC Extra | Company News

Axovant falls as CEO, president depart

Axovant Sciences Ltd. (NASDAQ:AXON) fell $0.38 (20%) to $1.54 on Monday after it shuffled its management team and board of directors. The neurology company said David Hung resigned as CEO and a director to pursue...
4:56 PM, Feb 12, 2018  |  BC Extra | Company News

Management tracks: Cytokinetics, Surface Oncology

Musculoskeletal company Cytokinetics Inc. (NASDAQ:CYTK) appointed ex-FDA Commissioner Robert Califf to its board of directors. Califf is vice chancellor for health data science at Duke Health and director of the Center for Health Data Science...