BioSpace News Archive

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Company Initiates Pivotal Clinical Study for Next Generation Deep Venous Stent

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that its gammaCore non-invasive vagus nerve stimulator (nVNS) has been selected for evaluation in a randomized controlled study for the treatment of opioid use disorders. The study is being run by Dr. Douglas Bremner at Emory University in collaboration with the Georgia Institute of Technology and the City University of New York and is supp

VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) announced today the peer reviewed publication of long-term safety and efficacy data for ZILXI™ (minocycline) topical foam, 1.5% in the Journal of Clinical and Aesthetic Dermatology (JCAD)

Sensus Healthcare, Inc. announces the publication of a prospective clinical study showing that a single low dose of superficial radiation therapy following excision of 14 keloids had an approximate 6.25% recurrence rate at six months, and for the 10 patients available for follow-up at 24 months none of the keloids had recurred.

– 40 Percent of Patients Treated with Mitapivat Achieved a Sustained Hemoglobin Increase of ≥1.5 g/dL Compared to 0 Placebo Patients (p <0. 0001 ) – – Safety Profile Consistent with Previously Reported Data – – Topline Data from the Mitapivat Phase 3 ACTIVATE -T Trial in Regularly Transfused PK Deficiency Expected in Q1 2021 –

On Track for Completing the BLA Submission in 1H2021 All PPQ Drug Substance and Drug Product Activities for Man ufacturing Now Successfully Completed Data from Phase 3 Propel Study Expected 1Q2021

Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to study the use of CERC-803 to treat Leukocyte Adhesion Deficiency Type II (LAD II). The company plans to initiate a pivotal trial of

BioCardia®, Inc. [Nasdaq: BCDA] today announced that the Company’s proprietary Helix Biotherapeutic Delivery System (the Helix System) demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery in an in-press corrected proof published in the journal, Cardiovascular Revascularization Medicine

Completion of rolling submission for the BLA expected in 1H2 1 NDA for u mbralisib monotherapy currently under review with the FDA ; PDUFA goal date of February 15, 2021 for MZL and June 15, 2021 for FL