22:29 , Mar 21, 2018 |  BC Extra  |  Company News

Weather delay for achondroplasia meeting

FDA postponed until further notice the March 22 joint meeting of the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) due to inclement weather. The committees are slated to discuss drug...
22:23 , Apr 6, 2017 |  BC Innovations  |  Targets & Mechanisms

Competing for growth

With little in the clinical pipeline for achondroplasia beyond BioMarin Pharmaceutical Inc.’s late-stage vosoritide, startups Therachon AG and BioClin Therapeutics Inc. are rethinking how to tackle the disease. By targeting FGFR3 directly, the two companies...
23:02 , Dec 14, 2016 |  BC Week In Review  |  Clinical News

Vosoritide: Ph III started

BioMarin began a double-blind, placebo-controlled, international Phase III trial to evaluate daily vosoritide for 52 weeks in about 110 patients ages 5-14. Patients who complete the trial may be eligible to enroll in an open-label...
07:00 , Apr 13, 2015 |  BC Week In Review  |  Clinical News

Cenderitide: Completed Phase II enrollment

Capricor completed enrollment of 14 patients in an open-label, dose-escalation, U.S. Phase II trial evaluating 0.5, 1, 2 and 3 ng/kg/min cenderitide given as a 48-hour continuous, subcutaneous infusion via Insulet’s OmniPod drug delivery system...
07:00 , Mar 9, 2015 |  BC Week In Review  |  Clinical News

Cenderitide: Phase II started

Capricor began an open-label, dose-escalation, U.S. Phase II trial to evaluate 0.5, 1, 2 and 3 ng/kg/min cenderitide given as a 48-hour continuous infusion via the Insulet Drug Delivery System for up to 8 days...
08:00 , Nov 24, 2014 |  BC Week In Review  |  Company News

Medtronic, Capricor Therapeutics deal

Capricor purchased Medtronic’s patent related to the formulation and pump delivery of natriuretic peptides to treat post-acute heart failure. Medtronic will receive a $100,000 upfront payment and is eligible for $7 million in milestones. Medtronic...
07:00 , Jul 15, 2013 |  BC Week In Review  |  Company News

Capricor, Nile Therapeutics deal

Capricor will reverse-merge with Nile in a stock deal. Nile will issue Capricor stockholders shares of Nile stock so that Capricor will own about 90% of the combined company, which will be called Capricor...
08:00 , Jan 2, 2012 |  BC Week In Review  |  Clinical News

Cenderitide: Phase I data

Top-line data from a placebo-controlled, U.S. Phase I trial in 58 patients with ADHF showed that subcutaneous infusions of cenderitide met the primary endpoint by achieving undisclosed target PK levels. Additionally, 24-hour subcutaneous infusions of...
07:00 , Oct 24, 2011 |  BC Week In Review  |  Clinical News

Cenderitide: Phase I ongoing

Nile completed dosing in a placebo-controlled, U.S. Phase I trial in 58 patients evaluating subcutaneous cenderitide. Patients received 2 bolus injections of cenderitide, or 2 fixed dose levels or a weight-based dose of cenderitide as...
07:00 , May 9, 2011 |  BC Week In Review  |  Clinical News

Cenderitide: Phase I started

Nile began a single-blind, placebo-controlled, U.S. Phase I trial in about 48 patients to evaluate subcutaneous cenderitide given as a bolus or an infusion delivered via subcutaneous pump technology from Medtronic Inc. (NYSE:MDT, Minneapolis,...