Investors propelled shares of Cara Therapeutics Inc. (NASDAQ:CARA) to a one-year high Thursday after the company reported top-line results from the phase II trial of lead kappa opioid agonist CR845, which hit its primary endpoint in treating moderate to severe uremic pruritus (UP). Read More
Biosimilar sponsors are looking to put their best foot forward now that the Federal Circuit has agreed with a lower court that they don't have to dance to the tune of the Biologic Price Competition and Innovation Act's (BPCIA) intricate patent information exchange. Read More
LONDON - The EMA is making moves to increase the number of drugs approved for use in children, revoking eight of the 32 class waivers currently in force, which free companies of any obligation to develop products for pediatric use, and revising 15 others. Read More
HONG KONG – The discovery by Japanese researchers of a single nucleotide polymorphism (SNP) in a gene linked to increased susceptibility to adolescent idiopathic scoliosis (AIS), could lead to the identification of new therapeutic targets for this common and currently incurable condition. Read More
BOGOTA, Colombia – Economic integration processes among Latin American countries are playing a key role in outlining regulatory standards for the life sciences industry. Read More
Gensight Biologics SA, of Paris, said it completed a series B preferred stock financing of about $36 million. New investors include Fidelity Management & Research Co., Jennison Associates, Sphera Global Healthcare Fund, Perceptive Advisors and Healthcap. Existing series A investors also participated in the round. Read More
Heron Therapeutics Inc., of Redwood City, Calif., said it started a second phase II trial of HTX-011, its Biochronomer-formulated long-acting formulation of local anesthetic bupivacaine in a fixed-dose combination with anti-inflammatory meloxicam for the prevention of postoperative pain. Read More
Omeros Corp., of Seattle, said it received FDA fast track designation for OMS721 for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). Read More
Celgene Corp., of Summit, N.J., reported net product sales of $2.254 billion for the second quarter, a 22 percent increase over the same period a year ago. Read More