IMS Institute for Healthcare Informatics is out with its latest prediction for sales of medicines through 2018, when global spending is expected to reach between $1.28 trillion and $1.31 trillion, an increase of $290 million to $320 million over 2013 levels. Read More
Alnylam Pharmaceuticals Inc. has begun enrolling patients for a phase III study of one of its most advanced experimental RNAi therapies, revusiran, a treatment for transthyretin (TTR)-mediated familial amyloidotic cardiomyopathy, a manifestation of TTR-mediated amyloidosis that afflicts about 40,000 people worldwide. Read More
SHANGHAI – Generon Corp. Ltd., believed to be the first Chinese biotech to complete a phase II global trial for a biologic, has announced the results for its lead candidate, F-627 (benegrastim), a next-generation drug to Amgen Inc.'s Neulasta (pegfilgrastim) for the treatment of neutropenia. Read More
The onslaught of new genomics information and what it means for figuring out how to come up with drugs for rare subsets of patients were subjects for an all-day public workshop sponsored by the FDA, which ended with few answers but included plenty of potentially useful interchanges between experts. Read More
Ending the year in a much better position than it started, Chemocentryx Inc. reported positive data from its 52-week phase II study of CCR2 inhibitor CCX140 in diabetic nephropathy (DN), positioning the drug for phase III development and, hopefully, a partnership. Read More
Prometic Life Sciences Inc., of Laval, Quebec, said it received a notice of exercise of the overallotment option to acquire an additional 1.98 million shares priced at $1.90 apiece for gross proceeds of $3.8 million, from the syndicate of underwriters led by Canaccord Genuity Corp. and including Paradigm Capital Inc., RBC Capital Markets and Beacon Securities Ltd. Read More
Pacira Pharmaceuticals Inc., of Parsippany, N.J., said the FDA approved changes to the Exparel packaging and label proposed by the company as part of a routine label supplement application, submitted late November 2013. Read More
Crealta Pharmaceuticals LLC, of Glendale, Wis., said the Journal of Clinical Rheumatology published a comprehensive review of a posthoc safety analysis that was completed for Krystexxa (pegloticase), including data from the two pivotal randomized phase III trials and one open-label extension trial. Read More
Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, gained FDA approval for its supplemental biologics license application for Fluzone intradermal quadrivalent vaccine. The vaccine has been available in trivalent formulation for three years, containing two strains of influenza A and one strain of influenza B. Read More
Ipsen SA, of Paris, said the International Breast Cancer Study Group presented results of the randomized phase III SOFT trial, which assessed the value of ovarian suppression in reducing breast cancer recurrence in young women receiving tamoxifen, and evaluated the role of aromatase inhibitor exemestane plus ovarian suppression in that population. Read More
Scientists from the British University of Cambridge and the Australian Monash University have identified a link between the satiety hormone leptin and the increased blood pressure that is one consequence of obesity. Read More
