Mylan Inc., of Pittsburgh, said a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against Glaxosmithkline plc, of London (GSK), relating to Paroxetine Hydrochloride Extended-release tablets. Read More
Cardiome Pharma Corp., of Vancouver, British Columbia, reported a net loss of $7.2 million, or 53 cents per share, for the fourth quarter of 2013, due largely to an increase in expenses incurred to support commercialization of atrial fibrillation drug Brinavess (vernakalant) and antiplatelet drug Aggrastat (tirofiban). Read More
Bluebird Bio Inc., of Cambridge, Mass., said the first subject with beta-thalassemia major was enrolled in its phase I/II Northstar Study (HGB-204) and has undergone infusion with the company’s Lentiglobin drug product in an autologous hematopoietic stem cell transplantation. Read More
Durata Therapeutics Inc., of Chicago, will be on hand Monday afternoon at the Anti-Infective Drugs Advisory Committee meeting to discuss the new drug application (NDA) for antibiotic dalbavancin, which is under FDA review for use in acute bacterial skin and skin structure infections caused by gram-negative microorganisms, including methicillin-resistant Staphylococcus aureus. Read More
Genmab A/S has made an eye-catching move into rabbit-based antibody discovery by entering a multitarget deal with Mab Discovery GmbH, a company founded by a group of big pharma scientists. Read More
LONDON –The trade body Europabio has published a biotech manifesto for 2014 to 2019 in advance of elections in May, which will see a new cast coming into office in the European Parliament and the European Commission. Read More
HONG KONG – China’s biotechnology industry continued to grow rapidly in 2013, expanding by almost 18 percent, according to new numbers from the National Development and Reform Commission (NDRC). Read More
LONDON – Reneuron plc has the go-head to start two new trials of its autologous stem cell therapy, receiving approval to use a new cryopreserved formulation that would allow the product to be available off the shelf, surmounting one of the major hurdles to commercialization. Read More
Investors met Applied Genetic Technologies Corp.’s Nasdaq debut Thursday with tepid interest as the clinical-stage developer of treatments for orphan eye diseases moved to raise $50 million through an initial public offering (IPO) priced at $12 per share, $1 below its intended $13 to $15 range. Read More
The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) unanimously voted against recommending approval for Novartis AG’s serelaxin based on the strength of a single pivotal trial in acute heart failure (AHF). Read More
Pfizer Inc., of New York, and Bristol-Myers Squibb Co., also of New York, said results of a pre-specified subanalysis of the phase III ARISTOTLE trial assessing the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) compared to warfarin according to blood pressure control. Read More
