Isis Pharmaceuticals Inc., of Carlsbad, Calif., said phase II results of ISIS-APOCIII in patients with high triglycerides and type 2 diabetes show it achieved statistically significant average mean percent reduction from baseline of 88 percent (p = 0.02) in apolipoprotein C-III and 69 percent (p = 0.02) in triglycerides, and an average mean percent increase of 42 percent (p = 0.03) in high-density lipoprotein cholesterol after 13 weeks of dosing. Read More
Biota Pharmaceuticals Inc., of Atlanta, said the Department of Health and Human Services and the Biomedical Advanced Research and Development Authority (BARDA) provided an interim update regarding the recent stop-work order from BARDA and its pending decision on an in-process review (IPR) of the contract supporting the development of laninamivir octanoate. Read More
Pacira Pharmaceuticals Inc., of Parsippany, N.J., said net product sales of postsurgical pain product Exparel (bupivacaine liposome injectable suspension) were $34.4 million in the first quarter of 2014, compared to $10.4 million in the first quarter of 2013. Read More
SAN FRANCISCO – Discussions on dealmaking, the focus of the recently concluded Allicense 2014 meeting, typically focus on terms, values and trends. But attendees of this year's meeting got a rare peek into the minds of business development (BD) executives whose negotiating prowess helped transform their respective companies and set them on various career tracks. Read More
Second Genome Inc. is partnering with Pfizer Inc. on a large observational study exploring the relationship between the trillions of microorganisms comprising the human microbiome and obesity and metabolic disorders. Read More
Despite pressure from biopharma and other industries to single out India as the worst of the worst in not honoring intellectual property (IP) rights, the U.S Trade Representative (USTR) declined to name the world's biggest exporter of drugs a Priority Foreign Country (PFC), the strongest censure the U.S. can give a trading partner in the annual Special 301 Report. Read More
Enterome Bioscience SA raised €10 million (US$13.9 million) in a first closing of a planned €20 million series B round to further development of its microbiome-based biomarkers in development for disease management. Read More
It was little surprise, after a Feb. 12 Cardiovascular and Renal Drugs Advisory Committee meeting that came down squarely against approval, that the FDA delivered a complete response letter (CRL) late Wednesday to The Medicines Co.'s (MDCO) new drug application (NDA) for the intravenous antiplatelet agent cangrelor to reduce thrombotic cardiovascular events. Read More
Glaxosmithkline plc, of London, won FDA approval for Incruse Ellipta (umeclidinium), its anticholinergic for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. Read More
