Exelixis Inc. will downsize by 70 percent in the wake of the pivotal phase III failure by Cometriq (cabozantinib) in prostate cancer (PC), and awaits results that are due next year from the late-stage experiment in renal cell carcinoma (RCC). Read More
LONDON – The first human volunteers in a 20-subject trial are being injected with an experimental Ebola virus vaccine at the NIH's National Institute of Health Clinical Center in Bethesda, Md., this week, following an expedited review of the clinical trial application by the FDA. Read More
United Therapeutics Corp. has prevailed in a legal effort to slow Sandoz Inc.'s plans to launch a generic version of the pulmonary arterial hypertension (PAH) therapy Remodulin (treprostinil), a drug that accounted for 44 percent of its revenue last year. The patent case ruling forestalls generic competition from Sandoz for at least three years and may block an additional challenge from Teva Pharmaceutical Industries Ltd. until then as well. Read More
LONDON – Novartis AG hailed the results of its Paradigm trial of LCZ696 as "a historical moment in the treatment of heart failure," with the combined ACE/neprilysin inhibitor reducing deaths by 20 percent, cutting hospitalizations by 21 percent and offering better quality of life, compared to treatment with ACE inhibitor enalapril alone. Read More
SHANGHAI – Over the last few weeks, multinational pharmaceutical companies have received notification from the CFDA of an additional administrative hurdle that will likely delay drug approvals for innovative imported drugs by a year, or possibly longer. Read More
HONG KONG – Just one month after its $764 million initial public offering (IPO) in Hong Kong, leading Chinese pharmaceutical company Luye Pharma took a significant expansionary step with the acquisition of Beijing Jialin Pharmaceutical. Read More
Syndax Pharmaceuticals Inc., of Waltham, Mass., updated terms for its initial public offering in a couple of months. It hopes to raise $60 million by offering 4.3 million shares at a price range of $13 to $15 each. Read More
Alder Biopharmaceuticals Inc., of Bothell, Wash., said it regained worldwide rights to clazakizumab, a humanized monoclonal antibody to the pro-inflammatory cytokine IL-6, from Bristol-Myers Squibb Co., of New York. Read More
Galleon Pharmaceuticals Inc., of Horsham, Pa., reported clinically and statistically significant (p < 0.01) results from a double-blind, placebo-controlled clinical proof-of-concept study of its lead investigational compound, GAL-021, in normal volunteers. Data were published in the most recent issue of Anesthesiology. Read More
Allergan Inc., of Irvine, Calif., gained extended marketing authorization from the European Commission to use Ozurdex (dexamethasone) as a therapy the for the treatment of adults with visual impairment due to diabetic macular edema who have artificial lens implants or are considered insufficiently responsive to, or unsuitable for noncorticosteroids therapy. Read More
Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, and partner Bayer Healthcare, of Leverkusen, Germany, reported results from the phase IIIb X-VeRT trial at the European Society of Cardiology meeting in Barcelona, Spain, showing that once-daily Xarelto (rivaroxaban) may be an alternative to vitamin K antagonists in treating and reducing the risk of blood clots in nonvalvular atrial fibrillation patients undergoing elective cardioversion. Read More
