Following Tuesday's market close, Tetraphase Pharmaceuticals Inc. reported top-line data from the lead-in portion of its two-part phase III IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) 2 trial, showing that both intravenous (I.V.)-to-oral dosing regimens of eravacycline (1.5 mg/kg I.V. followed by 200 mg or 250 mg) compared favorably to comparator drug levofloxacin to treat complicated urinary tract infections (cUTIs). Read More
LONDON – After failing to reach the primary endpoint in a 507-patient phase IIb trial in acute coronary syndrome (ACS), Cerenis Therapeutics SA has found a route forward for its CER-001 recombinant high-density lipoprotein (HDL), securing orphan drug status in two variants of an inherited rare disorder that causes HDL deficiency. Read More
TOKYO – The government of Prime Minister Shinzo Abe plans to bring together government institutions, private companies and academia to assist with the commercialization of Japan's first-class drugs and medical devices. Read More
BOGOTA, Colombia – Multinational companies have stepped up their hunt for partners in Latin America as they seek to grow their businesses while promoting research in a region that has somehow fallen behind in both areas. Read More
TOKYO – One more Japanese company has taken a step closer to the biosimilars market through a strategic drug development alliance with a U.S. company and a drug for rheumatoid arthritis. Read More
4SC AG, of Planegg-Martinsried, Germany, said it issued convertible notes in the amount of €500,000 (US$657,600). The notes constituted the second tranche of a total issuance of up to €15 million guaranteed by an agreement between YA Global MasterSPV Ltd. Read More
Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the National Institute for Health and Clinical Excellence Evaluation Committee acknowledged that FDA-approved Soliris (eculizumab) is an effective treatment option for patients with atypical hemolytic uremic syndrome, and that the use of eculizumab would be of significant value to patients with the life-threatening disorder who have no other treatment options. Read More
Nuvo Research Inc., of Mississauga, Ontario, said it completed enrollment in a phase II trial of WF10 in patients with refractory allergic rhinitis. The 16-week, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of a regimen of five infusions of either WF10 or its main constituents (sodium chlorite and sodium chlorate) relative to saline control in patients with multiple airborne allergies who suffer from moderate to severe allergic rhinitis. Read More
Eisai Inc., of Woodcliff Lake, N.J., said it entered an agreement with Concordia Pharmaceuticals Inc., of Barbados, a subsidiary of Concordia Healthcare Corp., to purchase Eisai's U.S. and Puerto Rican commercialization and distribution rights to epilepsy drug Zonegran (zonisamide). Read More
Merck KGgA, of Darmstadt, Germany, said its Merck Serono division detailed 26-week data from the phase IIIb SPARK study at the Society for the Study of Inborn Errors of Metabolism symposium in Innsbruck, Austria. Read More
