Antimicrobial developer Micurx Pharmaceuticals Inc. raised $25 million in a Series B to fund the U.S. development of MRX-I, its oral oxazolidinone antibiotic targeting infections from multidrug-resistant gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). Read More
The FDA has maintained a firm stance on clinical trial requirements for Basilea Pharmaceutica Ltd.'s broad-spectrum antibiotic ceftobiprole for skin infections. In its half-year financial update, Basilea indicated that the agency would require two pivotal trials per indication. Basilea's stock (SW:BSLN) closed Thursday at CHF70.75 (US$76.67), down CHF2.45. Read More
"There is standard-of-care treatment for heart failure," Amanda Christini told BioWorld Today. "But the natural history of Class 3 and 4 heart failure is 50 to 75 percent mortality within a year with optimal medical treatment." Read More
• Nuvo Research Inc., of Mississauga, Ontario, said U.S. licensee Mallinckrodt, of St. Louis, said the FDA accepted for filing a new drug application for Pennsaid (diclofenac sodium topical solution) 2 percent. Read More
• Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said it reached agreement with the FDA for two special protocol assessments for the company's pivotal Phase III program testing NAV5001 as an aid in the differential diagnosis of Parkinsonian syndromes from non-Parkinsonian tremor. Read More
• Takeda Pharmaceuticals International GmbH, of Zurich, Switzerland, part of Takeda Pharmaceutical Co. Ltd., established Takeda Peru, a wholly owned subsidiary that will be based in Lima. Read More
• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said favorable results from two Phase III studies, Gemini I and Gemini II, evaluating the humanized monoclonal antibody vedolizumab for moderately to severely active ulcerative colitis and Crohn's disease were published in the Aug. 22, 2013, issue of the New England Journal of Medicine. Read More
