Pharmaceuticals - Generic / Specialty
SANUWAVE Health Inc:Enrolled over ninety pct of minimum required patients in Phase III supplemental clinical trial using dermaPACE for treating diabetic foot ulcers as of March 31.
FDA Advisory Committee unanimously recommends approval of Cubist Pharmaceuticals Inc's SIVEXTRO (Tedizolid Phosphate) as Treatment for Serious Skin Infections
Cubist Pharmaceuticals Inc:U.S. FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist's investigational antibiotic SIVEXTRO.In unanimous 14 - 0 decision, AIDAC found that substantial evidence of the safety and effectiveness of SIVEXTRO for the treatment of acute bacterial skin and skin structure infections (ABSSSI) was provided.Company's New Drug Application (NDA) submission to FDA for SIVEXTRO is based on positive data from two global Phase 3 clinical studies, which met primary and secondary endpoints defined by FDA and European Medicines Agency (EMA).
Sagent Pharmaceuticals Inc:Launches Adenosine Injection, USP, a pharmacologic stress agent, in two preservative- free vial presentations.
Daiichi Sankyo Co Ltd:Starts enrolling patients into the ENSURE-AF multinational phase 3 study.Study will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban.Compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm).
Pacira Pharmaceuticals Inc:Receives FDA approval for additional bulk manufacturing suite, referred to as Suite C, for EXPAREL.Suite is housed at the company's Science Center Campus in San Diego, where EXPAREL is currently manufactured.
Takeda Pharmaceutical Co Ltd:Received New Drug Application (NDA) approval in Japan for cell cultured influenza vaccine H5N1 "TAKEDA" 1mL and cell cultured influenza vaccine "TAKEDA" 1mL for prevention of pandemic influenza.
Forest Laboratories, Inc and Gedeon Richter Plc. announce positive phase IIib topline results for cariprazine for the treatment of bipolar depression
Forest Laboratories, Inc and Gedeon Richter Plc:Announces positive topline results from a Phase IIb trial evaluating the efficacy and safety of the investigational antipsychotic cariprazine in patients with bipolar depression.Study consisted of up to 14 days of screening followed by 8 weeks of double-blind treatment, followed by a 1-week safety follow-up period.Trial consisted of four treatment groups: cariprazine 0.75 mg/day, 1.5 mg/day, 3.0 mg/day, and placebo.
Swedish Orphan Biovitrum publ AB:Says the US Food and Drug Administration has approved Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), the first recombinant, DNA derived haemophilia B therapy with prolonged circulation in the body.
General Biologicals Corp:Received conformite europeenne (CE) certificate for ANTISURASE B-96 II (TMB), which is used for testing antibody number in hepatitis B virus detection.
Glaxosmithkline PLC presents data from phase III STABILITY study of darapladib in patients with chronic coronary
Glaxosmithkline PLC:Presents data from the pivotal Phase III STABILITY study of darapladib.The global, double-blind, event-driven trial randomized 15,828 patients with chronic coronary heart disease (CHD) to receive 160mg of darapladib or placebo once daily on a background of standard of care.The primary endpoint was time to first occurrence of any major adverse cardiovascular event (MACE) comprising cardiovascular death, myocardial infarction (MI) and stroke.Secondary endpoints included coronary events comprising CHD death, urgent coronary revascularisation for myocardial ischemia, total coronary events comprising CHD death, MI, hospitalisation for unstable angina or any coronary revascularisation procedure.No difference was seen in the treatment groups in the time to first occurrence of MACE.During 3.7 years median follow-up, the primary endpoint of MACE occurred in 9.7 pct of patients in the darapladib group and 10.4 pct of patients in the placebo group, hazard ratio (HR) 0.94, 95 pct confidence interval (0.85 - 1.03), p=0.199.HRs for individual components were cardiovascular death 0.96 (0.83 - 1.11), MI 0.89 (0.77 - 1.03) and stroke 1.01 (0.81 - 1.27).The safety profile was well-characterised in this large outcome study.The study didn not meet its primary endpoint, the effects of darapladib on the reduction of coronary events are of potential interest.