|GSK and Theravance Announce Completion of the Relovair(TM)* Registrational Programme; Amylin Announces BYETTA European Approval|
|By Staff and Wire Reports|
|Friday, 23 March 2012 19:20|
GlaxoSmithKline (NYSE: GSK) and Theravance, Inc. (Nasdaq:THRX) announced the registrational programme for Relovair™ is now complete. In addition, results from two studies for the once-daily investigational medicine Relovair™ (fluticasone furoate "FF"/vilanterol "VI" (FF/VI)) in patients with chronic obstructive pulmonary disease and results from a study to evaluate the efficacy and safety of FF and FP (fluticasone propionate) compared to placebo in the treatment of persistent asthma in adults and adolescents were announced.
Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) and Eli Lilly and Company (NYSE:LLY) announced the European Commission has granted marketing authorization to BYETTA® (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced its partnership with NextDocs, a leading global provider of Microsoft SharePoint-based compliance solutions to life sciences organizations, to deliver solutions that provide easier access to clinical trial information and decrease the timeline for FDA submissions.
CNS Response, Inc. (OTCBB: CNSO) today announced that the U.S. Food and Drug Administration (FDA) responded to its proposal for a clinical trial of an Investigational Device, PEER Interactive, designed to support physicians in identifying the best treatments for certain mental illnesses.
Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced the receipt of a signed trial agreement from Shertech Pharmacy in Charlotte, North Carolina.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the Israeli Ministry of Health to initiate a Phase IIa clinical study evaluating the safety and efficacy of sustained erythropoietin (“EPO”) therapy produced and delivered by the Company’s EPODURE™ Biopumps™.
Progressive Care, Inc. (OTCBB: RXMD) and its subsidiary Pharmco, LLC ("PharmCo"), a provider of prescription pharmaceuticals, specializing in anti-retroviral patient care, long term care and durable medical equipment, have announced today that Avraham Friedman, the company's Chief Executive Officer, issued his inaugural annual letter to the shareholders.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces that nonclinical data on the immunologic mechanism of action of PV-10, presented at the Society of Surgical Oncology Annual Meeting, confirms that PV-10 chemoablation of melanoma lesions induces a systemic response that can lead to regression of synchronous lung metastases or synchronous subcutaneous melanoma.
As Rainbow Biosciences (OTCBB: RBCC) seeks entry into the $3-billion-and-growing market for Parkinson’s disease treatments, population trends point to the likelihood that incidence of the disease will double in the next 20 years.
Repligen Corporation (NASDAQ:RGEN) today announced that the U.S. Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the Company’s New Drug Application (NDA) for SecreFlo™ for the improved detection of pancreatic duct abnormalities in combination with magnetic resonance imaging (MRI) in patients with pancreatitis.