Alexion Pharmaceuticals, Inc. announced that the US Food and Drug Administration has approved Alexion's Rhode Island manufacturing facility in Smithfield, Rhode Island as a second source of commercial supply for Soliris. Earlier this year, Alexion reported that the European Medicines Agency had approved ARIMF as a second source of supply for Soli
Can-Fite BioPharma, an Israeli biotechnology company, has opened an investigational new drug application with the FDA for a Phase III study of its lead drug, CF101, in patients with moderate to severe dry eye syndrome. The randomized, double-masked trial will compare two doses of CF101 to placebo.
IRVINE, Calif., Sept. 8 Cardiogenesis Corporation today announced that the Wall Street Reporter has interviewed Cardiogenesis' Executive Chairman Paul J. McCormick. The interview is available at www.wallstreetreporter.com, or directly via this link: http://www.wallstreetreporter.com/2010/09/cardiogenesis-corporation-otc-qb-cgcp-management-interview
CytRx, a biopharmaceutical company, has initiated the Proact Phase II proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer. The open-label Proact trial is being conducted at City of Hope, California, as well as multiple clinical sites in India.
LONDON - DBV Technologies has won a U.S. National Institutes of Health grant to fund a three-year Phase II trial of its immunotherapeutic for desensitizing people who are allergic to peanuts. The product, Viaskin Peanut, is currently in Phase Ib trials at five centers in the U.S., after the company was given investigational new drug application app
Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced that it received CE Mark approval to market its expanded offering of Powerlink stent graft products and PowerFit Aortic Extensions in the European Union.
Pharmaceutical company Forest Laboratories Inc revealed on Tuesday that a US Food and Drug Administration advisory committee has recommended approval of the companyEURs ceftaroline fosamil for the treatment of community acquired bacterial pneumonia and complicated skin and skin structure infections.
- New Position to Support Global Customer Strategy and Accelerate Growth - BioClinica, Inc., a global provider of clinical trial management services, today announced the appointment of Garry D. Johnson as Senior Vice President and Chief Technology Officer, a newly created position.
UNDERSTANDING OUR FINANCIAL INFORMATION. The following discussion and analysis provides information management believes to be relevant to understanding the financial condition and results of operations of Medtronic, Inc. and its subsidiaries. Financial Trends.
Mylan, a generic and specialty pharmaceutical company, has completed the acquisition of Bioniche Pharma Holdings, an injectable pharmaceutical company. Bioniche Pharma is providing Mylan with immediate entry into the North American injectables market and a platform for the commercialization of future biosimilar product offerings.
Neuralstem, Inc. announced that it has filed an Investigational New Drug application with the United States Food and Drug Administration to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells.
Research findings, 'Bone-marker levels in patients with prostate cancer: potential correlations with outcomes,' are discussed in a new report. "Biochemical markers of bone turnover might fulfill this unmet need.
The US Food and Drug Administration approved Tekamlo tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna, with the widely used calcium channel blocker amlodipine.
Shire plc, the global specialty. biopharmaceutical company, announces that its subsidiary Shire Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition relating to Pentasa. The ruling granted-in-part and denied-in-part the requests from Shire.
Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.
ALLEGAN, Mich., Sept. 8 Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.
ALLEGAN, Mich. Aldara, made by Graceway Pharmaceuticals, is also used for superficial basal cell carcinoma and external genital and perianal warts in patients 12 years old or older. In addition to making pharmaceutical products, Perrigo, which is based in Allegan, Mich., makes infant formulas, nutritional products and pharmaceutical and medical dia
Promedior, a biotechnology company, has initiated a Phase IIa clinical study of PRM-151 to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery. This multicenter, multinational, randomized, double-masked, placebo-controlled Phase II study is expect
Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, will present at the Rodman & Renshaw 12th Annual Healthcare Conference in New York City on September 14, 2010 at 3:15 p.m. Eastern Time. Tim Scott, President of Provectus will be delivering the presentation.
PresbyLens Renamed Vue+ ReVision Optics, a leading company in the research, development and manufacture of implantable medical devices designed to assist patients that need reading glasses, announced today that it has completed enrollment and initial follow up in Phase I of its US clinical trial and has filed for expansion. The Vue+ study will eval
Rexahn Pharmaceuticals, a developer of oncology and central nervous system therapeutics, has submitted a Phase IIb protocol to the FDA for the clinical study of serdaxin for the treatment of major depressive disorder, or MDD. The Phase IIb study will assess serdaxin's efficacy as a treatment for major depressive disorder in approximately 300 subjec
Access Pharmaceuticals CEO Jeffrey Davis has recently been interviewed by OutsideIn Research about the company's FDA approved product MuGard, which is used for treatment and prevention of oral mucositis. OM is the ulceration of the skin lining in your mouth and esophagus, which is most commonly associated with chemotherapy and radiation treatment i
Use of an experimental targeted drug to treat metastatic melanoma tumors with a specific genetic signature was successful in more than 80 percent of patients in a phase 1 clinical trial.
Tekmira Pharmaceuticals, a Canadian biopharmaceutical company, has announced that its investigational new drug application for TKM-PLK1 has been cleared by the FDA allowing the company to initiate a Phase I human clinical trial. TKM-PLK1 is being developed as a treatment for patients with advanced solid tumor cancers who are not well served by curr
