Healthcare supplier Perrigo Company declared on Wednesday the receipt of approval from the US Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. The company said it will vertically integrate Imiquimod Cream, 5% with its own API.
CAMBRIDGE, Massachusetts, September 9, 2010 Shire plc, the global specialty biopharmaceutical company, today announced the expansion of its Human Genetic Therapies pipeline through the exclusive license, in markets outside of North America, for the activin receptor type IIB class of molecules being developed by Acceleron Pharma Inc., a private biot
Watson Pharmaceuticals, a specialty pharmaceutical company, has confirmed that its subsidiary, Watson Laboratories filed an abbreviated new drug application, or ANDA, with the FDA seeking approval to market Brimonidine Tartrate and Timolol Maleate ophthalmic solution, 0.2%/0.5%. Watson's Brimonidine Tartrate and Timolol Maleate ophthalmic solution,
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.
Toronto Stock Exchange Symbol: DND. Cipher Pharmaceuticals Inc., announced today that Larry Andrews, President and Chief Executive Officer, is presenting at the Rodman & Renshaw Annual Global Investment Conference, which is being held in New York City from September 12-15 at the New York Palace Hotel. Cipher's presentation will be webcast live.
RANCHO CORDOVA, Calif., Sept. 8 ThermoGenesis Corp., a leading supplier of innovative products and services that process and store adult stem cells, said today that findings from the use of concentrated bone marrow-derived stem cells in orthopedic and Critical Limb Ischemia applications will be presented at the upcoming International Stem Cell Ther
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.
Enzo Biochem, Inc., a leading biotechnology company specializing in gene identification and genetic and immune regulation technologies for diagnostic and therapeutic applications, announced today that Barry Weiner, President, and David Goldberg, Vice President, Corporate Development, will both be presenting at two upcoming institutional investor co
A report, 'Effect of axitinib on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients,' is newly published data in Cancer Science. "Twelve patients received single-dose axitinib 5 mg and were monitored for >or=48 h. Continuous 5 mg twice-daily dosing was then initiated.
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.
09/08/10 INC Research , a therapeutically focused contract research organization with a trusted process for delivering reliable results, is hosting an upcoming thought-leading webinar on "The Value of Strategic Alliances vs.
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.
New research, 'Lamotrigine versus lithium as maintenance treatment in bipolar I disorder: an open, randomized effectiveness study mimicking clinical practice. "Adult bipolar I disorder patients with at least two episodes within the last five years and an index episode requiring treatment were randomized to lithium or to lamotrigine as maintenance t
A new study, 'A phase 3, double-blind, placebo-controlled trial of idebenone in friedreich ataxia,' is now available. "Children's Hospital of Philadelphia and the University of California at Los Angeles. The researchers concluded: "Trial Registration clinicaltrials.gov Identifier: NCT00537680."
Current study results from the report, 'Phase I trial of ATRA-IV and Depakote in patients with advanced solid tumor malignancies,' have been published. "The combination of all-trans retinoic acid and the histone deacetylase inhibitor valproic acid has been previously studied in hematologic malignancies.
Fresh data on clinical trial research are presented in the report 'Multicenter phase II randomized trial evaluating antiangiogenic therapy with sunitinib as consolidation after objective response to taxane chemotherapy in women with HER2-negative metastatic breast cancer.'
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.
Acacia Pharma Ltd., of Cambridge, UK, started two development programs: APD421, an intravenous formulation of a currently marketed dopamine D2 antagonist, for the prevention and treatment of nausea and vomiting, and APD515, an optimized oromucosal formulation of another marketed drug, in xerostemia.
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
Thrombogenics NV is on course for a mid-2011 filing on both sides of the Atlantic with Microplasmin, a treatment for retinal disorders including focal vitreomacular adhesion and the related condition of full thickness macular hole, following two Phase III trials, each of which reached their primary endpoint with statistical significance.
