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Keryx Biopharmaceuticals Announces Highly Statistically Significant Positive Results From Phase 3 Study of Zerenex(TM) (Ferric Citrate) for the Treatment of Hyperphosphatemia in Dialysis Patients
Date: November 30, 2010
Client: Keryx Biopharmaceuticals, Inc.
Summary: Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex(TM) (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis. In this study, conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA), Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant dose response. In addition, key secondary endpoints were also met with high statistical significance.
Amarin Jumps on Positive Phase III Fish Oil Pill Data
Date: November 30, 2010
Client: Amarin Corp. plc
Summary: Shares of Amarin Corp. plc skyrocketed as high as 67 percent Monday after the biotech reported that its prescription grade omega-3 fatty acid drug AMR101 (ethyl icosapentate) not only lowered triglycerides in patients with high levels during a pivotal Phase III study, but the drug did not increase low-density lipoprotein cholesterol (LDL-C) – a claim GlaxoSmithKline plc's Lovaza (omega-3-acid ethyl esters) cannot make.
Argos Therapeutics Initiates Dosing of Patients in Phase 2b Clinical Trial of Arcelis™ Personalized Immunotherapy for Treatment of HIV Patients
Date: November 30, 2010
Client: Argos Therapeutics
Summary: DURHAM, N.C. – Nov. 30, 2010 – Argos Therapeutics today announced that it has initiated dosing of patients in a Phase 2b clinical trial of its Arcelis™ personalized immunotherapy for the treatment of HIV patients, AGS-004.
Micell Technologies Enrolls First Patient in DESSOLVE I First-In-Human Study of MiStent DES
Date: November 29, 2010
Client: Micell Technologies,™ Inc.
Summary: DURHAM, N.C., November 29, 2010-- Micell Technologies,™ Inc. today announced it has enrolled at Mercy Hospital in Auckland, New Zealand, the first patient in DESSOLVE I (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries), a first-in-human clinical trial of the company’s investigational MiStent™ Drug Eluting Coronary Stent System (MiStent DES).
Amarin's AMR101 Meets Pivotal Phase 3 Study Endpoints With Highly Statistically Significant Reductions in Triglycerides at 4 Gram and 2 Gram Doses in MARINE Trial With No Statistically Significant Increase in LDL-C and Safety Profile Similar to Placebo
Date: November 29, 2010
Client: Amarin Corporation plc
Summary: MYSTIC, Conn. and DUBLIN, Nov. 29, 2010 /PRNewswire-FirstCall/ -- Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101. The MARINE study, investigating AMR101 as a treatment for very high triglycerides (≥500 mg/dL), met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The Company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company's rights to this product through 2030.
Alder Biopharmaceuticals Announces That Data From Multiple Studies of ALD518 (BMS945429), an Investigational Antibody Therapeutic in Rheumatoid Arthritis Patients, to be Presented at Annual Meeting of the American College of Rheumatology
Date: November 6, 2010
Client: Alder Biopharmaceuticals Inc.
Summary: ATLANTA, Nov. 6, 2010 /PRNewswire/ -- Alder Biopharmaceuticals Inc. today announced that data from two clinical studies of its ALD518 investigational antibody therapeutic will be presented at the Annual Meeting of the American College of Rheumatology in Atlanta.
Arena Pharmaceuticals Provides Update on GPR119 Portfolio for Type 2 Diabetes
Date: November 4, 2010
Client: Arena Pharmaceuticals, Inc.
Summary: SAN DIEGO, Nov. 4, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that, following the completion of a Phase 1 clinical trial program for APD597 (JNJ-38431055) under its collaboration with Arena, Ortho-McNeil-Janssen Pharmaceuticals, Inc., has decided not to advance APD597 and has notified Arena that it is terminating the collaboration, effective December 28, 2010. APD597 is a GPR119 agonist intended for the treatment of type 2 diabetes, which, along with other compounds and intellectual property, will revert to Arena upon termination of the collaboration. Arena owns a patent portfolio covering a broad array of internally discovered, oral GPR119 agonists, including next generation compounds that were not part of the collaboration.
Arena Pharmaceuticals to Host Business and Financial Update Conference Call and Webcast on Tuesday, November 9
Date: November 4, 2010
Client: Arena Pharmaceuticals, Inc.
Summary: SAN DIEGO, Nov. 4, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced it will report third quarter 2010 financial results before the NASDAQ Global Market opens on Tuesday, November 9, 2010. That same morning, Jack Lief, Arena's President and Chief Executive Officer, and Robert E. Hoffman, Arena's Vice President, Finance and Chief Financial Officer, will host a conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss the financial results for the third quarter 2010 and to provide a business and financial update.
AbD Serotec Secures Exclusive Worldwide License to Research ‎Antibody from The Institute of Cancer Research
Date: November 4, 2010
Client: Insert Client here
Summary: MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its research and diagnostic antibodies unit AbD Serotec has signed a license agreement with The Institute of Cancer Research (ICR), London, which provides AbD Serotec with worldwide exclusive rights to commercialize the prototypic and most popular BrdU antibody clone for research applications. The agreement covers clone BU1/75 (also known as ICR1), allowing development in a range of formats suitable for various applications such as ELISA, flow cytometry and immunohistochemistry.
Cellular Dynamics Awarded Four Therapeutic Discovery Grants Totaling Almost $978,000 for Induced Pluripotent Stem Cell Programs
Date: November 4, 2010
Client: Cellular Dynamics International, Inc.
Summary: MADISON, Wis., Nov 4, 2010 – Cellular Dynamics International, Inc. (CDI) announced today that it has been awarded a total of $977,915 for investments in four qualifying therapeutic discovery projects. CDI, the world’s largest producer of human tissue cells for drug discovery and safety, will use the grant money to advance the development of its programs in hepatocytes, neurons, endothelial cells, and creation of multiple induced pluripotent stem cell (iPSC) lines. All of CDI’s products are based on iPSC technology.
Argos Therapeutics to Present on the Implementation, Cost Effectiveness and Benefits of Automation for its Arcelis™ Immunotherapy at The Cell Therapy Industry Summit-2010
Date: November 2, 2010
Client: Argos Therapeutics
Summary: Durham, NC– November 2, 2010 — Argos Therapeutics today announced that Fred Miesowicz, the company´s chief operating officer and vice president of manufacturing, will present on the implementation, cost effectiveness and benefits of automation for Argos´ Arcelis™ immunotherapy at The Cell Therapy Industry Summit-2010 in Carlsbad, Calif. at 2 p.m. PDT on Thursday, Nov. 4. The conference will take place at the Sheraton Carlsbad Resort & Spa.

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