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Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that Phase IIb data for its lead drug candidate Soluble Ferric Pyrophosphate (SFP) have been accepted for presentation at the XLVII European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress, organized in collaboration with the Deutsche Gesellschaft fur Nephrologie (DGfN) in Munich, Germany, June 25-28, 2010.

25 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

DAPT Study expands into seven countries in the EU: HCRI

The Harvard Clinical Research Institute announced today that the DAPT Study has expanded into seven countries in the European Union. John Irving, MBChB, MRCP, M.D., consultant cardiologist at Ninewells Hospital in Dundee, United Kingdom, was the first European investigator to enroll patients into the study.

25 May 2010

Preclinical results of AMEP for metastatic melanoma presented at ASGCT Annual Meeting

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, has presented efficacy, safety and biodistribution results on its new biotherapy AMEP™ for advanced and metastatic melanoma at the 13th Annual Meeting of the American Society of Gene and Cell Therapy in Washington, DC (May 17 - 22, 2010).

25 May 2010

Neuralstem updates progress of ongoing Phase I human clinical trial for ALS

Neuralstem, Inc. updated the progress of its ongoing Phase I human clinical trial to treat ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing the safety data from the first cohort of three patients, the Safety Monitoring Board has approved moving to the next cohort and transplantation of the fourth patient.

25 May 2010

Positive results from Phase 2 clinical trial for STA-9090 in Stage IIIB and Stage IV patients with NSCLC

Synta Pharmaceuticals Corp. today announced that clinical activity seen in the first stage of its trial for STA-9090 in Stage IIIB and Stage IV patients with non-small cell lung cancer, support advancing to the second stage of the trial. This result was achieved in the first pre-defined patient cohort to complete enrollment.

25 May 2010

Media outlets highlight studies presented at International Microbicides Conference

A study in Africa, presented Sunday at the International Microbicides Conference (M2010) in Pittsburgh, has shown that a man's risk of HIV infection doubles if his HIV-positive partner is pregnant, according to HealthDay News/U.S. News & World Report.

25 May 2010

Enrollment in phase II clinical trial of brentuximab vedotin for ALCL completed

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced that they have completed enrollment of a phase II clinical trial of brentuximab vedotin (SGN-35) for relapsed or refractory systemic anaplastic large cell lymphoma.

24 May 2010

Ortho-McNeil Pharmaceutical pleads guilty for promoting epilepsy drug Topamax for psychiatric use

Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing.

24 May 2010

Phase 1 clinical trial of OXY111A initiated

NormOxys Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body's ability to deliver oxygen to diseased tissues, today announced that it has initiated a Phase 1 clinical trial of OXY111A, a novel allosteric modulator of affinity of oxygen to hemoglobin. NormOxys plans to initially develop this compound as a treatment for chronic heart failure and cancer indications.

24 May 2010

Volcano to highlight extensive pipeline of imaging and therapy products at EuroPCR 2010

Volcano Corporation announced today the company's plans to highlight its new product launches, presence in live cases, and participation in late breaking trials during EuroPCR from May 25 – 28 in Paris.

24 May 2010

Lytix Biopharma receives approval to initiate Phase I/IIa clinical trial of Lytixar for MRSA

The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval by the Swedish Medical Products Agency to commence a Phase I/IIa clinical trial with Lytixar (LTX-109) for nasal decolonisation of MRSA.

24 May 2010

KIKA Clinical Solutions upgrades Veracity EDC platform for all clinical trial stakeholders

KIKA™ Clinical Solutions, the leader in advanced EDC solutions for Clinical Asset Management, announced a significant upgrade of its groundbreaking Veracity EDC platform today. KIKA will demonstrate Veracity 3.9 at the 46th DIA Annual Meeting in Washington D.C., June 13-17, Booth 2419.

24 May 2010

At-home blood pressure monitors help patients manage their high blood pressure: Research

The use of at-home blood pressure monitors and web-based reporting tools that connect clinicians and patients via the Internet appears to significantly improve patients' ability to manage their high blood pressure to healthy levels, according to research from Kaiser Permanente.

24 May 2010

Poor survival rates in non-Hodgkin's lymphoma patients attributed to lifestyle factors

A new study led by researchers from Mayo Clinic in collaboration with six other U.S. institutions has found that patients with non-Hodgkin's lymphoma who smoked, consumed alcohol or were obese before their cancer diagnosis had poorer overall survival, compared to patients who did not have these risk factors.

24 May 2010

Researchers test NicVAX vaccine to help people quit smoking, avoid relapses

In a unique twist to a decades-old health crisis, Michigan State University researchers are testing a new vaccine to help people quit smoking and avoid relapses.

21 May 2010

PLC Systems' RenalGuard to be showcased at EuroPCR 2010

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that it will demonstrate RenalGuard® at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), May 25-28, 2010, in Paris, France. More than 11,000 clinicians and professionals are expected to attend this event.

21 May 2010

ImmunoCellular Therapeutics to present clinical results of ICT-107 dendritic cell immunotherapy at 46th ASCO

ImmunoCellular Therapeutics, Ltd. a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it will be presenting results from its clinical trial of ICT-107 at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8 in Chicago.

21 May 2010

ArQule announces presentations on ARQ 197 c-Met inhibitor at 2010 ASCO

ArQule, Inc. today announced that the following presentations of clinical data for ARQ 197, a selective inhibitor of the c-Met receptor tyrosine kinase, will take place at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 4-8, 2010 in Chicago, Illinois.

21 May 2010

Study explores genetic imbalances that give rise to childhood brain tumors

The most comprehensive analysis yet of the genetic imbalances at the heart of childhood brain tumors known as high-grade gliomas (HGGs) identified a cancer gene that is unusually active in some tumors and is now the focus of a St. Jude Children's Research Hospital clinical trial.

21 May 2010

Clinical Trial News and Research

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

DAPT Study expands into seven countries in the EU: HCRI

Preclinical results of AMEP for metastatic melanoma presented at ASGCT Annual Meeting

Neuralstem updates progress of ongoing Phase I human clinical trial for ALS

Positive results from Phase 2 clinical trial for STA-9090 in Stage IIIB and Stage IV patients with NSCLC

Media outlets highlight studies presented at International Microbicides Conference

Enrollment in phase II clinical trial of brentuximab vedotin for ALCL completed

Ortho-McNeil Pharmaceutical pleads guilty for promoting epilepsy drug Topamax for psychiatric use

Phase 1 clinical trial of OXY111A initiated

Volcano to highlight extensive pipeline of imaging and therapy products at EuroPCR 2010

Lytix Biopharma receives approval to initiate Phase I/IIa clinical trial of Lytixar for MRSA

KIKA Clinical Solutions upgrades Veracity EDC platform for all clinical trial stakeholders

At-home blood pressure monitors help patients manage their high blood pressure: Research

Poor survival rates in non-Hodgkin's lymphoma patients attributed to lifestyle factors

Researchers test NicVAX vaccine to help people quit smoking, avoid relapses

PLC Systems' RenalGuard to be showcased at EuroPCR 2010

ImmunoCellular Therapeutics to present clinical results of ICT-107 dendritic cell immunotherapy at 46th ASCO

ArQule announces presentations on ARQ 197 c-Met inhibitor at 2010 ASCO

Study explores genetic imbalances that give rise to childhood brain tumors

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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