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Boston Scientific's PROMUS Everolimus-Eluting Coronary Stent System receives Japanese marketing approval

Boston Scientific Corporation announced today that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its PROMUS® Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease. The Company plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.

9 Jan 2010

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

World Heart Corporation, a developer of mechanical circulatory systems, announced today that it has received unconditional approval from the U.S. Food and Drug Administration ("FDA") for the bridge-to-transplant ("BTT") study of the Levacor Ventricular Assist Device ("VAD"). Study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously announced, the BTT study will begin initially at ten clinical sites.

8 Jan 2010

AUA updates clinical practice guideline on female stress urinary incontinence

A complete evaluation, including an assessment of post-void residual volume, is key when evaluating a female patient for surgery to treat stress urinary incontinence (SUI), according to a new clinical practice guideline released today by the American Urological Association (AUA).

8 Jan 2010

Japanese MHLW approves Abbott's XIENCE V Everolimus Eluting Coronary Stent System

Abbott announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V® Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

8 Jan 2010

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy.

8 Jan 2010

Access Pharmaceuticals completes enrollment for Prolindac monotherapy trail, begins combination study

ACCESS PHARMACEUTICALS, INC., today announced that it has completed enrollment and evaluation of the last additional cohort of patients in the ongoing clinical study of ProLindac as a monotherapy in ovarian cancer patients who have received at least two prior platinum based treatment regimens.

8 Jan 2010

Additional education to liver transplant candidates increases live donation and donor evaluation

A recent study found that living donation increased 42% and the number of individuals who presented for donation evaluation increased 74% at centers in New York. The surge in live donation and donor evaluation occurred after additional education was provided to liver transplant candidates.

8 Jan 2010

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

Chinese researchers have become the world's fifth most prolific contributors to peer-reviewed scientific literature on clock-reversing regenerative medicine even as a skeptical international research community condemns the practice of Chinese clinics administering unproven stem cell therapies to domestic and foreign patients.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Cell Medica, a clinical cellular therapeutics company developing proven cell therapies which address important unmet clinical needs in oncology and infectious diseases, announced today the signing of an R&D agreement with the Center for Cell and Gene Therapy, a joint program of Baylor College of Medicine, Texas Children’s Hospital and The Methodist Hospital, Houston, Texas.

8 Jan 2010

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

Tolerx, Inc., today announced the completion of patient enrollment in its Phase 3 clinical study DEFEND-1, which is evaluating the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.

8 Jan 2010

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for nonpegylated liposomal doxorubicin (Myocet(TM)) for first-line therapy of HER2 positive metastatic breast cancer.

7 Jan 2010

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

VIVUS, Inc. today announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication.

7 Jan 2010

Heart Force Medical closes its private, non-brokered financing after raising $4.8 million net

Heart Force Medical Inc., a Vancouver-based company that is developing a non-invasive cardiac assessment, monitoring and screening device, announces today that it has closed its private, non-brokered financing after raising $4.8 million net.

7 Jan 2010

Positive top-line results from Phase III study of aclidinium bromide announced

orest Laboratories, Inc. and Almirall, S.A. (ALM.MC) today announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing aclidinium 200µg and 400µg BID versus placebo.

7 Jan 2010

UMBI announces exclusive licensing of fully human antibody technology platform to Prolias

The University of Maryland Biotechnology Institute (UMBI) today announced the exclusive licensing of a fully human antibody technology platform to Prolias, a biotechnology company working to discover and develop novel therapeutic proteins and antibodies for treatment of disease.

7 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

New tools show potential for treating brain disorders

Neuroscientists at MIT have developed a powerful new class of tools to reversibly shut down brain activity using different colors of light.

7 Jan 2010

Enzon Pharmaceuticals treats first patient in Phase 2 studies of PEG-SN38

Enzon Pharmaceuticals, Inc. today announced that the first patient has been treated in the Phase 2 studies of PEG-SN38 for metastatic breast cancer. PEG-SN38 or EZN-2208 is Enzon’s PEGylated form of SN38, the active metabolite of the cancer drug Camptosar® (irinotecan HCl injection).

6 Jan 2010

Ensemble Discovery initiates strategic alliance with Pfizer

Ensemble Discovery today announced the initiation of a strategic alliance with Pfizer Inc. to discover and develop drug candidates of a novel class against a number of high-value pharmaceutical targets.

6 Jan 2010

Efficacy News and Research

Boston Scientific's PROMUS Everolimus-Eluting Coronary Stent System receives Japanese marketing approval

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

AUA updates clinical practice guideline on female stress urinary incontinence

Japanese MHLW approves Abbott's XIENCE V Everolimus Eluting Coronary Stent System

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Access Pharmaceuticals completes enrollment for Prolindac monotherapy trail, begins combination study

Additional education to liver transplant candidates increases live donation and donor evaluation

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

3Sbio submits registrational clinical trial application for Feraheme injection

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

Heart Force Medical closes its private, non-brokered financing after raising $4.8 million net

Positive top-line results from Phase III study of aclidinium bromide announced

UMBI announces exclusive licensing of fully human antibody technology platform to Prolias

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

New tools show potential for treating brain disorders

Enzon Pharmaceuticals treats first patient in Phase 2 studies of PEG-SN38

Ensemble Discovery initiates strategic alliance with Pfizer

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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