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Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter of 2011, has been designed as a Phase II/III trial.

7 Jan 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

BIND Biosciences announced today that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of BIND-014 in cancer patients. BIND-014, the first product candidate to enter clinical evaluation from BIND's broad proprietary Medicinal Nanoengineering platform, is a targeted polymeric nanoparticle containing the cytotoxic agent, docetaxel.

7 Jan 2011

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Plexxikon, Inc., announced today that it has signed an agreement with Genentech to co-promote PLX4032 (RG7204) in the United States. PLX4032, an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation, is being tested in late-stage clinical trials for the treatment of metastatic melanoma.

7 Jan 2011

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Cell Medica, a leading cellular therapeutics company which develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, is pleased to announce an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV).

7 Jan 2011

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

ZIOPHARM Oncology, a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector Technology.

7 Jan 2011

Regular blood test shows pre-diabetes risk factors, reduces treatment costs

A simpler form of testing individuals with risk factors for diabetes could improve diabetes prevention efforts by substantially increasing the number of individuals who complete testing and learn whether or not they are likely to develop diabetes.

7 Jan 2011

Positive results from LifeCycle Pharma's LCP-Tacro comparative trial in de novo liver transplant patients

LifeCycle Pharma A/S has announced positive top-line results from a Phase 2 clinical trial involving 58 patients comparing LCP-Tacro™ tablets administered once-daily versus Prograf® (tacrolimus) capsules (Astellas Pharma) administered twice-daily in de novo liver transplant patients for one year.

7 Jan 2011

Athersys completes patient enrollment in MultiStem Phase I study for leukemia

Athersys, Inc. today announced that it has completed patient enrollment of the single dose arm of a clinical study involving administration of MultiStem to patients being treated for leukemia or other blood born cancers.

7 Jan 2011

Altheus Therapeutics announces completion of Zoenasa phase I trial for ulcerative colitis

Altheus Therapeutics, announced that it has completed a two dose, double-blind, active-controlled Phase I clinical trial of the safety and tolerability of Zoenasa Rectal Suspension in adult patients with left-sided, or distal, ulcerative colitis.

6 Jan 2011

Acceleron recieves $1.5 million MDA grant for ACE-031 clinical study in Duchenne Muscular Dystrophy

Acceleron Pharma, a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced it has been awarded a $1.5 million grant from the Muscular Dystrophy Association to support clinical studies of ACE-031 in Duchenne Muscular Dystrophy, a disabling neuromuscular disease in which patients experience a progressive loss of muscle mass and strength.

6 Jan 2011

MacroGenics commences MGAH22 Phase I trail for patients with HER2-positive cancer

MacroGenics, a privately held biotechnology company that develops immunotherapeutics to treat autoimmune disorders, cancer and infectious diseases, today announced that it had administered drug to the first cohort of patients in a Phase I clinical trial of MGAH22.

6 Jan 2011

Antigenics announces name change to Agenus

Antigenics Inc. today announced that effective immediately it is changing its name to Agenus Inc. The company's stock will continue to be traded on NASDAQ under the symbol AGEN. The new name reflects the broadening of the company's product portfolio of clinical candidates beyond autologous antigen-based vaccines, as well as its commitment to actively pursuing licensing opportunities to leverage its development capabilities and expand its product portfolio.

6 Jan 2011

Lexicon Pharmaceuticals announces clinical trial, mechanistic study results of LX4211

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced data from a recently completed clinical trial and mechanistic study of a solid oral dose formulation for LX4211, a dual inhibitor of sodium-glucose co-transporters 1 and 2 (SGLT1 and SGLT2).

6 Jan 2011

Opexa completes meetings with FDA regarding planned development program for Tovaxin

Opexa Therapeutics, Inc., a leading cell therapy company developing Tovaxin for multiple sclerosis, today announced the successful completion of two separate meetings with the U.S. Food and Drug Administration regarding the Company's planned development program for Tovaxin.

6 Jan 2011

J&JPRD submits New Drug Application to FDA for rivaroxaban

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

6 Jan 2011

Mayo Clinic uses Arctic Front Cardiac CryoAblation Catheter system for treating AF

Mayo Clinic is the first in the U.S. to use the first minimally invasive freezing balloon technology for the treatment of atrial fibrillation approved in December by the U.S. Food and Drug Administration. The first patient received the treatment Tuesday, Jan. 4.

6 Jan 2011

Insite Vision announces completion of patient enrollment in ISV-303 Phase 1/2 trial for post surgical ocular pain, inflammation

InSite Vision Incorporated, a company developing novel ophthalmic therapeutics, today announced that patient enrollment was recently completed in the company's Phase 1/2 clinical trial of ISV-303, a novel compound being developed to reduce the pain and inflammation associated with ocular surgery.

6 Jan 2011

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

Ikaria, Inc. today announced that the U.S. Food and Drug Administration has granted INOMAX for inhalation an additional six months of marketing exclusivity, known as "pediatric exclusivity."

6 Jan 2011

Reproductive biologist achieves major breakthrough in IVF technology

A University of Adelaide reproductive biologist has achieved a major breakthrough in IVF technology that is expected to help millions of women around the world who have suffered previous miscarriages after IVF treatment.

6 Jan 2011

Clinical Trial News and Research

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

Regular blood test shows pre-diabetes risk factors, reduces treatment costs

Positive results from LifeCycle Pharma's LCP-Tacro comparative trial in de novo liver transplant patients

Athersys completes patient enrollment in MultiStem Phase I study for leukemia

Altheus Therapeutics announces completion of Zoenasa phase I trial for ulcerative colitis

Acceleron recieves $1.5 million MDA grant for ACE-031 clinical study in Duchenne Muscular Dystrophy

MacroGenics commences MGAH22 Phase I trail for patients with HER2-positive cancer

Antigenics announces name change to Agenus

Lexicon Pharmaceuticals announces clinical trial, mechanistic study results of LX4211

Opexa completes meetings with FDA regarding planned development program for Tovaxin

J&JPRD submits New Drug Application to FDA for rivaroxaban

Mayo Clinic uses Arctic Front Cardiac CryoAblation Catheter system for treating AF

Insite Vision announces completion of patient enrollment in ISV-303 Phase 1/2 trial for post surgical ocular pain, inflammation

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

Reproductive biologist achieves major breakthrough in IVF technology

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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