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Repligen first quarter total revenue increases 9% to $7,654,000

Repligen Corporation today reported results for the first quarter of fiscal year 2012, ended June 30, 2011.

27 Jul 2011

New preclinical data from Baxter's BAX 499 hemophilia study presented at ISTH

Baxter International Inc. announced today that new data from a series of studies on BAX 499, an investigational compound for potential subcutaneous hemophilia therapy, were presented this week during the 23rd annual congress of the International Society on Thrombosis and Haemostasis (ISTH) in Kyoto, Japan.

From Baxter International Inc. 27 Jul 2011

Menopause has no additional effect on risk for diabetes

Menopause has little to no impact on whether women become more susceptible to diabetes, according to a one-of-a-kind study.

27 Jul 2011

Special panel votes in favor of HDE approval for EXCOR Pediatric VAD

At the request of Dr. Bram Zuckerman, Director, Division of Cardiovascular Devices, Center for Devices and Radiologic Health of the United States Food and Drug Administration, a special panel was convened on Thursday July 21 in Gaithersburg, Maryland to review the results of the EXCOR® IDE clinical trial.

27 Jul 2011

Four-year study to test effectiveness of WHO Safe Childbirth program

Harvard School of Public Health (HSPH) has been awarded a $14.1 million, four-year grant from the Bill & Melinda Gates Foundation to test the effectiveness of an innovative checklist-based childbirth safety program in reducing deaths and improving outcomes of mothers and infants in 120 hospitals in India.

27 Jul 2011

FDA grants Orphan Drug Designation for Diffusion's TSC to treat glioblastoma multiforme

Diffusion Pharmaceuticals LLC announced today that trans sodium crocetinate (TSC), the company's lead drug candidate, has been granted an Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of primary brain cancer, also known as glioblastoma multiforme or GBM.

27 Jul 2011

Anavex presents data on neuroprotective evidence for lead compound for Alzheimer’s

Anavex Life Sciences Corp. is pleased to provide a summary of its second poster presentation at the Alzheimer’s Association International Conference (AAIC) held in Paris, entitled “Preclinical development of new tetrahydrofuran derivatives targeting the sigma-1 chaperone protein as neuroprotectants in Alzheimer’s disease.”

26 Jul 2011

Resolute drug-eluting stent superior to Taxus DES for coronary artery disease

The Resolute drug-eluting stent (DES) from Medtronic, Inc., showed superiority to Boston Scientific Corp.'s Taxus DES on the primary endpoint of the RESOLUTE Japan clinical study: in-stent late lumen loss at eight months.

26 Jul 2011

Adaptimmune announces opening of pilot clinical trial in synovial sarcoma

Adaptimmune announced today that it has opened a Pilot, open-label clinical trial in synovial sarcoma at the National Cancer Institute (NCI), Bethesda, Maryland, testing its enhanced T cell receptor T cell therapy. A second site is planned to open later this year at Washington University, St. Louis, Missouri.

25 Jul 2011

Enrollment commences in Lutonix LEVANT 2 drug-coated balloon IDE trial for PAD

Lutonix today announced the first patient enrolled in the LEVANT 2 clinical trial, a global, multicenter, randomized trial evaluating the safety and efficacy of the Moxy™ Drug Coated Balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD). The first case was performed at St. John's Hospital in Springfield, IL by Dr. Jeff Goldstein.

25 Jul 2011

Threshold reports initiation of TH-302 and bevacizumab clinical trial for astrocytoma

Threshold Pharmaceuticals, Inc., today announced that the University of Texas at San Antonio initiated a clinical trial of TH-302 in combination with bevacizumab in patients with recurrent high grade astrocytoma including glioblastoma.

25 Jul 2011

Baxter GAMMAGARD LIQUID for PI receives FDA approval for subcutaneous administration

Baxter International Inc. announced today that the U.S. Food and Drug Administration has approved the subcutaneous administration of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency.

From Baxter International Inc. 25 Jul 2011

BDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain

BioDelivery Sciences International, Inc. announced today that the last patient has completed the randomized portion of its Phase 3 clinical trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain, signifying completion of the trial.

25 Jul 2011

Mayo Clinic trial to evaluate folate receptor alpha-targeted breast/ovarian cancer vaccine

VaxOnco, a leading oncology biopharmaceutical company, today announced that following FDA IND approval, it will sponsor a Phase I folate receptor alpha-targeted therapeutic vaccine clinical trial in disease-free patients, previously diagnosed with either breast or ovarian cancer at Mayo Clinic.

25 Jul 2011

Large clinical trial to test new device for detecting Barrett's oesophagus

CANCER RESEARCH UK has launched a large multi-centre trial to test a new device for detecting Barrett's oesophagus - a condition that puts sufferers at increased risk of developing cancer of the oesophagus, one of the most deadly cancers.

25 Jul 2011

Researchers examine benefits of hyperbaric oxygen in treatment of aggressive brain cancer

In a unique study, researchers at The Long Island Brain Tumor Center at Neurological Surgery, P.C. are examining whether hyperbaric oxygen therapy - breathing pure oxygen while in a pressurized chamber - may prove a useful addition to the current standard of care for patients newly diagnosed with glioblastoma, an aggressive brain cancer.

22 Jul 2011

22nd Century receives FDA approval for X-22 IND to conduct Phase II-B smoking cessation trial

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) Application to conduct a Phase II-B clinical trial using X-22, a prescription smoking cessation aid in development.

22 Jul 2011

Michigan Cardiovascular Institute performs first Astron Pulsar stent procedure in the U.S.

BIOTRONIK announced today that the first endovascular procedure was completed in the BIOFLEX-I clinical trial—a trial set to evaluate the safety and performance of the Astron and Astron Pulsar self-expanding peripheral stents.

22 Jul 2011

UK regulators approve Europe's first clinical trial of plant-derived antibody for HIV

UK regulators have approved Europe's first clinical trial of a monoclonal antibody produced from genetically modified plants. This landmark decision sets the stage for the testing, in humans, of an anti-HIV product made from genetically modified tobacco plants. It will open the door for trials of additional plant-derived medicines treating a range of diseases.

22 Jul 2011

Taiho announces results of TAS-102 Phase II trial for metastatic colorectal cancer

Taiho Pharmaceutical Co., Ltd. announced on July 22 the results of a randomized, Phase II clinical trial for the novel oral nucleoside antitumor agent TAS-102 under development by the company for metastatic colorectal cancer, at the 9th Annual Meeting of the Japanese Society of Medical Oncology held in Yokohama.

22 Jul 2011

Clinical Trial News and Research

Repligen first quarter total revenue increases 9% to $7,654,000

New preclinical data from Baxter's BAX 499 hemophilia study presented at ISTH

Menopause has no additional effect on risk for diabetes

Special panel votes in favor of HDE approval for EXCOR Pediatric VAD

Four-year study to test effectiveness of WHO Safe Childbirth program

FDA grants Orphan Drug Designation for Diffusion's TSC to treat glioblastoma multiforme

Anavex presents data on neuroprotective evidence for lead compound for Alzheimer’s

Resolute drug-eluting stent superior to Taxus DES for coronary artery disease

Adaptimmune announces opening of pilot clinical trial in synovial sarcoma

Enrollment commences in Lutonix LEVANT 2 drug-coated balloon IDE trial for PAD

Threshold reports initiation of TH-302 and bevacizumab clinical trial for astrocytoma

Baxter GAMMAGARD LIQUID for PI receives FDA approval for subcutaneous administration

BDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain

Mayo Clinic trial to evaluate folate receptor alpha-targeted breast/ovarian cancer vaccine

Large clinical trial to test new device for detecting Barrett's oesophagus

Researchers examine benefits of hyperbaric oxygen in treatment of aggressive brain cancer

22nd Century receives FDA approval for X-22 IND to conduct Phase II-B smoking cessation trial

Michigan Cardiovascular Institute performs first Astron Pulsar stent procedure in the U.S.

UK regulators approve Europe's first clinical trial of plant-derived antibody for HIV

Taiho announces results of TAS-102 Phase II trial for metastatic colorectal cancer

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