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RegeneRx to initiate enrollment in RGN-259 Phase 2 trial for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. has announced that it is set to begin a Phase 2 clinical trial in 72 patients with dry eye syndrome.

29 Jul 2011

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

Curis second quarter net loss increases to $4.9 million

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the second quarter ended June 30, 2011.

28 Jul 2011

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

Ipsen today announced that its partner Inspiration Biopharmaceuticals, Inc. presented data from its clinical development program for OBI-1, an intravenous (IV) recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.

28 Jul 2011

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

Clinical Trial News and Research

RegeneRx to initiate enrollment in RGN-259 Phase 2 trial for dry eye syndrome

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Curis second quarter net loss increases to $4.9 million

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

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

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