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FDA approves Roxane's Naratriptan Tablets ANDA

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Naratriptan Tablets USP, 1mg and 2.5mg by the U.S. Food and Drug Administration. The product is available in bottles of 9 for immediate shipment to wholesalers and pharmacies nationwide.

9 Jul 2010

Qualaquin for treatment of night time leg cramps leads to serious side effects, FDA warns

The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

9 Jul 2010

BioCurex reports first set of results supporting RECAF blood test for monitoring cancer therapy

BioCurex Inc. today announced its first set of results supporting the use of the BioCurex RECAF blood test to monitor cancer therapy. The test included samples from 27 human patients with early stages of breast cancer that were tested before and after surgery. As a control, 15 samples from healthy individuals were also tested.

9 Jul 2010

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Phase I clinical data for BAY86-6150, a novel recombinant factor VIIa protein (rFVIIa) being developed by Bayer HealthCare, will be presented at the XXIX International Congress of the World Federation of Hemophilia (WFH) to be held in Buenos Aires, Argentina from Saturday, July 10-Wednesday, July 14.

9 Jul 2010

pSivida submits MAA for Iluvien to UK MHRA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien®.

8 Jul 2010

Study demonstrates causal relationship between onset of Creutzfeldt-Jakob disease and general surgery

A new study spearheaded by Spanish scientists demonstrates a causal relationship between the onset of Creutzfeldt-Jakob disease (CJD), caused by a protein called a prion, and general surgery. CJD manifests itself in hereditary acquired; and sporadic forms, or for unknown reasons, which accounts for the majority of cases.

8 Jul 2010

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate, a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.

8 Jul 2010

Fibrocell Science completes enrollment in azficel-T histology study

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the completion of enrollment of and first treatment visits for participants in its histology study (IT-H-001) of azficel-T. An autologous cell therapy, azficel-T is currently under review by the U.S. Food and Drug Administration for the treatment of moderate to severe nasolabial fold wrinkles.

8 Jul 2010

First patient enrolled in Boston Scientific's MultiSENSE clinical trial

Boston Scientific Corporation today announced enrollment of the first patient in its MultiSENSE clinical trial. The trial is designed to evaluate multiple physiologic sensors in the Company's COGNIS cardiac resynchronization therapy defibrillators. Boston Scientific plans to use the trial data to help develop a clinical alert that identifies the early onset of worsening heart failure.

8 Jul 2010

Alimera Sciences submits MAA for Iluvien to MHRA

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals has submitted a Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom for Iluvien (fluocinolone acetonide intravitreal insert).

8 Jul 2010

Study: 30-minute massage improves psychological, physiological state of patients with tension headache

Researchers at the University of Granada -in collaboration with the Clinical Hospital San Cecilio and the University Rey Juan Carlos- have proven that the psychological and physiological state of patients with tension headache improves within 24 hours after receiving a 30-minute massage.

8 Jul 2010

VDF announces launch of new PAD exercise training toolkit for health professionals

The Vascular Disease Foundation announced the launch of its new "Peripheral Arterial Disease Exercise Training Toolkit: A Guide for Health Care Professionals." This toolkit was developed jointly by the Vascular Disease Foundation and the American Association of Cardiovascular and Pulmonary Rehabilitation and may be accessed online at www.vdf.org/rehab-toolkit/index.php

8 Jul 2010

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR™ in the United States. Kiadis Pharma is currently enrolling patients in a multinational, pivotal clinical study at hospitals in Europe and Canada. With the approval of the IND, US hospitals will also participate in this study.

8 Jul 2010

USF granted patent for cell transplantation procedure

The University of South Florida's Department of Neurosurgery and Brain Repair has been granted a patent for a cell transplantation procedure combining human umbilical cord blood cells and a sugar-alcohol compound called "mannitol" that may make a big difference in treating life-threatening neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, multiple sclerosis and stroke, among others.

8 Jul 2010

Profil Institute for Clinical Research to support ADA's Step Out: Walk to Fight Diabetes

Profil Institute for Clinical Research, Inc., a company specializing in early phase clinical trials for diabetes and obesity, announced today that Dr. Marcus Hompesch, the company's President and CEO, will serve as San Diego's 2010 Corporate Chairman for Step Out: Walk to Fight Diabetes, the American Diabetes Association's largest fund-raising event.

8 Jul 2010

New surgery can improve outcomes in patients with severe adult flat foot deformity

A surgery developed at Hospital for Special Surgery can improve patient outcomes in individuals with severe adult flat foot deformity, a problem that is increasingly being seen in hospitals across the country. Patients who undergo the new surgery have better long-term outcome and mobility than those who undergo traditional surgery.

8 Jul 2010

CF patients recover from exacerbations equally well when treated at home or in hospital: Researchers

Patients with cystic fibrosis recover from exacerbations equally well if they are treated at home or in a hospital, according to researchers from Johns Hopkins University. Furthermore, longer treatment with antibiotics does not appear to offer any additional benefit over shorter courses.

8 Jul 2010

NOSCAR completes first NOTES transoral and transvaginal gallbladder removal in U.S. human trial

The Natural Orifice Surgery Consortium for Assessment and Research- (NOSCAR-), a joint effort of the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), announces the completion of the first transoral and transvaginal cholecystectomies (gallbladder removal) using Natural Orifice Translumenal Endoscopic Surgery- (NOTES-) in a multicenter human trial in the United States.

From Evident Corporation - Life Sciences 8 Jul 2010

ESMO releases revised set of clinical guidelines for cancer patient care

The European Society for Medical Oncology just released an enhanced and revised set of clinical recommendations designed to help oncologists deliver the best quality care to their patients.

8 Jul 2010

Vitamin D receptor emerges as key player amid gut bacteria, scientists find

Within the human digestive tract is a teeming mass of hundreds of types of bacteria, a potpourri of microbes numbering in the trillions that help us digest food and keep bad bacteria in check.

8 Jul 2010

Medical Condition News

FDA approves Roxane's Naratriptan Tablets ANDA

Qualaquin for treatment of night time leg cramps leads to serious side effects, FDA warns

BioCurex reports first set of results supporting RECAF blood test for monitoring cancer therapy

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

pSivida submits MAA for Iluvien to UK MHRA

Study demonstrates causal relationship between onset of Creutzfeldt-Jakob disease and general surgery

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Fibrocell Science completes enrollment in azficel-T histology study

First patient enrolled in Boston Scientific's MultiSENSE clinical trial

Alimera Sciences submits MAA for Iluvien to MHRA

Study: 30-minute massage improves psychological, physiological state of patients with tension headache

VDF announces launch of new PAD exercise training toolkit for health professionals

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

USF granted patent for cell transplantation procedure

Profil Institute for Clinical Research to support ADA's Step Out: Walk to Fight Diabetes

New surgery can improve outcomes in patients with severe adult flat foot deformity

CF patients recover from exacerbations equally well when treated at home or in hospital: Researchers

NOSCAR completes first NOTES transoral and transvaginal gallbladder removal in U.S. human trial

ESMO releases revised set of clinical guidelines for cancer patient care

Vitamin D receptor emerges as key player amid gut bacteria, scientists find

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