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FDA clears Aptus EndoStapling System to treat AAA

Aptus Endosystems, Inc., a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Aptus EndoStapling System, which will now be known as the HeliFX™ Aortic Securement System.

21 Nov 2011

USPTO to issue patent for CU's DCA to treat cancer

Viral Genetics reports that a patent under which it is exclusively licensed will be granted for using a compound known as DCA to treat cancer.

21 Nov 2011

New insights into immune-system changes that may trigger cartilage breakdown

Challenging long-held notions that osteoarthritis is a result mainly of wear and tear on the joints, researchers led by Dr. William H. Robinson of the Department of Veterans Affairs Palo Alto Health Care System and Stanford University have provided new insights into the immune-system changes that may trigger cartilage breakdown.

21 Nov 2011

Regeneron’s Eylea for treating age related macular degeneration gets FDA nod

Regeneron Pharmaceuticals has received marketing approval for their eye drug - Eylea, an injection meant to treat a common cause of blindness in older people. Eylea can be used to treat “wet” age-related macular degeneration. The only other drug approved for the condition is Lucentis from Roche, which was approved in 2006.

21 Nov 2011

Certain IBD patients at increased risk of skin cancer

Certain patients with inflammatory bowel disease (IBD) may have an increased risk of skin cancer, which is intensified by the use of immunosuppressant medications , according to two new studies in Gastroenterology, the official journal of the American Gastroenterological Association. Immunosuppressants are commonly used in the treatment of IBD.

21 Nov 2011

Nature Medicine publishes dexpramipexole Phase 2 ALS study results

Knopp Biosciences LLC today announced the publication in Nature Medicine of comprehensive results from the Phase 2 study of dexpramipexole, a small-molecule modulator of mitochondrial bioenergetics, in people with amyotrophic lateral sclerosis.

21 Nov 2011

Novel antibacterial protein could prevent or treat E. coli O157:H7-induced food-borne infections

A novel antibacterial protein targeted against E. coli O157:H7 may offer a way to prevent or treat serious food-borne bacterial infections, as demonstrated in a study published in the December issue of Antimicrobial Agents and Chemotherapy.

21 Nov 2011

2011 National Report Card on Lung Cancer notes significant change in grade for early detection

Today, Lung Cancer Alliance (LCA), the leading national support and advocacy voice for those at risk for or living with lung cancer, issued its annual 2011 National Report Card on Lung Cancer, an overall assessment of the nation's response to the continuing high mortality of lung cancer, the leading cause of cancer death.

21 Nov 2011

ChanRx to evaluate AFIB drug, vanoxerine with closed Series A funding

ChanRx is developing a superior drug for treatment of atrial fibrillation (AFIB), and has closed its Series A funding with investments from Sante Ventures and company founder, Dr. Arthur "Buzz" Brown. The company, a spin out of Cleveland-based ChanTest, will use the funding to further evaluate the safety and efficacy of its proprietary AFIB drug, vanoxerine.

21 Nov 2011

Akebia commences dosing in AKB-9778 Phase 1 study for diabetic macular edema and retinopathy

Akebia Therapeutics, Inc., a small molecule discovery and development company focused on anemia and vascular disorders, today announced that it has dosed the first subjects in a first-in-man Phase 1 study of AKB-9778, a first-in-class human protein tyrosine phosphatase beta (HPTPβ) inhibitor in development for diabetic macular edema (DME) and diabetic retinopathy (DR).

21 Nov 2011

Australia's TGA grants market authorisation for Pierre Fabre Médicament's milnacipran to treat fibromyalgia

The Therapeutic Goods Administration (TGA), Australia's regulatory body for therapeutic products, granted Pierre Fabre Médicament's milnacipran market authorisation for the treatment of fibromyalgia.

21 Nov 2011

PLoS ONE publishes study on darinaparsin, a multivalent chemotherapeutic

ZIOPHARM Oncology, Inc. announced today the publication of a darinaparsin (Zinapar or ZIO-101) study in the PLoS ONE, an international, peer-reviewed, open-access, online publication of the Public Library of Science.

21 Nov 2011

UTHealth and Memorial Hermann HVI first in Houston to implant FDA approved artificial heart valve

Cardiologists and cardiovascular surgeons at The University of Texas Health Science Center at Houston and Memorial Hermann Heart & Vascular Institute are the first in Houston to implant the artificial heart valve recently approved by the Food and Drug Administration, as well as a newer, smaller version that is part of a clinical trial.

21 Nov 2011

Consistent data from three studies support plans for rindopepimut with ACT IV Phase 3 study

Celldex Therapeutics, Inc. today announced the presentation of mature overall survival (OS) data for ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB).

21 Nov 2011

Impax initiates patent challenge related to Fentora

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Fentora® (fentanyl buccal tablets, 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg).

21 Nov 2011

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that REVLIMID (lenalidomide) has been granted approval by the Swiss agency for Therapeutic Products (Swissmedic) for use in patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

21 Nov 2011

EU's FP7 programme provides €6M grant for Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial

Dr Patricia Kearney, Department of Epidemiology & Public Health, UCC is one of a group of researchers from European Universities who will participate in a new research project investigating current treatment practices for people who suffer from a mildly underactive thyroid gland.

21 Nov 2011

ZEVALIN treatment for Non-Hodgkin lymphoma becomes simpler with removal of bioscan requirement

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, received approval from the U.S. Food and Drug Administration (FDA) on November 18, 2011 to remove the pre-treatment biodistribution evaluation requirement using Indium-111 ZEVALIN imaging dose followed by a gamma scan before administering the ZEVALIN therapeutic dose.

21 Nov 2011

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today positive preliminary results from its Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

21 Nov 2011

Adeona to develop and commercialize DNA-based therapeutic for PAH using Intrexon technology

Adeona Pharmaceuticals, Inc., and the Human Therapeutics Division of Intrexon Corporation, announced today the formation of a global exclusive channel collaboration through which Adeona intends to develop and commercialize a DNA-based therapeutic using Intrexon's UltraVector platform and RheoSwitch Therapeutic System for the treatment of pulmonary arterial hypertension (PAH).

21 Nov 2011

Medical Condition News

FDA clears Aptus EndoStapling System to treat AAA

USPTO to issue patent for CU's DCA to treat cancer

New insights into immune-system changes that may trigger cartilage breakdown

Regeneron’s Eylea for treating age related macular degeneration gets FDA nod

Certain IBD patients at increased risk of skin cancer

Nature Medicine publishes dexpramipexole Phase 2 ALS study results

Novel antibacterial protein could prevent or treat E. coli O157:H7-induced food-borne infections

2011 National Report Card on Lung Cancer notes significant change in grade for early detection

ChanRx to evaluate AFIB drug, vanoxerine with closed Series A funding

Akebia commences dosing in AKB-9778 Phase 1 study for diabetic macular edema and retinopathy

Australia's TGA grants market authorisation for Pierre Fabre Médicament's milnacipran to treat fibromyalgia

PLoS ONE publishes study on darinaparsin, a multivalent chemotherapeutic

UTHealth and Memorial Hermann HVI first in Houston to implant FDA approved artificial heart valve

Consistent data from three studies support plans for rindopepimut with ACT IV Phase 3 study

Impax initiates patent challenge related to Fentora

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

EU's FP7 programme provides €6M grant for Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial

ZEVALIN treatment for Non-Hodgkin lymphoma becomes simpler with removal of bioscan requirement

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Adeona to develop and commercialize DNA-based therapeutic for PAH using Intrexon technology

Evolving spectrophotometry for modern biopharma workflows

Scaling B-cell cloning workflows for antibody development

Fluidics in Modern Healthcare & Medical Device Innovation

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