Fibrosis News and Research

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Fibrosis is the growth of fibrous tissue.

FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

InterMune, Inc. announced today that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.

9 Mar 2010

NASDAQ halts trading of InterMune's common stock, FDA PADAC to discuss pirfenidone NDA

InterMune, Inc. announced that NASDAQ has today halted trading of InterMune's common stock. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration meets today to review and discuss the company's New Drug Application for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis.

9 Mar 2010

New article sheds light on the costs and benefits of screening for SMA

Spinal Muscular Atrophy is one of many serious disorders for which prenatal testing is available. SMA affects approximately 1 in 10,000 live births and is the leading genetic cause of infant mortality and the second most common autosomal recessive disorder, after cystic fibrosis. Although the American College of Medical Genetics recommends carrier testing for all couples, the American College of Obstetricians and Gynecologists has issued a recommendation to the contrary, citing lack of information about the costs and benefits of screening for SMA.

9 Mar 2010

Differentiation of cirrhosis from inflammation in patients with ALD: Novel bedside criteria identified

Alcoholic liver disease (ALD) is the most common cause of liver cirrhosis in the Western world. Liver biopsy is currently considered the gold standard for assessing hepatic fibrosis or cirrhosis in these patients. However, it is an invasive procedure, with rare but potentially life-threatening complications and its accuracy is limited due to sampling error. Transient elastography (FibroScan-, FS) is a novel rapid and noninvasive method to assess liver fibrosis via measurement of liver stiffness (LS).

6 Mar 2010

Research group performs randomized study to evaluate efficacy of ICCBco in treatment of lung lesions

To evaluate efficacy of Calculus Bovis compound preparation (ICCBco) in the treatment of lung lesions in portal hypertensive rabbits with schistosomiasis as the experimental animal model, a research group in China performed a randomized, double-blind, controlled trial to observe pathological changes and pathological effect mechanism of expression of fibronectin and laminin in the lung tissue of portal hypertensive rabbits with schistosomiasis.

6 Mar 2010

Humanetics' BIO 300 medical radiation countermeasure drug candidate issued U.S. patent

In an announcement today, Humanetics Corporation reported that its BIO 300 medical radiation countermeasure drug candidate has been issued a U.S. patent. The patent is assigned to the United States of America with Humanetics as the designated licensee.

5 Mar 2010

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. The proposed trade name for pirfenidone is Esbriet®.

5 Mar 2010

Enigma Diagnostics opens new Regional HQ office in San Diego

Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced today the opening of its new Regional HQ office in San Diego, CA and the appointment of Joel Centeno as VP Regulatory & Quality.

4 Mar 2010

Inspire Pharmaceuticals reports net loss of $2.6 million for 2009 fourth quarter

Inspire Pharmaceuticals, Inc. announced today financial results for the fourth quarter and year ended December 31, 2009, reporting a net loss of $2.6 million or ($0.03) per share for the fourth quarter and a net loss of $40.0 million or ($0.60) per share for the full year.

4 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

Greffex Group signs Strategic Alliance Framework Agreement with UPMC and ISMETT

The Greffex Group of regenerative medicine companies announces the signing of a Strategic Alliance Framework Agreement with UPMC and ISMETT, Italy.

2 Mar 2010

PARI Respiratory Equipment launches new aerosol delivery system

Today, PARI Respiratory Equipment launched their newest aerosol delivery system, the Vios. Paired with PARI's gold standard reusable nebulizers, Vios delivers fast treatments, small particle size, and high respirable drug dose to the lungs. Vios also features an extended warranty and Timestrip, an easy to use reminder for patients to replace their nebulizer every six months.

1 Mar 2010

Oral immunotherapy promising for egg allergies, SLIT for milk allergies

Children with egg allergies who consume increasingly higher doses of egg protein - the very nutrient they react to - appear to gradually overcome their allergies, tolerating eggs better over time and with milder symptoms, according to research conducted at Johns Hopkins Children's Center and elsewhere.

1 Mar 2010

Short-term dose of losartan-M6PHSA reduces liver inflammation and fibrosis: Study

A recent study found that rats with advanced fibrosis that were administered a short-term dose of losartan-M6PHSA had reduced liver inflammation and fibrosis. Those animals treated with oral losartan alone did not experience a similar reduction in disease activity. Results of this study appear in the March issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

1 Mar 2010

Study shows ghrelin prevents acute liver damage, reduces oxidative stress and inflammation

Spanish researchers determined that rats treated with recombinant ghrelin displayed a reduction in liver fibrosis. Ghrelin, a stomach hormone, reduced the amount of fibrogenic cells by 25% in the treated rodents. Research further showed ghrelin prevented acute liver damage and reduced oxidative stress and inflammation in the animal models.

1 Mar 2010

Article describing novel biological properties of Thymosin beta 4 peptide fragments published

REGENERX BIOPHARMACEUTICALS, INC. announced today that a university research team has published an article ahead of print in FASEB Journal, a high-impact scientific journal, describing novel biological properties of several Thymosin beta 4 (Tβ4) peptide fragments.

27 Feb 2010

CPF to partner with ATS to fund Pulmonary Fibrosis research

The Coalition for Pulmonary Fibrosis and the American Thoracic Society, the world's leading professional organization for pulmonary, critical care and sleep physicians, today announced that the CPF will again partner with the ATS to fund Pulmonary Fibrosis (PF) research.

26 Feb 2010

Regulus Therapeutics, GSK announce new collaboration on microRNA therapeutics targeting microRNA-122

Regulus Therapeutics Inc. today announced the establishment of a new collaboration with GlaxoSmithKline (GSK) to develop and commercialize microRNA therapeutics targeting microRNA-122 in all fields with Hepatitis C Viral infection (HCV) as the lead indication. Under the terms of the new collaboration, Regulus will receive additional upfront and early-stage milestone payments with the potential to earn more than $150 million in miR-122-related combined payments, and tiered royalties up to double digits on worldwide sales of products.

25 Feb 2010

Little Company of Mary installs Toshiba America Medical Systems' Vantage Atlas MR system

In response to concern over gadolinium-based contrast agents, Little Company of Mary, a not-for-profit Catholic community hospital in Evergreen Park, Ill., wanted to provide the highest quality and safest MRA procedures to its patients. To accomplish this, the facility installed Toshiba America Medical Systems, Inc.’s Vantage Atlas® MR system and utilized the full suite of proprietary contrast-free MRA techniques.

25 Feb 2010

Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

Aradigm Corporation today announced that it dosed the first patient in the U.S. as part of its ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial, an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE) under a U.S. IND. This orphan disease indication is a chronic, severe respiratory disease and there are currently no approved treatments for this disease in the U.S.

23 Feb 2010

Fibrosis News and Research

Further Reading

FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

NASDAQ halts trading of InterMune's common stock, FDA PADAC to discuss pirfenidone NDA

New article sheds light on the costs and benefits of screening for SMA

Differentiation of cirrhosis from inflammation in patients with ALD: Novel bedside criteria identified

Research group performs randomized study to evaluate efficacy of ICCBco in treatment of lung lesions

Humanetics' BIO 300 medical radiation countermeasure drug candidate issued U.S. patent

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

Enigma Diagnostics opens new Regional HQ office in San Diego

Inspire Pharmaceuticals reports net loss of $2.6 million for 2009 fourth quarter

InterMune seeks European marketing approval for pirfenidone

Greffex Group signs Strategic Alliance Framework Agreement with UPMC and ISMETT

PARI Respiratory Equipment launches new aerosol delivery system

Oral immunotherapy promising for egg allergies, SLIT for milk allergies

Short-term dose of losartan-M6PHSA reduces liver inflammation and fibrosis: Study

Study shows ghrelin prevents acute liver damage, reduces oxidative stress and inflammation

Article describing novel biological properties of Thymosin beta 4 peptide fragments published

CPF to partner with ATS to fund Pulmonary Fibrosis research

Regulus Therapeutics, GSK announce new collaboration on microRNA therapeutics targeting microRNA-122

Little Company of Mary installs Toshiba America Medical Systems' Vantage Atlas MR system

Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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