Pulmonary Fibrosis News and Research

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FDA grants NeoPharm's IL13-PE38QQR orphan-drug designation for treatment of IPF

NeoPharm, Inc., announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan-drug designation for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

17 May 2010

Amira Pharmaceuticals' LPA1 receptor antagonist program data published in British Journal of Pharmacology

Amira Pharmaceuticals, Inc. announced today that preclinical data from its LPA1 receptor antagonist program has been published in the British Journal of Pharmacology.

7 May 2010

FDA's call for further review of pirfenidone disappointing for Pulmonary Fibrosis patients, says CPF

The Coalition for Pulmonary Fibrosis (CPF), representing tens of thousands of patients, is responding to the news that the FDA chose to ask for further study of Pirfenidone, which will delay potential approval of the first drug in the treatment of Pulmonary Fibrosis (PF), a lethal lung disease that is irreversible, progressive and deadly in an average of three years. On March 9, 2010, an FDA Advisory Committee recommended approval of the drug by the FDA.

5 May 2010

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Celgene Corporation announced non-GAAP net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, or diluted earnings per share of $0.50 for the quarter ended March 31, 2010. GAAP net income for the first quarter of 2009 was $162.9 million, or diluted earnings per share of $0.35.

29 Apr 2010

Small piece of RNA plays big role in development of IPF: Researchers

A small piece of RNA appears to play a big role in the development of idiopathic pulmonary fibrosis (IPF), according to lung disease researchers at the University of Pittsburgh School of Medicine. Their study, which is the first to examine microRNAs in the disease, is available online in the American Journal of Respiratory and Critical Care Medicine.

29 Apr 2010

Three nonprofit organizations launch campaign to increase national awareness of PF

The Coalition for Pulmonary Fibrosis, The Pulmonary Fibrosis Foundation and the Pulmonary Fibrosis Association of Texas today announced the launch of a special, grassroots campaign to build increased national awareness of Pulmonary Fibrosis.

12 Apr 2010

U-M Medical School researchers earn $366M in NIH research funding in fiscal year 2009

University of Michigan Medical School physicians and scientists earned more than $366 million in National Institutes of Health research funding in federal fiscal year 2009, according to NIH data. In all, the School's faculty brought in more than $435 million in research funding from all sources in U-M fiscal year 2009.

12 Apr 2010

Updated report analyzing approval rates at FDA published

Sagient Research Systems, a leading publisher of independent research for the financial services, institutional investment and corporate intelligence communities, recently published an updated report analyzing approval rates at the U.S Food and Drug Administration. According to its research service, BioMedTracker, the rate of drugs that were approved by the FDA in 2008 and 2009 has remained close to the historical low seen in 2007.

7 Apr 2010

Lung transplant patients may one day benefit from synthetic peptide, researchers report

Lung transplant patients may one day benefit from a synthetic peptide that mimics the body's natural ability to reduce excess fluid accumulation, Medical College of Georgia researchers report.

26 Mar 2010

EMA validates InterMune's pirfenidone MAA for IPF

InterMune, Inc. today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.

23 Mar 2010

CPF, PFF applaud PF patients' efforts to plead with FDA Advisory Panel regarding lack of treatment options

The Coalition for Pulmonary Fibrosis and the Pulmonary Fibrosis Foundation are applauding the efforts of Pulmonary Fibrosis (PF) patients and family members for their work to convey to the FDA and an FDA Advisory Committee the sense of urgency and desperation regarding the disease and the lack of treatment options.

15 Mar 2010

NeoPharm seeks Orphan Drug Designation for IL13-PE38QQR in treatment of IPF

NeoPharm, Inc., announced today that it has filed an orphan drug application with the Office of Orphan Products Development of the United States Food and Drug Administration to have Orphan Drug Designation granted to IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis.

10 Mar 2010

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

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

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

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

IPF added to Social Security's "Compassionate Allowances" program

The Coalition for Pulmonary Fibrosis is praising Social Security Commissioner Michael Astrue's announcement this morning via press release that Idiopathic Pulmonary Fibrosis (IPF), also known as Pulmonary Fibrosis (PF), and a listing of 37 other diseases and life-threatening medical conditions are the latest additions to Social Security's "Compassionate Allowances" program.

12 Feb 2010