Pulmonary Fibrosis News and Research

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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

Bioactive lipid LPA mediates fibrogenesis in bleomycin mouse model of scleroderma

Amira Pharmaceuticals, Inc. announced today that their collaborators, Andrew Tager, M.D. and Flavia V. Castelino, M.D. of Massachusetts General Hospital, Harvard Medical School, will present a preclinical proof-of-concept study which demonstrates that the bioactive lipid lysophosphatidic acid (LPA), through its high affinity LPA1 receptor, is an important mediator of fibrogenesis in the bleomycin mouse model of scleroderma. Data will be presented as part of a poster session for the 1st Systemic Sclerosis World Congress to be held in Florence, Italy, February 11 to 13, 2010.

11 Feb 2010

Fourth-quarter and full-year 2009 results announced by Compugen

Compugen Ltd. today reported financial results for the fourth quarter and year ending December 31, 2009.

9 Feb 2010

New study may allow scientists to develop screening test for idiopathic pulmonary fibrosis

A simple blood test could predict which patients with the lung-scarring disease known as idiopathic pulmonary fibrosis (IPF) are soon to get far worse, an indicator that could one day influence their treatment, according to researchers at the University of Pittsburgh School of Medicine.

4 Feb 2010

Celgene reports total revenue of $758M for fourth-quarter of 2009

Celgene Corporation announced non-GAAP (Generally Accepted Accounting Principles) net income of $290.3 million, or non-GAAP diluted earnings per share of $0.62 for the quarter ended December 31, 2009. Non-GAAP net income for the fourth quarter of 2008 was $200.9 million or non-GAAP diluted earnings per share of $0.43. Based on U.S. GAAP, Celgene reported net income of $254.2 million, or diluted earnings per share of $0.54 for the quarter ended December 31, 2009. GAAP net loss for the fourth quarter of 2008 was $149.3 million, or diluted loss per share of $0.33.

28 Jan 2010

Palliative care program may complement patients' ongoing care with symptom management and support

Georgia Sue Huston knew she was really sick. Every time the 82-year-old woman tried to turn over in her bed in the coronary care unit at Stanford Hospital & Clinics, she’d panic because she couldn’t get enough air and because it hurt so much.

28 Jan 2010

Scientists and clinicians address diagnosis and treatment for autoimmune and autoinflammatory diseases

Autoimmune and autoinflammatory diseases are a major health issue. The National Institutes of Health reports that up to 23.5 million Americans are afflicted. The American Autoimmune Related Diseases Association reports the number is closer to 50 million. Scientists and clinicians at The University of Texas Health Science Center at Houston can address the diagnosis and treatment of these conditions, as well as the latest advances in research.

8 Jan 2010

NeoPharm submits IL13-PE38QQR IND for the treatment of IPF

NeoPharm, Inc., announced today that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is the most deadly disease of the lungs in humans with very high morbidity. There is currently no proven effective treatment for the cure of this disease.

5 Jan 2010

FDA grants Priority Review designation for InterMune's NDA for pirfenidone

InterMune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted Priority Review designation for the company's New Drug Application (NDA) for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

4 Jan 2010

CPF reports success in advocacy, research support and awareness of PF

The Coalition for Pulmonary Fibrosis (CPF) calls 2009 a year of success in advocacy, research support and awareness, even in a year plagued by the economic recession. PF is a fatal disease that has no known cause, no FDA-approved treatment, and no cure.

30 Dec 2009