Fibrosis News and Research

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Fibrosis is the growth of fibrous tissue.

Novation, Lantheus Medical to distribute ABLAVAR and DEFINITY diagnostic imaging agents

Lantheus Medical Imaging, a worldwide leader in diagnostic medical imaging, today announced a national contract with Novation for ABLAVAR and DEFINITY Vial For Injectable Suspension, providing increased access to these important diagnostic imaging agents for health care providers served by Novation.

23 Jan 2011

FibroGen announces FG-3019 interim results from phase 1/2 trial against pancreatic cancer

FibroGen, today announced interim results of a phase 1/2 trial of FG-3019, a therapeutic antibody against connective tissue growth factor, in combination with gemcitabine and erlotinib in individuals with unresectable pancreatic cancer.

23 Jan 2011

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C.

20 Jan 2011

USPTO grants KL4 surfactant combination product patent to Discovery Labs

Discovery Laboratories, Inc. has been notified that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent Number 7,863,241 titled "Compositions for Treatment and Prevention of Pulmonary Conditions." The patent provides broad coverage for compositions that employ a combination of certain pulmonary surfactants with a broad array of protease inhibitors, administered as either a liquid or aerosol, for treating pulmonary inflammation.

19 Jan 2011

Forest Laboratories third quarter net sales increase 6.7% to $1,063.9 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that reported earnings per share equaled $1.11 in the third quarter of fiscal 2011 after taking a charge for a new product licensing fee of $66.1 million or $0.23 per share, net of tax.

18 Jan 2011

Critical Diagnostics' Presage ST2 Assay effectively risk-stratifies chronic heart failure patients

Critical Diagnostics, the exclusive developer of the Presage® ST2 Assay, announces the publication of the Penn Heart Failure Study (PHFS) in an advance e-publication of the January 19, 2010 edition of Circulation: Heart Failure. The results of this study demonstrated that ST2 levels not only predict outcomes for ambulatory outpatients with chronic heart failure, they more effectively risk-stratify such patients.

18 Jan 2011

New way to halt lung inflammation

Acute inflammation of the lung is a poorly recognized human disease that develops in surprising and unexpected ways. The acute lung injury (ALI) or adult respiratory distress syndrome (ARDS) is a vital new concern for soldiers, but it can develop in anyone during a systemic infection, after severe trauma, as a result of bone fracture, following severe burns and in many other ways as well-- the initial cause may have nothing apparent to do with the lung itself.

18 Jan 2011

FibroGen initiates FG-3019 open-label phase 2 study in idiopathic pulmonary fibrosis

FibroGen, Inc. today announced initiation of an open-label phase 2 study to evaluate the safety, tolerability, and efficacy of FG-3019, a human monoclonal antibody against connective tissue growth factor (CTGF), in individuals with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, fatal lung disease for which there are no FDA-approved therapies.

13 Jan 2011

FDA Advisory Committee recommends non-approval of liprotamase for exocrine pancreatic insufficiency

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee voted today to recommend non-approval of liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), currently under FDA review for the treatment of exocrine pancreatic insufficiency (EPI).

13 Jan 2011

FDA panel rejects new pancreatic enzyme replacement drug

Eli Lilly & Co did not win the support of the U.S. advisory panel on Wednesday for its one-of-its kind drug not made from pig enzymes to help certain pancreatic patients digest food. A Food and Drug Administration panel of outside experts in a 7-4 vote said they were not convinced the experimental medicine, known chemically as liprotamase, worked well enough for patients to absorb enough needed nutrients. One member of the panel abstained.

12 Jan 2011

Neurology professor receives MFRF's 'See the Light' award for Tay-Sachs research

Miguel Sena-Esteves, PhD, associate professor of neurology at the University of Massachusetts Medical School, was presented with the annual "See the Light" award from the Mathew Forbes Romer Foundation in recognition of his work for leading the fight against children's genetic diseases of the brain.

12 Jan 2011

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro in Germany and the UK

Aradigm Corporation today announced that Zogenix, Inc. and Desitin Pharmaceuticals GmbH were granted approval of the Marketing Authorization Application for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache by the Federal Institute for Drugs and Medical Devices of Germany (BrArM) and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA).

11 Jan 2011

Study to identify early warning biomarkers for presence of breast and prostate cancers

Using biological samples taken from patients and state-of-the-art biochemical techniques, a Florida State University researcher is working to identify a variety of "biomarkers" that might provide earlier warnings of the presence of breast and prostate cancers.

11 Jan 2011

Pro-Pharmaceuticals to begin DAVANAT Phase III development program following FDA approval

Pro-Pharmaceuticals, the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that on December 17, 2010, Company representatives met with officials from the U.S. Food & Drug Administration to present its Phase III clinical development program for DAVANAT.

11 Jan 2011

Predator microbes may work against antibiotic resistant disease-causing bacteria: Study

There are predators in the bacterial world that consume other bacteria, much as predators attack prey in the animal world. A team led by researchers at the University of Medicine and Dentistry of New Jersey-New Jersey Dental School suggests that some of these predator microbes might be put to work against disease-causing bacteria that have become resistant to antibiotics.

11 Jan 2011

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter of 2011, has been designed as a Phase II/III trial.

7 Jan 2011

Critical Diagnostics' high sensitivity Presage ST2 Assay receives CE Mark approval

Critical Diagnostics announced today that it has received CE (Conformité Européenne) Mark for its high sensitivity Presage ST2 Assay and is commencing commercialization in Europe. The product is indicated for use as an aid in risk stratification of patients with heart failure or acute coronary syndrome. This regulatory milestone marks the first time that an assay has become commercially available for the clinical measurement of the biomarker soluble ST2.

7 Jan 2011

DARA regains compliance for continued listing on The NASDAQ Capital Market

DARA BioSciences, Inc. today announced that, on January 5, 2011, NASDAQ notified the Company that it has regained compliance with the minimum stockholders' equity requirement for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5550(b)(1).

7 Jan 2011

Targeted Genetics acquires Biocontrol

Targeted Genetics Corporation, today announced the completion of the acquisition of Biocontrol Limited.

7 Jan 2011

BG Medicine enters agreement to develop galectin-3 test for Siemens' automated immunoassay platforms

BG Medicine, Inc. announced today that it has entered into an agreement with Siemens Healthcare Diagnostics Inc., a division of Siemens Healthcare, one of the world's largest suppliers of clinical diagnostics to the healthcare industry, for the development and commercialization of a galectin-3 test for Siemens' automated immunoassay platforms for clinical laboratories.

7 Jan 2011

Fibrosis News and Research

Further Reading

Novation, Lantheus Medical to distribute ABLAVAR and DEFINITY diagnostic imaging agents

FibroGen announces FG-3019 interim results from phase 1/2 trial against pancreatic cancer

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

USPTO grants KL4 surfactant combination product patent to Discovery Labs

Forest Laboratories third quarter net sales increase 6.7% to $1,063.9 million

Critical Diagnostics' Presage ST2 Assay effectively risk-stratifies chronic heart failure patients

New way to halt lung inflammation

FibroGen initiates FG-3019 open-label phase 2 study in idiopathic pulmonary fibrosis

FDA Advisory Committee recommends non-approval of liprotamase for exocrine pancreatic insufficiency

FDA panel rejects new pancreatic enzyme replacement drug

Neurology professor receives MFRF's 'See the Light' award for Tay-Sachs research

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro in Germany and the UK

Study to identify early warning biomarkers for presence of breast and prostate cancers

Pro-Pharmaceuticals to begin DAVANAT Phase III development program following FDA approval

Predator microbes may work against antibiotic resistant disease-causing bacteria: Study

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Critical Diagnostics' high sensitivity Presage ST2 Assay receives CE Mark approval

DARA regains compliance for continued listing on The NASDAQ Capital Market

Targeted Genetics acquires Biocontrol

BG Medicine enters agreement to develop galectin-3 test for Siemens' automated immunoassay platforms

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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