Cystic Fibrosis News and Research

Latest Cystic Fibrosis News and Research

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

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

22 Feb 2010

Brain and tissue sample repository to help advance understanding and treatment of psychiatric diseases

Johns Hopkins Children's Center neurovirologist Robert Yolken, M.D., and collaborators from the Stanley Medical Research Institute have developed a large repository of brain and tissue samples to advance the understanding and treatment of bipolar disorder, major depression and schizophrenia.

20 Feb 2010

Genzyme announces fourth-quarter and full-year 2009 financial results

Genzyme Corp., a diversified, global biotechnology company, today announced fourth-quarter and full year 2009 financial results and provided 2010 guidance that reflects growth across its businesses and a focus on strengthening core areas of the company.

18 Feb 2010

Special issue reviews current state of science in fetal therapy

Repairing birth defects in the womb. Inserting a tiny laser into the mother's uterus to seal off an abnormal blood flow and save fetal twins. Advancing the science that may allow doctors to deliver cells or DNA to treat sickle cell anemia and other genetic diseases before birth.

17 Feb 2010

Abbott acquires Belgium-based Solvay Pharmaceuticals for $6.2 billion

Abbott today announced that it has completed its EUR 4.5 billion ($6.2 billion) acquisition of Belgium-based Solvay Pharmaceuticals, providing Abbott with a large and complementary portfolio of pharmaceutical products and expanding Abbott's presence in key global emerging markets.

16 Feb 2010

NorTech announces winners of annual Innovation Awards program

NorTech, in partnership with Crain's Cleveland Business, is pleased to announce the winners of its annual Innovation Awards program which honors the achievements of Northeast Ohio's most innovative organizations and leaders.

16 Feb 2010

Scientists identify bacterial protein VpsT as master regulator in Vibrio

Finding a biological mechanism much like an online social network, scientists have identified the bacterial protein VpsT as the master regulator in Vibrio, the cause of cholera and other enteric diseases. This discovery, now published in the journal Science, provides a major tool to combat enteric disease.

15 Feb 2010

Researchers identify defective signaling pathway that contributes to the severity of cystic fibrosis

In a study that could lead to new therapeutic targets for patients with the cystic fibrosis, a research team from the University of California, San Diego School of Medicine has identified a defective signaling pathway that contributes to disease severity.

15 Feb 2010

Hypnosis has potential therapeutic value in children with respiratory disorders

Hypnosis has potential therapeutic value in children with respiratory disorders for alleviating symptoms such as habit cough or unexplained sensations of difficulty breathing and for lessening a child's discomfort during medical procedures.

15 Feb 2010

Critical phases of brain development may be mistimed in autistic patients, says study

Research into Fragile X Syndrome - a genetic condition that is the leading known cause of autism - has discovered that critical phases in the brain's development may be mistimed in people with the condition.

11 Feb 2010

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

PARI Pharma has enrolled the first patient in its Phase 2b clinical trial studying inhaled liposomal cyclosporine A (L-CsA) delivered via a customized Investigational eFlow Nebulizer System. The multinational study is investigating the safety and efficacy of PARI's L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to PARI's drug-device combination were encouraging.

11 Feb 2010

Mutations that enable Pseudomonas to thrive in cystic fibrosis lung secretions may also guard them against antibiotics

People with cystic fibrosis, an inherited disease that clogs airways with thick mucous, frequently have lung infections that defy treatment. While the life expectancy for children with cystic fibrosis has increased over the past few decades, many lives are still shortened in young adulthood by the ravages of lung infections.

10 Feb 2010

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has enrolled the first patient into its pivotal clinical trial with its new breakthrough compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.

9 Feb 2010

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Solvay Pharmaceuticals, Inc. announced that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food.

5 Feb 2010

Aradigm's first U.S. sale of SUMAVEL DosePro needle-free delivery system triggers $4M milestone payment

Aradigm Corporation announced today that it received the $4 million milestone payment from Zogenix, Inc. (“Zogenix”) based upon the first commercial sale in the U.S. of SUMAVEL* DosePro* (sumatriptan injection) needle-free delivery system. The Company will receive quarterly royalty payments on all SUMAVEL DosePro sales. In 2006, the Company sold all assets related to the Intraject* needle-free injector technology (now rebranded as DosePro) to Zogenix in exchange for milestone and royalty payments.

5 Feb 2010

Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

NanoBio awarded sixth U.S. patent covering its novel nanoemulsion technology

NanoBio Corporation announced today that a sixth U.S. patent covering its novel nanoemulsion technology has been awarded. The patent encompasses composition of matter claims for the company’s lead anti-infective and vaccine product candidates.

3 Feb 2010

MPM Capital leads Alnara Pharmaceuticals' $35M Series B venture capital financing

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing non-systemic, orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that it has secured $35 million in Series B venture capital financing. The round was led by new investor MPM Capital, joined by current investors Third Rock Ventures, Frazier Healthcare and Bessemer Venture Partners. In conjunction with the MPM investment, managing director Ashley Dombkowski, Ph.D., will join Alnara’s board of directors.

28 Jan 2010

Cystic Fibrosis News and Research

Latest Cystic Fibrosis News and Research

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

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

Brain and tissue sample repository to help advance understanding and treatment of psychiatric diseases

Genzyme announces fourth-quarter and full-year 2009 financial results

Special issue reviews current state of science in fetal therapy

Abbott acquires Belgium-based Solvay Pharmaceuticals for $6.2 billion

NorTech announces winners of annual Innovation Awards program

Scientists identify bacterial protein VpsT as master regulator in Vibrio

Researchers identify defective signaling pathway that contributes to the severity of cystic fibrosis

Hypnosis has potential therapeutic value in children with respiratory disorders

Critical phases of brain development may be mistimed in autistic patients, says study

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

Mutations that enable Pseudomonas to thrive in cystic fibrosis lung secretions may also guard them against antibiotics

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Aradigm's first U.S. sale of SUMAVEL DosePro needle-free delivery system triggers $4M milestone payment

Phase 2a clinical trial results of VX-809 in patients with CF announced

NanoBio awarded sixth U.S. patent covering its novel nanoemulsion technology

MPM Capital leads Alnara Pharmaceuticals' $35M Series B venture capital financing

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

Cystic Fibrosis News and Research

Latest Cystic Fibrosis News and Research

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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