FDA Grants Orphan Drug Designation for Bayer ’ s Investigational Ciprofloxacin DPI (Dry Powder for Inhalation) for Treatment of Non-Cystic Fibrosis Bronchiectasis
WHIPPANY, N.J., April 22, 2014 /PRNewswire/ — Bayer HealthCare today announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development has granted orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis (NCFB). Patients with NCFB suffer from frequent severe acute pulmonary bacterial exacerbations which lead to further inflammation, airway and lung parenchyma damage.
The Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the...
Source: Cystic Fibrosis Worldwide Blog - April 24, 2014 Category: Respiratory Medicine Authors: Webmaster Tags: Research and Discovery Source Type: blogs
UVa creates virtual bacteria to shed light on cystic fibrosis infections
The two species of bacteria are genetically similar – both contagious, both drug resistant, both preying upon people with cystic fibrosis or weakened immune systems – yet they go about their sinister work very differently. There is much to be learned both from how they are alike and how they differ, and so researchers at the University of Virginia School of Medicine have recreated them in electronic form, building an elaborate computer model of each so that scientists can better understand them, better compare them and find new and better ways to stop them.
The new metabolic model lets scientists examine Burkholderia c...
Source: Cystic Fibrosis Worldwide Blog - April 24, 2014 Category: Respiratory Medicine Authors: Webmaster Tags: Research and Discovery Source Type: blogs
Camryn Koke continues her fight against Cystic fibrosis in Southold
In the basement of the Koke family’s home in Southold, 9-year-old Camryn is allowed to play with her dollhouse for one hour each morning before heading to school.
On a recent day, she held her favorite doll, Raquelle — a pretty fashionista who likes going to the spa and is featured on TV’s “Barbie: Life in the Dreamhouse.”
“She’s active and sassy — like me,” Camryn said with a smile as she smoothed the doll’s hair.
In Camryn’s other hand was a nebulizer. The fourth-grader also wore a vest that provides periodic electronic chest compressions.
Her mother, Jennifer, compared the motion to shaking a can o...
Source: Cystic Fibrosis Worldwide Blog - April 22, 2014 Category: Respiratory Medicine Authors: Webmaster Tags: Community Sponsors Source Type: blogs
Transplants give Garden Plain man a second chance at life
Chris Simon’s bucket list wasn’t anything fancy.
He simply wanted to be able to ride a bike again. Or take a swim. Or go camping with friends.
“Stuff I used to do all the time,” Simon said. “And all of a sudden it was taken away.”
Those once simple joys were stolen by cystic fibrosis, the same disease that claimed his younger sister Emily’s life in 2009.
The Simon family on Sunday will join millions of others around the world in celebrating Easter, a day symbolizing new beginnings. The holiday will have special significance for Chris, 26, who has another chapter dawning in his life after a double-lung/liver t...
Source: Cystic Fibrosis Worldwide Blog - April 20, 2014 Category: Respiratory Medicine Authors: Webmaster Tags: Uncategorized Source Type: blogs
Alcresta Announces Agreement with Cystic Fibrosis Foundation Therapeutics to Develop Point-of-Care Nutritional Products
NEWTON, Mass., Apr 17, 2014 (BUSINESS WIRE) — Alcresta®, a leading medical nutrition company developing innovative enzyme-based products for individuals with unique nutritional needs battling acute conditions or chronic diseases, today announced the company has signed an agreement with Cystic Fibrosis Foundation Therapeutics (CFFT) to accelerate the development of Alcresta’s enzyme-based point-of-care products to support the nutritional status of people with cystic fibrosis (CF). CFFT is the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation....
Source: Cystic Fibrosis Worldwide Blog - April 18, 2014 Category: Respiratory Medicine Authors: Webmaster Tags: Research and Discovery Source Type: blogs
Non-Cystic Fibrosis Bronchiectasis Patients Gain Mixed Results From Exercise, According To Study
Individuals with non-cystic fibrosis bronchiectasis are recommended to take on exercise training, however, the longer-term effects and benefits remain uncertain, according to researchers. A new randomized controlled study was performed to determine the effects of exercise training and review of airway clearance therapy (ACT) on exercise capacity, quality of life and the incidence of acute exacerbations in individuals with non-cystic fibrosis (CF) bronchiectasis.
85 trial participants (mean FEV1 74% predicted; median Modified Medical Research Council Dyspnea grade of 1 (IQR [1-3]) were randomly allocated to eight weeks o...
Source: Cystic Fibrosis Worldwide Blog - April 18, 2014 Category: Respiratory Medicine Authors: Webmaster Tags: Research and Discovery Source Type: blogs
AbbVie today announced that undergraduate and graduate students living with cystic fibrosis (CF) can now apply for the 2014 AbbVie CF Scholarship, which honors young adults with CF as they pursue higher education. Students can apply for the scholarship from now until Monday, June 9, at www.AbbVieCFScholarship.com .
NORTH CHICAGO, Ill., April 16, 2014 /PRNewswire/ — AbbVie today announced that undergraduate and graduate students living with cystic fibrosis (CF) can now apply for the 2014 AbbVie CF Scholarship, which honors young adults with CF as they pursue higher education. Students can apply for the scholarship from now until Monday, June 9, at www.AbbVieCFScholarship.com .
The AbbVie CF Scholarship acknowledges students with CF who demonstrate creativity, academic excellence, community involvement and the ability to serve as a positive role model for the CF community. In honor of the 22nd year of the program...
Source: Cystic Fibrosis Worldwide Blog - April 17, 2014 Category: Respiratory Medicine Authors: Webmaster Tags: Education Source Type: blogs
mBio - home of some really cool, #openaccess microbiology papers
Am really enjoying the suite of papers coming out in mBio - the Open Access PLOSOne like journal from the American Society for Microbiology. Here are some examples of recent papers that caught my eye:Biogeochemical Forces Shape the Composition and Physiology of Polymicrobial Communities in the Cystic Fibrosis Lung by Robert A. Quinn, Yan Wei Lim, Heather Maughan, Douglas Conrad, Forest Rohwer and Katrine L. WhitesonCauses for the Persistence of Impact Factor Mania by Arturo Casadevall and Ferric C. FangComparative Analysis of Salmonella Genomes Identifies a Metabolic Network for Escalating Growth in th...
Source: The Tree of Life - March 22, 2014 Category: Medical Scientists Authors: Jonathan Eisen Source Type: blogs
ACA fun...
My week so far...■ One client called. Her daughter has cystic fibrosis. In 2013, two of her meds had a 30% copay, with a $200 cap per Rx. In 2014, the cap was eliminated and the price went to $3600 when she went to fill it. She can't afford them and her daughter hasn't had her meds since early January. Appeals to Blue Shield for reclassification of her meds outside of Tier 4 had been declined. I (finally) found out that the Genentech and Novartis discount programs weren't being applied correctly.■ Four hours were spent on-hold at Anthem; three at Blue Shield. CoveredCA has a "we're t...
Source: InsureBlog - March 13, 2014 Category: Medical Lawyers and Insurers Source Type: blogs
Finally a homemade mayonnaise worth writing about! MCT mayo!
I have a love-hate relationship with homemade mayonnaise. I have known about the horrors of conventional mayo, (rancid soybean oil anyone?), not to mention the sugar and poor quality eggs used to make it. I knew I could do better than Hellman's. Until I couldn't do better. I love my Hellman's, (cue 'bring out the Hellman's and bring out the best!), and each time I made homemade mayo it just tasted bad in comparison. Smart me knew that what I had made was greatly superior to the store bought stuff, but man, it was not palatable. Mayo debacle after mayo debacle came in rapid succession. All olive oil? too bitter....
Source: the beautiful diabetic - February 19, 2014 Category: Diabetes Authors: Kathryn Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
And so, yet another working week will soon draw to a close. Not a moment too soon, yes? As always, this is our treasured signal to daydream about weekend plans. Our agenda is rather modest, although we do look forward to spending time not only with our full roster of short people but some of the Pharmalot ancestors. We also hope to catch up on sundry tasks and catch up on some reading. Why not, you know? But what about you? Given the upcoming holiday break, perhaps this marks the beginning of a longer stretch than usual. Presumably, all sorts of activities and possibilities are in store. Spending time with special people o...
Source: Pharmalot - December 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
All Night Saline Mist Nebulizer Under Development for Cystic Fibrosis Patients
Cystic fibrosis is an inherited disease that causes mucus, sweat, and digestive juices to become thick and sticky. Ordinary these fluids act like a lubricant, but for people with CF they tend to block tubes, ducts, and passagewaysContributor: Mark WhittingtonPublished: Dec 08, 2013 (Source: Most Recent Health Wellness - Associated Content)
Source: Most Recent Health Wellness - Associated Content - December 8, 2013 Category: Other Conditions Source Type: blogs
The Dispute between the FDA and 23andMe; What's Really Going On?
Much in the news recently is the friction between the FDA and 23andMe. I have blogged about the company and its goal of providing genetic testing directly to healthcare consumers (DCT testing) (see: Clinical Labs Have Much to Learn from the Genetic Testing Web Sites; 23andMe Requests FDA Clearance for DNA Saliva Testing). I am very much in favor of this goal. I think that the NYT presented an important slant about this dispute (see: F.D.A. Orders Genetic Testing Firm to Stop Selling DNA Analysis Service). Here is an excerpt from the article:
The...[FDA] seemed most concerned about a test for mutations that indicate a...
Source: Lab Soft News - November 29, 2013 Category: Pathologists Authors: Bruce Friedman Tags: Clinical Lab Industry News Clinical Lab Testing Direct Access Testing (DAT) Lab Processes and Procedures Lab Regulation Laboratory Industry Trends Medical Consumerism Medical Ethics Medical Research Source Type: blogs
Embryos with Genetic Disease Destroyed for Their Stem Cells, Cell Lines Added to NIH Registry
King's College in London is proud that they have provided 16 new embryonic stem cell lines to the United States' National Institutes of Health (NIH) registry of stem cell lines eligible for federal funding. On the King's College website they explain that they have created these stem cell lines with a variety of genetic disease for US researchers to work on:Scientists from Kings College London have announced that 16 human embryonic stem (hES) cell lines have been approved by the US National Institutes of Health (NIH) and placed on their Stem Cell Registry, making them freely available for federally-funded research in the ...
Source: Mary Meets Dolly - November 26, 2013 Category: Geneticists and Genetics Commentators Tags: Stem cells, Embryonic Source Type: blogs
Oxitone Wrist Based Pulse Oximeter for All Day Oxygen Saturation Monitoring (w/video)
Folks with asthma, COPD, cystic fibrosis, and other pulmonary problems may be able to improve their lifestyles and the effectiveness of prescribed therapies by keeping an eye on their blood oxygen saturation. Portable pulse oximeteters that provide continuous oxygen saturation readings are available from a variety of manufacturers, including one that works with an iPhone, but they all rely on a sensor that clips onto a fingertip or ear lobe. That’s because blood in those spots is close to the surface and the sensor can shine two wavelenghts of light through the tissue and measure how it’s attenuated.
This prese...
Source: Medgadget - November 18, 2013 Category: Technology Consultants Authors: Editors Tags: Medicine Pediatrics Source Type: blogs
