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Bayer HealthCare gains orphan drug designation for investigational Ciprofloxacin Dry Powder

BY Michael Johnsen

WHIPPANY, N.J. — Bayer HealthCare on Tuesday announced that the Food and Drug Administration’s Office of Orphan Products Development has granted orphan drug designation for Bayer’s investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis. 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 safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 but are not expected to recover the costs of developing and marketing a treatment drug.

Ciprofloxacin DPI is in development by Bayer HealthCare as chronic intermittent therapy for reducing the frequency of acute exacerbations in NCFB patients with bacterial respiratory pathogens. It comprises ciprofloxacin, a fluoroquinolone antibiotic, formulated into dry powder for inhalation using Novartis’ PulmoSphere technology and is administered with the T-326 Dry Powder inhaler. Ciprofloxacin DPI therapy in NCFB currently is being investigated in a global Phase III clinical trial program.

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Prettie Girls! take a bow at H-E-B

BY Ryan Chavis

HOUSTON — Last weekend marked the in-store retail debut of the Prettie Girls!, a line of multicultural dolls, at H-E-B stores. The dolls were well-received by customers and sold out completely after just a few hours, the grocer said.

"H-E-B was proud to be selected as the first retailer to offer the Prettie Girls! dolls in select Houston area stores” said James Harris, director of supplier diversity, H-E-B. “We were especially pleased at the sales, as two of the stores sold through on inventories. I applaud the efforts of the One World Doll Project in meeting the needs of our customers."

The Prettie Girls! differ from other fashion dolls on the market, as they mirror the evolving demographics of the United States. The line was created by the One World Doll Project, an organization that seeks to make a significant positive cultural impact through the doll category. The success of the line was paramount to the organization — it proved that children are enthusiastic about playing with dolls that they can relate to, which is important as American becomes more diverse.

“Many of the parents and children we met at the H-E-B stores told us that they are always on the lookout for dolls that look like they do, and were enthusiastic about the launch of the Prettie Girls! in their hometown,” said Trent T. Daniel, founder of the One World Doll Project.

The Prettie Girls! are currently available in select H-E-B locations, as well as nationally through online retailers including Wayfair.com, DollGenie.com, AngelicDreamz.com and PattyCakeDoll.com. The company hopes to further expand distribution this year.

 

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Cefaly makes Rx medical device for the preventive treatment of migraine headaches available online

BY Michael Johnsen

NEW YORK — Cefaly Technology announced Wednesday that the Cefaly medical device for the preventive treatment of migraine headaches is available for purchase and delivery in the United States for patients with a medical prescription at Cefaly.us.

The company that manufactures Cefaly expects to make the device available via select pharmacies and clinics in the months ahead. 

Cefaly is a battery-powered device that resembles a headband and is affixed to the center of the forehead using a self-adhesive electrode that applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. Cefaly is available by prescription-only and indicated for patients 18 years of age and older. It should only be used once daily for 20 minutes. Women who are pregnant or could become pregnant should check with their doctor before using Cefaly.

Cefaly costs $295 plus $29 shipping and handling. The electrodes needed to operate the device cost $25 for a set of three (each electrode will last for up to approximately 20-uses). There is a 60-day money back guarantee.

The Cefaly medical device received Food and Drug Administration approval for the preventative treatment for migraine headaches on March 11, 2014. It is the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of pain, the company stated.

 

 

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