Issue link: http://www.e-digitaleditions.com/i/932381
Recent news items on companies that develop, manufacture, and provide products and services that support development of orally inhaled and nasal drug products. Sunovion receives FDA approval of rst nebulized LAMA for COPD in US M A R L B O R O U G H , M A — Sunovion Pharmaceuticals, Inc. has announced the US Food and Drug Administration (FDA) approval of Lonhala™ Magnair™(glycopyrro- late) inhalation solution (25 mcg twice daily), (SUN-101/eFlow ® ) for long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmo- nary disease (COPD), including chronic bronchitis and/or emphy- sema. A company news release indi- cated it is the rst, nebulized, long acting muscarinic antagonist (LAMA) approved for COPD treatment in the US and the rst use of Magnair, based on the closed eFlow ® technology system devel- oped by PARI Pharma GmbH to treat COPD. The technology is a virtually silent, portable, closed sys- tem nebulizer designed to deliver drug in two to three minutes while patients breathe normally. Dance Biopharm and Phillips-Medisize sign joint development agreement SAN FRANCISCO, CA—Dance Biopharm Holdings, Inc. has entered into a joint development agreement with Phillips-Medisize, LLC to develop a version of the Dance 501 device that will o er data connectivity for better management of diabetes treatment, according to news releases from both companies. e Dance 501 is a small, handheld electronic inhaler that uses a pat- ented, vibrating mesh technology to deliver a soft mist of recombinant human insulin. It has not yet been approved by any regulatory author- ity. Phillips-Medisize will also provide commercial manufacturing of Dance's inhaled insulin device when it comes to market. "Inhaled insulin offers the possibility of a cost e ective, signi cant improve- ment in lifestyle—ease-of-use and compliance—for diabetic patients all over the world," said John Patton, chairman and chief execu- tive o cer of Dance Biopharm. 6 FEBRUARY 2018 Inhalation INDUSTRY NEWS FDA removes boxed warn- ings on LABA/ICSs FALLS CHURCH, VA—The United States Food and Drug A d m i n i s t r a t i o n ( F D A ) h a s announced removal of its Boxed Warnings about asthma-related death from labels of medicines con- taining long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS). In 2011, the FDA required manufac- turers to conduct four large clinical trials to evaluate the safety of the LABA/ICS combination compared to ICS alone. Results in more than 41,000 patients demonstrated the LABA/ICS combination did not significantly increase the risk of asthma-related hospitalizations, intubations or asthma-related deaths. They also showed LABA/ ICS combinations were more effective in decreasing asthma attacks than ICS alone. e agency said the new information has been added to the combination product labels and included in alerts to healthcare professionals. GENERIC & CUSTOMISED Medical Devices Made Easy www.merxin.com info@merxim.com Tel: +44 (0)1223 787300 MRX004 is a generic softmist inhaler for tiotropium or/and olodaterol. MRX004 is also ideal for life cycle management and new molecules. MERXIN: Reduce Cost, Reduce Risk, Increase Success.