NovaBiotics’ Lynovex for CF gets US orphan drug designation

NovaBiotics has announced that its Lynovex (NM001) cysteamine for the treatment of cystic fibrosis has been granted orphan drug designation by the FDA. NovaBiotics is developing both oral and dry powder inhalation formulations of the drug which, according to the company, breaks down mucus and prevents formation of biofilms in the lungs of CF patients. . . . Read more

Mylan announces Phase 3 trial of generic fluticasone/salmeterol DPI

According to Mylan, the company will initiate a Phase 3 clinical trial of its generic version of Advair/Seretide Diskus for the treatment of asthma in October 2014, with an expected completion in April 2015. Mylan obtained global rights to the fluticasone/salmeterol inhaler from Pfizer in November 2011. Mylan CEO Heather Bresch commented, “The commencement of . . . Read more

Galen to market Penthrox inhaled methoxyflurane in the UK and Ireland

Almac subsidiary Galen Ltd will pay Medical Developments International (MVP) approximately A$650,000 (~US$587,000) up front for a license to market and distribute MVP’s Penthrox inhaled methoxyflurane in the UK and Ireland. The deal also includes undisclosed regulatory and sales milestone payments. Penthrox, a non-opioid analgesic delivered via a proprietary vapor inhaler is to be used . . . Read more