According to Invion Limited, the company "has received a positive response" from the FDA during a pre-IND meeting regarding its INV102 inhaled nadolol for the treatment of asthma and COPD. Invion is developing the drug in partnership with 3M Drug Delivery Systems, and the company said that the agency has accepted both the formulation and proprietary MDI technology … [Read more...] about Invion announces successful pre-IND meeting with FDA for inhaled nadolol
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Verona says interim results from Phase 1/2 study of RPL554 look promising
Verona Pharma has announced what it calls "encouraging interim results" from a Phase 1/2 study of a new formulation of its RPL554 PDE3/4 inhibitor for the treatment of COPD exacerbations. The company had announced the initiation of the 120-subject study of the nebulized formulation in January 2015 and now says that the trial is ahead of schedule. According to … [Read more...] about Verona says interim results from Phase 1/2 study of RPL554 look promising
Insmed appoints Eugene Sullivan Chief Medical and Scientific Officer
Arikayce inhaled liposomal amikacin developer Insmed Incorporated has announced the appointment of Eugene Sullivan, a former FDA Deputy Director of the Division of Pulmonary and Allergy Products, as Chief Medical and Scientific Officer. Sullivan has also served as Chief Medical Officer of United Therapeutics and VP, Global Regulatory Affairs at Astra Zeneca. … [Read more...] about Insmed appoints Eugene Sullivan Chief Medical and Scientific Officer
Louiville, KY launches citywide inhaler sensor distribution program
A public/private partnership in Louisville, Kentucky called AIR Louisville will distribute 2,000 Propeller Health inhaler sensors to asthma patients across the city as part of a 2-year data collection program, according to Propeller. The FDA approved an updated version of the asthma tracking system, which includes sensors that snap onto standard MDIs, in April 2014. … [Read more...] about Louiville, KY launches citywide inhaler sensor distribution program
FDA advisory committes vote to recommend Breo Ellipta for asthma in adults 18 and over
The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee have voted 16-4 to recommend the approval of GSK's Breo Ellipta fluticasone/vilanterol DPI for the treatment of asthma in patients 18 and older. The FDA approved Breo Ellipta for the treatment of COPD in May 2013, and GSK submitted a supplemental NDA … [Read more...] about FDA advisory committes vote to recommend Breo Ellipta for asthma in adults 18 and over
Positive Phase 3 results for PT003 glycopyrronium/formoterol MDI
AstraZeneca has announced that data from two Phase 3 studies of its PT003 glycopyrronium/formoterol MDI for the treatment of COPD showed statistically significant improvements in lung function for patients using PT003 compared to each of its components and to placebo. In 2013, Pearl Therapeutics announced the initiation of the Phase 3 program less than a month before … [Read more...] about Positive Phase 3 results for PT003 glycopyrronium/formoterol MDI
Discovery Labs restructuring to focus on Aerosurf program
Discovery Laboratories has announced that it will switch its focus from Surfaxin lucinactant intratracheal suspension product to development of its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The company said that if it is unable to find a partner for Surfaxin, it will "cease the commercialization" of … [Read more...] about Discovery Labs restructuring to focus on Aerosurf program
FDA releases Sunovion from further postmarket studies of Xopenex
In a letter from the FDA to Sunovion dated March 12, 2015, the agency informed the company that all postmarketing requirements and commitments specified after the 2005 approval of the Xopenex HFA levalbuterol MDI have been completed. A labeling change regarding the use of Xopenex HFA in children less than four years old was also approved. The agency accepted the … [Read more...] about FDA releases Sunovion from further postmarket studies of Xopenex
Kitabis Pak rated as a therapeutic equivalent of TOBI by the FDA
The FDA has listed PARI's Kitabis Pak in the Orange Book as a therapeutic equivalent of Novartis's TOBI tobramycin inhalation solution with an AN rating, PARI has announced. Kitabis Pak, tobramycin inhalation solution packaged with a PARI nebulizer, was approved by the FDA for the treatment of P. aeruginosa infections in cystic fibrosis patients in December 2014. … [Read more...] about Kitabis Pak rated as a therapeutic equivalent of TOBI by the FDA
Pulmatrix to merge with Ruthigen
California-based biopharmaceutical company Ruthigen and inhaled drug developer Pulmatrix have announced a definitive merger agreement under whose terms Pulmatrix will become a wholly-owned subsidiary of Ruthigen. According to the announcement, conversion of Pulmatrix's outstanding debt and equity securities into Ruthigen common stock will account for over 80% of … [Read more...] about Pulmatrix to merge with Ruthigen