Windtree Therapeutics has announced that its Phase 2b clinical trial of Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants receiving nasal continuous positive airway pressure (nCPAP) failed to meet its primary endpoint, reduction in nCPAP failure at 72 hours. The study enrolled 221 infants that received … [Read more...] about Phase 2b trial of Aerosurf inhaled surfactant for RDS fails to meet primary endpoint
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Acorda submits NDA for Inbrija inhaled levodopa for Parkinson’s disease
Acorda Therapeutics has submitted a 505(b)(2) new drug application for Inbrija (CVT-301) levodopa for the treatment of symptoms during OFF periods in Parkinson's disease patients, the company said. According to the company, the FDA is expected to inform the company whether or not the application has been accepted by the end of September. In May 2017, Acorda … [Read more...] about Acorda submits NDA for Inbrija inhaled levodopa for Parkinson’s disease
AIR Louisville results show 82% reduction in rescue inhaler use
The AIR Louisville program, which distributed Propeller Health's inhaler monitoring technology to asthma and COPD patients in Louisville, Kentucky, has announced its final results. Beginning in 2015, the program enrolled 1,147 patients and captured data on over 250,000 inhaler puffs. According to AIR Louisville, participants using the Propeller reduced their use of … [Read more...] about AIR Louisville results show 82% reduction in rescue inhaler use
Vectura licenses VR2081 MDI to Sandoz
Vectura subsidiary Jagotec has entered into a development and license deal with Sandoz for its VR2081 combination therapy MDI for the treatment of asthma and COP, the company announced. Sandoz will pay $5 million up front and up to an additional $5 million in milestone payments, plus royalties on net sales, for US rights to the product. According to Vectura, … [Read more...] about Vectura licenses VR2081 MDI to Sandoz
Opiant licenses Intravail technology from Aegis Therapeutics
Intranasal drug developer Opiant Pharmaceuticals has signed an exclusive global licensing deal with Aegis Therapeutics for use of Aegis’ Intravail absorption enhancers with Opiant's opioid antagonists, the company said. No financial terms were disclosed. Opiant (formerly Lightlake Therapeutics) licensed its intranasal naloxone formulation for the reversal of opioid … [Read more...] about Opiant licenses Intravail technology from Aegis Therapeutics
Steve Thornton joins the board of Dance Biopharm
Inhaled insulin developer Dance Biopharm has announced the appointment of former Excelsior Medical President and CEO Steve Thornton to its board of directors. Thornton was also previously President and CEO of Bioniche Pharma and President of SkyePharma and has served on the boards of Halozyme Therapeutics and Pacira Pharmaceuticals. Dance Biopharm Chairman and CEO … [Read more...] about Steve Thornton joins the board of Dance Biopharm
Iconovo adds drug formulation development services, signs deal with Amneal
DPI device developer Iconovo AB announced that it has raised €.2.3 million in an oversubscribed share issue, which the company will use to fund expansion of its services to include drug formulation development. As part of that expansion, Iconovo has recently moved into larger facilities at the SmiLe Business Incubator in Medicon Village, Lund, Sweden, to support … [Read more...] about Iconovo adds drug formulation development services, signs deal with Amneal
Spyryx Biosciences gets additional funding for development of SPX-101 for CF
According to Spyryx Biosciences, Cystic Fibrosis Foundation Therapeutics (CFFT) will increase a development award to Spyryx to provide a total of up to $5 million. The company said that it plans to use the funds for its HOPE-1 Phase 2 study of SPX-101, an inhaled SPLUNC1-derived peptide, in CF patients. Earlier this year, Spyryx announced positive top line data … [Read more...] about Spyryx Biosciences gets additional funding for development of SPX-101 for CF
Boehringer Ingelheim files citizen petition challenging GSK’s NDA for triple combination DPI
Boehringer Ingelheim has filed a citizen petition with the FDA asking the agency to "request the Commissioner of Food and Drugs to ensure that any New Drug Application (“NDA”) for a fixed-dose, triple-combination, inhaled drug product intended for the treatment of patients with chronic obstructive pulmonary disease (“COPD”) is not approved as safe and effective unless … [Read more...] about Boehringer Ingelheim files citizen petition challenging GSK’s NDA for triple combination DPI
Consort Medical doubles pre-tax profit over previous fiscal year
Consort Medical, parent company of device manufacturer Bespak and CDMO Aesica, has announced that its pre-tax profits for fiscal year 2017 almost doubled from FY 2016, rising from £11.3 million to £21.9 million. Bespak earnings before interest and taxes (EBIT) rose 3.9% and Aesica's EBIT rose 17.7%. Consort acquired Aesica in 2014, and in November 2015, the … [Read more...] about Consort Medical doubles pre-tax profit over previous fiscal year