August 2012
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Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said. According… Read more . . .
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Savara Pharmaceuticals has presented interim results from a Phase 2 study of Aironite sodium nitrite inhalation solution for the treatment of pulmonary hypertension at the 4th Annual Drug Discovery and Development Symposium for Pulmonary Hypertension.… Read more . . .
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Lonza’s acquisition of CDMO Capsugelfrom KKR for $5.5 billion, which was initially announced in December 2016, is now complete, the company said. In 2011, Pfizer sold Capsugel to KKR for just under $2.4 billion, and… Read more . . .
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The FDA has accepted for review Sunovion’s resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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