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Sunovion partners with CHEST for “Delivery Makes a Difference” initiative

Sunovion Pharmaceuticals and the American College of Chest Physicians (CHEST) have launched an initiative called "Delivery Makes a Difference," which they say "seeks to understand patient and health care provider practices and to provide tools for matching patients with appropriate medications and delivery devices." According to the announcement, a steering … [Read more...] about Sunovion partners with CHEST for “Delivery Makes a Difference” initiative

PPD expands Athlone laboratory

PPD has added 4,300 sq ft to its GMP biopharmaceuticals and inhalation facility in Athlone, Ireland, the company has announced. The facility, which opened in 2010 and offers a wide range of formulation, development, and analytical testing services for MDIs, DPIs, nasal sprays, and inhalation solutions, is now more than 41,500 sq ft. According to the company's … [Read more...] about PPD expands Athlone laboratory

Mylan and Theravance announce positive Phase 3 results for inhaled revefenacin for COPD

Theravance Biopharma and Mylan have announced that two 12-week Phase 3 efficacy studies of nebulized revefenacin (TD-4208) for the treatment of COPD have met their primary efficacy endpoint of statistically significant increase in FEV1 for both doses studied compared to placebo. Patients receiving the 88 mcg dose averaged a 118 mL increase in tough FEV1 after 12 weeks … [Read more...] about Mylan and Theravance announce positive Phase 3 results for inhaled revefenacin for COPD

Propeller Health raises $21.5 million for expansion of inhaler monitoring platform

Propeller Health has closed on a $21.5 million Series C funding round to support expansion of its digital inhaler monitoring platform, the company said. Investors included 3M Ventures, S.R. One, Limited and Hikma Ventures, Safeguard Scientifics, and Social Capital. According to Propeller, the company has experienced rapid growth over the past year "driven by rapid … [Read more...] about Propeller Health raises $21.5 million for expansion of inhaler monitoring platform

Lovelace launches not-for-profit CRO Lovelace Biomedical

Drawing on resources from the Lovelace Respiratory Research Institute (LRRI) and associated companies, a not-for-profit preclinical contract research organization called Lovelace Biomedical is now offering services for pre-clinical development. The new company's services include toxicology, pharmacology, bioanalytical/analytical chemistry, and formulation for a range … [Read more...] about Lovelace launches not-for-profit CRO Lovelace Biomedical

Mast selects Philips Respironics’ I-neb nebulizer for delivery of AIR001

Mast Therapeutics has announced that its subsidiary Aires Pharmaceuticals has signed an agreement with Philips Respironics devices for the supply of I-neb AAD handheld nebulizers for delivery of the company's AIR001 sodium nitrite solution. AIR001 is in Phase 2 development for the treatment of heart failure with preserved ejection fraction (HFpEF). The I-neb … [Read more...] about Mast selects Philips Respironics’ I-neb nebulizer for delivery of AIR001

FDA issues bioequivalence guidances for umeclidinium bromide, triamcinolone acetonide, olopatadine hydrochloride

The FDA's October 2016 release of new bioequivalence recommendations for specific products includes draft BE guidances for umeclidinium bromide inhalation powder (Incruse Ellipta), triamcinolone acetonide nasal spray (Nasacort), and olopatadine hydrochloride nasal spray (Patanase). For equivalents to Incruse Ellipta, in addition to recommendations for in vitro, … [Read more...] about FDA issues bioequivalence guidances for umeclidinium bromide, triamcinolone acetonide, olopatadine hydrochloride

Coalesce Product Development announces new development center, management changes

Drug delivery device design company Coalesce Product Development has announced the opening of a new 375 sq m drug delivery development center in Cambridge, UK as well as several management changes, including the appointment of inhalation expert James Tibbatts as Head of Business Development. The company cited increased demand for its Concept to Clinic product … [Read more...] about Coalesce Product Development announces new development center, management changes

FDA accepts Sunovion’s NDA for SUN-101 glycopyrrolate inhalation solution

The FDA has accepted Sunovion's NDA for SUN-101 glycopyrrolate delivered by the PARI eFlow nebulizer for the treatment of COPD, the company said. The agency has set a PDUFA date of May 29, 2017 for completion of its review of the application. In April 2016, Sunovion announced that the GOLDEN-3 and GOLDEN-4 trials of SUN-101 had met their primary endpoints and said … [Read more...] about FDA accepts Sunovion’s NDA for SUN-101 glycopyrrolate inhalation solution