According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March 31, 2019 for both applications. The Tudorza sNDA requests to add COPD exacerbation reductions and cardiovascular safety data to the prescribing … [Read more...] about FDA accepts NDA for Duaklir, sNDA for Tudorza
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Adherium launches Hailie inhaler sensor in US
Adherium recently received OTC clearance for its Hailie inhaler monitoring platform in the US, and the company says that it has now launched direct-to-consumer sales through a web site. Hailie includes an inhaler sensor and a smartphone app that allows patients to monitor their own inhaler use, and a new web portal will provide health care providers with access to … [Read more...] about Adherium launches Hailie inhaler sensor in US
Rick Batycky to leave Acorda ahead of FDA decision on Inbrija
Acorda Therapeutics has announced that Chief Technology Officer Rick Batycky is leaving the company as of August 20, 2018 to head up a new private biotech firm. Batycky co-founded Civitas Therapeutics, which was acquired by Acorda in 2014, along with its CVT-301 levodopa DPI, (now known as Inbrija) and the ARCUS dry powder inhalation platform. The company filed … [Read more...] about Rick Batycky to leave Acorda ahead of FDA decision on Inbrija
Onspira’s inhaled therapy for bronchiolitis obliterans gets orphan drug designation
US-based Onspira Therapeutics has announced that its OSP-101, an inhaled interleukin-1 receptor antagonist (IL-1Ra) for the treatment of bronchiolitis obliterans, has been granted orphan drug designation by the FDA. Onspira is a private company created by NeXeption in 2017, and OSP-101 is currently its only candidate. Onspira Therapeutics President and CEO Brian … [Read more...] about Onspira’s inhaled therapy for bronchiolitis obliterans gets orphan drug designation
Haisco gets rights to distribute Pneuma Respiratory products in China
Haisco Pharmaceutical Group has acquired Chinese rights to products developed by Pneuma Respiratory in a deal that included a $10 million equity investment in Pneuma, the company said. In addition to the equity investment, Haisco will fund Chinese regulatory filings. In July 2018, Pneuma Respiratory said that it had completed a series A fundraising round that … [Read more...] about Haisco gets rights to distribute Pneuma Respiratory products in China
UCB’s midazolam nasal spray NDA accepted by the FDA
UCB announced that the FDA has accepted its new drug application for USL261 midazolam nasal spray for the rescue treatment of seizures in epilepsy patients. The company announced in April 2018 that it had acquired rights to the nasal spray from former Upsher Smith subsidiary Proximagen. USL261 has previously received both orphan drug designation and fast track … [Read more...] about UCB’s midazolam nasal spray NDA accepted by the FDA
Proveris hires John Masciola as VP of Product Development
Proveris Scientific Corporation has announced the appointment of John Masciola as VP of Product Development. Masciola was most recently Engineering Manager at Parker Precision Fluidics, and his experience in the life sciences industry includes positions as Director of Instrument Engineering and Director of R&D at Perkin Elmer and VP of Engineering at Zymark/Caliper … [Read more...] about Proveris hires John Masciola as VP of Product Development
Perrigo gets US rights to OTC version of Nasonex nasal spray
Perrigo has licensed the US rights to an over-the-counter version of Merck's Nasonex mometasone furoate nasal spray, the company said. The company did not disclose the financial terms of the deal, which give Perrigo the right to seek regulatory approval, market, sell, and distribute the product. Nasonex, which was approved by the FDA in 1997, is currently … [Read more...] about Perrigo gets US rights to OTC version of Nasonex nasal spray
United Therapeutics grants Watson license for generic version of Tyvaso inhalation solution
United Therapeutics has announced a settlement agreement with Watson Laboratories that includes a license for Watson to manufacture and sell a generic version of Tyvaso treprostinil inhalation solution as of January 1, 2026. Watson is currently a subsidiary of Teva. The settlement resolves litigation that had been ongoing since Watson filed an ANDA for the … [Read more...] about United Therapeutics grants Watson license for generic version of Tyvaso inhalation solution
Recall of oxymetazoline nasal spray due to P. aeruginosa contamination
Florida-based Product Quest Manufacturing has recalled a lot of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa. The company said that it had not received reports of any adverse events but acknowledged that use of a nasal spray contaminated with P. aeruginosa could potentially lead to deadly … [Read more...] about Recall of oxymetazoline nasal spray due to P. aeruginosa contamination