Vectura has announced results from a pharmacokinetic study of its VR647 nebulized budesonide inhalation suspension in asthma patients aged 4 to 8 and a methodology study of the use of a mouthpiece with the VR647 nebulizer (the Akita Jet nebulizer) by children aged 1 to 4. In January 2017, Vectura announced that it had received FDA approval of its IND for pediatric … [Read more...] about Vectura announces results from two studies of VR647 in pediatric asthma patients
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Catalent completes acquisition of Juniper Pharma Services
Catalent will continue to offer DPI development and manufacturing services at the Nottingham, UK Juniper Pharma Services facility that was part of its recently completed acquisition of Juniper Pharmaceuticals, the company says. Catalent announced its intent to acquire Juniper in July 2018. The Nottingham facility was originally owned by Molecular Profiles, which … [Read more...] about Catalent completes acquisition of Juniper Pharma Services
Evoke’s NDA for Gimoti accepted for review by the FDA
Evoke Pharma has announced that the FDA has accepted the company's 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, which Evoke submitted in June 2018. The PDUFA date has been set for April 1, 2019. In a separate letter, the agency also informed Evoke that it had conditionally … [Read more...] about Evoke’s NDA for Gimoti accepted for review by the FDA
FDA accepts NDA for Duaklir, sNDA for Tudorza
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
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