Canada has approved GSK's Incruse Ellipta umeclidinium (UMEC) DPI for the once-daily treatment of COPD, the first approval for its UMEC monotherapy, the company said. GSK received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) regarding its MAA for Incruse Ellipta in February 2014, and the company submitted an NDA for the … [Read more...] about Incruse Ellipta approved in Canada
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OPKO Health acquires Inspiro Medical and its Inspiromatic DPI
US pharmaceutical company OPKO Health has announced that it will acquire Israeli device company Inspiro Medical whose only product is the Inspiromatic dry powder inhaler. In June 2013, Inspiro announced positive results from a study of the device used to deliver formoterol. OPKO CEO and Chairman Phillip Frost said, "We are pleased to add this next generation … [Read more...] about OPKO Health acquires Inspiro Medical and its Inspiromatic DPI
Alexza hires Winston R. Brown, Jr. as VP, Quality
Alexza Pharmaceuticals has hired Winston R. Brown, Jr. as VP, Quality, the company has announced. Brown was most recently Global Head, Quality R&D - Pharmaceuticals, Biologics, and Vision Care Devices at Alcon Research. The company has made several hires recently as it is in the process of commercializing its Adasuve inhaled loxapine for the treatment of … [Read more...] about Alexza hires Winston R. Brown, Jr. as VP, Quality
Molecular Profiles looks to increase US business
CDMO Molecular Profiles says that it has hired Charles D. Maher as head of US sales in order to "increase awareness and uptake of its pharmaceutical development services in the North American market." The company's services include formulation development and clinical trial manufacturing of dry powder inhalers. Molecular Profiles CEO Nikin Patel commented, "Over … [Read more...] about Molecular Profiles looks to increase US business
Study shows nasal spray has potential to prevent the flu
Researchers from the University of St. Andrews, the University of Edinburgh, and St. Jude's Children's Research Hospital have published data demonstrating that a nasal spray designed to prevent the influenza virus from binding with receptors in the respiratory tract provided complete protection against flu in mice. The study, published in the Proceedings of the … [Read more...] about Study shows nasal spray has potential to prevent the flu
Gateway Analytical invites RDD attendees to special event
Gateway Analytical is inviting anyone attending RDD 2014 in Fajardo, Puerto Rico to a special VIP event on the evening of May 5. Attendees are invited to join Gateway for a sunset sail on a catamaran from 6:30-8:30 p.m. The sail, which leaves from La Marina Village at the El Conquistador Resort, includes cocktails and hors d'oeuvres. If you plan to attend RDD 2014 … [Read more...] about Gateway Analytical invites RDD attendees to special event
Prosonix licenses two MDIs to Mylan
Inhaled drug developer Prosonix has announced a global licensing agreement with Mylan for its generic versions of GSK's Flixotide and Flovent fluticasone propionate MDIs for the treatment of asthma. The deal covers two Prosonix MDIs, PSX1001 and PSX1050, with the same particle engineered formulation of fluticasone; PSX1050 differs from PSX1001 only in having a dose … [Read more...] about Prosonix licenses two MDIs to Mylan
Theravance begins Phase 2b study of LAMA inhalation solution
Theravance has initiated a dose-ranging Phase 2b study of its TD-4208 long-acting muscarinic antagonist (LAMA), the company announced. The study will compare four different dosages of TD-4208 and placebo, all delivered once daily via jet nebulizer, in about 350 patients with moderate to severe COPD over a 28-day period. According to the company, "The goal of … [Read more...] about Theravance begins Phase 2b study of LAMA inhalation solution
Study shows intranasal ketamine can provide antidepressant effects within 24 hours
Researchers from the Icahn School of Medicine at Mount Sinai have demonstrated that a single 50 mg dose of a ketamine nasal spray could alleviate depressive symptoms in patients with treatment-resistant major depressive disorder within 24 hours. The authors conclude that, "This study provides the first controlled evidence for the rapid antidepressant effects of … [Read more...] about Study shows intranasal ketamine can provide antidepressant effects within 24 hours
Copley to launch fluticasone propionate testing accessories at RDD
Copley Scientific will launch several new cascade impactor accessories designed to meet requirements for testing of fluticasone propionate inhalation powder set out in a new USP monograph at RDD 2014, the company has said. The new accessories include a glass dose uniformity sampling apparatus (DUSA) and a fluticasone propionate-specific induction port and … [Read more...] about Copley to launch fluticasone propionate testing accessories at RDD