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
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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
Hovione gets US patent for XCaps inhaler
According to Hovione, the United States Patent and Trademark Office (USPTO) has granted the company a patent for its XCAPs capsule-based dry powder inhaler. The European Patent Office granted the company a patent for the inhaler in September, 2013. Hovione VP Peter Villax, who is a co-inventor of the DPI, commented, “We give our customers an edge in speed of … [Read more...] about Hovione gets US patent for XCaps inhaler
PDUFA date for Afrezza now July 15, 2014
The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for MannKind's Afrezza inhaled insulin by three months, according to MannKind. The original date was April 15, 2014; the new date is July 15, 2014. The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of Afrezza on April 2, 2014. The delay was … [Read more...] about PDUFA date for Afrezza now July 15, 2014
FDA issues draft guidance for fentanyl citrate nasal spray
On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, "If the test product is qualitatively (Q1) and quantitatively (Q2) the same as the reference product, then bioequivalence may be documented by an in vitro approach in lieu of an in vivo approach." If bioequivalence cannot be … [Read more...] about FDA issues draft guidance for fentanyl citrate nasal spray