According to an FDA drug shortages report, the US shortage of sumatriptan nasal spray due to a shortage of active ingredient that was first reported in November 2015 should be completely resolved by February 2017. At this time, both GlaxoSmithKline and Sandoz are reported to have 5 mg/spray versions of the nasal spray available, and GSK has the 20 mg product … [Read more...] about Sumatriptan nasal spray shortage expected to be resolved by February 2017
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Windtree’s Aerosurf gets FDA Fast Track designation
According to Windtree Therapeutics, its Aerosurf inhaled lucinactant for the treatment of premature infants with respiratory distress syndrome (RDS) has received Fast Track designation from the FDA. Aerosurf is currently in Phase 2 development, with a Phase 2b clinical trial in premature infants receiving nasal continuous positive airway pressure (nCPAP) RDS … [Read more...] about Windtree’s Aerosurf gets FDA Fast Track designation
Medical Developments announces distribution deals, approval for Penthrox methoxyflurane inhaler
Purdue Pharma Canada will pay up to $3 million Canadian to Medical Developments International Limited (MDI) for Canadian rights to MDI's Penthrox methoxyflurane inhaler for the treatment of moderate to severe pain in trauma patients, and BL&H Co has obtained rights to the product in Korea, according to MDI. MDI also announced that Penthrox has been approved in the … [Read more...] about Medical Developments announces distribution deals, approval for Penthrox methoxyflurane inhaler
Evoke Pharma moving forward with NDA for intranasal metoclopramide
According to Evoke Pharma, the company held a pre‑NDA meeting with the FDA about its intranasal metocopramide for the treatment of diabetic gastroparesis in adult women and now believes that it will be able to complete the CMC and non-clinical sections of its 505(b)(2) NDA in a manner that will be acceptable to the agency. Evoke recently announced that a Phase 3 … [Read more...] about Evoke Pharma moving forward with NDA for intranasal metoclopramide
Capsugel expands micronization capacity
Capsugel has announced that it will add both pilot and commercial scale micronization capacity at a facility in Quakertown, PA which it acquired as part of its acquisition of Powdersize in January 2016. New equipment and suites are expected to be in operation by January 2017. By doubling the company's pilot-scale capacity and adding commercial scale capacity, … [Read more...] about Capsugel expands micronization capacity
Bespak to supply components for AstraZeneca’s Bevespi Aerosphere
Bepak parent company Consort Medical has announced a multi-year agreement with AstraZeneca to supply Bespak's MDI valves and actuators for use in AstraZeneca's Bevespi Aerosphere inhaler. The components for the project, which will be called VAL100, will be manufactured at Bespak's King's Lynn, UK facility. The Bevespi Aerosphere glycopyrrolate/formoterol fumarate … [Read more...] about Bespak to supply components for AstraZeneca’s Bevespi Aerosphere
Raptor presents data on Quinsair efficacy
Raptor Pharmaceutical has presented results from a network meta-analysis of data from clinical trials of inhaled tobramycin, colistimethate sodium, aztreonam and levofloxacin for the treatment of P. aeruginosa lung infections in CF patients. The data, which were presented at the 2016 European Respiratory Society International Congress, show the efficacy of its … [Read more...] about Raptor presents data on Quinsair efficacy
Positive Phase 2 results for Patara’s inhaled treatment for chronic cough in IPF patients
Patara Pharma has announced Phase 2 results for its PA101 inhaled treatment for refractory chronic cough in patients with idiopathic pulmonary fibrosis (IPF) showing that patients receiving PA101 experienced a statistically significant reduction in cough frequency after 14 days compared to patients receiving a placebo. PA101 is delivered via the PARI eFlow nebulizer … [Read more...] about Positive Phase 2 results for Patara’s inhaled treatment for chronic cough in IPF patients
Nanopharm appoints Mark Clement as Chairman of the Board
OINDP developer Nanopharm has announced the appointment of Mark Clement as non-executive Chairman of the Board. Clement has more than 25 years of experience in life sciences and is currently non-executive chairman or director of 6 companies in the industry. Nanopharm co-Founder and Director Rob Price said, "Mark’s extensive experience in managing Life Science … [Read more...] about Nanopharm appoints Mark Clement as Chairman of the Board
Orion to co-market Easyhaler DPIs with Menarini in several European countries
Orion Corporation has announced an agreement with Menarini Group to co-market its budesonide/formoterol Easyhaler DPI for the treatment of asthma and COPD in Germany, Italy, Spain, and Portugal. Each company will market the budesonide/formoterol inhaler under its own product name. Orion markets the DPI as Bufoler Easyhaler in the Netherlands, Fobuler in Italy, and … [Read more...] about Orion to co-market Easyhaler DPIs with Menarini in several European countries