According to Circassia Pharmaceuticals, the UK has approved the company's generic fluticasone propionate MDI for the treatment of asthma under the European decentralized procedure. The MAA includes the same three strengths (50µg, 125µg and 250µg per actuation) as GSK's Flixotide fluticasone propionate MDI, and the company will now submit marketing applications in … [Read more...] about Circassia’s fluticasone propionate MDI approved in UK based on in vitro data only
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Sumatriptan nasal spray shortage expected to last until February 2016
According to the FDA, GlaxoSmithKline has reported that 20 mg and 5 mg dosages of its Imitrex nasal spray for the treatment of migraine headaches will be unavailable until February 2016 due to an API shortage. The shortage, which was reported to the FDA on November 20, 2015, affects both dosages of an authorized generic sumatriptan nasal spray distributed by Sandoz … [Read more...] about Sumatriptan nasal spray shortage expected to last until February 2016
Hakan Edstrom steps down as CEO of MannKind Corporation
MannKind Corporation has announced the resignation of Hakan Edstrom, who was the company's President and CEO, as well as a director. In the wake of the resignation, Alfred Mann has been appointed interim CEO, effective November 19, 2015, and a board committee has begun a search for a new CEO. Edstrom took over as CEO from Mann in January 2015, prior to Sanofi's … [Read more...] about Hakan Edstrom steps down as CEO of MannKind Corporation
Phase 3 study shows indacaterol/glycopyrronium reduces COPD exacerbations better than Advair
Novartis today has announced that the Phase 3 FLAME study demonstrated that the Utibron Neohaler (Ultibro Breezhaler) indacaterol/glycopyrronium DPI reduced the rate of COPD exacerbations more effectively than the Advair (Seretide) fluticasone/salmeterol DPI over a 52-week period. FLAME involved over 3,360 COPD patients in 43 countries and was designed to demonstrate … [Read more...] about Phase 3 study shows indacaterol/glycopyrronium reduces COPD exacerbations better than Advair
Positive top-line results from several Teva Phase 3 DPI studies
Teva Pharmaceutical Industries has announced top-line results from three Phase 3 clinical studies of its generic fluticasone propionate/salmeterol DPI and a fluticasone propionate monotherapy DPI for the treatment of asthma. The company said that all of the studies met their primary endpoints and that it plans to submit regulatory applications to the FDA for both … [Read more...] about Positive top-line results from several Teva Phase 3 DPI studies
FDA approves Narcan nasal spray
The FDA has approved Adapt Pharma's Narcan naloxone nasal spray for the treatment of opioid overdoses less than four months after the submission of the company's NDA. Lightlake Therapeutics licensed the intranasal naloxone to Adapt in December 2014; Adapt submitted the NDA in July 2015; and the application was granted priority review by the FDA in September 2015. … [Read more...] about FDA approves Narcan nasal spray
Turing Pharmaceuticals says it will initiate a Phase 1 trial of intranasal ketamine in early 2016
Turing Pharmaceuticals, which is the subject of several investigations into its pricing strategies, has said that it plans to begin a Phase 1 trial of its TUR-002 intranasal ketamine in the first quarter of 2016. The company said that is developing TUR-002 for both post-traumatic stress disorder (PTSD) and major depressive disorder. Turing CEO Martin Shkreli said, … [Read more...] about Turing Pharmaceuticals says it will initiate a Phase 1 trial of intranasal ketamine in early 2016
Bespak and Aesica services combined for single source supply chain for OINDPs
Consort Medical has announced that it has created a single source supply chain for OINDPs by combining the services of device company Bespak with CDMO Aesica, which Consort acquired in September 2014. Together, the companies can supply API, formulation, and device development; pilot scale to commercial manufacturing; finished dose fill and finish; and secondary … [Read more...] about Bespak and Aesica services combined for single source supply chain for OINDPs
Discovery Labs announces additional Phase 2a data, says it is ready to advance Aerosurf to Phase 2b
Discovery Laboratories has announced additional data from its Phase 2a trials of Aerosurf aerosolized surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants 29 to 34 week gestational age. that are receiving nasal continuous positive airway pressure (nCPAP). The company said that the data are "encouraging" and demonstrate that Aerosurf … [Read more...] about Discovery Labs announces additional Phase 2a data, says it is ready to advance Aerosurf to Phase 2b
Iconovo inhaled vaccine project wins Lund University 2015 Innovation award
Swedish DPI specialist Iconovo has won the 2015 Lund University Innovation System Innovation Prize, which comes with a SEK 150,000 award, the Lund Life Science Incubator has announced. Iconovo's winning project, titled, "ICOone for inhaled vaccines" uses the company's unit dose disposable dry powder inhaler platform for delivery of shelf stable vaccines. Iconovo … [Read more...] about Iconovo inhaled vaccine project wins Lund University 2015 Innovation award