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
News
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
Insys Therapeutics announces management changes
Insys Therapeutics has announced the resignation of President and CEO Michael L. Babich and the appointment of John N. Kapoor to those positions, effective November 4, 2015. The company also named Daniel Brennan as Executive VP and COO. The effective date of the CEO change is the same day that CNBC aired an investigative report about Insys, which is under … [Read more...] about Insys Therapeutics announces management changes
Discovery Labs provides update on Aerosurf development
Discovery Laboratories has provided an update on its clinical development program for Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants. In March 2015, the company announced that it was restructuring to focus all its attention on Aerosurf. According to Discovery Labs, enrollment in a Phase 2a expansion … [Read more...] about Discovery Labs provides update on Aerosurf development
Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto
Acerus (formerly Trimel) has announced that it will pursue development of its Tefina nasal testosterone for the treatment of hypoactive sexual desire disorder (HSDD) instead of for female orgasmic disorder (FOD). In May 2014, the company announced positive results from a Phase 2 study of Tefina for FOD. The decision to switch course came after meeting with the FDA … [Read more...] about Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto