Turing Pharmaceuticals said that it has received a no objection letter from Health Canada regarding the initiation of Phase 1 trials of TUR-002 intranasal ketamine for the reduction of suicidal ideations and that it expects to complete the trials by mid-2016. The timing is in line with a November 2015 announcement from Turing that was made prior to the arrest and … [Read more...] about Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine
News
Health Canada approves Natesto nasal testosterone gel
Acerus Pharmaceuticals has received approval from Health Canada to market Natesto nasal gel as a testosterone replacement therapy in adult males with hypogonadism, and the product should be available in Canada by mid-2016, the company said. Acerus President and CEO Tom Rossi said, “Natesto addresses many of the gaps with current testosterone replacement therapies. … [Read more...] about Health Canada approves Natesto nasal testosterone gel
Mylan submits ANDA for fluticasone/salmeterol DPI
Mylan submitted an abbreviated new drug application (ANDA) to the FDA for its fluticasone propionate/salmeterol DPI, a generic version of GSK's Advair Diskus, for the treatment of asthma and COPD in December 2015, the company has confirmed. The application includes all of the doses for which Advair Diskus is marketed: 100, 250, and 500 μg fluticasone/50 μg salmeterol. … [Read more...] about Mylan submits ANDA for fluticasone/salmeterol DPI
Liquidia Technologies appoints new VP, Business Development & Strategy
Particle engineering specialist Liquidia Technologies announced that it has hired Jason Adair as VP, Business Development & Strategy. Adair was most recently Executive Director of Corporate Development at BioCryst and was previously Director of Business Development at MedImmune. Liquidia CEO Neal Fowler commented, "Jason brings extensive business development and … [Read more...] about Liquidia Technologies appoints new VP, Business Development & Strategy
MannKind appoints Matthew J. Pfeffer as CEO
MannKind Corporation has appointed Matthew J. Pfeffer as CEO effective January 10, 2016, replacing Alfred Mann. In November 2015, Mann temporarily resumed his role as CEO after Hakan Edstrom stepped down. On January 5, 2016, MannKind announced that Sanofi would return the rights to its Afrezza inhaled insulin and that it was considering options for the product. … [Read more...] about MannKind appoints Matthew J. Pfeffer as CEO
Theravance, Inc changes its name to Innoviva
Theravance, Inc, which spun off from Theravance Biopharma in 2013, will now be known as "Innoviva" and will trade on NASDAQ under the symbol "INVA," the company said. Innoviva is partnered with GSK on the Relvar/Breo Ellipta fluticasone furoate/vilanterol DPI, the Anoro Ellipta umeclidinium/vilanterol DPI, and a vilanterol monotherapy DPI in development. Innoviva … [Read more...] about Theravance, Inc changes its name to Innoviva
Vectura reveals its US partner for generic fluticasone/salmeterol DPI: BI subsidiary Roxane Laboratories
Vectura Group has confirmed that its US partner for the VR315 fluticasone/salmeterol DPI and the VR506 generic fluticasone propionate DPI is Boehringer Ingelheim subsidiary Roxane Laboratories. The company is partnered with Sandoz on VR315 in the rest of the world. When Vectura announced the VR315 US licensing deal in August 2011, it referred to its partner as "a … [Read more...] about Vectura reveals its US partner for generic fluticasone/salmeterol DPI: BI subsidiary Roxane Laboratories
Simplified Solutions partners with CSP Technologies for development of X-haler DPI
Swedish DPI developer Simplified Solutions announced that it has entered into an agreement with CSP Technologies for continued development of its X-haler dry powder inhaler through to commercial manufacturing. The credit-card sized multi-dose DPI will incorporate CSP's Activ-Polymer and moisture barrier technologies. Financial details were not disclosed. According … [Read more...] about Simplified Solutions partners with CSP Technologies for development of X-haler DPI
Qualcomm to develop disposable sensor module for the Breezhaler DPI
Qualcomm subsidiary Qualcomm Life will design a disposable module for the Breezhaler DPI that will sense and report inhaler usage data for Novartis's Breezhaler COPD products, including Ultibro, Seebri, and Onbrez. The Breezhaler DPIs are approved in the US as Utibron, Seebri, and Arcapta Neohalers. Novartis Pharmaceuticals Head David Epstein commented, "Novartis … [Read more...] about Qualcomm to develop disposable sensor module for the Breezhaler DPI
Sanofi to return Afrezza rights to MannKind
Sanofi will return development and commercialization rights for Afrezza inhaled insulin to MannKind after disapponting sales, and MannKind says that it is considering strategic options for the product. Afrezza was approved by the FDA in June 2014. According to MannKind, The parties will promptly commence transition discussions in order to effect a smooth and … [Read more...] about Sanofi to return Afrezza rights to MannKind