According to Smartinhaler manufacturer Nexus6, the FDA has granted 510(k) marketing clearance for a new version of the inhaler monitoring system called SmartTouch. The system includes a touch screen on the monitoring device and is available for a number of different MDIs, including Ventolin, Advair (Seretide), and Dulera. Nexus6 CEO Garth Sutherland commented, … [Read more...] about FDA clearance for new Smartinhaler system
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Parion announces management changes
Parion Sciences, which is developing a trans-nasal aerosol delivery system and several products for cystic fibrosis, has announced several changes to its executive team. Paul Boucher, previously VP of Finance & Business has been promoted to President; Joe Schachle, previously Head of Global Marketing Operations at Grifols, has been hired as Chief Operating Officer; … [Read more...] about Parion announces management changes
Retrophin names new President/COO and Executive VP of R&D
Retrophin, which is developing Syntocinon intranasal oxytocin, has named Stephen Aselage as President and Chief Operations Officer and Alvin Shih as Executive VP of Research and Development. Aselage, who has stepped down as CEO, was Executive VP and Chief Business Officer at BioMarin Pharmaceutical before joining Retrophin in 2012, and Shih is currently COO of … [Read more...] about Retrophin names new President/COO and Executive VP of R&D
Insmed adds former AstraZeneca CEO to its board
Arikayce inhaled liposomal amikacin developer Insmed has announced that former AstraZeneca CEO David R. Brennan will join the company's board of directors. Insmed Chairman of the Board Donald J. Hayden commented, "We are delighted to welcome David to the Insmed Board. David's deep and diverse set of global operating experiences will be invaluable as we build … [Read more...] about Insmed adds former AstraZeneca CEO to its board
FDA approves Trimel’s Natesto testosterone nasal gel
According to Trimel Pharmaceuticals, the FDA has approved its Natesto nasal testosterone for men with low levels of endogenous testosterone. Trimel submitted an NDA for the product, then called CompleoTRT, in April 2013. Trimel President and CEO Tom Rossi said, “The FDA approval for Natesto is a major achievement for our company, as it validates our clinical … [Read more...] about FDA approves Trimel’s Natesto testosterone nasal gel
Positive Phase 2 results for Trimel’s Tefina nasal testosterone
Trimel Pharmaceuticals has announced that an 84-day Phase 2 trial of its Tefina testosterone nasal gel for the treatment of anorgasmia in women found that the lowest of three doses tested produced a statistically significant increase in the number of orgasms experienced compared to placebo. The study involved more than 250 women in the US, Canada, and Australia. … [Read more...] about Positive Phase 2 results for Trimel’s Tefina nasal testosterone
Study shows reminders significantly improved inhaler adherence but increased adherence did not greatly improve asthma control
A six-month study conducted by the Woolcock Institute of Medical Research (WIMR) found that patients getting reminders from the Smartinhaler SmartTrack inhaler monitoring system manufactured by Nexus6 took 73% of prescribed doses on average compared to 46% for patients not using a reminder system. However, despite the significant difference in adherence between the … [Read more...] about Study shows reminders significantly improved inhaler adherence but increased adherence did not greatly improve asthma control
FDA approves QVAR HFA with dose counter
The FDA has approved Teva's QVAR beclomethasone HFA metered dose inhaler with a dose counter for the treatment of asthma, and the company plans to launch the product later in 2014, Teva said. Teva Global Respiratory Research and Development Senior VP Tushar Shah commented, “Bringing QVAR with a dose counter to market reaffirms Teva’s commitment to addressing unmet … [Read more...] about FDA approves QVAR HFA with dose counter
AZTherapies moving forward with Phase 3 study of inhaled Alzheimer’s therapy
Boston-based AZTherapies says that it plans to initiate a Phase 3 study of its ALZT-OP1, an inhaled combination product for the prevention and treatment of Alzheimer's disease, by the end of 2014 now that it has gotten the go-ahead from the FDA. Both drugs used in the combination therapy are already approved in the US, and the company plans to use data from the trial … [Read more...] about AZTherapies moving forward with Phase 3 study of inhaled Alzheimer’s therapy
GSK files application for UMEC monotherapy in Japan
GlaxoSmithKline has submitted an NDA for its umeclidinium (UMEC) Ellipta DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare, the company announced. The product was approved under the name Incruse Ellipta in the US, in Canada, and in Europe in April 2014. According to GSK, "Regulatory filings in other countries will take place … [Read more...] about GSK files application for UMEC monotherapy in Japan