Smartinhaler maker Adherium has announced a collaboration with pulmonary disease management provider Vitalus Health for promotion of Adherium's inhaler monitoring technology to COPD patients in the southwest US. In September 2017, Adherium's SmartTouch sensor received 510(k) clearance from the FDA for use with the Symbicort inhaler, and in March 2018, the … [Read more...] about Adherium announces collaboration with Vitalus Health
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Clement Clarke launches new inhaler training app
Clement Clarke International has announced the availability of a new smartphone app called the Trainhaler Buddy for use with its Trainhaler device to teach patients correct inhaler use technique. The Trainhaler Buddy app uses animations to provide visual feedback, reinforcing audio feedback provided by the whistling mouthpiece on the Trainhaler device, as the patient … [Read more...] about Clement Clarke launches new inhaler training app
Impax to sell azelastine and olopatadine nasal sprays to Perrigo for merger with Amneal
The US Federal Trade Commission (FTC) is requiring Impax to divest several products in order to complete a planned merger with Amneal that the companies announced in October 2017. To satisfy the FTC requirements, Impax will sell its azelastine and olopatadine nasal sprays to Perrigo, subject to completion of the merger. Impax and Perrigo had partnered on both … [Read more...] about Impax to sell azelastine and olopatadine nasal sprays to Perrigo for merger with Amneal
Mundipharma’s k-haler wins design awards
Mundipharma's k-haler breath-activated metered dose inhaler has won two platinum A’ Design Awards in the ‘Scientific Instruments, Medical Devices and Research Equipment Design’ and ‘Ease of Use and Universal Design’ categories. In October 2017, the company's Flutiform k-haler received marketing approval for the treatment of asthma through the European … [Read more...] about Mundipharma’s k-haler wins design awards
FDA no longer requiring REMS communication plan for Afrezza inhaled insulin
MannKind Corporation has announced that FDA is no longer requiring a Risk Evaluation and Mitigation Strategy (REMS) communication plan for Afrezza inhaled insulin. Afrezza was approved in the US in June 2014, with the FDA requiring a boxed warning about bronchospasm in asthma and COPD patients and several post-marketing studies. According to the company, the REMS … [Read more...] about FDA no longer requiring REMS communication plan for Afrezza inhaled insulin
The FDA approves expanded indication for Trelegy Ellipta
According to GlaxoSmithKline and Innoviva, the FDA has approved an expanded indication for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, allowing the use of Trelegy Ellipta for COPD patients with airflow limitation or with acutely worsening respiratory symptoms. GSK filed an sNDA for Trelegy Ellipta in November 2017 based on data from the … [Read more...] about The FDA approves expanded indication for Trelegy Ellipta
US company licenses cannabis pMDI
A US company called Honu Xpress says that it has acquired a license for the Mystabis cannabis MDI which it claims "provides pressurized metered-doses of cannabis oil directly to the lung's capillaries with little to no exhale" and up to 95% bioavailabilty. The company said that it plans to sell the inhaler in US and foreign markets except for Canada and Australia … [Read more...] about US company licenses cannabis pMDI
AOBiome initiates Phase 2 trial of intranasal ammonia oxidizing bacteria for episodic migraine
A US biotech company called AOBiome Therapeutics said that it has initiated a Phase 2 study of an ammonia oxidizing bacteria (AOB) nasal spray for the prevention of episodic migraine. According to AOBiome, the nasal spray, which contains a single strain of Nitrosomonas eutropha, is expected to repopulate the nasal microbiome where it will convert naturally occurring … [Read more...] about AOBiome initiates Phase 2 trial of intranasal ammonia oxidizing bacteria for episodic migraine
Iconovo extends deal with TOA, will develop DPI for the Japanese market
Swedish inhaled product developer Iconovo has announced a deal with Japanese pharmaceutical company TOA for development of Iconovo's ICOone unit dose dry powder inhaler for the treatment of asthma and COPD. TOA's Nishihongo facility includes a building dedicated to DPI manufacturing and filling that has been in operation since 2007. According to Iconovo, the … [Read more...] about Iconovo extends deal with TOA, will develop DPI for the Japanese market
UCB acquires midazolam nasal spray from Proximagen
Belgian pharmaceutical company UCB has acquired the rights to Proximagen's USL261 midazolam nasal spray for $150 million up front and potential milestone payments of up to $220 million, the company said. An NDA for USL261 is expected to be filed by the end of 2018. Proximagen, a former subsidiary of Upsher-Smith, reported positive Phase 3 results for USL261 in … [Read more...] about UCB acquires midazolam nasal spray from Proximagen