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
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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
Copley Scientific’s Mark Copley answers questions about USP Chapter <1602>
Copley Scientific CEO Mark Copley discusses the recently published USP Chapter <1602> for testing "Spacers & Valved Holding Chambers Used with Inhalation Aerosols" Q: What does this new USP Chapter cover? A: Chapter <1602>, published by the United States Pharmacopeia (USP) in 2017, defines standardized methods for characterizing the in vitro … [Read more...] about Copley Scientific’s Mark Copley answers questions about USP Chapter <1602>
Inhalation Sciences names Lena Heffler as CEO
Swedish instrument company Inhalation Sciences has announced the appointment of Lena Heffler as its new CEO effective May 7, 2018. She will succeed Fredrik Sjövall, who is expected to become Chairman of the Board. Heffler said, "Inhalation Sciences is a company with a unique and very exciting technology platform that has the potential to make a huge difference to … [Read more...] about Inhalation Sciences names Lena Heffler as CEO
FDA issues revised draft guidance for MDI and DPI quality considerations
The FDA has issued a revised draft guidance, "Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations." The guidance is scheduled for publication in the Federal Register on April 19, 2018; comments regarding the document should be submitted to the FDA within 60 days of publication. According to a draft of the Federal Register … [Read more...] about FDA issues revised draft guidance for MDI and DPI quality considerations
Insys to begin clinical research program for dronabinol inhaler
Insys Therapeutics has announced that it plans to advance clinical research of a breath activated dronabinol (THC) inhaler in the second half of 2018. The company said that it plans to develop the inhaler for the treatment of anorexia in AIDS and cancer patients and for agitation in Alzheimer's disease patients. In 2015, Insys announced that it had licensed the … [Read more...] about Insys to begin clinical research program for dronabinol inhaler