The FDA has approved a 505(b)(2) NDA for Hikma's Kloxxado naloxone nasal spray for the reversal of opioid overdose. Hikma says that it expects to launch the nasal spray, which was approved for use in pediatric and adult patients, in the second half of this year. Kloxxado delivers 8 mg of naloxone per dose, twice as much as the higher dose of Narcan naloxone nasal … [Read more...] about FDA approves Hikma’s Kloxxado naloxone nasal spray
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DDL 2021 issues call for papers for virtual conference
The organizers of DDL 2021 have announced that the Drug Delivery to the Lungs meeting will once again take place online due to the COVID-19 pandemic, and they have issued a call for papers for the virtual conference. In addition, nominations are now open for the Pat Burnell Young Investigator Award and for the Emerging Scientist Award. The meeting will take place … [Read more...] about DDL 2021 issues call for papers for virtual conference
Health Canada approves the Syqe medical cannabis inhaler
Health Canada has approved Syqe Medical's metered dose medical cannabis inhaler, the company said. The Syqe inhaler, which uses a cartridge pre-loaded with granulated cannabis, has been available to patients in Israel since June 2019. In September 2019, the company announced that it had signed a deal with TerrAscend for distribution of the device in … [Read more...] about Health Canada approves the Syqe medical cannabis inhaler
Ampio says trial of inhaled Ampion in COVID-19 patients demonstrates 78% reduction in all-cause mortality
Ampio Pharmaceuticals has announced that the final results from the AP-014 Phase 1 trial of inhaled Ampion in COVID-19 patients demonstrated a greater reduction in all-cause mortality than was seen in the preliminary results. In March 2021, Ampio reported that preliminary data from the trial showed a 62% reduction in all-cause mortality. After all patients completed … [Read more...] about Ampio says trial of inhaled Ampion in COVID-19 patients demonstrates 78% reduction in all-cause mortality
Ryaltris nasal spray approved in the EU
Glenmark Pharmaceuticals said that it plans to launch Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of allergic rhinitis in 16 European Union countries and the UK after finalizing marketing approval. Menarini Group will commercialize Ryaltris in some of the companies, including France, Italy, Spain, and the Balkans, under a December 2020 … [Read more...] about Ryaltris nasal spray approved in the EU
AireHealth names Kien Nguyen as CEO
Connected nebulizer maker AireHealth has announced the appointment of Kien Nguyen as its new CEO and as a member of its board. Nguyen was most recently Chief Commercial Officer at Progenerative Medical. In December 2020, AireHealth announced that it had received 510(k) clearance for its VitalMed connected portable vibrating mesh nebulizer. AireHealth Kien … [Read more...] about AireHealth names Kien Nguyen as CEO
Chiesi gets EC approval for Trimbow Nexthaler triple combination DPI for the treatment of COPD
The European Commission has approved Chiesi's Trimbow Nexthaler extrafine beclometasone dipropionate / formoterol fumarate / glycopyrronium DPI for the treatment of moderate to severe COPD in patients not adequately treated with an ICS/LABA or LABA/LAMA combination, the company said. Chiesi's Trimbow triple combination MDI was approved in Europe for the treatment … [Read more...] about Chiesi gets EC approval for Trimbow Nexthaler triple combination DPI for the treatment of COPD
Nob Hill Therapeutics names Paul Atkins as Executive Chairman
Dry powder nebulizer maker Nob Hill Therapeutics has named former Oriel Therapeutics President and CEO Paul Atkins as Executive Chairman. Atkins headed DPI developer Oriel until the company was acquired by Sandoz in 2010 and subsequently served as VP, Operations at Sandoz until 2020. According to the Nob Hill web site, its DryNeb "dry powder nebulizer is a … [Read more...] about Nob Hill Therapeutics names Paul Atkins as Executive Chairman
Hikma re-starts launch of its generic version of Advair Diskus
Hikma Pharmaceuticals said that the FDA has approved an amendment to the company's ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of the inhaler. The FDA initially approved the ANDA in December 2020, and the company said that it was launching the DPI at that time. Hikma … [Read more...] about Hikma re-starts launch of its generic version of Advair Diskus
Inhalation Sciences takes steps to expand its business in the US
Swedish aerosol research instrument maker Inhalation Sciences (ISAB) says that the company intends to expand its presence in the US in 2021 and has signed agreements with lead generation company Cience and with CRO consultant Coelus Bio to help it achieve that goal. In October 2020, ISAB announced that it had been granted a US patent for its PreciseInhale laboratory … [Read more...] about Inhalation Sciences takes steps to expand its business in the US