PureIMS has appointed Frank Lambert as Executive Director Commercialization. Lambert, who was most recently Executive Director of Business Development for Early Development Services at ICON, will lead commercialization efforts for the company's Cyclops pre-filled disposable dry powder inhaler. PureIMS has Cyclops DPI formulations of levodopa, epinephrine, and … [Read more...] about PureIMS names Frank Lambert Executive Director of Commercialization
News
NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models
Researchers at North Carolina State University have published an article in Nature Materials describing preclinical development of an inhalation powder they are calling "SHIELD" (Spherical Hydrogel Inhalation for Enhanced Lung Defense) that has demonstrated the ability to block viral lung infections in mouse and non-human primate models. Studies found that the SHIELD … [Read more...] about NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models
Copley Scientific launches DUSA Shaker DTS 100i
Copley Scientific has announced the launch of its next generation DUSA Shaker, a semi-automated tool for rinsing dose uniformity sampling apparatus (DUSA) collection tubes. According to the company, the the new DTS 100i is a "comprehensively re-engineered and updated" version of the original DUSA Shaker that "provides full, fast, repeatable rinsing" and can be used … [Read more...] about Copley Scientific launches DUSA Shaker DTS 100i
Spexis gets funding for Phase 3 trials of ColiFin inhaled colistimethate sodium
Spexis has announced a deal with SPRIM Global Investments (SGI) for funding of up to half of Spexis' costs related to Phase 3 development of ColiFin nebulized colistimethate sodium for the treatment of P. aeruginosa lung infections in patients with cystic fibrosis. Spexis was formed in December 2021 through a merger of Polyphor, which was developing inhaled … [Read more...] about Spexis gets funding for Phase 3 trials of ColiFin inhaled colistimethate sodium
Tonix initiates Phase 2 trial of TNX-1900 intranasal oxytocin for the prevention of migraines
Tonix Pharmaceuticals has announced the initiation of the Phase 2 PREVENTION study of the company's TNX-1900 intranasal potentiated oxytocin for the prevention of migraine headaches. Tonix licensed TNX-1900 for the treatment of migraine from Trigemina in June 2020, and the company announced in November 2021 that the FDA had cleared an IND for a Phase 2 trial of … [Read more...] about Tonix initiates Phase 2 trial of TNX-1900 intranasal oxytocin for the prevention of migraines
Access to Advanced Health Institute gets award worth up to $9.9 million for development of intranasal RNA flu vaccine
Nonprofit biotech research institute Access to Advanced Health Institute (AAHI) said that it has received an award worth up to $9.9 million for a 40-month project aimed at development of liquid and dry powder versions of an intranasal influenza RNA vaccine candidate targeting the A(H5N1) and A(H7N9) avian influenza subtypes. The funding, which will support … [Read more...] about Access to Advanced Health Institute gets award worth up to $9.9 million for development of intranasal RNA flu vaccine
Seelos Therapeutics initiates Phase 1 ethnobridging study of SLS-002 intranasal racemic ketamine
Seelos Therapeutics said that it has initiated a Phase 1 study comparing PK profiles of SLS-002 intranasal racemic ketamine in Japanese and non-Asian adults. In May 2021, the company announced positive Phase 2 results for SLS-002 for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The intranasal ketamine is delivered … [Read more...] about Seelos Therapeutics initiates Phase 1 ethnobridging study of SLS-002 intranasal racemic ketamine
Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Pulmatrix has announced the initiation of a Phase 2b trial of its PUR1900 dry powder itraconazole in patients with allergic bronchopulmonary aspergillosis (ABPA) and asthma. In 2020, PUR1900 received fast track designation for that indication. Pulmatrix is partnered with Cipla subsidiary Cip Tec on development of the itraconazole DPI, which it has previously called … [Read more...] about Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Orexo submits NDA for OX124 intranasal naloxone
Orexo announced that it has submitted an NDA for its OX124 intranasal naloxone for the reversal of opioid overdose. The company notes that FDA review is likely to take a little more than a year and says that it is planning for a launch in the first half of 2024. OX124 is based on the company's amorphOX particle engineering technology, which also underlies its … [Read more...] about Orexo submits NDA for OX124 intranasal naloxone
PTAB again supports Liquidia, denies United Therapeutics rehearing request for Tyvaso patent
According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has denied a request by United Therapeutics to revisit the board's July 2022 determination that none of the claims in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are patentable. Liquidia said that it expects United Therapeutics to appeal the denial of the rehearing to the US Court … [Read more...] about PTAB again supports Liquidia, denies United Therapeutics rehearing request for Tyvaso patent