Swedish aerosol research specialists Inhalation Sciences AB (ISAB) have announced a new partnership with German OINDP development company Actarmo Medical to offer development services for inhalation products from preclinical through formulation and device development and clinical trial supplies. ISAB says that the partnership is part of a new emphasis on its … [Read more...] about Inhalation Sciences and Actarmo Medical team up to offer OINDP development services
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FDA issues CRL to Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine
According to Satsuma Pharmaceuticals parent company Shin Nippon Biomedical Laboratories, the FDA has issued a complete response letter to Satsuma's NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine. SNBL said that the CRL cited CMC issues only and did not request any additional clinical data or new clinical trials. The company added that it … [Read more...] about FDA issues CRL to Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine
Kindeva Drug Delivery acquires Summit Biosciences
Kindeva Drug Delivery has acquired CDMO Summit Biosciences, a nasal drug delivery specialist, the company announced. In 2020, Summit said that it had concluded a significant expansion to its facility in Lexington, KY, USA, bringing the facility to 44,000 sq ft. According to the Kindeva press release, the Summit cGMP facility in Kentucky is currently 55,000 sq ft and … [Read more...] about Kindeva Drug Delivery acquires Summit Biosciences
PureIMS says it is on a path to an abbreviated application for Levodopa Cyclops DPI based on Phase 1 trial results
PureIMS announced that a Phase 1 PK study that compared the company's Levodopa Cyclops to Inbrija levodopa DPI, demonstrated "high comparability with a marketed inhaled levodopa product," with faster initial absorption and no safety or tolerability concerns reported. The company announced the initiation of the Phase 1 study in August 2023. The company says that it … [Read more...] about PureIMS says it is on a path to an abbreviated application for Levodopa Cyclops DPI based on Phase 1 trial results
Cyrano raises $9 million for continued development of CYR-064 intranasal theophylline for the treatment of hyposmia
Cyrano Therapeutics said that the company will use proceeds from a $9 million Series B financing round to fund an ongoing Phase 2 trial of CYR-064 theophylline nasal spray for the treatment of loss of smell due to viral infection. Cyrano previously announced in December 2020 that it had raised $12.8 million in Series A financing for a Phase 2 trial of CYR-064. In … [Read more...] about Cyrano raises $9 million for continued development of CYR-064 intranasal theophylline for the treatment of hyposmia
Intertek joins IPAC-RS as an associate member
Contract research company Intertek announced that it has joined the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) as an associate member, citing its long-term commitment to support for OINDP development. In the announcement Intertek pointed to its Centre of Excellence for the development of inhaled and nasal drugs, which … [Read more...] about Intertek joins IPAC-RS as an associate member
Gary Pitcairn joins Iconovo as Senior Scientific Advisor
Iconovo has announced that OINDP expert Gary Pitcairn will join the company as Senior Scientific Advisor to support development projects, particularly reformulation of drugs for inhalation. Pitcairn, who was most recently Chief Scientific Officer at Nanologica, previously headed respiratory groups at AstraZeneca, Mylan, Pfizer, and Pharmaceutical Profiles. He is also … [Read more...] about Gary Pitcairn joins Iconovo as Senior Scientific Advisor
Pulmatrix to stop Phase 2b trial of PUR1900 itraconazole DPI; Cipla to take over development
Pulmatrix announced that it will halt a Phase 2b trial of PUR1900 dry powder itraconazole (Pulmazole) in patients with allergic bronchopulmonary aspergillosis (ABPA) that was initiated in February 2023. The company says that the move is part of an amended agreement with Cipla, which has been partnered with Pulmatrix on development of PUR1900 for the treatment of ABPA … [Read more...] about Pulmatrix to stop Phase 2b trial of PUR1900 itraconazole DPI; Cipla to take over development
Liquidia announces initiation of safety and tolerability study of Yutrepia in PH-ILD patients and provides update on L606 liposomal treprostinil inhalation suspension
Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected to enroll 60 PH-ILD patients. The FDA tentatively approved Yutrepia for the treatment of pulmonary … [Read more...] about Liquidia announces initiation of safety and tolerability study of Yutrepia in PH-ILD patients and provides update on L606 liposomal treprostinil inhalation suspension
US Senate committee launches investigation of inhaler prices
Members of the United States Senate Committee on Health, Education, Labor, and Pensions (HELP) have sent letters to the CEOs of AstraZeneca, Boehringer Ingelheim, GSK, and Teva asserting that "There is no reason for inhalers to be so expensive" and that each company "has manipulated the regulatory system to extend its monopolies over its inhaler products." The letters … [Read more...] about US Senate committee launches investigation of inhaler prices