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
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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
Essential Pharma acquires European rights to Colobreathe colistimethate sodium DPI from Teva
Essential Pharma announced that it has acquired European rights to Teva's Colobreathe colistimethate sodium inhalation powder from Teva. Colobreathe, which was developed by Forest Laboratories, was approved by the EMA for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older in 2012. According to Essential, Colobreathe is marketed in … [Read more...] about Essential Pharma acquires European rights to Colobreathe colistimethate sodium DPI from Teva
Theravance says Phase 4 trial fails to demonstrate superiority to Yupelri inhalation solution over Spiriva HandiHaler for the treatment of severe COPD
Theravance Biopharma announced that the Phase 4 PIFR-2 study of nebulized Yupelri revefenacin inhalation solution versus Spiriva HandiHaler tiotropium DPI in patients with severe to very severe COPD failed to demonstrate any significant difference in the improvement in lung function between the two arms. The company announced the initiation of the 12-week Phase 4 … [Read more...] about Theravance says Phase 4 trial fails to demonstrate superiority to Yupelri inhalation solution over Spiriva HandiHaler for the treatment of severe COPD