According to Liquidia Corporation, the FDA has informed the company that the agency will not meet the PDUFA goal date of January 24, 2004 for completion of the review of Liquidia's sNDA to add an indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD) for Yutrepia treprostinil DPI. The company said that the FDA "informed the Company … [Read more...] about Liquidia announces that the FDA will miss the PDUFA goal date for review of Yutrepia sNDA to add PH-ILD indication
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Recipharm and Medspray extend their partnership on Resyca SMIs to include nasal delivery
CDMO Recipharm has announced an extension of its existing partnership with spray nozzle developer and manufacturer Medspray to include development of soft mist nasal delivery devices. In February 2021, Recipharm and Medspray announced the launch of their joint venture Resyca to develop soft mist inhalation products using Medspray nozzle technology. The new … [Read more...] about Recipharm and Medspray extend their partnership on Resyca SMIs to include nasal delivery
AstraZeneca launches Airsupra albuterol / budesonide MDI in the US
AstraZeneca has announced the US launch of its Airsupra albuterol / budesonide MDI, which was approved by the FDA in January 2023 for the treatment of asthma in people aged 18 and over. Airsupra (PT027) was developed by AstraZeneca subsidiary Pearl Therapeutics. The company points out that the MDI is the only approved SABA/ICS inhaler and the only one that includes … [Read more...] about AstraZeneca launches Airsupra albuterol / budesonide MDI in the US
Inhalation Sciences and Actarmo Medical team up to offer OINDP development services
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
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