Kindeva Drug Delivery has announced the opening of a 32,000 sq ft laboratory facility in Woodbury, MN, USA that will be home to the company's new analytical services business unit. According to the announcement, the analytical services offered include medical device, container closure, and extractables and leachables testing. The company said that extractables and … [Read more...] about Kindeva opens new laboratories, launches analytical services business
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Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA
Defender Pharmaceuticals announced that the FDA has issued a complete response letter in response to the NDA for DPI-386 scopolamine nasal gel that the company submitted in July 2023. The FDA accepted the NDA for review in September 2023, with a PDUFA goal date of January 26, 2024. Defender President and CEO Barry I. Feinberg commented, “Following our review of … [Read more...] about Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA
Dr. Ferrer BioPharma wins Pharmapack award for its GentleMist nasal delivery technology
The Patient-Centric Design award at CPHI Pharmapack 2024 went to Florida-based Dr. Ferrer BioPharma for its GentleMist nozzle for intranasal delivery devices, which was developed as part of a partnership with researchers at South Dakota State University, Bona Pharma, and the Cleveland Clinic. According to the company, "GentleMist Technology utilizes advanced fluid … [Read more...] about Dr. Ferrer BioPharma wins Pharmapack award for its GentleMist nasal delivery technology
Liquidia announces that the FDA will miss the PDUFA goal date for review of Yutrepia sNDA to add PH-ILD indication
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
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