CDMO Catalent has announced the addition of DPI capsule filling capacity for potent drugs at its facility in the Boston, MA, USA area, including isolators for processing of potent compounds and cleanroom upgrades. According to Catalent, spray drying capacity has also increased, giving the company the largest cGMP manufacturing capacity for DPI capsules. The CDMO … [Read more...] about Catalent adds DPI capsule filling capacity for potent drugs
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Adherium announces the appointment of Paul Mastoridis as CEO
Adherium has announced that former Novartis executive Paul Mastoridis will succeed Rick Legleiter as CEO of the Hailie inhaler monitoring system maker. Legleiter recently announced his resignation from the company. Mastoridis was most recently Global Medical Head of Respiratory at Novartis and previously served as a brand director for respiratory at that company. … [Read more...] about Adherium announces the appointment of Paul Mastoridis as CEO
Lupin launches cyanocobalamin nasal spray in US
Lupin announced that it has launched its generic cyanocobalamin nasal spray for the prevention and treatment of vitamin B12 deficiency in the US. The FDA approved the company's ANDA for the 500 mcg/spray intranasal cyanocobalamin in June 2023. The Lupin cyanocobalamin nasal spray is a generic of Par Pharmaceutical's Nascobal nasal spray, which was approved by the … [Read more...] about Lupin launches cyanocobalamin nasal spray in US
Microbion’s pravibismane gets orphan drug designation for NTM indication
Microbion Corporation announced that the FDA has granted orphan drug designation for pravibismane for the treatment of non-tuberculous mycobacterial (NTM) infections. Pravibismane, which Microbion is developing as a topical treatment as well as an inhalation suspension, already had orphan drug designation for the treatment of lung infections in cystic fibrosis … [Read more...] about Microbion’s pravibismane gets orphan drug designation for NTM indication
Kindeva opens new laboratories, launches analytical services business
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
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