Cipla US has announced a voluntary recall of 6 batches of albuterol MDIs after a report of valve leakage in a single inhaler manufactured in November 2021. The company said that no adverse events have been reported and that it is recalling all batches of the metered dose inhalers that used the same lot of valves out of "an abundance of precaution." The recalled … [Read more...] about Cipla recalls some albuterol MDIs due to a reported valve leak
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Copley launches Flow Rate Sensor for inhaler testing
OINDP testing experts Copley Scientific have announced the launch of the FRS bi-directional flow sensor, which is designed for use in inhaler testing. According to Copley, the device can be integrated with the company's Breath Actuation Controller BAC 100i or Critical Flow Controller TPK 100i for measurement of flow rate, pressure, and temperature in delivered dose … [Read more...] about Copley launches Flow Rate Sensor for inhaler testing
FDA approves Lupin’s ANDA for cyanocobalamin nasal spray
According to Lupin, the FDA has approved the company's ANDA for a generic version of Par Pharmaceutical's Nascobal single dose cyanocobalamin nasal spray. Lupin said that it will manufacture the nasal spray at its plant in Somerset, NJ, USA. The FDA approved the NDA for Nascobal single dose nasal spray for the treatment of pernicious anemia and other vitamin B12 … [Read more...] about FDA approves Lupin’s ANDA for cyanocobalamin nasal spray
Krystal Biotech initiates Phase 1 study of KB407 inhaled gene therapy for CF
Krystal Biotech has announced the initiation of the Phase 1 CORAL-1/US dose escalation trial of its KB407 inhaled gene therapy for the treatment of cystic fibrosis. The Phase 1 study, which is being conducted at the Cystic Fibrosis Institute of Chicago, is expected to enroll approximately 20 CF patients who will receive either KB407 delivered over 30 minutes on 1 day, … [Read more...] about Krystal Biotech initiates Phase 1 study of KB407 inhaled gene therapy for CF
Phase 2/3 trial of MannKind’s MNKD-101 clofazimine inhalation suspension faces delay
MannKind Corporation has filed a notice with the US Securities and Exchange Commission (SEC) stating that manufacturing of clinical trial supplies for its planned Phase 2/3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacteria (NTM) lung infections will be delayed up to 6 months due to a fire at the facility that was set to … [Read more...] about Phase 2/3 trial of MannKind’s MNKD-101 clofazimine inhalation suspension faces delay
Liquidia acquires North American rights to L606 liposomal treprostinil inhalation suspension from Pharmosa
Liquidia Corporation will pay Pharmosa Biopharm $10 million up front plus development and sales milestones worth up to $215 million and royalties on potential sales for North American development and commercialization rights to Pharmosa's L606 liposomal treprostinil inhalation suspension, the company said. In addition, Liquidia will have the right of first … [Read more...] about Liquidia acquires North American rights to L606 liposomal treprostinil inhalation suspension from Pharmosa
Orion to add DPI filling line to increase Easyhaler production capacity
Orion Pharmaceuticals has announced plans for a €30 million expansion of its production facility in Espoo, Finland, including a new filling line for its Easyhaler dry powder inhalers. The company said that it is responding to a projected increase in demand due to the perception by healthcare providers that DPIs are more sustainable than MDIs. Orion expects the project … [Read more...] about Orion to add DPI filling line to increase Easyhaler production capacity
TFF gets almost $3 million from NIAID for development of dry powder universal flu vaccine
According to TFF Pharmaceuticals, the company has received a 3-year Direct to Phase 2 Small Business Innovation Research (SBIR) grant worth ~$2.97 million from the National Institute of Allergy and Infectious Diseases (NIAID) for further pre-clinical development of a dry powder pan-influenza vaccine formulation based on the company's thin film freezing technology. The … [Read more...] about TFF gets almost $3 million from NIAID for development of dry powder universal flu vaccine
Cystetic initiates Phase 1 trial of CM001 “molecular prosthetic” DPI
US-based start-up Cystetic Medicines has announced the initiation of a Phase 1 SAD/MAD trial of its CM001 dry powder "molecular prosthetic" in healthy volunteers. The company is developing CM001 for the treatment of cystic fibrosis and said that it plans to evaluate the DPI in CF patients later this year. CM001 is based on technology developed by Martin Burke of the … [Read more...] about Cystetic initiates Phase 1 trial of CM001 “molecular prosthetic” DPI
Tonix Pharmaceuticals acquires Tosymra intranasal sumatriptan
Tonix Pharmaceuticals announced that it will acquire the US rights to Tosymra sumatriptan nasal spray from Upsher-Smith along with Zembrace SymTouch sumatriptan injection, both for the treatment of migraines. Dr. Reddy's subsidiary Promius Pharma submitted an NDA for Tosymra in April 2018, and the FDA approved the product in January 2019. Upsher-Smith acquired the US … [Read more...] about Tonix Pharmaceuticals acquires Tosymra intranasal sumatriptan