Intertek Pharmaceutical Services Commercial Director Chris Vernall on how the new FDA nasal bioequivalence guidances support an in vitro only bioequivalence pathway and continue wider industry focus on evolving analytical and in silico tools for generic OINDP testing What is the main difference in in-vitro bioequivalence (IVBE) recommendations between the May 2023 … [Read more...] about Q&A with Intertek’s Chris Vernall on in-vitro only BE and the new nasal bioequivalence guidances
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Kindeva, H&T Presspart, and Chiesi sign deal for dose counters
H&T Presspart will expand cleanroom facilities and add a new production line to manufacture Kindeva Drug Delivery's dose counters and dose indicators for use in Chiesi MDIs, the companies have announced. According to the announcement, the dose counters will be used in Chiesi's new lower-GWP MDIs. H&T Presspart previously signed a licensing deal with 3M (now … [Read more...] about Kindeva, H&T Presspart, and Chiesi sign deal for dose counters
Tonix initiates Phase 2 trial of TNX-1900 intranasal potentiated oxytocin for the treatment of obesity in pediatric patients
Tonix Pharmaceuticals has announced the initiation of the Phase 2 POWER study of its TNX-1900 potentiated oxytocin nasal spray in subjects aged 12-18 whose body mass index (BMI) is in the 95th percentile or higher for their age and gender. The study, which is taking place at Massachusetts General Hospital, is expected to enroll 75 participants who will use either … [Read more...] about Tonix initiates Phase 2 trial of TNX-1900 intranasal potentiated oxytocin for the treatment of obesity in pediatric patients
Pendopharm recalls one lot of Rhinaris Nasal Mist in Canada
Health Canada announced that Pharmascience's Pendopharm division is recalling one lot of Rhinaris Nasal Mist saline nasal spray after "testing showed that the preservative in the product may not be as effective as expected." Specifically, the agency said that testing indicated the potential for P. aeruginosa to grow in the product. The lot affected by the recall is … [Read more...] about Pendopharm recalls one lot of Rhinaris Nasal Mist in Canada
Cipla recalls some albuterol MDIs due to a reported valve leak
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
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