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Business

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

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

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

Virpax announces that NIH group will conduct preclinical studies of NobrXiol intranasal CBD for the treatment of epilepsy

Virpax Pharmaceuticals said that it has signed a cooperative research and development agreement (CRADA) for evaluation of the company's NobrXiol (VRP324) cannabidiol nasal powder in rodent models of epilepsy and seizures by the Epilepsy Therapy Screening Program (ETSP) of the National Institute of Neurological Disorders and Stroke, part of the National Institutes of … [Read more...] about Virpax announces that NIH group will conduct preclinical studies of NobrXiol intranasal CBD for the treatment of epilepsy

Padagis announces submission of ANDA for generic of Kloxxado naloxone nasal spray

Padagis announced two recent ANDA submissions, including an ANDA for a generic version of Hikma's Kloxxado naloxone nasal spray for the reversal of opioid overdose. Kloxxado, which delivers an 8 mg dose of naloxone compared to a 4 mg dose for Narcan nasal spray, was approved by the FDA in April 2021. Padagis launched a generic version of Narcan in the US in June … [Read more...] about Padagis announces submission of ANDA for generic of Kloxxado naloxone nasal spray

Resyca announces new Chief Technical Officer, licensing deal with Thaerapy

Soft mist inhaler developer Resyca, a joint venture of Medspray Pharma and Recipharm, has announced the promotion of current Head of Development and Project Management Nicolas Buchmann to Chief Technical Officer. Buchman will take over from Wilbur de Kruijf, who is leaving to serve as CEO of a start-up inhaled drug developer called Thaerapy. Resyca also announced that … [Read more...] about Resyca announces new Chief Technical Officer, licensing deal with Thaerapy

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