The FDA has granted Breakthrough Therapy designation to Zambon's CMS I-neb colistimethate sodium for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult patients with chronic P. aeruginosa lung infections, the company said. The FDA had previously granted QIDP and Fast Track designations to the colistimethate sodium powder, which is delivered as a … [Read more...] about Zambon’s CMS I-neb inhaled colistimethate sodium gets Breakthrough Therapy designation
Regulatory
FDA allows additional MS patients in intranasal Foralumab expanded access program
Tiziana Life Sciences said that the FDA has issued a Study May Proceed letter allowing Brigham and Women’s Hospital (BWH) to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) with Tiziana's intranasal Foralumab under an Intermediate-Size Patient Population Expanded Access IND. The agency evaluated data from treatment of two … [Read more...] about FDA allows additional MS patients in intranasal Foralumab expanded access program
FDA clears IND for Blue Lake intranasal RSV vaccine
CyanVac subsidiary Blue Lake Biotechnology is planning a Phase 1 trial of its BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) after receiving FDA clearance for its IND, CyanVac said. The Phase 1 trial will evaluate BLB-201 in two different cohorts, one aged 18-59 and the other aged 60-75. According to the company, preclinical studies of BLB-201 in … [Read more...] about FDA clears IND for Blue Lake intranasal RSV vaccine
Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company's application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired the Chinese rights to OC-01 and OC-02 simpinicline nasal spray for the treatment of dry eye disease from Oyster Point Pharma in August 2021. In the … [Read more...] about Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
FDA approves Rx-to-OTC switch for Perrigo’s Nasonex 24HR Allergy nasal spray
According to Perrigo, the FDA has approved its NDA for Nasonex 24HR Allergy mometasone furoate nasal spray for the treatment of allergy symptoms, the first branded Rx-to-OTC switch for Perrigo, and the company expects to launch Nasonex 24HR Allergy sometime in 2022. In 2018, the company announced that it had acquired US rights to an OTC version of Nasonex from Merck. … [Read more...] about FDA approves Rx-to-OTC switch for Perrigo’s Nasonex 24HR Allergy nasal spray
FDA approves Mylan (Viatris) generic of Symbicort MDI (updated)
The FDA has approved a generic version of AstraZeneca's Symbicort budesonide / formoterol fumarate MDI from Mylan (now Viatris), the agency announced. The FDA tentatively approved the Mylan ANDA in March 2021 just after a court had ruled in favor of AstraZeneca in its suit against Mylan and Kindeva Drug Delivery (formerly 3M Drug Delivery). In December 2021, an … [Read more...] about FDA approves Mylan (Viatris) generic of Symbicort MDI (updated)
Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According to the announcement, Massachusetts General Hospital will conduct a Phase 2 trial of TNX-1900 for the treatment of binge … [Read more...] about Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
FDA lifts clinical hold on Penthrox methoxyflurane inhaler
According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP's Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain that is expected to begin recruiting by the end of this year. The FDA issued the clinical hold letter to MVP in 2018, and MVP said in July 2019 that it … [Read more...] about FDA lifts clinical hold on Penthrox methoxyflurane inhaler
FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail
Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro and in vivo studies of STI-9199 have demonstrated that the antibody cocktail has activity against multiple variants of SARS-CoV-2, including three … [Read more...] about FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail
Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB
According to Armata Pharmaceuticals, the FDA has cleared the company's IND for a clinical trial of AP-PA02, an inhaled phage cocktail, in non-cystic fibrosis bronchiectasis (NCFB), and the company plans to initiate a Phase 2 trial of AP-PA02 in NCFB patients this year. AP-PA02 is already in clinical development for the treatment of lung infections in cystic … [Read more...] about Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB