OINDPnews


H&T Presspart Low GWP Banner

Regulatory

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

FDA approves Lupin’s arformoterol tartrate inhalation solution

The FDA has now fully approved Lupin's ANDA for its generic version of Sunovion's Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Brovana was approved by the FDA in 2006. The agency tentatively approved Lupin's ANDA for the arformoterol tartrate inhalation solution in April 2020, and in June 2021, Lupin announced the launch of an … [Read more...] about FDA approves Lupin’s arformoterol tartrate inhalation solution

Celltrion submits IND for Phase 3 study of inhaled antibody cocktail for COVID-19

Celltrion Group announced that it has submitted an IND application for a Phase 3 trial of an inhaled COVID-19 antibody cocktail for the treatment of mild-to-moderate COVID-19. In July 2021, Celltrion announced that it had partnered with Inhalon Biopharma on development of an inhaled formulation of regdanvimab for the treatment of COVID-19. The proposed Phase 3 trial, … [Read more...] about Celltrion submits IND for Phase 3 study of inhaled antibody cocktail for COVID-19