News
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The FDA has granted orphan drug and rare pediatric disease designations to Spirovant Sciences’s SPIRO-2101, an inhaled adeno-associated virus (AAV) gene therapy for the treatment of cystic fibrosis, the company said. SPIRO-2101 works by replacing defective… Read more . . .
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Bharat Biotech and Precision Virologics have acquired the rights to a single dose intranasal COVID-19 vaccine developed at the Washington University School of Medicine in St. Louis, the companies said. The agreement gives Precision Virologics… Read more . . .
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Verona Pharma has announced the initiation of the Phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program to study the use of nebulized ensifentrine for the treatment of moderate to severe COPD.… Read more . . .
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Neurelis has announced plans to conduct a clinical trial of Valtoco diazepam nasal spray in children with epilepsy aged 2-5 and said that the company intends to file an sNDA to expand the use of… Read more . . .
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Recordati has acquired marketing rights to ARS Pharmaceuticals’ ARS-1 epinephrine nasal spray in the EU, Iceland, Liechtenstein, Norway, Switzerland, the UK, Russia/CIS, Turkey, the Middle East, and francophone African countries, the companies said. ARS will… Read more . . .
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Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma’s ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they… Read more . . .
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Clement Clarke International is highlighting the results of a study done in partnership with Egypt’s Beni-Suef University Research demonstrating that the company’s Clip-Tone audible feedback device can improve MDI technique. The data were presented at… Read more . . .
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French biotech company Alaxia has announced a collaboration with the Department of Molecular Medicine (DMM) at the University of Padua for in vitro testing of its ALX-009 hypothiocyanite / lactoferrin inhalation solution against SARS-CoV-2 as… Read more . . .
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Ampio Pharmaceuticals said that the FDA has cleared its IND for clinical trials of an inhaled formulation of its Ampion anti-inflammatory biologic in patients with COVID-19. The company had announced its plans to develop Ampion for… Read more . . .
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Teva Respiratory has launched its AirDuo Digihaler fluticasone propionate / salmeterol and ArmonAir Digihaler fluticasone propionate DPIs in the US, the company said. The company announced the launch of its ProAir Digihaler albuterol sulfate DPI in July 2020. AirDuo… Read more . . .
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