Regulatory
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According to Teva Pharmaceuticals Europe, the company has received marketing authorization in the EU for duplicate DPIs Seffalair Spiromax salmeterol xinafoate/ fluticasone propionate and BroPair Spiromax salmeterol xinafoate/ fluticasone propionate for the treatment for asthma… Read more . . .
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Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to… Read more . . .
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According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension… Read more . . .
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The UK National Institute for Health Research has designated the PROTECT-V trial of Union Therapeutics’ UNI91103 niclosamide nasal spray for the treatment of COVID-19 in kidney patients as an Urgent Public Health (UPH) priority, the… Read more . . .
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The Japanese Ministry of Health, Labour and Welfare has approved Insmed’s Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in patients who have… Read more . . .
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Meissa Vaccines announced that the FDA has cleared the company’s IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND… Read more . . .
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Canadian biotech SaNOtize said that a Phase 2 trial of its nitric oxide nasal spray (NONS) in COVID-19 patients demonstrated that the nasal spray reduced viral load by about 95% within 24 hours post dose… Read more . . .
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The US District Court for the Northern District of West Virginia has upheld claims in three patents protecting Symbicort budesonide / formoterol. AstraZeneca sued Mylan (now Viatris) in October 2018, and subsequently 3M (now Kindeva… Read more . . .
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Sorrento Therapeutics said that the FDA has cleared its IND for a Phase 1 study of STI-2099 intranasal neutralizing antibody (CoviDrops) in healthy volunteers and in patients with mild COVID-19. The company said that it… Read more . . .
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According to Oyster Point Pharma, the FDA has accepted the company’s NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease and has set a PDUFA goal date of October 17,… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA