Regulatory
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According to United Therapeutics, the FDA has cleared the company’s IND for the 16-week Phase 2 SUMMIT trial of treprostinil SMI in patients with pulmonary hypertension associated with COPD, which is expected to enroll approximately… Read more . . .
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According to Liquidia, the company has reached a settlement with United Therapeutics to end all litigation related to patent infringement by Liquidia’s Yutrepia treprostinil DPI. A United States District Court judge recently ruled that Yutrepia… Read more . . .
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Lupin has announced the approval of its Formoflo-G glypocyrronium / formoterol / fluticasone propionate MDI for the treatment of COPD by the Drug Controller General of India (DCGI) and the subsequent launch of the inhaler… Read more . . .
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A judge in the United States District Court for the District of Delaware has found infringement by Liquidia of two claims included in US Patent No. 11,826,327 (“Treatment for interstitial lung disease”), which was issued… Read more . . .
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AstraZeneca announced that the European Commission has approved the company’s Trixeo (Breztri) Aerosphere budesonide / glycopyrrolate / formoterol MDI for the treatment of asthma in patients aged 12 and older whose asthma is not adequately… Read more . . .
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Insmed announced that the FDA has accepted the company’s sNDA to expand the use of Arikayce amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex (MAC) lung disease. Arikayce is delivered by PARI‘s Lamira nebulizer. According to… Read more . . .
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California-based SMSbiotech announced that the FDA has cleared its IND for a Phase 1b trial of its inhaled small mobile stem (SMS) cell therapy in patients with COPD and that the company intends to initiate… Read more . . .
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According to Aurobindo Pharma, the FDA has issued a final approval of the company’s ANDA for 40 mcg and 80 mcg dose versions of a generic equivalent of Teva’s QVAR beclomethasone HFA MDI for the… Read more . . .
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According to Nasus Pharma, the FDA has cleared an IND for a study of Nasus’s NS002 intranasal dry powder epinephrine for the treatment of anaphylaxis. Nasus says that it also plans to initiate a pivotal… Read more . . .
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According to Hikma Pharmaceuticals, regulators in the US, Europe, and the UK have accepted submissions for the company’s epinephrine nasal spray for the treatment of anaphylaxis, and the company has also filed a submission in… Read more . . .
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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