Regulatory
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Impel NeuroPharma announced that it has submitted an NDA for its INP104 dihydroergotamine mesylate intranasal (DHE) for the treatment of migraine headaches with or without aura, which is delivered via the company’s Precision Olfactory Delivery… Read more . . .
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The FDA has approved Chiesi’s Bronchitol mannitol DPI for the treatment of cystic fibrosis in adult CF patients after a lengthy review process. The FDA issued a complete response letter to the original NDA in… Read more . . .
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The EC has granted marketing authorization to Insmed’s Arikayce nebulized lipsomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adult patients without cystic fibrosis who have limited treatment… Read more . . .
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According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC… Read more . . .
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According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s Trixeo Aerosphere formoterol fumarate/ glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to… Read more . . .
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Liquidia Technologies said that the US Patent Trial and Appeal Board (PTAB) has issued decisions on two patents related to Tyvaso treprostinil inhalation solution, which is marketed by United Therapeutics for the treatment of pulmonary arterial hypertension… Read more . . .
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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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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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GlaxoSmithKline and Innoviva have announced that the Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI has been approved by the FDA for the treatment of asthma in adult patients. The approved doses for the… Read more . . .
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Marinomed Biotech said that it has submitted an MAA via the decentralized marketing authorization procedure for a xylometazoline decongestant nasal spray formulated with the company’s Carragelose red algae extract. The company currently markets a range… Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA