Regulatory
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of of GSK and Theravance’s Breo Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of COPD. The PADAC meeting had been rescheduled from… Read more . . .
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Allergan, which recently acquired MAP Pharmaceuticals, has announced that it has received a Complete Response Letter (CRL) from the FDA in regard to its NDA for Levadex inhaled dihydroergotamine for the treatment of migraines. The… Read more . . .
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According to Discovery Laboratories its Aerosurf aerosolized surfactant development program “currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013” and is unaffected by the FDA’s recent questions about… Read more . . .
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The FDA draft guidance on albuterol sulfate MDIs published April 8, 2013 includes recommendations for a total of 7 studies, including 5 in vitro studies, 1 PK study, and 1 PD study to establish bioequivalence.… Read more . . .
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According to Insmed Incorporated, the US FDA has granted orphan drug designation to its Arikace liposomal amikacin for inhalation for the treatment of non-tuberculous mycobacteria (NTM) infections. Insmed is also developing Arikace for the treatment… Read more . . .
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The UK’s National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending Novartis’s Tobi Podhaler tobramycin DPI and Forest Lab’s Colobreathe colistimethate sodium DPI for the treatment of P. aeruginosa lung… Read more . . .
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According to the EMA, its Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion regarding the Labazenit budesonide/salmeterol dry powder inhaler. Belgian pharmaceutical company Laboratoires SMB applied to market the product, which… Read more . . .
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The FDA has approved Novartis’s TOBI Podhaler tobramycin inhalation powder for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. The agency’s Anti-Infective Drugs Advisory Committee (AIDAC) voted in favor of approval of… Read more . . .
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The Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting regarding Breo Ellipta originally scheduled for March 7, 2013 has been rescheduled for April 17, 2013, from 8 am to 5 pm. The meeting was rescheduled due to… Read more . . .
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According to Pharmaxis, the FDA has issued a complete response letter regarding its Bronchitol inhaled mannitol for the treatment of cystic fibrosis. The company says that the FDA requested another clinical trial. The Pharmaxis press… Read more . . .
Upcoming Events
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September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
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
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden