Regulatory
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Acorda Therapeutics says that it has completed its acquisition of Neuronex, including Neuronex’s diazepam nasal spray formulation, for $6.8 million. The company also announced that it plans to submit a 505(b)(2) NDA in 2013 for… Read more . . .
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GlaxoSmithKline and Theravance say that they have submitted an NDA to the US FDA for an umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD to be marketed under the name “Anoro… Read more . . .
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding Alexza Pharmaceutical’s marketing application for Adasuve Staccato loxapine for the treatment of agitation in… Read more . . .
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An effort to return remaining units of Primatene Mist epinephrine inhalers to the market failed in the US House of Representatives on December 12, 2012 by a vote of 229-182. Primatene Mist, a CFC-propelled MDI… Read more . . .
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The FDA issued a letter to Alcon dated November 13, 2012 regarding a sales aid that the agency says overstates the efficacy of Alcon’s Patanase olopatadine hydrochloride nasal spray. In the four-page letter, the agency… Read more . . .
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Maryland-based CRO Next Breath, which specializes in OINDP analysis, has announced that an October 15, 2012 GMP inspection by the FDA found the company’s Baltimore facility to be compliant. The inspection resulted in no Form… Read more . . .
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According to Savara Pharmaceuticals, the company’s AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients has been granted orphan drug status by the FDA. Aerovanc inhalation powder, which… Read more . . .
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QVA149 developers Vectura and Sosei have confirmed that Novartis has submitted an application for Japanese approval of the inhaled fixed dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of COPD. Novartis, which… Read more . . .
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Pharmaxis’s Bronchitol mannitol dry powder for inhalation has become the first treatment for cystic fibrosis to receive a positive recommendation from he UK National Institute for Health and Clinical Excellence (NICE), according to the company.… Read more . . .
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Novartis has filed a marketing application with the EMA for its QVA149 indacaterol maleate/glycopyrronium bromide DPI for the treatment of COPD. The filing triggered milestone payments of $5 million each to the drug’s developers, Vectura… 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
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal