Regulatory
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Pharmaxis has announced that it “filed a minor resubmission with the Pharmaceutical Benefits Advisory Committee (PBAC)” for its Bronchitol mannitol dry powder inhaler for the treatment of cystic fibrosis. According to the company, the committee’s… Read more . . .
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In an article in the December 15 issue of the New England Journal of Medicine, regulators from the FDA’s Center for Drug Evaluation and Research (CDER), with Badhul Chowdhury, director of Division of Pulmonary, Allergy,… Read more . . .
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After meeting to discuss concerns about the safety of Alexza Pharmaceutical’s Adasuve Staccato loxapine, the FDA’s Psychopharmacologic Drugs Advisory Committee voted 9 to 8, with 1 abstention, to recommend approval for a single dose in… Read more . . .
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The US FDA has announced a December 12 meeting of the Psychopharmacologic Drugs Advisory Committee to discuss safety concerns related to Alexza’s Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or… Read more . . .
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Shortly after announcing a co-promotion deal with Eisai for its inhaled COPD drugs in Japan, Novartis has filed a new drug application in that country for one of those drugs, NVA237 inhaled glycopyrronium bromide, according… Read more . . .
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Within the last week, Discovery Laboratories has announced that its aerosolized KL4 surfactant has received orphan drug designation from the EU for the treatment of cystic fibrosis, and it has presented data on a new… Read more . . .
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US Senator Jim DeMint, a Republican from South Carolina, failed to persuade the US Senate to prohibit the use of tax dollars for enforcement of the FDA ban on the CFC-propelled OTC epinephrine inhaler Primatene… Read more . . .
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Swedish pharmaceutical company Meda has submitted a marketing authorization application for Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of moderate-to-severe allergic rhinitis and rhinoconjuctivitisto the EMA. An NDA for Dymista was submitted to… Read more . . .
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Alexza Pharmaceuticals has submitted a marketing authorization application to the European Medicines Agency (EMA) for its Adasuve Staccato loxapine for adult patients with schizophrenia or with bipolar disorder. Grupo Ferrer will market Adasuve in Europe… Read more . . .
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In its third quarter results for 2011, Novartis announced that, “In the US, NVA237 will require additional clinical data to support submission and thus will be delayed.” Furthermore, the company warned, “The changes to the… 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