Regulatory
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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 . . .
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) Pharmaxis has adopted a positive opinion recommending the approval of a marketing authorization for Bronchitol inhaled dry powder mannitol formulation “for the treatment… Read more . . .
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SkyePharma has announced a delay in the review of the European Marketing Authorisation Application (“MAA”) for the Flutiform fluticasone propionate/formoterol fumarate metered dose inhaler (MDI) because the 21 Concerned Member States failed to reach consensus… Read more . . .
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Days after Insmed announced that the FDA was continuing its hold on Phase 3 clinical trials of Arikace inhaled liposomal amikacin for the treatment of cystic fibrosis, the company says that the FDA has also… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
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