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 next scheduled meeting is in March 2012, at which time it will consider the submission. Bronchitol received marketing … [Read more...] about Pharmaxis files resubmission for Bronchitol to PBAC
Regulatory
The FDA explains its decision on indacaterol
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, and Rheumatology Products, as lead author, detail the decision making process that led to approval of a single 75 μg dose of Novartis's Arcapta … [Read more...] about The FDA explains its decision on indacaterol
FDA committee recommends approval of Adasuve inhaled loxapine
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 24 hours when used with the FDA-recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in … [Read more...] about FDA committee recommends approval of Adasuve inhaled loxapine
FDA committee to discuss safety of Adasuve loxapine inhalation powder
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 bipolar disorder. Alexza resubmitted an NDA for the product in August 2011. The company first submitted the NDA in December … [Read more...] about FDA committee to discuss safety of Adasuve loxapine inhalation powder
Novartis files NDA in Japan for NVA237
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 to Vectura, which licensed the drug to Novartis. Vectura CEO Chris Blackwell remarked, “The Japanese market is a large and growing market with … [Read more...] about Novartis files NDA in Japan for NVA237
Discovery Labs announces progress on inhaled therapies
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 product, Afectair, which it calls "a series of proprietary ventilator circuit/patient interface connectors and related componentry" that "simplifies the … [Read more...] about Discovery Labs announces progress on inhaled therapies
US Senate votes down bill that would have banned enforcement of the CFC inhaler phaseout
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 Mist. The Senate voted 54-44 against DeMint's bill. DeMint expressed outrage at the outcome of the vote: “Fifty-four Senators voted to appease extreme … [Read more...] about US Senate votes down bill that would have banned enforcement of the CFC inhaler phaseout
MAA for Meda’s Dymista nasal spray filed
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 the FDA in April 2011. Meda CEO Anders Lönner said, "The regulatory filing for … [Read more...] about MAA for Meda’s Dymista nasal spray filed
Alexza submits MAA for Adasuve inhaled loxapine
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 if the EMA approves the application. In the US, the company resubmitted an NDA for the product in August 2011 after … [Read more...] about Alexza submits MAA for Adasuve inhaled loxapine
Novartis warns of delays in US approval process for NVA237 and QVA149
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 US NVA237 program will similarly impact approval timing for QVA149 in the US where additional clinical studies will be required. The QVA149 … [Read more...] about Novartis warns of delays in US approval process for NVA237 and QVA149