Regulatory

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

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

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 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

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 of cystic fibrosis in adults as an add‐on therapy to best standard of care,” says Pharmaxis. Patients with CF who … [Read more...] about CHMP adopts positive recommendation on Bronchitol MAA

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 during the designated time period. Mundipharma, which has licensed European rights to Flutiform, filed the MAA … [Read more...] about Concerned Member States fail to reach consensus on Flutiform MAA

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 requested additional data on Arikace before continuing a Phase 3 trial in patients with non-tuberculous mycobacterial (NTM) lung disease. The FDA initially … [Read more...] about FDA requires more data on Arikace inhaled amikacin for NTM lung disease

The FDA has notified Insmed Incorporated that it will continue a clinical hold on Phase 3 trials of the company's Arikace liposomal amikacin inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company says that it has yet to receive word from the FDA about the hold placed on the Arikace trials in patients with … [Read more...] about Clinical hold on Arikace Phase 3 trials for CF to continue