Regulatory

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 . . .

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 . . .

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 . . .

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… Read more . . .

The US FDA has approved Boehringer Ingelheim’s Combivent Respimat tiotropium/albuterol inhalation spray for the treatment of COPD. The Combivent Respimat soft mist inhaler will replace the Combivent CFC-propelled MDI, which is to be phased out… Read more . . .

According to the British Pharmacopoeia website: “The British Pharmacopoeia Commission has recently endorsed the formation of a new Working Party for Inhaled Products (IP). The remit of the Working Party will be to review the… Read more . . .

After the FDA’s acceptance of Alexza Pharmaceuticals’s resubmitted NDA for Adasuve, the company has announced that the Prescription Drug User Fee Act (PDUFA) goal date will be February 4, 2012. Alexza had received a complete… Read more . . .