Regulatory

GSK has announced that the European Commission has granted marketing authorization for its Incruse Ellipta umeclidinium DPI for the treatment of COPD with a dosage of 55 mcg. According to the company’s announcement, launches in… Read more . . .

The European Commission has approved Teva’s DuoResp Spiromax budesonide/formoterol DPI for the treatment of asthma and COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion… Read more . . .

The US FDA has proposed a new rule that would require e-cigarette makers to register with the agency, disclose ingredients used in their inhalation solutions, and provide scientific evidence to support claims of reduced risk… Read more . . .

Australia’s Therapeutic Goods Administration (TGA) has approved the Breo Ellipta fluticasone furoate/vilanterol for the treatment of asthma and COPD, according to GSK Australia and Theravance. GSK Medical Director Andrew Yeates commented, “We are delighted that… Read more . . .

The FDA has granted orphan drug designation to a ciprofloxacin DPI being developed by Bayer HealthCare for the treatment of non-cystic fibrosis bronchiectasis, the company has announced. The dry powder formulation, based on Novartis’s PulmoSphere… Read more . . .

Canada has approved GSK’s Incruse Ellipta umeclidinium (UMEC) DPI for the once-daily treatment of COPD, the first approval for its UMEC monotherapy, the company said. GSK received a positive opinion from the EMA’s Committee for… Read more . . .

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for MannKind’s Afrezza inhaled insulin by three months, according to MannKind. The original date was April 15, 2014; the new date is July… Read more . . .

On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, “If the test product is qualitatively (Q1) and quantitatively (Q2) the same… Read more . . .

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of MannKind’s Afrezza inhaled insulin for both Type 1 and Type 2 diabetes. The vote was 13-1 in agreement that the product… Read more . . .

Meeting documents for the upcoming April 1 meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on MannKind’s Afrezza inhaled insulin include questions about the efficacy of Afrezza compared to subcutaneous insulin and… Read more . . .