Regulatory

MannKind, which resubmitted its NDA for Afrezza inhaled insulin earlier this month, has announced that, "The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014." The FDA goal is to "Review and act on 90 percent of Class 2 resubmitted original … [Read more...] about MannKind gets PDUFA date for Afrezza

According to GlaxoSmithKline, the company has submited a new drug application (NDA) to the US FDA for a once-daily fluticasone furoate (FF) dry powder inhaler for the treatment of asthma. The NDA is for 100mcg and 200mcg doses of FF delivered by the Ellipta DPI. The FDA approved GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment … [Read more...] about GSK submits NDA for fluticasone furoate DPI

Boehringer Ingelheim has announced the approval of Striverdi Respimat olodaterol SMI for the treatment of COPD in the United Kingdom, Denmark and Iceland, noting that additional approvals in EU countries "will follow in due course." Boehringer Ingelheim Corporate Senior VP Medicine Klaus Dugi commented, "The improvements in lung function and quality of life seen … [Read more...] about Striverdi Respimat approved in the EU

Discovery Laboratories has submitted an investigational new drug (IND) application for its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants, the company has announced. Assuming the FDA review proceeds without objection, the company says, enrollment in a planned Phase 2 study could be initiated in the 4th … [Read more...] about Discovery Labs submits IND for Aerosurf

According to MannKind Corporation, the company resubmitted its new drug application for Afrezza insulin inhalation powder for the treatment of type 1 and type 2 diabetes to the FDA on October 13, 2013. The resubmitted application includes all data from the product's clinical development program, the company said. Earlier this year, MannKind announced positive results … [Read more...] about MannKind resubmits Afrezza NDA

Teva has announced that the US FDA has approved its tobramycin inhalation solution, a generic equivalent to Novartis's TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. According to Teva, the company will launch the product in November 2013 in accordance with an agreement with Novartis. Teva UK's marketing … [Read more...] about Teva’s generic tobramycin inhalation solution approved by FDA

The European Parliament has voted to regulate e-cigarettes under less stringent rules than drug delivery products, unless the products make medical claims. The Parliament voted to prohibit sales of e-cigarettes to any one under 18 years old, to limit products to 30mg/ml of nicotine, and to require health warnings. Linda McAvan, the member designated as the lead … [Read more...] about European Parliament rejects regulation of e-cigarettes as medicines

According to Eleison Pharmaceuticals, the European Commission has granted Orphan Drug Designation for the company's inhaled lipid-complexed cisplatin (ILC) for the treatment of osteosarcoma. The sustained-release inhalation solution, which Eleison licensed from Insmed in 2011, is currently in a Phase 2 clinical trial. Eleison Chief Medical Officer Forrest Anthony … [Read more...] about Orphan drug designation for inhaled lipid-complexed cisplatin

Just days after its approval in Japan, Novartis has announced that the Ultibro Breezhaler indacaterol/glycopyrronium (QVA149) DPI has been approved in Europe for the treatment of COPD. The approval triggers $10 million milestone payments to Sosei and Vectura. Novartis Pharmaceuticals Division Head David Epstein commented, "We are very pleased that the European … [Read more...] about European approval for Ultibro Breezhaler