Regulatory

According to Savara Pharmaceuticals, the company's AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients has been granted orphan drug status by the FDA. Aerovanc inhalation powder, which is delivered using a capsule-based DPI, has completed Phase 1 trials, and Savara says that it is … [Read more...] about Savara’s AeroVanc gets orphan drug designation in US

QVA149 developers Vectura and Sosei have confirmed that Novartis has submitted an application for Japanese approval of the inhaled fixed dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of COPD. Novartis, which licensed the DPI from the two companies, also recently submitted an application for the product in Europe. Japan … [Read more...] about Novartis files application for QVA149 in Japan

Pharmaxis's Bronchitol mannitol dry powder for inhalation has become the first treatment for cystic fibrosis to receive a positive recommendation from he UK National Institute for Health and Clinical Excellence (NICE), according to the company. The recommendation allows for reimbursement by the National Health Service. Pharmaxis CEO Alan Robertson commented, … [Read more...] about NICE approves Bronchitol inhalation powder for CF

Novartis has filed a marketing application with the EMA for its QVA149 indacaterol maleate/glycopyrronium bromide DPI for the treatment of COPD. The filing triggered milestone payments of $5 million each to the drug's developers, Vectura and Sosei. Vectura Chief Executive Chris Blackwell, “The IGNITE program is among the largest COPD clinical trial programs … [Read more...] about Novartis files MAA for QVA149

MAP Pharmaceuticals has resubmitted its New Drug Application (NDA) for Levadex inhaled dihydroergotamine for the treatment of migraine to the FDA, the company has announced. The FDA issued a complete response letter to MAP in March, 2012 and a form 483 to its contract manufacturer. MAP President and CEO Timothy S. Nelson said, "We have worked diligently on our … [Read more...] about MAP resubmits Levadex NDA

As expected, the European Commission has approved Novartis's Seebri Breezhaler glycopyrronium bromide DPI for the treatment of COPD. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for glycopyrronium in June 2012. The announcement comes just days after the announcement of the approval of Seebri … [Read more...] about EC approves Seebri Breezhaler

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Novartis's Seebri glycopyrronium bromide inhalation capsules, delivered by the Breezhaler DPI, for the treatment of COPD. The product should be available in Japan by the end of 2012. The glycopyrronium inhalation formulation was co-developed by Sosei and Vectura, which licensed it to Novartis … [Read more...] about Seebri inhalation capsules approved in Japan

The British Pharmacopoeia (BP) Inhaled Products Working Party has published its recommendations for BP monographs for inhalation as of September 17, 2012. According to the document, "Safety and efficacy are critical considerations; the Working Party has taken the view that the inhalation monographs would ensure products that are safe and efficacious by maintaining … [Read more...] about British Pharmacopoeia publishes policy document on inhaled products

GlaxoSmithKline says that it submitted a Japanese New Drug Application (JNDA) for its fluticasone furoate (FF)/vilanterol(VI) dry powder inhaler for the treatment of COPD and asthma on September 25, 2012. The FF/VI combination will be delivered by a DPI known as the Ellipta. GSK and Theravance also announced the acceptance of the FF/VI NDA in the US and said that … [Read more...] about GSK submits Japanese NDA for FF/VI DPI, gets PDUFA goal date in US

Acton Pharmaceuticals has announced plans to launch its Aerospan flunisolide HFA metered dose inhaler in early 2013 after having received FDA approval for the MDI. The product is approved for for the maintenance treatment of asthma in patients 6 years old and older, and the Aerospan device includes a built-in spacer. Acton acquired the Aerospan NDA from Forest … [Read more...] about FDA approves Acton’s Aerospan flunisolide MDI