MicroDose Therapeutx has completed the Phase 1 clinical program for its inhaled antiviral fusion inhibitor MDT-637 for the treatment of respiratory syncytial virus infection and plans to present data from the three studies at the upcoming International Respiratory Syncytial Virus Symposium. The company announced completion of the first two studies in April 2012. … [Read more...] about Microdose announces completion of Phase 1 studies for inhaled RSV treatment
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Seebri inhalation capsules approved in Japan
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
British Pharmacopoeia publishes policy document on inhaled products
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
GSK submits Japanese NDA for FF/VI DPI, gets PDUFA goal date in US
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
Hovione offering expanded particle design services
Hovione has announced the addition of services for crystal design, particle size reduction to the micro or nano-scale, and amorphous solid dispersions. The company, which provides particle engineering, formulation development, and clinical manufacture to Phase 2 for dry powder inhalers and has its own proprietary DPIs, will by providing more details on the new … [Read more...] about Hovione offering expanded particle design services
Aegis gets patent for triptan nasal sprays
The US Patent and Trade Office has awarded Aegis Therapeutics US Patent No. 8,268,791 for "Alkylglycoside compositions for drug administration." The company is highlighting the patent's coverage of fast-acting intranasal triptan formulations for the treatment of migraine headaches that use Aegis's Intravail transmucosal absorption enhancers. Aegis says that this is … [Read more...] about Aegis gets patent for triptan nasal sprays
Lightlake appoints former FDA commissioner as advisor
Lightlake Therapeutics, which is developing naloxone nasal sprays for several eating disorders, has announced the appointment of former FDA Commissioner David Kessler as a strategic advisor. Kessler is the author of The End of Overeating: Taking Control of the Insatiable American Appetite. Lightlake CEO Roger Crystal commented, "We are very pleased to add Dr. … [Read more...] about Lightlake appoints former FDA commissioner as advisor
FDA approves Acton’s Aerospan flunisolide MDI
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
Ablynx completes Phase 1 study of inhaled nanobody for RSV
Belgian biopharmaceutical company Ablynx has announced positive results from a Phase 1 of its ALX-0171 inhaled Nanobody for the treatment of respiratory syncytial virus (RSV) infections. According to the company, the study demonstrated the safety and tolerability of ALX-0171 delivered by nebulizer. The double-blind, randomized trial tested six dose levels ranging … [Read more...] about Ablynx completes Phase 1 study of inhaled nanobody for RSV
Melbourn Scientific adds dedicated GMP nasal spray laboratory
In order to meet rising demand for its GMP nasal spray testing services, Melbourn Scientific has dedicated a laboratory to analysis of droplet size, particle characterization, spray pattern, plume geometry, and device performance testing. The company has also appointed Liz Parkhouse as business development executive for the nasal spray testing service. According … [Read more...] about Melbourn Scientific adds dedicated GMP nasal spray laboratory