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
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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
Proveris expands UK operations, promotes Ivan Prince
OINDP testing specialist Proveris Scientific UK Limited, a wholly owned subsidiary of Proveris Scientific Corporation, is expanding its operations to support increasing business in Asia and Europe. In addition to hiring a new field service engineer specifically for those regions, the company plans to have a new training center at the Chichester headquarters completed … [Read more...] about Proveris expands UK operations, promotes Ivan Prince
FDA approves InnoPharma’s acetylcysteine inhalation solution
The FDA has approved InnoPharma's ANDA for acetylcysteine solution. The New Jersey company has a deal with Fresenius Kabi USA to market acetylcysteine solution in the US, where there has been a shortage of the product. Bedford Laboratories recalled acetylcysteine solution earlier this year and American Regent/Luitpold has experienced recurring manufacturing problems. … [Read more...] about FDA approves InnoPharma’s acetylcysteine inhalation solution
Mucosis appoints Thomas Johnston as CEO
Dutch biotech company Mucosis B.V. has promoted Thomas Johnston, the company's Chief Business Officer since May 2011, as CEO, replacing Govert Schouten. Prior to joining Mucosis, which is developing intranasal vaccines based on its Mimopath platform, Johnston was VP of Strategy at Novavax. Mucosis Chairman of the Board John Lambert said, "Tom has more than 15 years … [Read more...] about Mucosis appoints Thomas Johnston as CEO