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
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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
Combivent Respimat soft mist inhaler now available in US
Boehringer Ingelheim has launched the Combivent Respimat ipratropium bromide/albuterol soft mist inhaler for the treatment of COPD in the United States. The Combivent Respimat includes enough doses for 30 days, compared to the Combivent MDI, which provides only enough medication for 25 days of treatment. The Combivent MDI, which uses a CFC propellant, will be … [Read more...] about Combivent Respimat soft mist inhaler now available in US
Pulmatrix gets funding from Cystic Fibrosis Foundation Therapeutics for development of PUR118
Cystic Fibrosis Foundation Therapeutics (CFFT) will provide up to $1.4 million to Pulmatrix to support Phase 1b trials of Pulmatrix's lead candidate, PUR118, for the treatment of CF. The collaboration between the nonprofit affiliate of the Cystic Fibrosis Foundation and Pulmatrix also includes "introductions to world-class cystic fibrosis academic researchers and … [Read more...] about Pulmatrix gets funding from Cystic Fibrosis Foundation Therapeutics for development of PUR118
Pearl Therapeutics completes Phase 2b study of glycopyrrolate MDI
Pearl Therapeutics says that it has completed a Phase 2b dose-ranging study of its PT001 glycopyrrolate (GP) metered dose inhaler in patients with moderate-to-severe COPD. The randomized, double-blind study included 6 doses from 18 µg to 600 ng twice daily. According to Pearl, it will present data from its dose-ranging studies of PT001 at "appropriate medical … [Read more...] about Pearl Therapeutics completes Phase 2b study of glycopyrrolate MDI
New CEO for Insmed
Arikace developer Insmed Incorporated has appointed Will Lewis, co-founder of Aegerion Pharmaceuticals, to succeed Tim Whitten as President and Chief Executive Officer. According to the company, Whitten has resigned from the board of directors as well, and Lewis will join the board. Donald J. Hayden, Jr., who was appointed Executive Chairman earlier this year, … [Read more...] about New CEO for Insmed
Perrigo files ANDA for albuterol MDI, Teva sues for patent infringement
Teva has filed a lawsuit in the US District Court for the District of Delaware against Perrigo and Catalent after Perrigo filed an ANDA for a generic version of Teva's ProAir HFA albuterol sulfate MDI. The suit alleges infringement of US patents 7,566,445 (Medicinal aerosols and methods of delivery thereof) and 7,105,152 (Suspension aerosol formulations). The '445 … [Read more...] about Perrigo files ANDA for albuterol MDI, Teva sues for patent infringement
Civitas Therapeutics appoints Bryan Stuart as Chief Business Officer
Civitas Therapeutics has appointed Bryan Stuart as Chief Business Officer. Civitas, which was spun off from Alkermes, is developing carrier-free inhaled drugs based on its ARCUS particle engineering platform and inhaler. The company's lead candidate is CVT-301 inhaled L-dopa for the treatment of Parkinson's disease. Civitas CEO Glenn Batchelder said, “We are very … [Read more...] about Civitas Therapeutics appoints Bryan Stuart as Chief Business Officer
FDA committee recommends approval of tobramycin inhalation powder
The Anti-Infective Drugs Advisory Committee (AIDAC) of the FDA voted 13 to 1 in favor of approval of Novartis's tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa-infected cystic fibrosis patients six years old and older. Briefing materials for the meeting had questioned the safety and efficacy of TIP and whether it had any advantages compared to … [Read more...] about FDA committee recommends approval of tobramycin inhalation powder