According to Insmed Incorporated, the US FDA has granted orphan drug designation to its Arikace liposomal amikacin for inhalation for the treatment of non-tuberculous mycobacteria (NTM) infections. Insmed is also developing Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company also has announced the appointment of Matthew Pauls … [Read more...] about Insmed gets orphan drug designation for Arikace, appoints new chief commercial officer
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Nypro to build plant in Ireland
Device design and manufacturing company Nypro plans to build a device manufacturing facility in Waterford, Ireland and, according to the company, will hire 200 workers to staff the new plant. Nypro's capabilities include injection molding and assembly of plastic components for metered dose inhalers (MDIs) and dry powder inhalers (DPIs). The facility will manufacture … [Read more...] about Nypro to build plant in Ireland
Actavis plans to launch generic version of Pulmicort Respules after favorable court ruling
Actavis says that it will launch 0.25 mg and 0.5 mg vials of its generic budesonide inhalation suspension immediately after the United States District Court for the District of New Jersey ruled that the products do not infringe AstraZeneca's patents on Pulmicort Respules. Actavis (then Watson) received FDA approval for its ANDA for the 0.25 and 0.5 mg strengths of the … [Read more...] about Actavis plans to launch generic version of Pulmicort Respules after favorable court ruling
NICE issues final guidance on Tobi Podhaler and Colobreathe for some CF patients
The UK's National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending Novartis's Tobi Podhaler tobramycin DPI and Forest Lab's Colobreathe colistimethate sodium DPI for the treatment of P. aeruginosa lung infections in cystic fibrosis patients when patients are unable to use other treatments. In January 2013, NICE issued a final … [Read more...] about NICE issues final guidance on Tobi Podhaler and Colobreathe for some CF patients
Micron Technologies acquired by private equity firm
Pharmaceutical micronization specialist Micron Technologies has been acquired by private equity firm Arlington Capital Partners. Micron, which is based in Malvern, PA and has a facility in Dartford, UK, provides micronization services for both development and commercial production of drugs, including inhaled drugs, as well as analytical services. Arlington Capital … [Read more...] about Micron Technologies acquired by private equity firm
CHMP adopts negative opinion on Labazenit
According to the EMA, its Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion regarding the Labazenit budesonide/salmeterol dry powder inhaler. Belgian pharmaceutical company Laboratoires SMB applied to market the product, which is delivered using its Axahaler DPI device, for the treatment of asthma in adults. The CHMP expressed … [Read more...] about CHMP adopts negative opinion on Labazenit
FDA approves TOBI Podhaler
The FDA has approved Novartis's TOBI Podhaler tobramycin inhalation powder for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. The agency's Anti-Infective Drugs Advisory Committee (AIDAC) voted in favor of approval of the dry powder inhaler in September 2012. According to Novartis, the product will be available in the second quarter of … [Read more...] about FDA approves TOBI Podhaler
PADAC meeting on Breo Ellipta rescheduled
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting regarding Breo Ellipta originally scheduled for March 7, 2013 has been rescheduled for April 17, 2013, from 8 am to 5 pm. The meeting was rescheduled due to weather concerns. The purpose of the meeting is to discuss GSK's new drug application for its fluticasone furoate/vilanterol dry powder inhaler. … [Read more...] about PADAC meeting on Breo Ellipta rescheduled
New inhalation testing and consulting company launched in Australia
Inhalation experts from the Woolcock Institute of Medical Research and the University of Sydney have launched a new company called Pulmatix to provide analytical services ranging from evaluation of APIs and formulations in respiratory cells to formulation and device design optimization. Directors of the new company are Paul M. Young, Daniela Traini, Judy Black, and … [Read more...] about New inhalation testing and consulting company launched in Australia
Melbourn awarded Manufacturer’s/Importer’s Authorization
According to Melbourn Scientific the company has recently been awarded a Manufacturer's/Importer’s Authorization (MIA), which allows it to act as a testing and release site for the EU. Melbourn is among the largest suppliers of OINDP-focused contract research in Europe and offers services from formulation development through clinical trials manufacturing. Melbourn … [Read more...] about Melbourn awarded Manufacturer’s/Importer’s Authorization