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
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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
AstraZeneca says study shows COPD treatment with budesonide/formoterol beats fluticasone/salmeterol
According to AstraZeneca, data from the PATHOS real world study show fewer exacerbations and fewer hospitalizations for COPD patients treated with the Symbicort Turbuhaler than for those treated with Seretide (Advair). The study was published online in the Journal of Internal Medicine. The PATHOS study reviewed the medical records of 5,468 patients in Sweden who were … [Read more...] about AstraZeneca says study shows COPD treatment with budesonide/formoterol beats fluticasone/salmeterol
Acorda Phase 1 data shows diazepam nasal spray has comparable biovailability to rectal gel
Acorda Therapeutics presented data from a Phase 1 study of its diazepam nasal spray at the American Academy of Neurology Annual Meeting this week showing that the plasma bioavailability of a 20 mg dose of diazepam nasal spray was comparable to that of a 20 mg dose of diazepam rectal gel. The company acquired the product, which is being developed for the treatment of … [Read more...] about Acorda Phase 1 data shows diazepam nasal spray has comparable biovailability to rectal gel
Additional funding for Savara’s AeroVanc
Savara Pharmaceuticals has received additional funding for Phase 2 development of its AeroVanc vancomycin inhalation powder for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients. The company brought its Series B financing to a total of $16 million after closing a $7.4 million second tranche and has also received … [Read more...] about Additional funding for Savara’s AeroVanc