The FDA has notified Insmed Incorporated that it will continue a clinical hold on Phase 3 trials of the company's Arikace liposomal amikacin inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company says that it has yet to receive word from the FDA about the hold placed on the Arikace trials in patients with … [Read more...] about Clinical hold on Arikace Phase 3 trials for CF to continue
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FDA approves Combivent Respimat inhaler
The US FDA has approved Boehringer Ingelheim's Combivent Respimat tiotropium/albuterol inhalation spray for the treatment of COPD. The Combivent Respimat soft mist inhaler will replace the Combivent CFC-propelled MDI, which is to be phased out by December 31, 2013. The Combivent Respimat inhaler, which does not use any propellant, will be available by mid-2012. … [Read more...] about FDA approves Combivent Respimat inhaler
Michael Yeadon appointed to Pulmatrix scientific advisory board
Inhaled pharmaceuticals developer Pulmatrix has named former Pfizer VP Michael Yeadon as an advisor to its management team and as the newest member of its scientific advisory board. Yeadon joined Pfizer in 1995 and was most recently that company's Vice President and Chief Scientific Officer of the Allergy and Respiratory Unit. He is currently an industry … [Read more...] about Michael Yeadon appointed to Pulmatrix scientific advisory board
Teva UK launches generic HFA salmeterol MDI
Teva UK has announced the launch of a generic CFC-free salmeterol metered dose inhaler in the UK; the product is a suspension pMDI that delivers 25 mcg per actuation. The UK granted marketing authorization for the Neovent/Sereflo inhaler for the treatment of asthma and COPD to Neolab Limited in April 2011. Kim Innes, Teva UK Commercial Director, commented, "We are … [Read more...] about Teva UK launches generic HFA salmeterol MDI
Alexza teams with Grupo Ferrer on Staccato loxapine inhaler
Alexza Pharmaceuticals and Spanish pharmaceutical company Grupo Ferrer International have formed a partnership to register, distribute, and promote the Adasuve Staccato loxapine inhaler for the treatment of agitation in patients with schizophrenia or bipolar disorder in Europe, Commonwealth of Independent States countries, and Latin America. The deal includes a $10 … [Read more...] about Alexza teams with Grupo Ferrer on Staccato loxapine inhaler
Lightlake announces Phase 2 trial of nasal spray for bulimia nervosa
King's College London will be the site of Phase 2 trials of Lightlake Therapeutics's opioid antagonist-based nasal spray treatment for bulimia nervosa, the company has announced. Lightlake currently has Phase 2 trials underway in Finland to demonstrate the effectiveness of its naloxone nasal spray for the treatment of binge eating disorder in overweight and obese … [Read more...] about Lightlake announces Phase 2 trial of nasal spray for bulimia nervosa
BASF and Ineos join forces in Styrolution
Inhaler manufacturers who have been purchasing acrylonitrile butadiene styrene (ABS) for inhaler housings from either BASF or Ineos will now have a new supplier: Styrolution. Ineos's Lustran, Novodur, and Absolac brands and BASF's Terluran brand will be sold by the new company, a 50/50 joint venture of BASF and Ineos, which is headquartered in Frankfurt/Main, Germany, … [Read more...] about BASF and Ineos join forces in Styrolution
Mymetics reclaims intranasal flu vaccine that had been licensed to Solvay
Swiss vaccine developer Mymetics Corporation has reclaimed an intranasal influenza vaccine that it had licensed to Solvay prior to Solvay's acquisition by Abbott Laboratories. Solvay had conducted a Phase 1 trial that found the vaccine to be well tolerated and safe and had made a milestone payment to Mymetics before stopping work on the project. Mymetics CFO Ronald … [Read more...] about Mymetics reclaims intranasal flu vaccine that had been licensed to Solvay
Quebec is first Canadian province to offer formulary access to TOBI Podhaler
Novartis Pharmaceuticals Canada has announced that the Québec provincial government will now provide reimbursement for the TOBI Podhaler tobramycin DPI for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients.The company cites data from Cystic Fibrosis Canada that show about 1,200 cystic fibrosis patients residing in Québec. TOBI Podhaler … [Read more...] about Quebec is first Canadian province to offer formulary access to TOBI Podhaler
Second nasal delivery device contract for Bespak
Only about a month after entering the nasal delivery device market, Bespak has announced a second contract for development of an intranasal device. The company says that "a major global manufacturer of generic medicines" has awarded Bespak a contract for both development of its Unidose nasal drug delivery device for an undisclosed application and for manufacturing and … [Read more...] about Second nasal delivery device contract for Bespak