According to the FDA, American Regent/Luitpold has now released several batches of acetylcysteine inhalation solution, including 10 ml vials of both 100 mg/ml and 200 mg/ml solutions and 30 ml vials of the 200 mg/ml solution. The company's facility in Shirley, NY was closed in April 2011 due to safety concerns. Two other manufacturers, Roxanne Laboratories and … [Read more...] about Some acetylcysteine inhalation solution now available
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Fentanyl nasal spray now available in the US
Archimedes Pharma has officially launched its Lazanda fentanyl nasal spray for the treatment of breakthrough pain in adult cancer patients in the United States. Lazanda, the first fentanyl nasal spray available in the US, was approved by the FDA at the end of June 2011. In Europe, where the product is marketed as PecFent, the spray is available in a handful of … [Read more...] about Fentanyl nasal spray now available in the US
FDA requires more data on Arikace inhaled amikacin for NTM lung disease
Days after Insmed announced that the FDA was continuing its hold on Phase 3 clinical trials of Arikace inhaled liposomal amikacin for the treatment of cystic fibrosis, the company says that the FDA has also requested additional data on Arikace before continuing a Phase 3 trial in patients with non-tuberculous mycobacterial (NTM) lung disease. The FDA initially … [Read more...] about FDA requires more data on Arikace inhaled amikacin for NTM lung disease
Azelon gets financing for osteoporosis nasal spray, adds to management team
Prospect Venture Partners, Lighthouse Capital Partners, and Covington Venture Fund will provide a total of $4.5 million in Series A financing to Azelon Pharmaceuticals, formerly Zelos Therapeutics, for continued clinical development of Azelon’s ZT-034 teriparatide nasal spray for the treatment of osteoporosis. Teriparatide is a parathyroid hormone analog and is … [Read more...] about Azelon gets financing for osteoporosis nasal spray, adds to management team
Acton publishes positive Phase 3b data for flunisolide inhaler
Acton Pharmaceuticals has published positive results from a Phase 3b clinical trial of its Aerospan flunisolide HFA metered dose inhaler in the October issue of Annals of Allergy, Asthma & Immunology. The article, titled, "Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled hydrofluoroalkane in prepubescent children with mild persistent … [Read more...] about Acton publishes positive Phase 3b data for flunisolide inhaler
Trimel concludes Phase 2 study of intranasal gel for female sexual dysfunction
Trimel Pharmaceuticals plans to present data from a recently completed Phase 2 "vibro-tactile stimulation (VTS) study" of its TBS-2 intranasal gel for the treatment of anorgasmia in women to the FDA at a meeting scheduled for November 2011. According to Trimel, in August 2011, it notified the CRO conducting the study that "patient enrolment would be considered … [Read more...] about Trimel concludes Phase 2 study of intranasal gel for female sexual dysfunction
Clinical hold on Arikace Phase 3 trials for CF to continue
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
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