At its January 29, 2013 meeting, the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of the 5 µg dose of Boehringer Ingelheim's Striverdi Respima olodaterol soft mist inhaler for the maintenance treatment of COPD. BI VP of Clinical Development and Medical Affairs, Respiratory Tunde Otulana said, “We at Boehringer Ingelheim are pleased … [Read more...] about FDA advisory committee recommends approval of Striverdi Respimat
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NICE recommends TOBI Podhaler and Colobreathe for CF patients
The UK's National Institute for Health and Clinical Excellence (NICE) has issued a qualified recommendation for Forest Lab's Colobreath colistimethate sodium and Novartis's TOBI Podhaler tobramycin dry powders for inhalation as options for the treatment of P. aeruginosa lung infections in patients with cystic fibrosis. The recommendation is a final draft; the final … [Read more...] about NICE recommends TOBI Podhaler and Colobreathe for CF patients
FDA issues final cGMP rule for combination products
On January 22, 2013, the FDA published its final cGMP rule for combination products in the Federal Register. According to the rule's summary, "This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a … [Read more...] about FDA issues final cGMP rule for combination products
Meda’s Dymista gets European approval
According to Meda, the EU has approved the company's Dymista azelastine/fluticasone nasal spray for the treatment of seasonal and perennial allergic rhinitis. Meda submitted an MAA for the product in late 2011. The company announced the FDA's approval of Dymista in May 2012. The European approval was made through the decentralized procedure, and Meda says that it … [Read more...] about Meda’s Dymista gets European approval
Allergan to acquire MAP Pharmaceuticals
Allergan will acquire Levadex inhaled dihydroergotamine developer MAP Pharmaceuticals for $25 per share. The two companies entered into an agreement to co-promote Levadex in January 2011, and MAP submitted an NDA for the product later that year. The FDA issued a complete response letter for Levadex in March 2012, and MAP resubmitted the NDA in October of that year. … [Read more...] about Allergan to acquire MAP Pharmaceuticals
Freeman Technology appoints distributor in Canada
Powder characterization specialist Freeman Technology has named ATS Scientific Inc. as the Canadian distributor of the company's FT4 Powder Rheometer. The powder rheometer generates data that can be used for optimization of aerosolization in dry powder inhalation formulations. Freeman Technology Managing Director Tim Freeman commented, “I am delighted to be … [Read more...] about Freeman Technology appoints distributor in Canada
Pearl Therapeutics hires Michael Riebe
Pearl Therapeutics, which is developing several inhaled drugs, has announced that it has hired Michael Riebe as VP, Pharmaceutical Development and Research, effective immediately. Riebe, a past chair and current steering committee member of the AAPS Inhalation and Nasal Technology Focus Group, was most recently VP of Research and Development at iCeutica and previously … [Read more...] about Pearl Therapeutics hires Michael Riebe
Unigene says that it welcomes FDA meeting on calcitonin salmon nasal spray
Unigene Laboratories has issued a statement in response to an FDA announcement of an upcoming advisory committee meeting scheduled for March 5, 2013 to discuss whether the benefits of calcitonin salmon outweigh the risk. The company manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis. Unigene CEO Ashleigh Palmer commented, “We are … [Read more...] about Unigene says that it welcomes FDA meeting on calcitonin salmon nasal spray
FDA committee schedules meetings to discuss inhalation NDAs
The FDA's Pulmonary-Allergy Drugs Advisory Committee has scheduled discussion of a number of new drug applications for inhalation products in the next few months. The meetings are open to the public and will be available as live webcasts. The committee will meet on January 29, 2013 to discuss the new drug application (NDA) for Boehringer Ingelheim's olodaterol MDI … [Read more...] about FDA committee schedules meetings to discuss inhalation NDAs
Fast food consumption linked to severity of asthma, rhinitis in children
An article posted online in Thorax on January 14, 2013 finds that children and teens who eat three or more servings of fast food per week have a significantly increased risk of severe asthma. The same fast food intake was also associated with increased risk of eczema and rhinitis, while fruit consumption was found to have an inverse association with severe asthma and … [Read more...] about Fast food consumption linked to severity of asthma, rhinitis in children