According to Pharmaxis, the company has obtained up to $40 million from NovaQuest Pharma Opportunities Fund III for development, manufacturing, and commercialization of Bronchitol mannitol inhalation powder in the US and EU. At the same time, the company announced that Bronchitol had received a negative recommendation for the treatment of cystic fibrosis patients from … [Read more...] about Pharmaxis gets financing for Bronchitol commercialization, negative recommendation from PADAC
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FDA issues warning to company for unapproved inhaler
The FDA and the US Federal Trade Commission (FTC) have issued a warning to a Florida company called Flu and Cold Defense LLC regarding its claims for an over-the-counter nasal vapor inhalation product called GermBullet. The warning cites claims such as, "[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and … [Read more...] about FDA issues warning to company for unapproved inhaler
Bend Research gets EU GMP certificate
The Swedish Medical Products Agency (MPA) has granted Bend Research a certificate of compliance with European Union good manufacturing practice (GMP) regulations for the company's manufacture and testing of clinical pharmaceutical supplies. All European health authorities recognize the MPA GMP certificate, as do agencies in some additional countries. Bend CEO Rod … [Read more...] about Bend Research gets EU GMP certificate
FDA advisory committee recommends approval of Striverdi Respimat
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
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