The FDA has approved a generic equivalent to Meda's Astepro, an azelastine nasal spray, 0.1876MG, manufactured by Apotex. Meda filed a patent infringement suit in January 2012 after Apotex submitted its ANDA. The two companies settled after a similar suit regarding Apotex's generic version of Astelin in 2008. View the FDA approval history. … [Read more...] about FDA approves Apotex azelastine nasal spray
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Tiotropium plus olodaterol improve lung function in Phase 2 study
According to Boehringer Ingelheim, a combination of tiotropium and olodaterol delivered using the Respimat soft mist inhaler significantly improved 24-hour FEV1 in COPD patients compared to olodaterol monotherapy at all doses tested. The 4-week double-blind study with 232 COPD patients testing doses of tiotropium of 1.25, 2.5, and 5 μg with either 5 μg or 10 μg of … [Read more...] about Tiotropium plus olodaterol improve lung function in Phase 2 study
Aradigm gets new method of treatment patent for nicotine inhaler
The United States Patent and Trademark Office has issued a method of treatment patent to Aradigm for its inhaled nicotine formulations. US Patent No. 8,256,433, for Systems and Methods for Effecting Cessation of Tobacco Use, provide exclusivity for the systems until January 7, 2024. Aradigm President and CEO Igor Gonda commented, “Tobacco smoking remains an … [Read more...] about Aradigm gets new method of treatment patent for nicotine inhaler
Rigel initiates Phase 2 study of inhaled SYK inhibitor for asthma
Rigel Pharmaceuticals says that it has begun a Phase 2 clinical study of its R343 nhaled SYK inhibitor that is being evaluated as a potential treatment for allergic asthma. The 8-week study, called SITAR (SYK Inhibition for Treatment of Asthma with R343), will compare two doses R343 and placebo in approximately 270 adult asthma patients and is expected to be completed … [Read more...] about Rigel initiates Phase 2 study of inhaled SYK inhibitor for asthma
Almirall opens Canadian affiliate, presents positive Phase 3 results for Eklira Genuair
Almirall has opened a new affiliate in Toronto, Canada. Having a presence in Canada will help the company roll out its recently approved aclidinium DPI for COPD, among other drugs, Almirall says. The company will co-market aclidinium as Tudorza Pressair with Forest Laboratories. In Europe, aclidinium bromide inhalers are being marketed as the Eklira Genuair and … [Read more...] about Almirall opens Canadian affiliate, presents positive Phase 3 results for Eklira Genuair
Study finds that inhaled budesonide for children reduces adult height
A study by the Childhood Asthma Management Program (CAMP) Research Group published online in the New England Journal of Medicine on September 3 finds that children who received 400 μg of inhaled budesonide daily for 4-6 years had a mean adult height 1.2 cm less than children who received placebo. The researchers obtained height measurements from 943 participants out … [Read more...] about Study finds that inhaled budesonide for children reduces adult height
Australian court issues injunction against Apotex in Nasonex case
The Federal Court of Australia has granted an injunction against Apotex, banning it from selling generic mometasone furoate nasal sprays in the country pending the outcome of a patent infringement lawsuit by Merck Sharpe & Dohme Australia. Apotex, which claims that MSD's patent is invalid, had already begun marketing the nasal sprays and intended to begin shipping … [Read more...] about Australian court issues injunction against Apotex in Nasonex case
Pulmatrix appoints Robert Clarke as CEO
Pulmatrix has announced that Robert Clarke will succeed Robert Connelly as the company's Chief Executive Officer. Clarke has been with the company, which is developing inhaled drugs based on its proprietary iSPERSE (inhaled small particles easily respirable and emitted) platform, since 2004 as VP of Research & Development and as Chief Scientific Officer. Clarke … [Read more...] about Pulmatrix appoints Robert Clarke as CEO
FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
The FDA briefing materials for the September 5, 2012 meeting of the Anti-Infective Drugs Advisory Committee, which will consider the use of Novartis's Tobi tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa infections in cystic fibrosis patients, question both the efficacy and safety of the product, especially when compared to TOBI tobramycin … [Read more...] about FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
Elevation to be acquired by Sunovion
Elevation Pharmaceuticals, which is developing several inhalation products, has agreed to be acquired by Sunovion. Both boards have approved the deal. The agreement includes an upfront payment of $100 million and milestone payments for development of Elevation's EP-101 glycopyrrolate inhalation solution that could total as much as $90 million. EP-101 is currently … [Read more...] about Elevation to be acquired by Sunovion