August 2012
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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… Read more . . .
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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… Read more . . .
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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,… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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 &… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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