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
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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
Hovione appoints new General Manager of its Technology Transfer Center
Hovione has named Mike Ironside as General Manager of its Technology Transfer Center (TTC), which is located in New Jersey. Ironside was most recently with Anacor Pharmaceuticals and has previously worked for GSK and AMRI. Hovione VP of Corporate R&D Thomas Eisele said, "This is a key appointment at an important time for Hovione. We are certain that Dr. Ironside's … [Read more...] about Hovione appoints new General Manager of its Technology Transfer Center
Positive Phase 3 results for QVA 149, filings expected by the end of the year
According to Novartis, the latest Phase 3 study of the QVA149 indacaterol/glycopyrronium DPI demonstrated a significant reduction in exacerbations of moderate-to-severe COPD compared to the Seebri Breezhaler glycopyrronium bromide DPI alone. The company says that it plans to submit regulatory filings in Europe and Japan by the end of 2012 and in the US at the end of … [Read more...] about Positive Phase 3 results for QVA 149, filings expected by the end of the year
Liquidia hires Benjamin Yerxa as Chief Scientific Officer
Particle manufacturing specialist Liquidia Technologies has named Benjamin Yerxa, most recently at Clearside Biomedical, as its new Chief Scientific Officer. Yerxa will oversee R&D, "including a focus on scientific collaborations," for the company. Liquidia's PRINT nanofabrication technology can produce particles of specified sizes and shapes for inhalation powders … [Read more...] about Liquidia hires Benjamin Yerxa as Chief Scientific Officer