August 2012
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The US House of Representatives held a meeting on July 18, 2012 regarding the “Asthma Inhalers Relief Act of 2012,” which is intended “To direct the Administrator of the Environmental Protection Agency to allow for… Read more . . .
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The FDA has approved the Tudorza Pressair aclidinium bromide dry powder inhaler for the treatment of COPD. The DPI will be distributed by Forest Pharmaceuticals, a division of Forest Laboratories, which licensed US rights to… Read more . . .
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Alexza Pharmaceuticals has announced that it has issued 80,429 shares of common stock to Azimuth Opportunity as the two companies have reached an agreement for a committed equity financing facility under which Alexza has the… Read more . . .
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Supermarket chain Asda says that it will become the first retailer in the UK to sell asthma reliever inhalers over the counter when its pharmacies begin offering salbutamol (albuterol) inhalers for sale on July 24.… Read more . . .
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According to Alexza Pharmaceuticals, the company has submitted responses to the Day 120 List of Questions it received from the EMA’s Committee for Medicinal Products for Human Use in March 2012 regarding its marketing application… Read more . . .
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Grifols has announced that its inhaled alpha1-proteinase inhibitor received orphan drug designation from the FDA in April 2012 and that the company will begin a safety study of the drug by the end of the… Read more . . .
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Par Pharmaceutical’s board of directors has voted unanimously in favor of acquisition by private investment firm TPG for $1.9 billion, with Par shareholders getting $50 cash per share of Par common stock. Par and its… Read more . . .
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The Device Working Group of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) is offering a webinar on July 19 from 11:30 a.m. to 12:30 p.m. Eastern Time dealing with human factors assessments… Read more . . .
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The FDA has issued a 483 to Exemplar citing observations regarding problems with MDI filling from its March 21, 2012 inspection of the company’s Massachusetts facility. Exemplar is referring inquiries about the issue to MAP… Read more . . .
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The FDA has granted 510(k) clearance to Asthmapolis’s asthma sensor system and mobile app. The sensor attaches to the top of an MDI canister, records data from an accelerometer and GPS receiver, and transmits the… Read more . . .
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