Calls for papers
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The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD, GlaxoSmithKline and Theravance have announced. In April 2013, the companies announced that they had… Read more . . .
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Theravance appoints Theodore J. Witek Senior VP Corporate Partnerships, Clinical and Medical Affairs
Theravance has announced the appointment of Theodore J. Witek, Jr. as Senior VP Corporate Partnerships, Clinical and Medical Affairs. In that capacity, the company says Witek “will be focused on the further development of the… Read more . . .
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Boehringer Ingelheim has announced that it has applied for approval to market its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD in the EU. Both of the individual drugs in the new combination… Read more . . .
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Otsuka has announced the launch of its new Meptin Swinghaler procaterol hydrochloride DPI for the treatment of asthma and COPD in Japan as of July 2, 2014. The Meptin Swinghaler was approved in Japan in… Read more . . .
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Alexza Pharmaceuticals has promoted Edwin S. Kamemoto from VP, Regulatory Affairs to the newly created position of Senior VP, Regulatory Affairs. He was hired in 2006 as Associate Director, Regulatory Affairs; and promoted to Director,… Read more . . .
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GSK and Theravance have submitted a supplemental New Drug Application (sNDA) to the FDA for the Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma in patients 12 years old and older, the companies… Read more . . .
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Vectura has announced a new US partnership for its VR506, which it describes as “an ICS for the treatment of asthma” and as “clinical stage asthma monotherapy delivered using Vectura’s proprietary technology.” Elsewhere, the company… Read more . . .
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According to Allergan, the FDA has issued another Complete Response Letter (CRL) in response to Allergan’s NDA for Semprana inhaled dihydroergotamine (formerly Levadex) for the treatment of acute migraine. Allergan acquired the product when it… Read more . . .
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The Australian Research Council (ARC) has awarded a 3-year, $482,738 linkage grant titled “One for all and all for one- Engineering a drug delivery platform for DNA vaccines to the lung” to members of the… Read more . . .
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The US FDA has announced the approval of MannKind Corporation’s Afrezza inhaled insulin for the treatment of diabetes. The PDUFA date for Afrezza had been set for July 15, 2014 after the FDA’s Endocrinologic and… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA