The US Patent and Trade Office (USPTO) has awarded Aegis Therapeutics US Patent No. 8,772,231 for "dramatically stabilized insulin formulations suitable for metered nasal spray delivery or injection based upon Aegis’ patented Intravail transmucosal absorption enhancer and ProTek protein stabilization technologies," the company said. According to Aegis, the company … [Read more...] about Aegis gets patent for stable insulin for intranasal delivery, announces intranasal octreotide license availability
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Lightlake signs manufacturing contract for its intranasal naloxone
According to Lightlake Therapeutics, the company has signed a contract with a manufacturer for commercial production of its intranasal naloxone for the reversal of opioid overdose. In December 2013, the company announced positive initial results from a PK study of the product and said that it planned to submit an NDA in 2014. Lightlake CEO Roger Crystal commented, … [Read more...] about Lightlake signs manufacturing contract for its intranasal naloxone
Brovana inhalation solution safety study data published
Sunovion Pharmaceuticals has announced publication of data from a year-long safety study showing an approximately 40% lower risk of COPD exacerbation-related hospitalization or death due to respiratory disease for patients using Brovana arformoterol tartrate inhalation solution than for patients using a placebo. The data were published online in Chest on June 26, … [Read more...] about Brovana inhalation solution safety study data published
Anoro Ellipta approved in Japan
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 submitted a marketing application to the MHLW. The approval triggers a $10 million milestone payment from Theravance to … [Read more...] about Anoro Ellipta approved in Japan
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 respiratory programs partnered with Glaxo Group Limited (GSK)," including the Anoro and Breo/Ellipta DPIs. Witek was most recently President and … [Read more...] about Theravance appoints Theodore J. Witek Senior VP Corporate Partnerships, Clinical and Medical Affairs
BI submits marketing application for tiotropium/olodaterol Respimat in Europe
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 inhaler are already available as Respimat products; tiotropium delivered by the SMI is marketed as Spiriva Respimat and olodaterol as Striverdi … [Read more...] about BI submits marketing application for tiotropium/olodaterol Respimat in Europe
Otsuka launches Meptin Swinghaler DPI in Japan
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 February 2014. According to the company, Japan has over 1 million asthma patients, and Meptin's share of the Japanese market is over 50%. The Swinghaler, … [Read more...] about Otsuka launches Meptin Swinghaler DPI in Japan
Alexza names Edwin S. Kamemoto as Senior VP of Regulatory Affairs
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, Regulatory Affairs, then to Senior Director, Regulatory Affairs, and then, in 2010, to Executive Director, Regulatory Affairs. … [Read more...] about Alexza names Edwin S. Kamemoto as Senior VP of Regulatory Affairs
GSK and Theravance file sNDA for Breo Ellipta for the treatment of asthma
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 announced. The FDA approved Breo Ellipta 100/25mcg for the treatment of COPD in May 2013. The approval of Breo Ellipta for asthma required a … [Read more...] about GSK and Theravance file sNDA for Breo Ellipta for the treatment of asthma
Vectura announces new partnership for generic fluticasone propionate DPI
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 has identified the product as a fluticasone propionate DPI. According to Vectura, it has signed the new agreement for development … [Read more...] about Vectura announces new partnership for generic fluticasone propionate DPI