GSK and Theravance have announced the launch of Anoro Ellipta umeclidinium/vilanterol inhalation powder in the United States, triggering a $30 million milestone payment from Theravance to GSK. The FDA approved Anoro Ellipta for the treatment of COPD in December 2013. Senior VP of GSK's Respiratory Business Unit Jorge Bartolome commented, "We understand that COPD … [Read more...] about Anoro Ellipta launched in the US
News
FDA looks to regulate e-cigarettes
The US FDA has proposed a new rule that would require e-cigarette makers to register with the agency, disclose ingredients used in their inhalation solutions, and provide scientific evidence to support claims of reduced risk for their products. The rule would also require health warnings and add minimum age requirements for sales. In February 2011, the US Supreme … [Read more...] about FDA looks to regulate e-cigarettes
Australia approves Breo Ellipta
Australia's Therapeutic Goods Administration (TGA) has approved the Breo Ellipta fluticasone furoate/vilanterol for the treatment of asthma and COPD, according to GSK Australia and Theravance. GSK Medical Director Andrew Yeates commented, “We are delighted that Breo Ellipta is now approved in Australia. GSK is committed to supporting innovation in respiratory … [Read more...] about Australia approves Breo Ellipta
Bayer ciprofloxacin DPI gets orphan drug status from the FDA
The FDA has granted orphan drug designation to a ciprofloxacin DPI being developed by Bayer HealthCare for the treatment of non-cystic fibrosis bronchiectasis, the company has announced. The dry powder formulation, based on Novartis's PulmoSphere platform, is delivered using the T-326 (Podhaler) DPI. The product is currently in Phase 3 trials. Bayer is also … [Read more...] about Bayer ciprofloxacin DPI gets orphan drug status from the FDA
Theravance announces $450 million in financing
Theravance has announced that its LABA Royalty Sub wholly owned subsidiary "issued $450 million in aggregate principal amount of PhaRMA 9% Notes due on or before May 15, 2029. The notes are secured by a security interest in a segregated bank account established to receive 40% of royalties from global net sales of Relvar/Breo Ellipta (fluticasone furoate/vilanterol … [Read more...] about Theravance announces $450 million in financing
New Phase 3 study of FF/VI for COPD announced
GSK and Theravance have announced a Phase 3 study of fluticasone furoate (FF)/vilanterol (VI) (the Relvar Ellipta DPI) including Japanese COPD patients. In July 2013, GSK withdrew its application for Relvar for the treatment of COPD in Japan because the available Japanese patient data at the time showed that the FF component failed to produce a statistically … [Read more...] about New Phase 3 study of FF/VI for COPD announced
Genoa announces additional positive results for inhaled pirfenidone
Genoa Pharmaceuticals has announced that studies conducted in conjunction with McMaster University have shown that peak pirfenidone activity can be achieved by lung levels of the drug that remain for only a short period of time. Genoa previously announced that its GP-101 inhaled pirfenidone demonstrated greater anti-fibrotic effects with smaller doses than oral … [Read more...] about Genoa announces additional positive results for inhaled pirfenidone
Incruse Ellipta approved in Canada
Canada has approved GSK's Incruse Ellipta umeclidinium (UMEC) DPI for the once-daily treatment of COPD, the first approval for its UMEC monotherapy, the company said. GSK received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) regarding its MAA for Incruse Ellipta in February 2014, and the company submitted an NDA for the … [Read more...] about Incruse Ellipta approved in Canada
OPKO Health acquires Inspiro Medical and its Inspiromatic DPI
US pharmaceutical company OPKO Health has announced that it will acquire Israeli device company Inspiro Medical whose only product is the Inspiromatic dry powder inhaler. In June 2013, Inspiro announced positive results from a study of the device used to deliver formoterol. OPKO CEO and Chairman Phillip Frost said, "We are pleased to add this next generation … [Read more...] about OPKO Health acquires Inspiro Medical and its Inspiromatic DPI
Alexza hires Winston R. Brown, Jr. as VP, Quality
Alexza Pharmaceuticals has hired Winston R. Brown, Jr. as VP, Quality, the company has announced. Brown was most recently Global Head, Quality R&D - Pharmaceuticals, Biologics, and Vision Care Devices at Alcon Research. The company has made several hires recently as it is in the process of commercializing its Adasuve inhaled loxapine for the treatment of … [Read more...] about Alexza hires Winston R. Brown, Jr. as VP, Quality