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GSK and Theravance submit application for UMEC/VI in Europe

GlaxoSmithKline and Theravance have submitted a marketing application to the EMA for their umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD. The product, which is delivered using the Ellipta DPI, would be marketed as Anoro. The two companies submitted an NDA to the FDA for UMEC/VI in December 2012. The MAA is for 55/22mcg … [Read more...] about GSK and Theravance submit application for UMEC/VI in Europe

Catalent to invest $20 million to expand inhalation capabilities

Catalent Pharma Solutions has announced that it will invest $20 million to enhance pMDI clinical and commercial supply capabilities, along with other enhancements, at its Inhalation Center of Excellence in Research Triangle Park (RTP), North Carolina. The company offers a range of development and manufacturing services for inhaled products and says that it also … [Read more...] about Catalent to invest $20 million to expand inhalation capabilities

Asthmapolis named a finalist for Bluetooth Breakthrough Awards

The Bluetooth Special Interest Group (SIG) has named Asthmapolis a finalist in the "Breakthrough Products" category for the Bluetooth Breakthrough Awards. The FDA granted 510(k) clearance to the Asthmapolis inhaler sensor system and mobile app in July 2012. When attached to the top of an MDI canister, the sensor records accelerometer and GPS data, which it transmits … [Read more...] about Asthmapolis named a finalist for Bluetooth Breakthrough Awards

Prosonix gets grant for development of multi-component particle inhaled drugs

The Biomedical Catalyst, a joint program of the UK's Medical Research Council and the Technology Strategy Board, has awarded a grant of up to £1.3M in matched funding to Prosonix for support of a research consortium focused on pre-clinical development of the Prosonix Multi-Component Particle (MCP) platform for excipient-free inhaled combination drugs. The consortium … [Read more...] about Prosonix gets grant for development of multi-component particle inhaled drugs

Trimel names Tom Rossi new CEO

Trimel Pharmaceuticals has named Tom Rossi as CEO to replace Bruce D. Brydon, who has stepped down as CEO. Rossi has been President of Trimel since he joined the company in August 2011 and also became Chief Operating Officer in March 2012. Brydon, who will continue as chairman of the board of directors, commented, "After 18 months as a reporting issuer on the … [Read more...] about Trimel names Tom Rossi new CEO

Teva Pro-Air MDI with dose counter now available in US

Teva Respiratory says that the ProAir HFA metered dose inhaler with dose counter for the treatment of asthma is now available. The albuterol MDI with dose counter was approved by the FDA in March 2012. At the time, the company announced that the new inhaler would be available by the end of 2012. Teva says that it needed time to manufacture a sufficient inventory to … [Read more...] about Teva Pro-Air MDI with dose counter now available in US

Mitsubishi to acquire Qualicaps

The Carlyle group has agreed to sell Mitsubishi Chemical Holdings Corporation all outstanding shares of pharmaceutical capsule manufacturer Qualicaps. Products manufactured by Qualicaps include both gelatin and hypromellose capsules for use with dry powder inhalers. Mitsubishi will pay approximately ¥55.8 billion, or about $660 million, for the company. Read … [Read more...] about Mitsubishi to acquire Qualicaps