Unigene Laboratories has issued a statement in response to an FDA announcement of an upcoming advisory committee meeting scheduled for March 5, 2013 to discuss whether the benefits of calcitonin salmon outweigh the risk. The company manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis. Unigene CEO Ashleigh Palmer commented, “We are … [Read more...] about Unigene says that it welcomes FDA meeting on calcitonin salmon nasal spray
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FDA committee schedules meetings to discuss inhalation NDAs
The FDA's Pulmonary-Allergy Drugs Advisory Committee has scheduled discussion of a number of new drug applications for inhalation products in the next few months. The meetings are open to the public and will be available as live webcasts. The committee will meet on January 29, 2013 to discuss the new drug application (NDA) for Boehringer Ingelheim's olodaterol MDI … [Read more...] about FDA committee schedules meetings to discuss inhalation NDAs
Fast food consumption linked to severity of asthma, rhinitis in children
An article posted online in Thorax on January 14, 2013 finds that children and teens who eat three or more servings of fast food per week have a significantly increased risk of severe asthma. The same fast food intake was also associated with increased risk of eczema and rhinitis, while fruit consumption was found to have an inverse association with severe asthma and … [Read more...] about Fast food consumption linked to severity of asthma, rhinitis in children
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
MVIC announces new member, date for next symposium
Lars Borgström Consulting has joined the Medicon Valley Inhalation Consortium (MVIC), bringing the group of companies involved in inhalation product development in the Skåne-Copenhagen region to 14 members. Borgström, the first recipient of RDD's Charles G. Thiel award, recently retired from AstraZeneca and is offering "advice on clinical aspects of inhaled medication … [Read more...] about MVIC announces new member, date for next symposium
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
New CEO, board appointments for Discovery Labs
Discovery Laboratories has named John G. Cooper as President and CEO replacing W. Thomas Amick, who had been chairman of the board since March 2007 and CEO since October 2010. Cooper was Executive VP and CFO from 2002-2010 and has served as President and CFO since in 2010. He will continue as CFO. The company has also appointed John R. Leone chairman of the board … [Read more...] about New CEO, board appointments for Discovery Labs
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