A UK innovation agency, the Technology Strategy Board, has awarded Team Consulting a grant to fund an 8-month feasibility test of its Occoris inhaler "engine" technology, the company said. According to Team, the Occoris engine, approximately the size of a pea, can deliver API-only dry powder formulations accurately and repeatably. The feasibility testing funded by … [Read more...] about Team Consulting gets grant for inhaler testing
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Teva to market Alexza’s Adasuve loxapine inhalation powder in US
Alexza Pharmaceuticals and Teva Pharmaceuticals USA have announced that Teva will market Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar I disorder in the US. The FDA approved Adasuve in December 2012. Teva will pay Alexza $40 million up front, up to $195 million in milestone payments, and additional tiered … [Read more...] about Teva to market Alexza’s Adasuve loxapine inhalation powder in US
MedPharm expands laboratory facilities
Contract research organization MedPharm has announced the opening of a new GLP laboratory at its Guildford, UK headquarters. According to the company, "The additional space will provide further capacity for MedPharm’s proprietary in vitro/ex vivo performance and equivalence testing models for topical, ophthalmic, nail, nasal and inhaled drugs/medical devices which … [Read more...] about MedPharm expands laboratory facilities
More positive Phase 3 results for aclidinium/formoterol DPI
Almirall and Forest Labs have announced positive results from the Phase 3 AUGMENT/COPD study of their fixed dose combination aclidinium bromide/formoterol fumarate dry powder inhaler in patients with COPD. The announcement followed several weeks after the companies announced positive results from another Phase 3 study of aclidinium/formoterol, the ACLIFORM/COPD study. … [Read more...] about More positive Phase 3 results for aclidinium/formoterol DPI
GSK submits NDA for UMEC monotherapy
According to GlaxoSmithKline, the company has submitted an application to the FDA for umeclidinium bromide (UMEC) administered using the Ellipta DPI for the treatment of COPD. The filing comes just days after GSK announced the submission of an MAA in Europe for UMEC monotherapy. The company says that it plans additional filings for the product this year. GSK and … [Read more...] about GSK submits NDA for UMEC monotherapy
Trimel submits NDA for intranasal testosterone to FDA
Trimel Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA regarding its CompleoTRT bioadhesive intranasal gel testosterone for the treatment of testosterone deficiency in men. According to the company, the intranasal gel is fully absorbed within half and hour and would avoid the potential transference problems presented by topic gel products. … [Read more...] about Trimel submits NDA for intranasal testosterone to FDA
Inhalation consortium announces formation of jointly-owned company
The 19 member companies of the Medicon Valley Inhalation Consortium (MVIC) have announced the creation of a single company called MVIC AB in order to simplify customer relationships with the organization. Orest Lastow of Zenit Design, who founded the consortium, will be CEO. MVIC AB has 2 GMP facilities and provides a full range of inhalation product services, … [Read more...] about Inhalation consortium announces formation of jointly-owned company
Andain announces launch of inhaled nano-particle drug delivery technology
Israeli/American biotech company Andain Inc. says that it has developed an "innovative lipid-based drug delivery nano-particles capable of carrying hydrophilic and hydrophobic drugs to a targeted human organ with timely drug release capabilities" and announced that it has developed an inhalation solution for the treatment of COPD using the technology. The company … [Read more...] about Andain announces launch of inhaled nano-particle drug delivery technology
GSK submits EU regulatory application for UMEC monotherapy
GlaxoSmithKline says that it has submitted a Marketing Authorisation Application (MAA) to the EMA for umeclidinium bromide (UMEC) monotherapy to be delivered using the Ellipta DPI for the treatment of COPD. UMEC is a long-acting muscarinic antagonist (LAMA). GSK and Theravance recently submitted an application in Japan for the Anoro Ellipta UMEC/vilanterol inhaler, … [Read more...] about GSK submits EU regulatory application for UMEC monotherapy
Theravance to split into two companies as inhalers move toward commercialization
The board of directors of Theravance, Inc. has decided to split the organization into two separate companies by late 2013 or early 2014 in a move "designed to unlock potential value, facilitate return of capital to stockholders and further strategy of advancing medicines that address unmet medical needs," the company has announced. One company, called Theravance … [Read more...] about Theravance to split into two companies as inhalers move toward commercialization