According to Sunovion Pharmaceuticals, data from a year-long clinical trial comparing the safety of Brovana arformoterol tartrate inhalation solution versus placebo in patients with moderate-to-severe COPD show no increased risk of exacerbations or death due to a respiratory event. Fewer than 10% of patients treated with 15 mcg of Brovana twice daily had serious … [Read more...] about Safety studies show no increased risk with use of Brovana inhalation solution
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Pearl Therapeutics initiates Phase 3 program for LAMA/LABA MDI
Pearl Therapeutics has announced the initiation of a Phase 3 program called PINNACLE for its PT003 glycopyrrolate/formoterol fumarate metered dose inhaler for patients with moderate-to-severe COPD. The program will include two studies involving more than 2,700 patients in North America, Europe, Australia, and New Zealand. Enrollment is expected to be complete by … [Read more...] about Pearl Therapeutics initiates Phase 3 program for LAMA/LABA MDI
Aegis gets second patent for intranasal formulations of triptans
According to Aegis Therapeutics, the company has been granted US Patent No. 8,440,631 for fast-acting formulations of triptans for the treatment of migraines. The patent is the second for Aegis's triptan nasal sprays using its Intravail transmucosal absorption enhancers; the company got the first patent in September 2012. Clinical trials have demonstrated that … [Read more...] about Aegis gets second patent for intranasal formulations of triptans
Insmed gets European patent for Arikace
The European Patent Office will grant Insmed Incorporated EU Patent No. 1909759 for Arikace liposomal amikacin for inhalation, according to Insmed. The composition of matter patent, titled "Sustained release of anti-infective aminoglycosides," covers formulations of aminoglycosides, including amikacin, with Insmed's liposomal delivery platform, formulation methods, … [Read more...] about Insmed gets European patent for Arikace
Elan makes billion dollar deal for inhaled drug royalites
Elan Corporation has announced that it will pay Theravance $1 billion for a 21% participation interest in future royalty payments from sales of Breo (Relvar) Ellipta, Anoro Ellipta, MABA '081 bifunctional muscarinic antagonist-beta2 agonist monotherapy, and vilanterol monotherapy. Elan CEO Kelly Martin explained, “This transaction, upon closing, will immediately … [Read more...] about Elan makes billion dollar deal for inhaled drug royalites
New joint venture in China to develop inhaled drugs
Vectura has announced that it has partnered with Chinese pharmaceutical company Tianjin KingYork Group and Hong Kong private equity investor Zendex Bio Strategy to create Tianjin Kinnovata Pharmaceutical Company Limited ("Kinnovata"). The new company will develop, manufacture, and market inhaled drugs for asthma and COPD in Asia. Kinnovata will be an independent … [Read more...] about New joint venture in China to develop inhaled drugs
FDA approves Breo Ellipta
The FDA has approved GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol inhalation powder for the treatment of COPD). The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted to recommend approval of Breo Ellipta in April 2013. Theravance will make a $30 million milestone payment to GSK following the approval. The FDA notes that, "The drug … [Read more...] about FDA approves Breo Ellipta
Team Consulting gets grant for inhaler testing
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
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