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
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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
QVA149 data demonstrates superior reduction of COPD exacerbations compared to glycopyrronium alone
Novartis's QVA149 indacaterol maleate/glycopyrronium DPI demonstrated 15% greater reduction in all COPD exacerbations compared to glycopyrronium and 14% compared to tiotropium according to study results published April 23 2013 in Lancet Respiratory Medicine. QVA149 reduced moderate-to-severe exacerbations by 12% over glycopyrronium. The study also showed improved lung … [Read more...] about QVA149 data demonstrates superior reduction of COPD exacerbations compared to glycopyrronium alone
Anoro Ellipta application submitted in Japan
GlaxoSmithKline and Theravance have submitted an application for the Anoro Ellipta umeclidinium bromide /vilanterol (UMEC/VI) DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare (MHLW), the companies said. The submission in Japan is for 62.5/25mcg and 125/25mcg doses of UMEC/VI. In the US, the Anoro Ellipta has a PDUFA date of … [Read more...] about Anoro Ellipta application submitted in Japan
GW receives Notice of Allowance for patent on spray device
GW Pharmaceuticals has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance in response to its patent application for a metered dose spray device for sublingual delivery of Sativex liquid cannabis extract formulation. The application serial number is 13/606,742. GW CEO Justin Gover commented, “This Notice of … [Read more...] about GW receives Notice of Allowance for patent on spray device