Hosokawa Micron has introduced the Mini Cyclomix lab mixer for use in development of dry powder formulations for inhalation, the company announced. According to the company, the lab-sized blender is designed to disperse API in a lactose carrier while minimizing the energy imparted in order to avoid affecting aerosolization. The lab blender is a smaller version of … [Read more...] about Hosokawa Micron introduces lab blender for DPI formulation development
News
FDA advisory committees to review Breo Ellipta sNDA (updated)
Theravance has announced that the the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee will meet jointly on March 19, 2015 to discuss whether the Breo Ellipta fluticasone/vilanterol DPI should be approved for the treatment of asthma in patients 12 and older. Theravance and GSK filed sNDA 204275-S001 in … [Read more...] about FDA advisory committees to review Breo Ellipta sNDA (updated)
GSK and Theravance initiate Phase 3 study of triple combination inhaler
GlaxoSmithKline and Theravance have announced the beginning of the FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) Phase 3 study of a fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI in patients with COPD. The randomized double-blind study is expected to enroll approximately 1,800 patients. An earlier Phase 3 study … [Read more...] about GSK and Theravance initiate Phase 3 study of triple combination inhaler
Respira hires Andy Clark as VP and Chief Technology Officer
DPI developer Respira Therapeutics has hired inhalation drug development pioneer Andy Clark as Vice President and Chief Technology Officer. Clark most recently served as Site Head and CTO at the Novartis pulmonary development facility in San Carlos, CA. He previously served as CTO at Nektar/Inhale and held positions at Genentech and Fisons. Clark, a past president … [Read more...] about Respira hires Andy Clark as VP and Chief Technology Officer
Arvind Agrawal joins Lightlake Therapeutics
Lightlake Therapeutics has announced today that it has hired former Mundipharma Head of Medical Affairs for New Products Arvind Agrawal as Executive VP, Medical Affairs, effective January 2015. Agrawal has also held Medical Affairs positions at Reckitt Benckiser and AstraZeneca. In December 2014, Lightlake announced that it had licensed its intranasal naloxone … [Read more...] about Arvind Agrawal joins Lightlake Therapeutics
Orphan Drug Designation for AIT’s nitric oxide product for CF
Israeli biopharmaceutical company Advanced Inhalation Therapies (AIT) has announced that it received Orphan Drug Designation from the FDA last fall for its AIT-CF high dose nitric oxide formulation for the treatment of lung infections in cystic fibrosis patients. The company says that its proprietary delivery system for the 160 ppm formulation "continuously monitors … [Read more...] about Orphan Drug Designation for AIT’s nitric oxide product for CF
Innovus Pharmaceuticals acquires fluticasone nasal spray
Innovus Pharmaceuticals has announced that the acquisition of Novalere FP and its FlutiCare fluticasone propionate nasal spray. According to documents related to the merger filed with the US Securities and Exchange Commission (SEC), Novalere FP filed an ANDA for the product with the FDA in November 2014. The company says that it expects that the ANDA "may be approved … [Read more...] about Innovus Pharmaceuticals acquires fluticasone nasal spray
AstraZeneca acquires Tudorza Pressair, other Actavis respiratory drugs in US and Canada
AstraZeneca will pay Actavis $600 million plus royalties for US and Canadian rights to Daliresp roflumilast and the Tudorza Pressair aclidinium bromide DPI, plus development rights to an aclidinium/formoterol DPI which was approved in Europe as Duaklir Genuair. AstraZeneca acquired Almirall's respiratory portfolio in 2014. Almirall had licensed US rights to … [Read more...] about AstraZeneca acquires Tudorza Pressair, other Actavis respiratory drugs in US and Canada
Oxford Lasers introduces new optical spray characterization system
Oxford Lasers has announced the launch of its EnVision QC system for spray pattern and plume geometry testing of both MDIs and nasal sprays for quality control purposes. The Envision QC system includes automatic device positioning, and it automatically detects the fully developed phase of the spray and records measurements to meet FDA requirements. Oxford Lasers … [Read more...] about Oxford Lasers introduces new optical spray characterization system
Bespak gets contract for integrated dose counter in MDI
Consort Medical has announced that its Bespak subsidiary has entered into a multi-year agreement to supply its proprietary integrated dose counter system and the valve for a commercial pMDI. This is the first commercial use of the Bespak integrated dose counter (IDC) in an orally inhaled MDI; the IDC is already used in Teva's QNASL beclomethasone HFA nasal aerosol, … [Read more...] about Bespak gets contract for integrated dose counter in MDI