News
-
The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 in favor of approval for GSK’s Anoro Ellipta umeclidinium/vilanterol dry powder inhaler for the treatment of COPD, according to GlaxoSmithKline and Theravance. The… Read more . . .
-
Inhaler monitoring specialist Asthmapolis has announced that the company has changed its name to Propeller Health. The company said that the name change reflects a widening focus that includes products for inhaled COPD medications as… Read more . . .
-
The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013. According to the agency, public… Read more . . .
-
Boehringer Ingelheim has presented new data from several Phase 3 studies of olodaterol for the treatment of COPD and from the TIOSPIR tiotropium Respimat study at the European Respiratory Society (ERS) Annual Congress 2013. Data… Read more . . .
-
Smartinhaler manufacturer Nexus6 has announced three new management appointments: Veronique Bouchet as VP of Business Development for Europe, Christopher Stevens as Chief Operating Officer, and Chris Mander as Head of Regulatory and Quality. According to… Read more . . .
-
Capsugel will acquire Bend Research for an undisclosed amount, the companies have announced. Bend will become part of Capsugel’s Dosage Form Solutions (DFS) business unit. Although the press release highlights Capsugel’s new “access to a… Read more . . .
-
Theravance has announced that a dose-ranging 7-day Phase 2b study of TD‑4208 inhalation solution, an investigational long-acting muscarinic antagonist (LAMA) for the treatment of COPD, met its primary endpoints for all six doses. TD-4208 showed… Read more . . .
-
Civitas Therapeutics has initiated a 28-day Phase 2b efficacy and safety study of CVT-301 inhaled levodopa for the treatment of intermittent motor fluctuations in Parkinson’s patients, the company said. The study is partially funded by… Read more . . .
-
A study appearing online first in the New England Journal of Medicine finds that “Tiotropium Respimat at a dose of 5 μg or 2.5 μg had a safety profile and exacerbation efficacy similar to those… Read more . . .
-
Swedish pharmaceutical company Meda has agreed to acquire Massachusetts-based Acton Pharmaceuticals for $135 million plus a $10 million milestone payment and royalty milestones. According to Acton, the deal could be worth up to $200 million.… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
No events are found.