Device manufacturer Gerresheimer reported a 6.3% increase in revenues and a 7.4% increase in net income in the second quarter of 2015, crediting "very strong growth" in medical plastic products such as inhalers. According to the company, it is continuing to expand its production capacity for inhalers and other plastic products in the Czech Republic and in the US. … [Read more...] about Gerresheimer reports increase in revenues in second quarter
News
Moerae Matrix hires Bill Bradford as Chief Medical Officer
Moerae Matrix, which is developing inhaled therapies for the treatment of idiopathic pulmonary fibrosis and other lung diseases, has announced the appointment of Bill Bradford as Chief Medical Officer. Bradford was most recently a Senior Fellow at Intermune. Bradford commented, "I am excited to be joining Moerae at this important time in the company's evolution as … [Read more...] about Moerae Matrix hires Bill Bradford as Chief Medical Officer
FDA issues product-specific guidances for several OINDPs
The FDA has issued product-specific recommendations for demonstrating the bioequivalence of over 40 drug products, including several OINDPs. The newly added documents include guidances for azelastine HCL/fluticasone propionate nasal spray, budesonide/formoterol fumarate MDI, and levalbuterol tartrate MDI. Comments on the new guidances can be submitted to the FDA … [Read more...] about FDA issues product-specific guidances for several OINDPs
Hovione adds spray drying capacity
Hovione is adding new spray drying capacity at its facility in Loures, Portugal, the company has announced. The company says that the new spray dryer, which is designed with the ability to handle highly potent APIs, will be fully operational by March 2016. According to the company, the additional spray drying capacity is part of a larger program to expand the … [Read more...] about Hovione adds spray drying capacity
BMJ article argues that GOLD criteria lead to signficant misdiagnosis of COPD and overprescription of inhaled therapies
According to the authors of an article published in The BMJ on July 1, 2015, the Global Initiative for Obstructive Lung Disease (GOLD) criteria for COPD diagnosis result in significant overdiagnosis and overprescription of inhalers, especially in older men, and should be modified. Martin Miller of the University of Birmingham and Mark Levy of the Harrow Clinical … [Read more...] about BMJ article argues that GOLD criteria lead to signficant misdiagnosis of COPD and overprescription of inhaled therapies
Study finds that discontinuing ICS reduces risk of pneumonia in COPD patients
A study published online in CHEST on June 25, 2015 finds that discontinuing inhaled corticosteroids for COPD patients reduced the risk of pneumonia by 37%, with the greatest reduction in risk associated with stopping inhaled fluticasone. The reduction in risk was not as great after discontinuation of budesonide. The study authors identified over 103,000 COPD … [Read more...] about Study finds that discontinuing ICS reduces risk of pneumonia in COPD patients
DuoResp Spiromax wins silver Medical Design Excellence Award
Teva Pharmaceutical's DuoResp Spiromax multidose DPI has won a Silver award at the 2015 Medical Design Excellence Awards (MDEA), with Gerresheimer receiving credit as a supplier. DuoResp Spiromax received European marketing authorization in April 2014. Teva Global Specialty Medicines President and CEO Rob Koremans commented, "Innovative, patient-focused design is … [Read more...] about DuoResp Spiromax wins silver Medical Design Excellence Award
Spiolto Respimat approved in a number of European countries
According to Boehringer Ingelheim, the United Kingdom, Croatia, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain have approved the Spiolto Respimat tiotropium/olodaterol SMI for the treatment of COPD. BI recently announced the launch of the tiotropium/olodaterol soft mist inhaler in the US, where it is marketed as Stiolto Respimat. Boehringer … [Read more...] about Spiolto Respimat approved in a number of European countries
Canadian agency calls for patient input on Breo Ellipta
The Canadian Agency for Drugs and Technology in Health (CADTH) has issued a call for patient input regarding GSK's Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma. According to the announcement, the agency has received notice of a pending submission and is seeking input from patient groups for purposes of a Common Drug Review. According … [Read more...] about Canadian agency calls for patient input on Breo Ellipta
Israeli patent issued for AAT pulmonary delivery system
The Israeli Patent Office has issued Patent No. 193318, “System for Pulmonary Delivery of Alpha-1 Proteinase Inhibitor,” to Kamada and PARI Pharma, Kamada has announced. The patent relates to delivery of Kamada’s inhaled alpha-1 proteinase inhibitor (AAT) using a custom eFlow nebulizer from PARI. Kamada CEO Amir London commented, “We continue to fortify our … [Read more...] about Israeli patent issued for AAT pulmonary delivery system