The International Society of Aerosol Medicine (ISAM) has resumed accepting poster abstracts for the 2015 ISAM Congress, to be held May 30-June 3, organizers have announced. Topics include Pediatrics & CF, Regulatory & Standardization, New Devices & Emerging Therapy, Environmental/Occupational Health/Toxicology, and Imaging, Modelling & Physiology of Aerosols in the … [Read more...] about ISAM reopens abstract submission for 2015 Congress
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Aradigm appoints Robert A. Reed VP, Regulatory and Quality
Inhaled drug developer Aradigm has announced the appointment of Robert A. Reed as VP, Regulatory (CMC) and Quality. Reed was most recently Senior VP of CMC and Technical Operations at Celsion Corporation and has also previously held positions at XenoPort and Merck. Aradigm President and CEO Igor Gonda commented, “We are delighted that Dr. Reed has joined our team … [Read more...] about Aradigm appoints Robert A. Reed VP, Regulatory and Quality
Court of Appeals upholds Mylan Perforomist patents
According to Mylan, the United States Court of Appeals for the Federal Circuit has affirmed a lower court's March 2014 decision upholding the validity of four Mylan patents related to Perforomist formoterol fumarate inhalation solution and infringement of the patents by Teva. The patents (Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645) protect Perforomist … [Read more...] about Court of Appeals upholds Mylan Perforomist patents
Positive results for Adamis Pharmaceutical’s generic albuterol MDI
Adamis Pharmaceuticals has announced that a clinical study comparing its APC-2000 albuterol MDI with GSK's Ventolin Evohaler MDI met its primary endpoint, showing equivalence in change from baseline of FEV1 for both doses tested (100 and 200 mcg). The company said that the study, which involved 124 patients with mild to moderate asthma, took place "outside of the … [Read more...] about Positive results for Adamis Pharmaceutical’s generic albuterol MDI
AstraZeneca partners with PatientsLikeMe
AstraZeneca announced that it has entered into a five-year partnership agreement with patient network PatientsLikeMe for access to patient-reported data in several treatment areas, including respiratory. PatientsLikeMe offers a program called "data for good," whose slogan is "donate your data for you, for others, for good." On its website, the company informs … [Read more...] about AstraZeneca partners with PatientsLikeMe
Molecular Profiles changes name to Juniper Pharma Services
CDMO Molecular Profiles has announced that the company has a new name: Juniper Pharma Services. The company, whose services include formulation development and clinical trial manufacturing of dry powder inhalers, was acquired in 2013 by US-based Columbia Laboratories, now called Juniper Pharmaceuticals. In April 2014, Molecular Profiles announced that it planned to … [Read more...] about Molecular Profiles changes name to Juniper Pharma Services
Vectura to close former Activaero site in Gemünden
Vectura has announced that it will close the former Activaero nebulizer manufacturing site in Gemünden, Germany by March 2016, transfering many of the site's operations to other Vectura facilities in Germany and the UK. Commercial production will be transferred to a contract manufacturing organization. Vectura acquired the Gemünden site when it acquired Activaero in … [Read more...] about Vectura to close former Activaero site in Gemünden
Evoke Pharma’s intranasal metoclopramide formulations get European patent
The European Patent Office has granted Evoke Pharma patent no. 2376075 for its EVK-001 intranasal metoclopramide for the treatment of diabetic gastroparesis symptoms in women, the company said. Earlier this year, Evoke announced that Phase 3 development of EVK-001 has been delayed by slower than expected enrollment in an ongoing clinical trial. Evoke President and … [Read more...] about Evoke Pharma’s intranasal metoclopramide formulations get European patent
Aptar Pharma gets license for preservative free multidose nasal devices in China
Aptar Pharma has announced that the Chinese State Food and Drug Administration (SFDA) has issued the company an import license for its preservative-free multi-dose opthalmic and nasal devices in accordance with regulations that require “Examination and approval for packaging materials and containers in direct contact with drugs” prior to marketing. Aptar's APF … [Read more...] about Aptar Pharma gets license for preservative free multidose nasal devices in China
PARI Pharma’s Vantobra inhalation solution approved in Europe
PARI Pharma has received European marketing authorization for its Vantobra 170 mg tobramycin/1.7 ml inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older, the company said. Vantobra is delivered via the Tolero nebulizer and is packaged together with the device. PARI Pharma submitted the marketing authorization … [Read more...] about PARI Pharma’s Vantobra inhalation solution approved in Europe