Sandoz has launched its AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD in Portugal and Ireland, the company said. AirFluSal is now available in twelve European countries, South Korea, and Mexico. The Portuguese Health Authority approved the DPI in October 2014, and Ireland approved the inhaler in November, 2014. Sandoz Head … [Read more...] about Sandoz launches AirFluSal Forspiro in Portugal and Ireland
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KCL’s Abhinav Kumar to work with Inhalation Sciences on dissolution project
2014 Pat Burnell New Investigator Award winner Abhinav Kumar of King’s College London will collaborate with Inhalation Sciences AB onsite in Stockholm, Sweden, the company has announced. The joint research project will explore the use of KCL's simulated lung fluid for in vitro dissolution testing. The KCL team has already been using ISAB's DissolvIt module with the … [Read more...] about KCL’s Abhinav Kumar to work with Inhalation Sciences on dissolution project
Recipharm names Thomas Beck as VP Quality Management
Swedish CDMO Recipharm has announced the appointment of Thomas Beck to the new senior role of Vice President Quality Management, effective April 1, 2015. Beck has been Head of Quality Control and Assurance at Recipharm Stockholm since 2010 and also serves as chairman of the Quality Assurance section of the Swedish Academy of Pharmaceutical Science. Recipharm offers … [Read more...] about Recipharm names Thomas Beck as VP Quality Management
AmpliPhi announces $13 million private placement financing
AmpliPhi BioSciences (formerly Targeted Genetics) has announced that it has raised approximately $13,000,000 in a private placement financing that it will use for three development programs. The company's lead candidate, AmpliPhage-001, is an inhaled bacteriophage for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. According to the … [Read more...] about AmpliPhi announces $13 million private placement financing
Apple introduces new app for asthma research
Apple has announced that its new ResearchKit open source software framework intended to help medical researchers collect patient data will be available next month, and the company has introduced a suite of apps used to collect the data. An Asthma Health app developed by the Icahn School of Medicine and LifeMap Solutions is now available on the App Store for download … [Read more...] about Apple introduces new app for asthma research
Teva gets tentative approval for the ProAir RespiClick albuterol DPI
The FDA has tentatively approved Teva's ProAir RespiClick albuterol dry powder inhaler as of March 5, 2015. Teva filed an NDA for an albuterol "MDPI" (multi-dose dry powder inhaler) for the treatment of asthma in July 2014. At the time, it referred to the product as "ProAir Spiromax." The company applied for a trademark on the name "ProAir RespiClick" in an … [Read more...] about Teva gets tentative approval for the ProAir RespiClick albuterol DPI
FDA issues draft BE guidance for ipatropium bromide MDIs
The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers. In the US, Boehringer Ingelheim markets its ipatropium MDI for the treatment of COPD under the brand name Atrovent. The recommended tests included five in vitro tests, a PK study, and a PD study. The draft guidance notes that if the reference … [Read more...] about FDA issues draft BE guidance for ipatropium bromide MDIs
Study shows oxytocin nasal spray lowers calorie intake in men
Data to be presented at the upcoming annual meeting of The Endocrine Society show that healthy men treated with intranasal oxytocin consumed fewer calories and had reduced insulin sensitivity after use of the nasal spray. The randomized, placebo-controlled study, conducted by researchers from Harvard Medical School, involved 25 men, half of whom were normal weight and … [Read more...] about Study shows oxytocin nasal spray lowers calorie intake in men
Juhua now offering pharmaceutical grade HFA-134a (updated)
Zhejiang Juhua has announced that the US FDA accepted a drug master file (DMF) for pharmaceutical-grade HFA 134a submitted by its fluorochemicals subsidiary on December 26, 2014 and that the company also received accreditation for a drug registration certificate from the CFDA on February 15, 2015, representing the culmination of a 7-year registration process. … [Read more...] about Juhua now offering pharmaceutical grade HFA-134a (updated)
PMCPA reprimands Chiesi for misleading claims about Fostair
The UK's Prescription Medicines Code of Practice Authority (PMCPA) has reprimanded Chiesi for a misleading and unsubstantiated claim regarding the company's Fostair beclometasone/formoterol inhaler. The authority has published advertisements in the BMJ, The Pharmaceutical Journal, and The Nursing Standard that say, "The Code of Practice Panel reported the company to … [Read more...] about PMCPA reprimands Chiesi for misleading claims about Fostair