Upsher Smith presented positive Phase 1 data for its USL261 intranasal midazolam at the American Academy of Neurology (AAN) Meeting this week. The company launched a website to recruit patients for a Phase 3 study of the product last year. The intranasal formulation is being developed for the rescue treatment of seizures in epilepsy patients and is "intended to … [Read more...] about Upsher Smith presents positive Phase 1 data for intranasal midazolam
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Pharmaxis gets complete response letter for Bronchitol
According to Pharmaxis, the FDA has issued a complete response letter regarding its Bronchitol inhaled mannitol for the treatment of cystic fibrosis. The company says that the FDA requested another clinical trial. The Pharmaxis press release quotes the CRL, which says, “The submitted data do not provide a favorable benefit‐risk balance to support the use of inhaled … [Read more...] about Pharmaxis gets complete response letter for Bronchitol
Mylan levalbuterol inhalation solution ANDA approved
According to Mylan, its subsidiary Mylan Specialty L.P. has received FDA approval for its Abbreviated New Drug Application (ANDA) for levalbuterol inhalation solution, a generic version of Sunovion's Xopenex inhalation solution. The product is used for the treatment of bronchospasm caused by asthma and COPD. Mylan says that it has begun shipping product. Sunovion … [Read more...] about Mylan levalbuterol inhalation solution ANDA approved
Pearl Therapeutics wins Drug Delivery Partnerships Innovation Award
Pearl Therapeutics was awarded the 2013 Drug Delivery Partnerships (DDP) Innovation Award for its co-suspension formulation technology, according to the company. The company is developing several metered dose inhalation products using the technology. President and CEO Chuck Bramlage said, “We truly appreciate this award by our peers in the drug delivery industry. … [Read more...] about Pearl Therapeutics wins Drug Delivery Partnerships Innovation Award
Alexza hires Peter Schineller as Senior VP and Chief Commercial Officer
Alexza Pharmaceuticals has hired Peter W. Schineller as its new Senior VP and Chief Commercial Officer, responsible for global commercialization of the company's Adasuve Staccato inhaled loxapine. The FDA approved Adasuve for the treatment of agitation in patients with schizophrenia or bipolar I disorder in December 2012. In Europe, the product was approved in … [Read more...] about Alexza hires Peter Schineller as Senior VP and Chief Commercial Officer
University of East Anglia to team with Procarta on anti-MRSA nasal spray
The University of East Anglia (UEA) Medical School will fund research to adapt a MRSA-specific antibiotic being developed by Procarta Biosystems into a nasal spray for decolonization of patients before major surgery, according to Procarta. The company says that use of the spray against methicillin-resistant Staphylococcus aureus (MRSA) infections "promises to speed … [Read more...] about University of East Anglia to team with Procarta on anti-MRSA nasal spray
FDA panel votes against calcitonin nasal spray
In a joint meeting of the FDA's Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM), panelists voted 12-9 that the risk of cancer from calcitonin outweigh its potential benefits for osteoporosis. The panel also voted 20-1 that developers of new calcitonin products would have to prove efficacy in … [Read more...] about FDA panel votes against calcitonin nasal spray
PADAC meeting on Breo Ellipta postponed
The March 7 meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) for discussion of the Breo Ellipta inhaler, has been postponed due to weather. As of March 6, the meeting on GSK's application for the fluticasone furoate/vilanterol dry powder inhaler has not been rescheduled. Read the meeting announcement. … [Read more...] about PADAC meeting on Breo Ellipta postponed
The Lancet launches new respiratory medicine journal
The first issue of the Lancet Respiratory Medicine journal is now available online and in print. Volume 1, Issue 1 includes articles on the efficacy of ICS/LABA combination inhalers and on the appropriateness of GOLD COPD categories among others. The issue includes a section called "Country in Focus," plus spotlights, comment, news, and 2012 research highlights … [Read more...] about The Lancet launches new respiratory medicine journal
Study shows that use of Asthmapolis system improves asthma control
A study published February 27, 2013 in PLOS ONE found that patients using the Asthmapolis remote inhaler monitoring system who received weekly email reports on their inhaler usage experienced significant reduction in symptoms and reported improved control. At the end of the study 75% of participants had achieved control of their asthma as measured by the the Asthma … [Read more...] about Study shows that use of Asthmapolis system improves asthma control