A jury has awarded $18 million to Sunovion Pharmaceuticals after finding that Mylan willfully infringed on patents for Xopenex levalbuterol hydrochloride inhalation solution when its subsidiary Dey marketed generic versions of the product. The trial took place in the US District Court for the District of Delaware. The patents involved are US patents numbers … [Read more...] about Mylan says it will challenge verdict in Sunovion Xopenex patent infringement suit
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Herbal nasal sprays recalled
A Dallas, TX company called Wholistic Herbs Inc. has recalled all of the nasal spray products it distributed from March 2009 through February 2012 under the name "Koff & Kold" and "Kold Sore" after an FDA inspection determined that the products are not sterile. The products were distributed through the company's website, which is no longer accessible, and through … [Read more...] about Herbal nasal sprays recalled
EMA outlines objections to Adasuve MAA in Day 80 assessment report
Alexza Pharmaceuticals says that the Day 80 Assessment Report it has received from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve Staccato loxapine indicates that the report "outlines major objections pertaining to the extrapolation of the Phase 3 study population to the intended patient population, pulmonary … [Read more...] about EMA outlines objections to Adasuve MAA in Day 80 assessment report
Generic Symbicort fails to show equivalence
Finnish pharmaceutical company Orion Corporation has announced its intention to continue development of a generic budesonide/formoterol DPI despite the fact that "equivalence with the reference product, which is required under the guideline of the European Medicines Agency, was not reached" in recent studies. According to the company, study results received early this … [Read more...] about Generic Symbicort fails to show equivalence
Insmed moving ahead with Arikace trials despite FDA clinical hold
Insmed Incorporated has announced that it will go ahead with two clinical trials of its Arikace liposomal amikacin for inhalation for non-tuberculous mycobacteria (NTM) lung disease and for P. aeruginosa infections in CF patients despite the continuing clinical hold placed by the FDA on the latter application. The FDA lifted the hold on Arikace for NTM earlier … [Read more...] about Insmed moving ahead with Arikace trials despite FDA clinical hold
Report estimates 6.2% increase in nebulizer sales over 5-year period
A new report from IbisWorld foresees a positive outlook for nebulizer sales after estimated annualized growth rate of 6.2% from 2007 to 2012. The report suggests that an aging population and increasing diagnoses of respiratory illnesses, plus an improving economy will help manufacturers to overcome "some market saturation and new federal regulations." Total revenue … [Read more...] about Report estimates 6.2% increase in nebulizer sales over 5-year period
GSK tests Rotacaps inhaler versus Diskus for Advair
As GSK announced its 2011 results, which included sales declines for Advair (Seretide) in the US and Europe, and after the announcement that it plans to file a marketing application for its Relovair fluticasone furoate/vilanterol DPI despite disappointing data, Bloomberg took note of GSK's recent study of a cheaper capsule-based inhaler for delivery of Advair … [Read more...] about GSK tests Rotacaps inhaler versus Diskus for Advair
Akela gets funding for its PharmaForm subsidiary
Akela Pharma has announced completion of a private placement totaling $2,310,000 that it will use primarily for expansion of spray drying and hot melt extrusion capabilities at its subsidiary, PharmaForm. Although PharmaForm specializes in solid dosage forms, it also offers services for nasal sprays and dry powder formulation development. The parent company, … [Read more...] about Akela gets funding for its PharmaForm subsidiary
Almirall files new applications for Sativex in Europe
Almirall has announced the filing of new applications for its Sativex endocannabinoid oromucosal spray for the treatment of spasticity in multiple sclerosis in ten additional countries: Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The product is currently available in Denmark, Germany, Spain, UK, Canada, and … [Read more...] about Almirall files new applications for Sativex in Europe
Team Consulting opens new respiratory physics laboratory
Team Consulting has announced the opening of its new Respiratory Physics Laboratory at the company headquarters in Ickleton, Cambridgeshire, UK. Recent hire Mark Shepherd will manage the cGMP laboratory. “In recent years we have worked for six of the world’s top ten pharma companies and for them it is important to see us making this investment in facilities and … [Read more...] about Team Consulting opens new respiratory physics laboratory