GSK has voluntarily recalled 593,088 Ventolin inhalers manufactured at its Zebulon, North Carolina facility due to an "Elevated number of units with out of specification results for leak rate." The lots involved in the level 2 recall, which was initiated on March 22, 2017, were distributed throughout the United States and Puerto Rico. In 2015, GSK recalled … [Read more...] about GSK recalls almost 600,000 Ventolin inhalers in US
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Therapix Biosciences licenses nasal drug delivery tech for delivery of cannabinoids
Therapix Biosciences has signed a licensing agreement with Yissum Research Development Company for nasal drug delivery technology that it plans to use for intranasal delivery of cannabinoids, the company said. Yissum Research Development Company is Hebrew University's technology transfer company. In 2016, Therapix announced that it had licensed an intranasal … [Read more...] about Therapix Biosciences licenses nasal drug delivery tech for delivery of cannabinoids
Sunovion launches Utibron Neohaler in US
Sunovion has launched the Utibron Neohaler indacaterol/glycopyrrolate DPI for the treatment of COPD in the United States, the company announced. Sunovion acquired the US rights to the Utibron, Seebri, and Arcapta Neohalers from Novartis in December 2016. Utibron Neohaler, which is marketed as Ultibro Breezhaler outside of the US, was approved by the FDA in … [Read more...] about Sunovion launches Utibron Neohaler in US
Verona Pharma announces development agreements, appointment of Richard Hennings as Commercial Director
Verona Pharma has announced a clinical development services agreement with QuintilesIMS for Verona's RPL554, an inhaled PDE3/PDE4 inhibitor for the treatment of acute exacerbations in COPD patients. The company also said that it is planning to develop RPL554 as both an MDI and as a DPI in partnership with two European technology companies. In addition, Verona … [Read more...] about Verona Pharma announces development agreements, appointment of Richard Hennings as Commercial Director
Lannett found to have infringed on patents related to Zomig nasal spray
Judge Richard G. Andrews of the US District Court, District of Delaware, has found that Lannett has infringed on the US patents 6,750,237 and 7,220,767 related to Zomig zolmitriptan nasal spray, Impax Laboratories has announced. In 2014, Impax filed suit against Lannett after Lannett filed an ANDA for a generic version of Zomig nasal spray. In 2012, Impax … [Read more...] about Lannett found to have infringed on patents related to Zomig nasal spray
PARI Pharma licences inhaled therapy for bronchiolitis obliterans syndrome to Breath Therapeutics
According to PARI Pharma, the company has licensed a formulation of liposomal cyclosporine A for the treatment of bronchiolitis obliterans syndrome (BOS) to Breath Therapeutics. Breath Therapeutics, a spin off of PARI, recently announced that it has raised €43.5 million in Series A Financing, which it will use for Phase 3 trials of the product, regulatory … [Read more...] about PARI Pharma licences inhaled therapy for bronchiolitis obliterans syndrome to Breath Therapeutics
Circassia acquires rights to Tudorza and Duaklir DPIs in the US
AstraZeneca has announced an agreement with Circassia Pharmaceuticals for development and commercialization of the Tudorza and Duaklir dry powder inhalers in the US. AstraZeneca will receive $50 million in Circassia ordinary shares and $100 million on approval of Duaklir in the US or June 30, 2019, whichever comes first. Circassia will have the option to acquire … [Read more...] about Circassia acquires rights to Tudorza and Duaklir DPIs in the US
Pharmaxis announces completion of treatment in Phase 3 trial of Bronchitol for CF
According to Pharmaxis, treatment has been concluded in a Phase 3 trial of its Bronchitol mannitol DPI for the treatment of cystic fibrosis. A total of 423 patients in 21 countries were treated in the 26-week randomized, double-blind parallel group study. The company expects to report topline results in the second quarter of 2017 and, if results are positive, to … [Read more...] about Pharmaxis announces completion of treatment in Phase 3 trial of Bronchitol for CF
Vectura announces that it met royalty cap on Ellipta products a year earlier than expected
Vectura met the £9 million calendar year royalty cap on GSK's Ellipta DPI products in 2016, a year earlier than predicted, the company said. The £9 million calendar year royalty cap is included in a legacy Skyepharma/GSK agreement that pays Vectura low single-digit royalties on net sales of Ellipta dry powder inhaler products. The company said that it will record … [Read more...] about Vectura announces that it met royalty cap on Ellipta products a year earlier than expected
Dauntless Pharmaceuticals initiates Phase 1 study of intranasal octreotide
Dauntless Pharmaceuticals has initiated a Phase 1 clinical study of its DP1038 intranasal octreotide acetate, the company said. The study will compare DP1038 to Sandostatin octreotide acetate injection in healthy volunteers. DP1038 is in development for the treatment of acromegaly and neuroendocrine tumors. In July 2014, Aegis Therapeutics announced that it was … [Read more...] about Dauntless Pharmaceuticals initiates Phase 1 study of intranasal octreotide