August 2012
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Mylan Pharmaceuticals has announced the launch of the Wixela Inhub fluticasone propionate/salmeterol DPI in Canada. According to the company, Health Canada approved Wixela Inhub, a generic version of Advair Diskus, in January 2020 for asthma and COPD.… Read more . . .
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Vectura has announced the appointment of Mark Bridgewater as Chief Commercial Officer, a position the company said it has created as it “continues with its strategy to become a leading inhalation specialist in the pharmaceutical… Read more . . .
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The FDA has announced the publication of a batch of new and revised product specific guidances for development of generic versions of a number of drugs, including a number of inhaled and nasal drug products,… Read more . . .
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Virpax Pharmaceuticals has announced the successful completion of a pre-IND meeting with the FDA regarding the company’s NES100 intranasal enkephalin formulation for the management of acute and chronic pain. NES100 is a molecular envelope technology… Read more . . .
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Neurelis has announced the launch of Valtoco diazepam nasal spray for the treatment of seizure clusters in the US. The FDA approved Valtoco for the treatment of acute repetitive seizures in epilepsy patients aged 6… Read more . . .
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Sumitovant Biopharma subsidiary Altavant Sciences has announced the appointment of Howard M. Lazarus as Chief Medical Officer, a newly created position. Lazarus was most recently Medical Expert/Executive Director in Clinical Development and Medical Affairs at… Read more . . .
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Hikma Pharmaceuticals has signed an agreement with Glenmark Pharmaceuticals for exclusive US rights to Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, the companies said. According to the announcement, the… Read more . . .
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GSK and Innoviva have announced that the EMA accepted a regulatory submission to expand the use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI to add the treatment of asthma in adults as an indication. Trelegy Ellipta… Read more . . .
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Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020.… Read more . . .
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The FDA has announced the approval of Perrigo’s ANDA for a generic of Teva’s ProAir HFA albuterol MDI for the treatment of asthma in patients 4 years old and older. Perrigo initially filed its ANDA for… Read more . . .
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