Regulatory
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According to Impel NeuroPharma, the FDA has given the company a notice to proceed with clinical study of INP101 intranasal dihydroergotamine (DHE) for the treatment of acute migraine. A Phase 3 study is expected to… Read more . . .
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Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a… Read more . . .
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Novus Therapeutics said that it recently had a Type C meeting with the FDA regarding its OP-02 intranasal dipalmitoylphosphatidylcholine (DPPC)/cholesteryl palmitate (CP) suspension for the treatment of otitis media and has received confirmation of its… Read more . . .
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Insmed has announced that the FDA’s Division of Antimicrobial Products has set an advisory committee meeting for August 7, 2018 for review of the company’s NDA for ALIS amikacin liposome inhalation suspension for the treatment… Read more . . .
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Mylan has announced that it was informed by the FDA on June 13, 2018 that the agency will issue a complete response letter regarding Mylan’s ANDA for its generic Advair Diskus fluticasone/salmeterol DPI on June… Read more . . .
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MannKind Corporation has announced that a previously announced Phase 1 study of its Treprostinil Technosphere (TreT) DPI in healthy volunteers has met its primary endpoint of safety and tolerability, and the company is now preparing… Read more . . .
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Evoke Pharma has submitted a 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, the company said. Earlier this year, Evoke announced that it had… Read more . . .
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Apotex has issued a voluntarily recall for one lot of fluticasone propionate nasal spray (lot NJ4501), which was shipped to wholesalers and distributors throughout the US and has an expiration date of July 2020. Apotex… Read more . . .
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GSK Australia has announced that the Australian Pharmaceutical Benefits Scheme (PBS) will reimburse for Trelegy Ellipta for the treatment of moderate to severe COPD as of June 1, 2018. According to a document on the… Read more . . .
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GSK and Innoviva have announced that an NDA for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW). Trelegy Ellipta… Read more . . .
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December 9-December 11: DDL 2026, Edinburgh, Scotland