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 begin enrolling patients in the second half of this year. The company said that it had recently submitted an investigational new drug application to the … [Read more...] about Impel plans for Phase 3 study of intranasal DHE for migraine
Regulatory
Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
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 pre-IND meeting for AB569. The study began recruiting volunteers in February 2018. Arch Biopartners CEO Richard Muruve said, “We have … [Read more...] about Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Novus Therapeutics gets FDA guidance on development of nasal MDI for otitis media
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 development plans. The company explains that OP-2, which is delivered via a metered dose inhaler, "is intended to … [Read more...] about Novus Therapeutics gets FDA guidance on development of nasal MDI for otitis media
Date set for FDA advisory committee to review Insmed’s NDA for Alis
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 of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Insmed submitted the NDA in March 2018 and … [Read more...] about Date set for FDA advisory committee to review Insmed’s NDA for Alis
Mylan says it expects CRL for its generic version of Advair Diskus
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 27, 2018. According to Mylan, the reason for the CRL is that the FDA "has identified minor deficiencies." Mylan received a previous CRL for its generic … [Read more...] about Mylan says it expects CRL for its generic version of Advair Diskus
Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint
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 for a study in patients with pulmonary arterial hypertension (PAH). According to the company, data from the study, which … [Read more...] about Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint
Evoke submits NDA for Gimoti metoclopramide nasal spray for diabetic gastroparesis
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 amended its deal with Mallinckrodt to defer milestone payments due on acceptance of review of the Gimoti NDA on final approval, with a single … [Read more...] about Evoke submits NDA for Gimoti metoclopramide nasal spray for diabetic gastroparesis
Apotex recalls lot of fluticasone nasal spray in US
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 said that the FDA is aware of the recall and wholesalers and distributors have been notified. According to the company, a consumer complaint … [Read more...] about Apotex recalls lot of fluticasone nasal spray in US
Australian Pharmaceutical Benefits Scheme to reimburse for Trelegy Ellipta
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 Therapeutic Goods Administration (TGA) website, Trelegy Ellipta was entered into the Australian Register of Therapeutic Goods as of January 16, 2018. … [Read more...] about Australian Pharmaceutical Benefits Scheme to reimburse for Trelegy Ellipta
GSK submits marketing application for Trelegy Ellipta in Japan
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 was approved in the US and in Europe for the treatment of COPD in 2017 and was approved in Canada earlier this year. The FDA … [Read more...] about GSK submits marketing application for Trelegy Ellipta in Japan