Regulatory

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

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 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

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 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

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 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

Indian pharma company Sava Healthcare has announced that its DPI capsule manufacturing line has received approval from the Russian Ministry of Health (MOH). Sava said that it manufactures tiotropium, formoterol, salmeterol/fluticasone, and budesonide/formoterol DPIs for the Russian and CIS markets. According to Sava, its Surendranagar facility, which also … [Read more...] about Sava Healthcare gets Russian GMP approval for Indian DPI capsule manufacturing line