• FDA approves MannKind’s sBLA for pediatric use of Afrezza insulin DPI

  MannKind Corporation announced that the FDA has approved the company’s sBLA for use of Afrezza inhaled dry powder insulin for the treatment of Type 1 and Type 2 diabetes in children aged 6 and older. Afrezza was… [Read more . . .]

• Kvvit acquires rights to Merz’s Inbrija levodopa DPI in mainland China, Hong Kong, and Macao

  Jiangxi Kvvit Pharmaceutical is paying an undisclosed amount up front, plus potential milestones and royalties, to Merz Therapeutics to acquire the rights to develop and commercialize Merz’s Inbrija levodopa dry powder inhaler in mainland China,… [Read more . . .]

• Inhaled SSO developer Rage Bio rebrands as Atisama Therapeutics

  Australian biotech Rage Bio, which has been developing an inhaled splice-switching oligonucleotide (SSO) for the treatment of COPD, has announced that it has changed its name to Atisama Therapeutics. According to the announcement, the name… [Read more . . .]

• FDA tentatively approves Lupin’s ANDA for generic of Yupelri revefenacin inhalation solution

  According to Lupin, the FDA has tentatively approved the company’s ANDA for revefenacin inhalation solution, a generic of Mylan’s Yupelri inhalation solution. Yupelri was approved by the FDA for the treatment of COPD in 2018.… [Read more . . .]

• Quince Therapeutics to acquire Orphai Therapeutics and its LAM-001 rapamycin DPI

  Quince Therapeutics announced that it has agreed to acquire Orphai Therapeutics (formerly AI Therapeutics, formerly LAM Therapeutics) and its LAM-001 inhaled dry powder rapamycin (sirolimus) for $115 million up front and up to an additional… [Read more . . .]

• SNBL announces new effort to get Satsuma’s Atzumi DHE nasal powder for migraine into the US market

• Vertex ceases development of VX-522 inhaled RNA therapy for CF after stopping Phase 1/2 trial due to tolerability issues

• Enterprise Therapeutics says Phase 2 trial of ETD001 inhaled ENaC blocker for CF met its primary endpoint

• Chance Pharma reports NMPA acceptance of NDA for CXG87 budesonide / formoterol DPI, Phase 3 results

• Hovione and IDC announce new single-use capsule-based intranasal delivery device for dry powder formulations

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