Defender Pharmaceuticals announced that the FDA has issued a complete response letter in response to the NDA for DPI-386 scopolamine nasal gel that the company submitted in July 2023. The FDA accepted the NDA for review in September 2023, with a PDUFA goal date of January 26, 2024. Defender President and CEO Barry I. Feinberg commented, “Following our review of … [Read more...] about Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA
Regulatory
Liquidia announces that the FDA will miss the PDUFA goal date for review of Yutrepia sNDA to add PH-ILD indication
According to Liquidia Corporation, the FDA has informed the company that the agency will not meet the PDUFA goal date of January 24, 2004 for completion of the review of Liquidia's sNDA to add an indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD) for Yutrepia treprostinil DPI. The company said that the FDA "informed the Company … [Read more...] about Liquidia announces that the FDA will miss the PDUFA goal date for review of Yutrepia sNDA to add PH-ILD indication
FDA issues CRL to Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine
According to Satsuma Pharmaceuticals parent company Shin Nippon Biomedical Laboratories, the FDA has issued a complete response letter to Satsuma's NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine. SNBL said that the CRL cited CMC issues only and did not request any additional clinical data or new clinical trials. The company added that it … [Read more...] about FDA issues CRL to Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine
PureIMS says it is on a path to an abbreviated application for Levodopa Cyclops DPI based on Phase 1 trial results
PureIMS announced that a Phase 1 PK study that compared the company's Levodopa Cyclops to Inbrija levodopa DPI, demonstrated "high comparability with a marketed inhaled levodopa product," with faster initial absorption and no safety or tolerability concerns reported. The company announced the initiation of the Phase 1 study in August 2023. The company says that it … [Read more...] about PureIMS says it is on a path to an abbreviated application for Levodopa Cyclops DPI based on Phase 1 trial results
Liquidia announces initiation of safety and tolerability study of Yutrepia in PH-ILD patients and provides update on L606 liposomal treprostinil inhalation suspension
Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected to enroll 60 PH-ILD patients. The FDA tentatively approved Yutrepia for the treatment of pulmonary … [Read more...] about Liquidia announces initiation of safety and tolerability study of Yutrepia in PH-ILD patients and provides update on L606 liposomal treprostinil inhalation suspension
US Senate committee launches investigation of inhaler prices
Members of the United States Senate Committee on Health, Education, Labor, and Pensions (HELP) have sent letters to the CEOs of AstraZeneca, Boehringer Ingelheim, GSK, and Teva asserting that "There is no reason for inhalers to be so expensive" and that each company "has manipulated the regulatory system to extend its monopolies over its inhaler products." The letters … [Read more...] about US Senate committee launches investigation of inhaler prices
Firebrick no longer seeking approval of Nasodine nasal spray in Australia
Firebrick Pharmaceuticals announced that it has withdrawn its appeal of a decision by the Therapeutic Goods Administration (TGA), which refused to approve the company's Nasodine povidone-iodine nasal spray as a treatment for the common cold. Firebrick said that the withdrawal was due to "the significant distraction and legal costs associated with proceeding," … [Read more...] about Firebrick no longer seeking approval of Nasodine nasal spray in Australia
FDA issues Refuse to File letter in response to Milestone’s NDA for etripamil nasal spray
According to Milestone Pharmaceuticals, the FDA has refused to file the company's NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and has "requested clarification about the time of data recorded for adverse events" during Phase 3 trials. Milestone submitted the NDA in October 2023. Milestone initiated the Phase 3 … [Read more...] about FDA issues Refuse to File letter in response to Milestone’s NDA for etripamil nasal spray
Court upholds PTAB ruling invalidating United Therapeutics’ patent at center of suit delaying final approval Liquidia’s Yutrepia treprostinil DPI
According to Liquidia Corporation, the company will immediately take steps toward getting final FDA approval of Yutrepia treprostinil DPI now that the US Court of Appeals has upheld a decision by the Patent Trial and Appeal Board (PTAB) invalidating all of the claims of US Patent No. 10,716,793. Earlier this year, the Court of Appeals upheld a District Court ruling … [Read more...] about Court upholds PTAB ruling invalidating United Therapeutics’ patent at center of suit delaying final approval Liquidia’s Yutrepia treprostinil DPI
FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis
The FDA has extended the review period for Optinose's sNDA seeking approval of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps, Optinose said. Xhance was originally approved by the FDA in 2017 for the treatment of nasal polyps. The agency originally accepted the sNDA in May 2023 and set a PDUFA goal … [Read more...] about FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis