According to Agomab Therapeutics, the company's AGMB-447 inhaled ALK5 inhibitor has received orphan drug designation from the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). Agomab initiated a Phase 1 trial of AGMB-447 in December 2023. Agomab Chief Medical Officer Philippe Wiesel commented, “Receiving orphan drug designation from the FDA provides … [Read more...] about Agomab’s AGMB-447 inhaled ALK5 inhibitor gets orphan drug designation from the FDA
Regulatory
Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
According to Liquidia Corporation, a judge in the US District Court for the District of Delaware has denied a United Therapeutics motion seeking a preliminary injunction to prevent Liquidia from launching Yutrepia treprostinil DPI for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Earlier this year, the company said that … [Read more...] about Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
FDA accepts Milestone’s NDA for Cardamyst etripamil nasal spray
Milestone Pharmaceuticals announced that the FDA has accepted the company’s NDA for Cardaymyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone originally submitted the NDA in October 2023, and the FDA issued a Refuse to File letter in December 2023. The company re-submitted the NDA in March 2024. Milestone … [Read more...] about FDA accepts Milestone’s NDA for Cardamyst etripamil nasal spray
FDA grants Fast Track designation to SpliSense’s SPL84 inhaled antisense oligonucleotide for CF
According to SpliSense, the FDA has granted Fast Track designation to the company's SPL84 inhaled antisense oligonucleotide for the treatment of cystic fibrosis. SPL84 had already received Orphan Drug designation from both the FDA and the EMA. Earlier this year, the FDA cleared an IND for a Phase 2 trial of SPL84 in patients with cystic fibrosis associated with the … [Read more...] about FDA grants Fast Track designation to SpliSense’s SPL84 inhaled antisense oligonucleotide for CF
FDA approves Amphastar’s ANDA for generic of ProAir HFA albuterol MDI
Amphastar Pharmaceuticals announced that the FDA has approved the company's ANDA for a generic version of Teva's ProAir HFA albuterol MDI for the treatment of asthma and said that it plans to launch the inhaler in the 3rd quarter of 2024. Amphastar's currently marketed OINDPs include Baqsimi intranasal dry powder glucagon, Rextovy naloxone nasal spray, and Primatene … [Read more...] about FDA approves Amphastar’s ANDA for generic of ProAir HFA albuterol MDI
EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
EVŌQ Bio said that it had positive feedback from the FDA following a pre-IND meeting about EVQ-218 inhaled non-ionic silver nanoparticle, which the company is developing for the treatment of pulmonary bacterial infections in cystic fibrosis patients with funding from the Cystic Fibrosis Foundation. According to parent company EVŌQ Nano's web site, an IND submission … [Read more...] about EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
ENA Respiratory gets US patent covering INNA-051 intranasal antiviral
ENA Respiratory announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application titled “Novel molecules” (US 18/112091), which covers the company's INNA-051 intranasal TLR2/6 agonist. According to ENA, INNA-051 is now covered by 30 patents in the US, Europe, and other markets. The FDA recently cleared the … [Read more...] about ENA Respiratory gets US patent covering INNA-051 intranasal antiviral
MannKind’s clofazimine inhalation suspension gets Fast Track designation
MannKind Corporation announced that its MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections has been granted Fast Track designation by the FDA. MNKD-101 had already received orphan drug and qualified infectious disease product (QIDP) designations. The FDA recently cleared MannKind's IND for the Phase 3 … [Read more...] about MannKind’s clofazimine inhalation suspension gets Fast Track designation
ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company's MAA for Neffy epinephrine nasal spray to the EMA's Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the MAA by mid-2024. The company said that it received Day 180 comments in late 2023 requesting results from a repeat dose study of Neffy under nasal … [Read more...] about ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM
MannKind Corporation announced that the FDA has cleared the company's IND for the ICoN-1 Phase 3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). The company said that it expects to initiate the study in the US by mid-2024 and elsewhere by the end of the … [Read more...] about FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM