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
Regulatory
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
FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
According to ENA Respiratory, the FDA has cleared the company's IND for a Phase 1b study of a dry powder formulation of INNA-051, a TLR2/6 agonist, which the company has been developing as a pan-viral nasal spray. ENA said that it expects the study to begin in mid-2024. Development of the dry powder formulation is partially funded by the US Department of Defense … [Read more...] about FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
FDA approves Amneal’s generic version of Narcan naloxone nasal spray
Amneal Pharmaceuticals announced that it has launched a generic over-the-counter naloxone nasal spray for the reversal of opioid overdose after its ANDA for the product was approved by the FDA. Amneal had announced the agency's acceptance of the ANDA in March 2023. The nasal spray is a generic version of Narcan, which was approved for OTC sales later in March … [Read more...] about FDA approves Amneal’s generic version of Narcan naloxone nasal spray
Adherium’s Hailie Smartinhaler monitor cleared for use with Airsupra and Breztri
According to inhaler monitor company Adherium, the FDA has cleared the Hailie Smartinhaler sensor for use with the Airsupra albuterol / budesonide MDI and with the Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI, both from AstraZeneca. The Hailie system is already approved for use with a number of different inhalers, including GSK's Ventolin, … [Read more...] about Adherium’s Hailie Smartinhaler monitor cleared for use with Airsupra and Breztri
SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
The Cystic Fibrosis Foundation announced that it making an additional investment of up to $8.5 million to support a Phase 2 trial of SpliSense's nebulized SPL84 antisense oligonucleotide in patients with cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has received Orphan Drug designation from both the EMA and the FDA. According to SpliSense, the … [Read more...] about SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
ARS Pharmaceuticals said that it has submitted its response to the complete response letter it received from the FDA in September 2023 regarding the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis. The CRL included a request for a repeat dose nasal allergen challenge study of Neffy, which was completed … [Read more...] about ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
Liquidia Corporation announced today that the expiration of United Therapeutics' new clinical investigation exclusivity for the use of Tyvaso treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) on March 31, 2024, along with court rulings on March 28 and March 29, has cleared the way for the FDA to issue final … [Read more...] about Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray for the treatment of PSVT
Milestone Pharmaceuticals announced that it has resubmitted its NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). The FDA had issued a Refuse to File letter in December 2023 in response to the NDA, which the company had submitted in October 2023. In February 2024, Milestone announced that it had held a Type A meeting … [Read more...] about Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray for the treatment of PSVT