According to Arcturus Therapeutics, the FDA has cleared an investigational new drug application allowing the company to proceed with a Phase 2 MAD trial of its ARCT-032 inhaled mRNA therapy in people with cystic fibrosis. The nebulized therapy, which is designed to deliver CFTR mRNA, has both orphan drug and rare pediatric disease designations from the FDA and orphan … [Read more...] about FDA clears IND for Phase 2 trial of Arcturus’ ARCT-032 inhaled mRNA therapy in CF patients
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MVIC names Mats Håkansson as new CEO
The Medicon Valley Inhalation Consortium (MVIC) announced that marketing specialist Mats Håkansson will take over the CEO role from Lars Asking. According to the announcement, Asking, who had served as the CEO of MVIC since 2017, will continue to lead projects for the consortium, which acts as a contract research organization. According to Håkansson's LinkedIn … [Read more...] about MVIC names Mats Håkansson as new CEO
ENA Respiratory announces advancement into Phase 1b study of INNA-051 intranasal dry powder antiviral
ENA Respiratory announced that it has completed a Phase 1a study and has initiated a Phase 1b study of its INNA-051 TLR2/6 agonist pan-viral nasal powder in people aged 60 and older. Earlier this year, the company announced that the FDA had cleared an IND for the Phase 1b trial. According to the company, the new trial is expected to enroll up to 40 … [Read more...] about ENA Respiratory announces advancement into Phase 1b study of INNA-051 intranasal dry powder antiviral
ARS Pharma’s EURneffy adrenaline nasal spray approved in Europe
ARS Pharmaceuticals announced that the European Commission has approved the company's EURneffy adrenaline nasal spray for the treatment of anaphylaxis. The approval comes soon after the FDA's approval of the US version, Neffy epinephrine nasal spray. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the EURneffy MAA in … [Read more...] about ARS Pharma’s EURneffy adrenaline nasal spray approved in Europe
Liquidia files suit to challenge FDA’s grant of exclusivity to Tyvaso DPI in ongoing litigation over Yutrepia DPI approval
Soon after the FDA granted temporary approval to Liquidia's sNDA for Yutrepia treprostinil DPI, the company announced that it has filed a lawsuit challenging the FDA's grant of 3-year new clinical investigation exclusivity to United Therapeutics' Tyvaso treprostinil DPI, which is standing in the way of final approval of Yutrepia. Exclusivity for Tyvaso DPI is … [Read more...] about Liquidia files suit to challenge FDA’s grant of exclusivity to Tyvaso DPI in ongoing litigation over Yutrepia DPI approval
Pharma Nordic acquires Swedish and Danish rights to Altamira’s Bentrio bentonite-based nasal spray
Pharma Nordic has expanded its distribution agreement with Altamira Medica for Bentrio nasal spray, adding Sweden and Denmark, the companies announced. Bentrio is an OTC bentonite-based nasal spray gel marketed for the prevention and treatment of allergic rhinitis. In July 2023, Pharma Nordic acquired the distribution rights for Bentrio in Norway, and the company … [Read more...] about Pharma Nordic acquires Swedish and Danish rights to Altamira’s Bentrio bentonite-based nasal spray
Proveca acquires global rights to Cessatech’s CT001 sufentanil / ketamine nasal spray
Cessatech and pediatric medicines specialist Proveca have announced a deal that gives Proveca global commercialization rights to Cessatech's CT001 sufentanil / ketamine analgesic nasal spray. Earlier this year, Cessatech initiated a Phase 3 trial of CT001 in children with moderate-to-severe pain under care in the emergency department. According to the … [Read more...] about Proveca acquires global rights to Cessatech’s CT001 sufentanil / ketamine nasal spray
FDA tentatively approves Liquidia’s sNDA for Yutrepia treprostinil DPI to add PH-ILD as an indication
According to Liquidia Corporation, the FDA has granted tentative approval of the company's sNDA for Yutrepia dry powder treprostinil for inhalation powder to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication. In November 2021, the FDA tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension … [Read more...] about FDA tentatively approves Liquidia’s sNDA for Yutrepia treprostinil DPI to add PH-ILD as an indication
Avalyn initiates Phase 1b study of APO2 inhaled nintedanib
Avalyn Pharma has initiated a Phase 1b SAD/MAD trial of its AP02 inhaled nintedanib delivered via the PARI eFlow nebulizer in healthy adults, the company said. Avalyn is developing AP02, along with AP01 inhaled pirfenidone, for the treatment of pulmonary fibrosis. In September 2023, the company announced that it had raised $175 million for continued development of … [Read more...] about Avalyn initiates Phase 1b study of APO2 inhaled nintedanib
FDA approves ARS Pharmaceutical’s Neffy intranasal epinephrine for the treatment of anaphylaxis
The FDA has approved ARS Pharmaceutical's NDA for Neffy epinephrine nasal spray for the treatment of Type 1 allergic reactions, including anaphylaxis, in patients who weigh 30 kg or greater. In response, ARS Pharma announced that the product should be available in the US within 8 weeks and also said that it plans to submit an sNDA seeking approval for the use of Neffy … [Read more...] about FDA approves ARS Pharmaceutical’s Neffy intranasal epinephrine for the treatment of anaphylaxis