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
News
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
Oragenics says pre-clinical study demonstrated that ONP-002 intranasal dry powder likely has a large cardiac safety margin
Oragenics announced that a GLP human Ether-à-go-go-Related Gene study conducted by Charles River Laboratories found that ONP-002, an intranasal neurosteroid, would likely not cause heart arrhythmias. ONP-002 is a new chemical entity formulated as a dry powder and delivered via a breath-activated nasal delivery device. The nasal powder is in development for the … [Read more...] about Oragenics says pre-clinical study demonstrated that ONP-002 intranasal dry powder likely has a large cardiac safety margin
Bespak joins IPAC
According to Bespak, the company has joined the International Pharmaceutical Aerosol Consortium (IPAC), which is the parent organization of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Earlier this year, Bespak spun out of Recipharm, which joined IPAC-RS as a member in 2022. Bespak will be represented on the IPAC board … [Read more...] about Bespak joins IPAC
Nasus Pharma says its FMXIN002 intranasal dry powder epinephrine demonstrated 5 years stability
According to Nasus Pharma, a stability study of the company's FMXIN002 nasal epinephrine powder demonstrated full stability for the formulation and device over 5 years of storage at 15 to 25℃. The company said that at 5 years, the epinephrine level was at 97.5%, with degradation products at 0.37%. Nasus noted that a previous stability test at 40℃ and 75% humidity … [Read more...] about Nasus Pharma says its FMXIN002 intranasal dry powder epinephrine demonstrated 5 years stability
NeOnc initiates Phase 2 trial of NEO100 intranasal perillyl alcohol in patients with high-grade meningiomas
NeOnc Technologies has announced the initiation of a Phase 2 trial of NEO100 intranasal perillyl alcohol in patients with tumors of the membranes surrounding the brain and/or spinal cord. A Phase 2 trial of the intranasal formulation in patients with grade 4 gliomas was initiated in May 2016 and recently expanded to include patients with a type of astrocytoma. Two … [Read more...] about NeOnc initiates Phase 2 trial of NEO100 intranasal perillyl alcohol in patients with high-grade meningiomas