Adherium announced that the FDA has granted 510(k) clearance for use of Adherium's next-generation Hailie inhaler sensor with GSK's Ventolin, Advair, and Flovent MDIs. The company had announced submission of the 510(k) application in August 2022. Adherium CEO Rick Legleiter said, "This is the third 510(k) market clearance of the next-generation Hailie sensors … [Read more...] about Adherium’s Hailie sensor gets 510(k) clearance for use with Ventolin, Advair, and Flovent MDIs
Regulatory
Opiant completes rolling NDA submission for OPNT003 intranasal nalmefene
According to Opiant Pharmaceuticals, the submission of its NDA for OPNT003 nalmefene nasal spray for the treatment of opioid overdose has been completed, and the FDA's decision on acceptance of the application is expected in February 2023. The company announced that it had initiated the rolling NDA submission at the beginning of June 2022. Aptar Pharma’s Unit Dose … [Read more...] about Opiant completes rolling NDA submission for OPNT003 intranasal nalmefene
FDA solicits comments regarding a potential switch to nonprescription naloxone products, including nasal sprays
The FDA has issued a notice in the Federal Register titled, "Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use." The agency says that its preliminary opinion is that autoinjectors with doses up to 2 mg and nasal sprays with doses up to 4 mg such as Narcan nasal spray could be appropriately approved as nonprescription … [Read more...] about FDA solicits comments regarding a potential switch to nonprescription naloxone products, including nasal sprays
Court finds Symbicort patent invalid in win for Viatris and Kindeva
According to Viatris, the US District Court for the Northern District of West Virginia has determined that US Patent No. 10,166,247, which covers AstraZeneca's Symbicort budesonide / formoterol MDI, is invalid. In March 2021, the same court upheld claims in three other patents protecting Symbicort. An appeals court reversed the March 2021 decision in December 2021 and … [Read more...] about Court finds Symbicort patent invalid in win for Viatris and Kindeva
PADAC recommends approval of PT027 albuterol/budesonide MDI for the treatment of asthma in adults
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 that the benefit of Avillion and AstraZeneca's PT027 albuterol / budesonide MDI for the treatment of asthma in adults outweighs the risks. However, the committee voted 9 to 8 that the risk outweighs the benefits for adolescents aged 12 to 17 and voted 16 to 1 against the use of PT027 for … [Read more...] about PADAC recommends approval of PT027 albuterol/budesonide MDI for the treatment of asthma in adults
FDA grants Fast Track designation to Codagenix’s CodaVax intranasal vaccine against RSV
According to Codagenix, the FDA has granted Fast Track designation to the company's CodaVax-RSV live-attenuated intranasal vaccine candidate against respiratory syncytial virus (RSV). Earlier this year, the FDA cleared an IND for CodaVax-RSV. The company now says that the Phase 1 dose escalation study in children aged 6 months to 5 years is expected to start after the … [Read more...] about FDA grants Fast Track designation to Codagenix’s CodaVax intranasal vaccine against RSV
FDA issues warning letter to Nephron for cGMP violations
On October 11, 2022, the FDA issued a lengthy warning letter to Nephron SC, a manufacturer of inhalation solutions and suspensions as well as a contract manufacturer of other sterile drug products. The letter does not refer specifically to any inhalation products but notes that the company recently recalled a lot of an injection product and suspended manufacturing of … [Read more...] about FDA issues warning letter to Nephron for cGMP violations
United Therapeutics request for review of PTAB decision on Tyvaso patent is denied
According to Liquidia, the US Patent and Trademark Office's Precedential Opinion Panel (POP) will not review a July 2022 Patent Trial and Appeals Board (PTAB) decision which determined that none of the claims in US Patent No. 10,716,793, which covers United Therapeutics' Tyvaso inhaled treprostinil, are valid. United Therapeutics had requested both a POP review of the … [Read more...] about United Therapeutics request for review of PTAB decision on Tyvaso patent is denied
FDA accepts NDA for ARS Pharmaceuticals’ Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis
According to Silverback Therapeutics and ARS Pharmaceuticals, the FDA has accepted ARS's NDA for its Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, with a PDUFA date set for mid-2023. The two companies recently announced that they would merge, with the resulting company operating as ARS Pharmaceuticals and focused on … [Read more...] about FDA accepts NDA for ARS Pharmaceuticals’ Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis
Hibiocy enters contract with Genscript for manufacturing of Covitrap nasal spray for the prevention of COVID-19
According to CDMO GenScript ProBio, the company has signed an agreement with Thai company Hibiocy for manufacturing of Covitrap, an intranasal antibody cocktail for the prevention of COVID-19. GenScript said that the deal includes both clinical trial and commercial manufacturing of Covitrap, as well as work on development of new products. The company said that … [Read more...] about Hibiocy enters contract with Genscript for manufacturing of Covitrap nasal spray for the prevention of COVID-19