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
Regulatory
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
Incannex announces completion of pre-IND meeting with FDA regarding IHL-216A inhaled CBD/isoflurane
Australian cannabinoid developer Incannex Healthcare said that its pre-IND meeting with the FDA regarding its IHL-216A inhaled CBD/isoflurane for the treatment of traumatic brain injury was "constructive." In June 2021, Incannex signed an agreement with inhalation CDMO Vectura for preclinical development services for IHL-216A. The company said at that time that … [Read more...] about Incannex announces completion of pre-IND meeting with FDA regarding IHL-216A inhaled CBD/isoflurane
Harm Reduction Therapeutics initiates rolling NDA submission for RiVive intranasal naloxone
Harm Reduction Therapeutics announced that it has made an initial filing for a rolling review of its NDA for RiVive naloxone nasal spray, an OTC product for the treatment of opioid overdose. In August 2022, the company announced that it had received Fast Track designation for RiVive (HRT001) and had signed a commercial supply agreement. The company said that it is … [Read more...] about Harm Reduction Therapeutics initiates rolling NDA submission for RiVive intranasal naloxone
Health Canada approves Ryaltris nasal spray for the treatment of seasonal allergic rhinitis
According to Bausch Health and Glenmark, Health Canada has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in people aged 6 and older. Bausch Health acquired the Canadian rights to Ryaltris in March 2021. Ryaltris has been approved in Australia since December 2019, in Europe since April 2021 and in the US … [Read more...] about Health Canada approves Ryaltris nasal spray for the treatment of seasonal allergic rhinitis