According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has found that none of the claims included in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are valid. The company said that the PTAB ruling would have to be upheld on appeal before it can affect a court ruling holding up final approval of Liquidia's NDA for … [Read more...] about PTAB rules in Liquidia’s favor, finds another Tyvaso patent’s claims are not patentable
Regulatory
FDA approves Beyond Air’s LungFit PH inhaled NO system for PPHN
According to Beyond Air, the FDA has approved the company's LungFit PH inhaled nitric oxide (iNO) generation and delivery system for the treatment of babies with persistent pulmonary hypertension of the newborn (PPHN). The approval is the first for the company, which is also developing LungFit iNO systems for the treatment of COVID-19 pneumonia, bronchiolitis, and … [Read more...] about FDA approves Beyond Air’s LungFit PH inhaled NO system for PPHN
Altamira’s Bentrio nasal spray gets 510(k) clearance
Altamira Therapeutics (formerly Auris Medical) announced that the company has received 510(k) clearance to sell its Bentrio Allergy Blocker nasal spray over the counter for the treatment of allergic rhinitis in the US. The company said that it is in talks with "established OTC consumer health companies" regarding distribution of Bentrio in the US and elsewhere and … [Read more...] about Altamira’s Bentrio nasal spray gets 510(k) clearance
Padagis launches generic of Narcan naloxone nasal spray
Padagis, formerly Perrigo's generic prescription pharmaceutical business, has announced the launch of a generic version of Narcan naloxone nasal spray for the reversal of opioid overdose. The Padagis generic is the second approved in the US since the FDA's initial approval of Narcan in 2015. Teva’s version of Narcan was approved by the FDA in April 2019 and was … [Read more...] about Padagis launches generic of Narcan naloxone nasal spray
Savara’s molgramostim gets Innovation Passport from the MHRA
Savara announced that the UK Medicines and Healthcare Products Regulatory Agency has awarded an Innovation Passport to molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The Innovation Passport provides entry into the agency's Innovative Licensing and … [Read more...] about Savara’s molgramostim gets Innovation Passport from the MHRA
Opiant begins rolling NDA submission for OPNT003 intranasal nalmefene
Opiant Pharmaceuticals said that it has filed the first part of a 505(b)(2) NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose and that it expects to complete the submission later this year. The company recently announced that a PD study of OPNT003 met its primary endpoint. Opiant President and CEO Roger Crystal commented, "The opioid … [Read more...] about Opiant begins rolling NDA submission for OPNT003 intranasal nalmefene
FDA clears IND for Codagenix intranasal RSV vaccine
According to Codagenix, the FDA has cleared the company's IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study in children aged 6 months to 5 years. Codagenix previously conducted a Phase 1 study of CodaVax-RSV in adults aged … [Read more...] about FDA clears IND for Codagenix intranasal RSV vaccine
FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI
According to Avillion, the FDA has accepted the company's NDA for AstraZeneca's PT027 albuterol/budesonide MDI for the treatment of asthma in patients aged 4 and older for review. In March 2018, Avillion announced that it was partnering with Pearl Therapeutics on development of PT027; Pearl was acquired by AstraZeneca in 2013. AstraZeneca has an option to … [Read more...] about FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI
FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD
United Therapeutics has announced the FDA's approval of its NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil Technosphere from MannKind Corporation in September 2018 and submitted the NDA for Tyvaso DPI in … [Read more...] about FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD
Blue Lake’s intranasal RSV vaccine gets Fast Track designation
According to CyanVac subsidiary Blue Lake Biotechnology, the FDA has granted Fast Track designation for the company's BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) in children under 2 and adults over 60. The vaccine is based on an attenuated strain of canine parainfluenza virus (PIV5). In March 2022, Blue Lake announced that the FDA had … [Read more...] about Blue Lake’s intranasal RSV vaccine gets Fast Track designation