OINDPnews


Copley Scientific banner

Regulatory

Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs

Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to be used with GSK's Ventolin, Advair, and Flovent MDIs. The new Hailie sensor measures various parameters, including respiratory flow rate, and connects to the company's Hailie … [Read more...] about Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs

Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients

Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans in bilateral lung transplant patients who have recently had a reduction in lung function. ARINA-1, which is delivered via the PARI eFlow nebulizer … [Read more...] about Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients

Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal

Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company's new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA in March 2022. The company said that the new clearance means that Hailie is now eligible for reimbursement on 18 of the top 20 branded inhalers … [Read more...] about Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal

PTAB rules in Liquidia’s favor, finds another Tyvaso patent’s claims are not patentable

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

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