Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to Lannett, which acquired US rights to the generic version of Advair Diskus in October 2019. Lannett said that the term of that deal has recently been extended to 12 … [Read more...] about Respirent submits ANDA for generic version of Advair Diskus
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FDA approves Tyvaso inhalation solution for the treatment of PH-ILD
According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension since July 2009. United Therapeutics submitted the sNDA for the PH-ILD indication in August 2020, … [Read more...] about FDA approves Tyvaso inhalation solution for the treatment of PH-ILD
Iconovo to develop inhaled COVID-19 vaccine delivered by the ICOone device for ISR
According to Iconovo, Swedish immunotherapy developer Immune System Regulation (ISR) will pay up to 18.1 million Swedish kronor plus potential royalties for development of a dry powder COVID-19 vaccine delivered via Iconovo’s ICOone single dose DPI. The deal also includes an option for ISR to use the ICOone device for delivery of vaccines for other respiratory … [Read more...] about Iconovo to develop inhaled COVID-19 vaccine delivered by the ICOone device for ISR
Coster and Lindal announce the launch of joint venture RxPack to market inhalation and nasal devices, filling equipment
Coster and Lindal have announced that they will each transfer their pharmaceutical aerosol businesses into a new company called RxPack, which will operate independently of both parent companies. RxPack will distribute Coster's aerosol filling equipment in addition to manufacturing MDIs, nasal spray pumps, and other OINDP devices; Coster and Lindal will continue to … [Read more...] about Coster and Lindal announce the launch of joint venture RxPack to market inhalation and nasal devices, filling equipment
Positive Phase 1 results for Neupharma’s inhaled teicoplanin in CF patients
Neupharma, which is developing inhaled teicoplanin for the treatment of MRSA lung infections in CF patients in partnership with Rare Partners, has announced that a Phase 1 PK study of the formulation in cystic fibrosis patients demonstrated that the concentration of teicoplanin measured in the sputum 24 hours post-dose was dose dependent and exceeded the minimum … [Read more...] about Positive Phase 1 results for Neupharma’s inhaled teicoplanin in CF patients
Valeo Pharma gets Canadian rights to Enerzair Breezhaler and Atectura Breezhaler
Valeo Pharma has acquired the rights to commercialize Novartis' Enerzair Breezhaler indacaterol / glycopyrronium / mometasone furoate and Atectura Breezhaler indacaterol / mometasone furoate) DPIs in Canada, the company said. Terms of the deal were not announced. Valeo CEO Steve Saviuk said, "We are extremely pleased to be partnering with Novartis to launch these … [Read more...] about Valeo Pharma gets Canadian rights to Enerzair Breezhaler and Atectura Breezhaler
Study of Union’s intranasal niclosamide for the treatment of COVID-19 in kidney patients gets UPH designation
The UK National Institute for Health Research has designated the PROTECT-V trial of Union Therapeutics' UNI91103 niclosamide nasal spray for the treatment of COVID-19 in kidney patients as an Urgent Public Health (UPH) priority, the company said. Union announced the initiation of the PROTECT-V trial in February 2021. Union co-founder Morten Sommer commented, "We … [Read more...] about Study of Union’s intranasal niclosamide for the treatment of COVID-19 in kidney patients gets UPH designation
Leyden Labs raises €40 Million for development of intranasal vaccines
Dutch startup Leyden Laboratories, which has formed to develop intranasal vaccines, has closed a €40 Million Series A financing led by GV (formerly known as Google Ventures), the company said. Leyden Labs was founded by former Mckinsey Partner Koenraad Wiedhaup, Janssen Senior Advisor Jaap Goudsmit, and former Crucell CEO Ronald Brus, with Wiedhaup as CEO, Goudsmit as … [Read more...] about Leyden Labs raises €40 Million for development of intranasal vaccines
LloydsPharmacy to launch Starpharma’s Viraleze nasal spray in the UK
Starpharma has announced the signing of a UK sales and distribution agreement for its Viraleze astodrimer sodium antiviral nasal spray with LloydsPharmacy and its parent company McKesson, with LloydsPharmacy set to launch the nasal spray on its web site within a week and in its stores sometime in April 2021. Viraleze was approved for sale in the UK and in Europe in … [Read more...] about LloydsPharmacy to launch Starpharma’s Viraleze nasal spray in the UK
Oxford announces Phase 1 trial of intranasal version of its COVID-19 vaccine
The University of Oxford has announced that it is recruiting subjects for a Phase I trial of a nasal spray version of its COVID-19 vaccine. The trial is expected to enroll 30 healthy adults aged 18–40 who will receive the ChAdOx1 nCoV-19 vaccine intranasally, and researchers from the university's Jenner Institute will follow the subjects for four months post dosing. … [Read more...] about Oxford announces Phase 1 trial of intranasal version of its COVID-19 vaccine