GSK has announced that data generated from recently early stage trials support advancing a reformulated version of its Ventolin salbutamol (albuterol) MDI using HFA 152a as the propellant into Phase 3 trials. The company said that it expects to initiate those studies in the first half of 2024 with plans to file regulatory submissions for the reformulated product in … [Read more...] about GSK announces upcoming Phase 3 trials of HFA 152a version of Ventolin salbutamol (albuterol) MDI
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Altamira sells majority stake in Bentrio bentonite nasal spray
Altamira Therapeutics announced that a private investor has acquired a 51% stake in Altamira Medica, a subsidiary of Altamira that owns Bentrio bentonite nasal spray, which is sold over the counter for the treatment of allergic rhinitis. According to Altamira, the deal includes more than CHF 2 million (~$2.3 million) in cash, and the company will get 25% of future … [Read more...] about Altamira sells majority stake in Bentrio bentonite nasal spray
Ab Initio Pharma opens new R&D facility
Australian CDMO Ab Initio Pharma has announced the opening of a new R&D facility in Sydney, which the company says is "fitted out to provide state-of-the-art testing and R&D services to Australian and overseas companies developing innovative therapeutics." Ab Initio also has a GMP manufacturing facility that was granted a license by the TGA in 2022 to … [Read more...] about Ab Initio Pharma opens new R&D facility
Inhalon Biopharma gets additional funding from the US Army for development of inhaled antibody against SARS-CoV-2
Inhalon Biopharma has announced that the company received a $5.7 million contract from the United States Army Medical Research and Development Command (USAMRDC) for development of a nebulized therapy against all variants of SARS-CoV-2. The company's web site says that it received the contract for a study of "IN-007, an Inhaled ACE2-Targeting Therapeutic for … [Read more...] about Inhalon Biopharma gets additional funding from the US Army for development of inhaled antibody against SARS-CoV-2
Viatris and Theravance Biopharma say Chinese Phase 3 trial of Yupelri revefenacin inhalation solution met its primary endpoint
Viatris and Theravance Biopharma say that a Phase 3 trial of Yupelri revefenacin inhalation solution for the treatment of COPD conducted in China met its primary endpoint and that Viatris expects to file a marketing application for Yupelri in China next year. Yupelri has been approved for the treatment of COPD in the US since 2018. In 2015, Viatris (then Mylan) … [Read more...] about Viatris and Theravance Biopharma say Chinese Phase 3 trial of Yupelri revefenacin inhalation solution met its primary endpoint
Milestone says Phase 2 study of etripamil nasal spray in AFib-RVR met its primary endpoint
Milestone Pharmaceuticals has published data from the Phase 2 ReVeRA trial of etripamil nasal spray in patients experiencing atrial fibrillation with rapid ventricular rate (AFib-RVR) that the company says "support further development of self-administered etripamil for the treatment of AFib-RVR." The article appeared in the journal Circulation: Arrhythmia and … [Read more...] about Milestone says Phase 2 study of etripamil nasal spray in AFib-RVR met its primary endpoint
Altamira gets European patent for intranasal betahistine
Altamira Therapeutics (formerly Auris Medical) said that the European Patent Office (EPO) has issued a notice that it will grant a patent (No. 3698791) covering the company's AM-125 intranasal formulation of betahistine until February 2038. Altamira says that it has been granted composition of matter and methods of use patents for intranasal betahistine in 50 … [Read more...] about Altamira gets European patent for intranasal betahistine
New versions of Vertus and DecaVertus automated shake and fire systems available from Copley Scientific
OINDP testing specialists Copley Scientific have launched new versions of their Vertus automated shake and fire system for testing of MDIs and nasal sprays. According to Copley, the Vertus III+ is "comprehensively updated to meet testing requirements for an even wider range of device types," and the DecaVertus III "is a complementary, high throughput … [Read more...] about New versions of Vertus and DecaVertus automated shake and fire systems available from Copley Scientific
TFF and Aptar Pharma publish data from feasibility study of intranasal dry powder mAbs
TFF Pharmaceuticals has published a paper on bioRxiv titled "Feasibility of Intranasal Delivery of Thin-film Freeze-dried Monoclonal Antibodies" describing characterization and deposition studies of TFF's dry powder AUG-3387 mAbs delivered by Aptar Pharma's Unidose (UDS) powder nasal spray system. In 2021, TFF partnered with Augmenta Bioworks on development of dry … [Read more...] about TFF and Aptar Pharma publish data from feasibility study of intranasal dry powder mAbs
FTC challenges the listing of dozens of inhaler device patents in the Orange Book
The United States Federal Trade Commission (FTC) announced that it has challenged the Orange Book listings of more than 100 patents related to combination products, with most of those patents related to inhaler device components such as dose counters. According to warning letters that the FTC sent to sponsors of the NDAs affected by challenges, the inhalers involved … [Read more...] about FTC challenges the listing of dozens of inhaler device patents in the Orange Book