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
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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
Avalyn Pharma announces appointment of four executives
After recently raising $175 million for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib, Avalyn Pharma has announced four new executive hires. The new appointments include former Boehringer Ingelheim interstitial lung disease (ILD) expert Craig Conoscenti as Senior VP, clinical development; Jim Bishop as Senior VP, Business Operations; … [Read more...] about Avalyn Pharma announces appointment of four executives
Biopas submits marketing applications for Inbrija levodopa DPI in six Central and South American countries
According to Acorda Therapeutics, Biopas Laboratories has submitted marketing applications for Inbrija levodopa inhalation powder for the treatment of OFF episodes in Parkinson's disease in Argentina, Colombia, Costa Rica, Ecuador, Panama, and Peru. In May 2022, Biopas acquired the rights to Inbrija in those 6 countries, plus Brazil, Chile, and Mexico. Acorda says … [Read more...] about Biopas submits marketing applications for Inbrija levodopa DPI in six Central and South American countries
New paper from IPAC-RS discusses methods for APSD testing of aqueous nasal sprays
The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC‑RS) is highlighting the recent publication of a new paper titled "Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC‑RS)" … [Read more...] about New paper from IPAC-RS discusses methods for APSD testing of aqueous nasal sprays
Inhalon Biopharma licenses human metapneumovirus antibodies for inhaled delivery
Inhalon Biopharma announced that it has licensed human metapneumovirus (hMPV) antibodies from the University of Georgia and intends to develop inhaled hMPV antibodies for the treatment of hMPV respiratory infections. According to the company's website, its pipeline includes a candidate designated IN-003 against hMPV. Inhalon's pipeline of inhaled therapies based … [Read more...] about Inhalon Biopharma licenses human metapneumovirus antibodies for inhaled delivery
United Therapeutics initiates Phase 3 TETON PPF study of Tyvaso treprostinil inhalation solution in patients with progressive pulmonary fibrosis
United Therapeutics has announced the initiation of the 52-week TETON PPF trial, which will evaluate the efficacy of Tyvaso treprostinil inhalation solution in almost 700 patients with progressive pulmonary fibrosis (PPF). The company said that the effort to expand the use of Tyvaso to patients with PPF with or without pulmonary hypertension (PH) is based on data from … [Read more...] about United Therapeutics initiates Phase 3 TETON PPF study of Tyvaso treprostinil inhalation solution in patients with progressive pulmonary fibrosis
SyqeAir cannabis inhaler gets TGA approval
According to Syqe Medical, Australia's Therapeutic Goods Administration (TGA) has approved the company's SyqeAir cannabis inhaler, which includes 60 metered doses of milled cannabis flowers. The cartridge-based inhaler will now appear in the Australian Register of Therapeutic Goods (ARTG). Novachem sponsored the application and will distribute SyqeAir in Australia. … [Read more...] about SyqeAir cannabis inhaler gets TGA approval