Issue link: https://www.e-digitaleditions.com/i/1524818
News about companies that support development of orally inhaled and nasal drug products (OINDPs), including regulatory approvals, new partnerships, new products and services, and results of clinical studies. 8 August 2024 Inhalation caused by mycobacterium avium complex (MAC), followed by an open-label extension. Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence world- wide, association with shortened life span and significant impact on patients' daily living. Individuals with underlying conditions such as COPD, asthma and bronchiectasis are prone to NTM. e disease is more common in women over age 65, with a predominance in those of Caucasian and Asian descent. Chiesi and Gossamer to collaborate on development P A R M A , I TA LY — P h a r m a times.com reported that Chiesi Group and Gossamer Bio have announced a global collaboration and license agreement to develop and commercialize seralutinib to treat respiratory diseases. Seralutinib is an inhaled inhibitor, designed for delivery by dry powder inhaler. Chiesi will support Gossamer's ongoing work with seralutinib for the potential treatment of pulmo- nary arterial hypertension (PAH), and its development for the treat- ment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). PAH is a rare, progressive condition that causes high blood pressure in the arteries of the lungs. In the US, it is esti- mated PAH affects up to 50,000 patients while PH-ILD affects up to 100,000 patients. "is collab- oration enables seralutinib to move directly into a Phase III trial in PH-ILD, an indication with a pau- city of available treatments and a disease which we believe seralutinib is specifically designed to address," said Faheem Hasnain, Cofounder, Chairman and Chief Executive Officer, Gossamer. "Seralutinib is a potential paradigm shifting therapy in PAH and PH-ILD and we…[are] excited to partner with Gossamer to develop and bring this therapy to patients worldwide," commented Giuseppe Accogli, Group Chief Executive Officer, Chiesi. and Drug Administration (FDA) for the company's Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, previously known as AMP-008. e inhalation prod- uct is intended for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the preven- tion of exercise- induced broncho- spasm in patients four years of age and older. e FDA determined that Amphastar's product is bio- equivalent and therapeutically equivalent to Teva Respiratory's ProAir ® HFA (albuterol sulfate) Inhalation Aerosol. is marks Amphastar's first FDA approval of a generic inhalation product. e company plans to launch its Albuterol Sulfate Inhalation Aero- sol in the third quarter of 2024. MannKind receives US FDA fast track for treatment of NTM DANBURY, CONNECTICUT and WESTLAKE VILLAGE, CALIFORNIA, US—MannKind Corporation announced that the US Food and Drug Administra- tion (FDA) has granted Fast Track designation of clofazimine inha- lation suspension (MNKD-101) for the treatment of nontubercu- lous mycobacterial (NTM) lung disease, according to Globe News- wire. e designation is intended to facilitate development and expedited review of medicines to treat serious conditions and fill an unmet medical need. e FDA previously designated clofazimine inhalation suspension as both an orphan drug and a qualified infec- tious disease product (QIDP) for the treatment of pulmonary NTM infections. MannKind will conduct the ICoN-1 study, a multi- national, randomized, double-blind, placebo- controlled trial to evaluate the efficacy and safety of clofazimine inhala- tion suspension when added to guideline- based therapy in adults with refractory NTM lung disease INDUSTRY NEWS Broughton launches medicinal cannabis batch testing SKIPTON, UNITED KING- DOM—To streamline and speed up the UK supply chain of medic- inal cannabis, Broughton has announced it will offer analytical testing to ensure the safety, reg- ulatory compliance, purity and consistency of UK- and Channel Island-grown medicinal cannabis. is can help clients avoid sending cannabis products to continental Europe for testing, thereby saving time and helping products get to patients faster. "What we've seen up to now is medicinal canna- bis products being transported to Portugal or Spain for batch release testing," explained Chris Allen, CEO, Broughton. "is isn't easy with a Schedule 1 Controlled Sub- stance and adds a long lead time. With an ever-increasing demand for medicinal cannabis products, the industry needs a better way of quality checking these life- enhancing products." Per Euro- pean Pharmacopoeia Monograph (Ph. Eur. 2038), the batch release testing methods include three identification tests: macroscopic appearance and odor testing of the flower; microscopic examination of the plant-based properties of the flower; and flower type identifica- tion with high- performance thin layer chromatography (HTPLC). e company can also determine the amount of foreign matter pres- ent, measure moisture content, test for total cannabinol (CBN) present, and quantify the amount of THC and CBD to ensure these comply with a client's label claim. US FDA approves Amphastar's albuterol sulfate inhalation aerosol RANCHO CUCAMONGA, CALIFORNIA, US—Accord- ing to Pharmbiz.com, Amphastar Pharmaceuticals has announced approval by the United States Food