After posting positive top-line data in August from its phase III ENHANCE-2 study of ensifentrine for treating chronic obstructive pulmonary disease (COPD), Verona Pharma plc now has positive results from the companion phase III study. The ENHANCE-1 trial of ensifentrine as a COPD maintenance treatment hit its primary and key secondary endpoints, prompting the company to say it plans to submit an NDA for the treatment to the U.S. FDA sometime in the first half of 2023.
U.S. federal authorities have made a lot of noise over inappropriate medical testing in the past two years, largely due to the COVID-19 pandemic, but Paul Garcia, a partner in the San Diego office of Hooper, Lundy & Bookman PC, says this trend will not ebb at all in the coming year. Garcia told BioWorld that the lookback period for Medicare testing claims runs several years and that not only will enforcement results continue to surface next year, but also that the associated civil monetary penalties could force a testing lab to shutter its operations permanently.
Investigators from Army Medical University reported the discovery and preclinical characterization of a novel cannabinoid receptor 2 (CB2 receptor) agonist, YX-2102, being developed as a potential therapeutic candidate for alleviating lung fibrosis.
Roche has synthesized pyruvate dehydrogenase kinase 1 (PDK1) inhibitors reported to be useful for the treatment of systemic lupus erythematosus, psoriasis, inflammatory bowel diseases, idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease and cancer.
Vertex Pharmaceuticals Inc. has received clearance from the FDA for its IND application for VX-522, a messenger ribonucleic acid (mRNA) therapy targeted at treating the underlying cause of cystic fibrosis (CF).
Sionna Therapeutics Inc. has received FDA clearance of its IND application for SION-638, a small molecule designed to target the first nucleotide-binding domain (NBD1) of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A phase I study is now dosing healthy volunteers.
The U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward.
Hyloris Pharmaceuticals SA has announced the development of HY-083, a new proprietary intranasal formulation of a TRPV1 agonist to treat idiopathic rhinitis. Hyloris' treatment approach is to activate and depolarize TRPV1 receptors leading to restoration of a normal function of the nasal mucosa.
Suzhou Suncadia Biopharmaceuticals Co. Ltd. and Jiangsu Hengrui Medicine Co. Ltd. have synthesized isoquinolone compounds acting as phosphodiesterase PDE3A and/or PDE4 inhibitors reported to be useful for the treatment of asthma, chronic obstructive pulmonary disease (COPD), sepsis, nephritis, diabetes, allergic rhinitis, allergic conjunctivitis and rheumatic diseases.
Boehringer Ingelheim Pharma GmbH & Co. KG has divulged imidazo[4,5-d]pyridazinonyl derivatives acting as transient receptor potential cation channel subfamily A member 1 (TRPA1) antagonists reported to be useful for the treatment of cough, fibrosis, respiratory tract inflammation and idiopathic pulmonary fibrosis.
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