Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Lee’s Pharmaceutical (HK) Ltd. and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., expanded their rights to lucinactant Surfaxin, lyophilized lucinactant Surfaxin LS and Aerosurf from Windtree Therapeutics Inc. in a $78.9 million global license deal to develop and commercialize the candidates for the treatment of preterm infants with respiratory distress syndrome and other potential indications.
Preclinical data has been reported for RCD-405, which is being developed by Arcede Pharma, a spin-out from Respiratorius AB, for the treatment of severe asthma and chronic obstructive pulmonary disease (COPD).
Top-line data from Verona Pharma plc’s phase III ENHANCE-2 study show its inhaled ensifentrine hit the primary and secondary endpoints in treating chronic obstructive pulmonary disease (COPD). Next up: data from the companion phase III, ENHANCE-1, which is expected by the end of 2022.
Structure Therapeutics Inc. raised $33 million in a financing round to speed up clinical trials of its lead assets targeting chronic diseases and to improve its technology platform. Previously known as Shouti Inc., the company also has rebranded itself as Structure to “reflect its foundation in structural biology and computational design.”
AbbVie has patented cystic fibrosis transmembrane conductance regulator (CFTR) (deltaF508 mutant) correctors reported to be useful for the treatment of cystic fibrosis.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
Structure Therapeutics Inc. raised $33 million in a financing round to speed up clinical trials of its lead assets targeting chronic diseases and to improve its technology platform. Previously known as Shouti Inc., the company also has rebranded itself as Structure to “reflect its foundation in structural biology and computational design.”
Researchers from APIE Therapeutics presented preclinical data for the novel apelin receptor (APJ) agonist, APT-101, being developed as a small-molecule antifibrotic and anti-inflammatory agent.
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