In pulmonary hypertension (PH), upregulated signaling by ActRIIA ligands, such as myostatin, activin A and GDF11, activates SMAD2/3 mediated pathways that drive pulmonary vascular remodeling and right ventricular dysfunction. Therapeutic blockade of these ligands using ligand traps such as sotatercept improves vascular remodeling and ameliorates PH pathology.
Idorsia Pharmaceuticals Ltd. has divulged macrocyclic compounds acting as cystic fibrosis transmembrane conductance regulator (CFTR) modulators reported to be useful for the treatment of cystic fibrosis.
The Trump administration has launched an investigation into the national security effects of imports of medical equipment, devices, consumables and equipment, laying the groundwork for a potential increase in tariffs targeting the industry. A separate investigation into robotics and industrial machinery began the same day. Med-tech stocks dropped significantly in response to the news as investors fear increased tariffs on the sector. In April, the administration initiated a similar review of the pharmaceutical industry and in August threatened 200% tariffs on that sector.
As Royal Philips NV works to rebuild trust after a global device recall, it is investing in new models of access, affordability, and technology to close gaps in sleep apnea diagnosis and therapy across Asia.
While U.S. policymakers are scaling back funding on mRNA vaccine research, Australia is accelerating investment in the technology. At the center of this effort is Moderna Inc., which is establishing an mRNA research and manufacturing footprint in the country and banking on decades of local expertise to bring new therapies to the clinic and serve as a regional hub for Asia Pacific.
Allrock Bio Inc. secured $50 million in a series A round co-led by Versant Ventures and Westlake Biopartners to advance ROC-101, an oral pan-rho-associated protein kinase (ROCK) inhibitor to treat pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease.
Three-year-old Areteia Therapeutics Inc. hit the primary endpoint in its Exhale-4 phase III study of dexpramipexole for eosinophilic asthma, bringing the oral small molecule one step closer to the U.S. market, where it could challenge currently approved injectable anti-IL-5/5R biologics.
Activity in some clinical parameters is leading Atyr Pharma Inc. to plan a sit-down with regulators, even though the tRNA synthetase-derived drug efzofitimod missed its primary endpoint of steroid tapering in the phase III Efzo-Fit study against the interstitial lung disease pulmonary sarcoidosis (PS). CEO Sanjay Shukla said his firm maintains “a high degree of conviction” regarding the candidate. “But I want to make sure we have the best briefing book possible” before consulting with the U.S. FDA, which will happen as soon as possible.
Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
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