China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
Denali Therapeutics Inc.’s extensive update on clinical programs in central nervous system diseases at the start of this year included plans for lead asset DNL-310 in mucopolysaccharidosis II (MPS II), also known as Hunter syndrome – a space where other notable players include such names as Regenxbio Inc. and Takeda Pharmaceutical Co. Ltd.
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.
Sosei Heptares and Eli Lilly and Co. have signed a potential $731 million deal to discover, develop and commercialize small molecules that modulate G protein-coupled receptor (GPCR) targets associated with diabetes and metabolic diseases.
The positively charged nanoparticle polyamidoamine generation 3 (P-G3) can be specifically targeted to either visceral or subcutaneous fat, and affects both types of fat in different ways, researchers from Columbia University reported in two papers recently published.
Innovent Biologics Inc. said that, compared to a placebo, both doses of its anti-PCSK-9 monoclonal antibody tafolecimab tested in a phase III trial “yielded significant and durable reductions” in low-density lipoprotein cholesterol levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia.
The bad news in March 2022 from Takeda Pharmaceutical Co. Ltd. regarding Natpara, its recombinant human parathyroid hormone for hypoparathyroidism (HPT), served to generate more interest in the already bubbling space, where a handful of players large and small own prospects at various clinical stages.
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.”
The U.S. FDA has placed a clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AT-845 following a serious adverse event of peripheral sensory neuropathy in one of the trial participants. AT-845 is an adeno-associated virus (AAV) gene replacement therapy being studied in adults with late-onset Pompe disease.
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