Lexeo Therapeutics Inc. feels like it’s in a faster lane to a BLA for its Friedreich ataxia cardiomyopathy gene therapy after talking with the U.S. FDA. The agency told Lexeo that LX-2006 could be on the accelerated approval path if there is a mingling of the company’s data and studies.
The FDA has cleared AD-NP1, a drug developed by University of California, Los Angeles (UCLA) for heart tissue regeneration, to enter clinical trials. The monoclonal antibody blocks the production of ENPP1 protein, which was found to interfere with healing after a heart attack.
Astrazeneca AB has patented new proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitors reported to be useful for the treatment of cardiovascular disorders.
Hypertension is a frequent chronic condition commonly affecting the elderly, but its incidence is increasing among younger individuals. The estimates predict that 1.28 billion individuals aged 30-79 are currently living with hypertension worldwide. Despite the availability of effective treatments, monotherapy often leads to resistance and the management of adverse effects remains cumbersome.
At the recent European Respiratory Society meeting, researchers from 35Pharma Inc. presented data on HS-235, an activin receptor inhibitor designed to neutralize activins and growth differentiation factors (GDFs). Disorders such as heart failure (HF) and pulmonary hypertension (PH) are associated with dysregulated activin and GDFs without neutralizing bone morphogenetic proteins such as BMP-9 and BMP-10, which play key roles in lymphatic and vascular homeostasis.
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
The University of California has synthesized proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitors reported to be useful for the treatment of cancer, atherosclerosis and stroke.
Boston Scientific Corp. continues to prove out its strategy of active acquisitions combined with industry-leading organic growth with the closing of its $88 million acquisition of Elutia Inc.’s Bioenvelope business and very positive targets for growth presented during its investor day on Sept. 30.
Many patients who survive myocardial infarction go on to experience heart failure. Researchers at Qilu Hospital of Shandong University found that bone morphogenetic protein 1 (BMP1) was upregulated in patients after myocardial infarction, as well as in a mouse model of the same condition.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYH-2070 injection, a double-stranded small interfering RNA (siRNA) drug for the treatment of hypertriglyceridemia or mixed hyperlipidemia.
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