Branded Lipfendra, Merck & Co. Inc.’s oral PCSK9 inhibitor enlicitide, part of the FDA Commissioner’s National Priority Voucher pilot program, won U.S. approval to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
Two med-tech companies agreed to settlements with the U.S. government to resolve False Claims Act (FCA) allegations that they submitted Medicare claims for medically unnecessary testing and devices.
Pulmonary arterial hypertension (PAH) is a fatal condition characterized by abnormal vascular remodeling from excessive proliferation of pulmonary arterial smooth muscle cells (PASMCs). Recent evidence has suggested that structural maintenance of chromosomes 4 (SMC4) is upregulated in pulmonary tissue from patients with PAH and may be a potential target for therapy, since it has been tied to modulating pathological cell proliferation.
Atrium Therapeutics Inc. has obtained IND clearance from the FDA for ATR-1072 for the treatment of protein kinase AMP-activated non-catalytic subunit γ2 (PRKAG2) syndrome.
Drug Farm Biotechnology Co. Ltd. closed a $55 million series D round to advance its AI-developed alpha-protein kinase 1 (ALPK1) inhibitor, DF-003, in a phase III trial for ROSAH syndrome, a rare genetic disease that can lead to blindness.
Edwards Lifesciences Corp. and Genesis Medtech Group Ltd. will pay a total of $12 million in penalties as part of a U.S. FTC settlement resolving allegations that they intentionally structured a deal in which Edwards acquired Genesis’ JC Medical to avoid complying with the notification and waiting period requirements of the Hart-Scott-Rodino Act.
Wuhan Createrna Science and Technology Co. Ltd. has reported new complement factor D (CFD) inhibitors potentially useful for the treatment of cardiovascular, immunological, eye, genitourinary, renal, respiratory, neurological disorders and hematological diseases.
The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc.
The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services, has announced the teams for the THRIVE (Treating Hereditary Rare diseases with In Vivo prEcision genetic medicines) program. With a commitment of up to $160 million over 5 years, THRIVE aims to accelerate solutions for rare genetic pediatric diseases across multiple technological approaches, clinical trial designs and deployment models.
News of the unexpected phase III failure of the gene silencing drug Wainua (eplontersen) in the treatment of transthyretin-mediated amyloid cardiomyopathy sent Astrazeneca plc’s shares (NYSE:AZN) down $10.88 to close July 9 at $178.40.
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