Biologically Active Substance
Profluent Raises $106M to Accelerate Frontier AI Models for Programmable Biology, Backed by Jeff Bezos
Profluent; AI biotech; protein design; programmable biology; Jeff Bezos; Altimeter Capital; $106M funding; Bezos Expeditions; CRISPR; biologics; Protein Atlas; synthetic biology; drug development
Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)
Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug
Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer
Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing
Genmab Discontinues ProfoundBio-Derived ADC GEN1107 After Acquisition, Paralleling J&J’s Ambrx Buyout Area Developments
Genmab; ProfoundBio; antibody-drug conjugate (ADC); GEN1107; PTK7; Ambrx; Johnson & Johnson (J&J); oncology; drug development; biotech acquisition; AbbVie lawsuit
Zealand Pharma Pauses Development of GLP-1/GLP-2 Dual Agonist Dapiglutide for Obesity
Zealand Pharma; dapiglutide; GLP-1/GLP-2 dual agonist; obesity therapy; clinical development; obesity drug market; pipeline management; petrelintide; survodutide
Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025
Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis
Odyssey Therapeutics Appoints Dennis Dean as EVP, Head of Non-Clinical Development
Odyssey Therapeutics; Dennis Dean; Executive Vice President; Head of Non-Clinical Development; preclinical research; autoimmune diseases; drug development; biopharmaceutical
Nkarta Reports Third Quarter 2025 Financial Results and Corporate Highlights
Nkarta; Q3 2025 financial results; net loss; operating expenses; EPS; research and development; impairment; market capitalization; clinical-stage biopharma; corporate highlights
Amgen’s Repatha Reduces First-Time Cardiovascular Events by 25% in Major Clinical Trial
Amgen; Repatha; evolocumab; cholesterol drug; PCSK9 inhibitor; cardiovascular events; clinical trial; VESALIUS-CV; primary prevention; heart attack; LDL cholesterol
Ionis Claims Curative Potential for Tryngolza in Severe Triglyceride Disease
Ionis; Tryngolza; severe hypertriglyceridemia; curative potential; triglyceride reduction; acute pancreatitis; antisense oligonucleotide; FDA submission; Phase III trial; RNA-targeted therapy