Disease or Syndrome – Page 16

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

2 months ago talkbio0Tagged Clinical Trials, concerns, Drug withdrawal syndrome, Injury of liver, Intercept Pharmaceuticals, Liver diseases, Ocaliva, Primary Biliary Cholangitis, regulatory setbacks, Safety, United States Food and Drug Administration

Intercept Pharmaceuticals; Ocaliva; liver disease; primary biliary cholangitis; FDA; drug withdrawal; safety concerns; liver injury; clinical trial hold; regulatory setbacks

Merck Moves All R&D Operations Out of UK, Citing Unfavorable Environment

2 months ago talkbio0Tagged Biological Science Disciplines, Brexit impact, Drug Discovery, Government, Investments, layoffs, London Bioscience Innovation Centre, Merck, Multiple Sulfatase Deficiency Disease, Relocation of home or business, UK

Merck; MSD; R&D relocation; UK life sciences; drug discovery; Brexit impact; London Bioscience Innovation Centre; Francis Crick Institute; government investment; layoffs

Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

2 months ago talkbio0Tagged Approved, Avidity, Biosciences, Blackfoot language, Breakthrough Therapy, Clinical Trials, Functional, Improvements, Muscular Dystrophy, Duchenne, skipping, Submission, United States Food and Drug Administration

Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission

Odyssey Therapeutics Secures $213M Series D to Accelerate Autoimmune Clinical Portfolio

2 months ago talkbio0Tagged Autoimmune Diseases, clinical pipeline, Immunoregulation, Inhibitor, investors, Odyssey, Precision - temporal, preclinical programs, Protac, RIPK2, Series D financing, Technology

Odyssey Therapeutics; Series D financing; $213 million; autoimmune diseases; clinical pipeline; preclinical programs; precision immunomodulation; RIPK2 inhibitor; PROTAC technology; investors

Second MAHA Report Emphasizes Chronic Disease, Tilts at Vaccine Reform

2 months ago talkbio0Tagged childhood health, childhood vaccine schedule, Chronic disease, Commission, federal directives, Food Policy, MAHA, Prescription Drug Overuse, public health medicine (field), Robert F. Kennedy Jr., Vaccine Reform

MAHA Commission; chronic disease; vaccine reform; Robert F. Kennedy Jr.; childhood health; food policy; medication overuse; public health; federal directives; childhood vaccine schedule

Amgen, Kyowa Kirin Bolster Safety Profile for Atopic Dermatitis Drug Rocatinlimab

2 months ago talkbio0Tagged amgen, ASCEND trial, Dermatitis, Atopic, Eczema, Kyowa Kirin, Long-term, OX40 receptor, Programs - Publication Format, Rocatinlimab, Rocket, Safety

Amgen; Kyowa Kirin; rocatinlimab; atopic dermatitis; OX40 receptor; ASCEND trial; ROCKET program; long-term safety; eczema

Lilly Opens AI Drug-Discovery Models to Biotechs for Free via TuneLab Platform

2 months ago talkbio0Tagged Antibodies, Artificial Intelligence, biotech startups, Drug Discovery, eli lilly, federated learning, Insitro, Machine Learning, Small Molecule, TuneLab

Eli Lilly; AI drug discovery; TuneLab; biotech startups; machine learning; small molecules; antibodies; data sharing; federated learning; Insitro

ICER Draft Report: High-Cost GLP-1 Obesity Drugs Deemed Cost-Effective—Affordability Still a Concern

2 months ago talkbio0Tagged Affordability, cardiovascular benefits, Cost-Effectiveness, CREM gene, Glucagon-Like Peptide 1, Health Policy, Obesity, semaglutide, tirzepatide, value-based pricing

ICER; GLP-1; semaglutide; tirzepatide; obesity drugs; cost-effectiveness; health policy; affordability; value-based pricing; cardiovascular benefits

Novartis Acquires Tourmaline Bio for $1.4B to Bolster Cardiovascular Pipeline with Promising Phase 2 Drug

2 months ago talkbio0Tagged Acquisition, Anti-Inflammatory Agents, Antibodies, C-reactive protein, Cardiovascular Diseases, Chronic Kidney Diseases, interleukin-6, Novartis, pacibekitug, Phase 2 trial, Tourmaline Bio

Novartis; Tourmaline Bio; acquisition; $1.4 billion; pacibekitug; cardiovascular disease; anti-inflammatory; IL-6 antibody; ASCVD; phase 2 trial; C-reactive protein; chronic kidney disease

Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

2 months ago talkbio0Tagged Capricor Therapeutics, Cell Therapy, Clinical Trials, data misinterpretation, deramiocel, Effectiveness, Endpoints, HOPE-2 trial, Muscular Dystrophy, Duchenne, Non-Parametric Test, Rejection, Statistical Significance, United States Food and Drug Administration

Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy