Functional Concept – Page 4 – Talk Bio

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Outsmarting Data Bottlenecks in Pharma: The Clinical Terminology Advantage

1 month ago talkbio0Tagged Aortic Valve Insufficiency, clinical terminology, data bottlenecks, Data Integration, Drug Industry, Interoperability, Pharma, Regulatory Compliance

data bottlenecks; clinical terminology; pharmaceutical industry; data integration; interoperability; regulatory compliance; AI in pharma; patient outcomes

GSK’s ViiV Expands Licensing Deal to Increase Access to Long-Acting Injectable HIV Treatment

1 month ago talkbio0Tagged cabotegravir, Environmental pool, generic manufacturing, Global Health, HIV, licensing agreement, SmithKline Beecham, ViiV Healthcare

GSK; ViiV Healthcare; long-acting HIV treatment; cabotegravir; licensing agreement; Medicines Patent Pool; generic manufacturing; HIV; global health

Biopharma Layoffs Continue to Surge in First Half of 2025

1 month ago talkbio0Tagged Biopharma, biotech closures, Increase, Industry, layoffs, trends qualifier

biopharma; layoffs; 2025; workforce reductions; industry trends; biotech closures; year-over-year increase

ALTO-203 Misses Depression Endpoint but Shows Positive Biomarker and Cognitive Signals

2 months ago talkbio0Tagged ALTO-203, Attention, Biological Markers, development aspects, drug activity, Electroencephalography, Neuroscience discipline, theta/beta ratio, Wakefulness, William Blair

ALTO-203; Alto Neuroscience; Phase 2 trial; major depressive disorder; EEG biomarkers; theta/beta ratio; attention; wakefulness; William Blair; drug activity; future development

Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity

2 months ago talkbio0Tagged Approved, concerns, COVID19 (disease), delays, Intact, Interferes with, Novavax, political, Regulation of biological process, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference

Vor Bio’s $4B+ Revival Deal for RemeGen’s Autoimmune Drug Triggers Divergent Stock Moves

2 months ago talkbio0Tagged Autoimmune Diseases, CEO, Changing, Myasthenia Gravis, PIPE financing, RemeGen, Stock Reaction, Vor Bio

Vor Bio; RemeGen; telitacicept; autoimmune disease; $4 billion deal; myasthenia gravis; stock reaction; CEO change; PIPE financing

Biogen Ushers Spinraza Follow-Up (Salanersen) Into Pivotal SMA Studies

2 months ago talkbio0Tagged Antistreptolysin O, Biogen, Clinical Trials, motor milestones, Nerve Degeneration, Novartis, Pediatric brand name, Phase III, salanersen, Spinal Muscular Atrophy, Spinraza, Zolgensma

Biogen; SMA; Spinraza; salanersen; Phase III; clinical trials; neurodegeneration; motor milestones; pediatric; Novartis Zolgensma; ASO therapy

Amgen Adjusts Phase 3 Dosing for MariTide After Midstage Side Effects Concerns

2 months ago talkbio0Tagged Adverse event, amgen, Clinical Trials, Dosage, Escalation, gastric inhibitory polypeptide receptor, GLP-1 receptor, MariTide, Obesity, Phase 3, Vomiting

Amgen; MariTide; Phase 3; obesity treatment; dose escalation; vomiting; adverse events; clinical trial; GLP-1 receptor; GIP receptor

Vertex’s Islet Cell Therapy Shows Dramatic Reduction in Dangerous Low Blood Sugar Levels in Type 1 Diabetes Trial

2 months ago talkbio0Tagged Cell Therapy, Diabetes Mellitus, Insulin-Dependent, Endogenous, Hypoglycemia, Insulin, islet, Stem Cell Therapy, zimislecel

Vertex; islet cell therapy; zimislecel; Type 1 diabetes; hypoglycemia; phase 1/2 trial; endogenous insulin; stem cell therapy

FDA’s Top Cell and Gene Therapy Leaders Exit Amid CBER Upheaval

2 months ago talkbio0Tagged Anatol, biopharma regulation, CBER, Cell Therapy, Changing, gene therapy, Leadership, Nicole Verdun, Peter Marks, Rachael, United States Food and Drug Administration

FDA; cell therapy; gene therapy; CBER; Nicole Verdun; Rachael Anatol; Peter Marks; leadership changes; biopharma regulation