Functional Concept

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

3 days 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

3 days 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

4 days 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

4 days 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

6 days 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

1 week 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

1 week 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

Draig Therapeutics Raises $140M Series A to Advance Neuropsychiatric Drug Pipeline

2 weeks ago talkbio0Tagged AMPA receptor modulator, Cardiff University, Draig, DT-101, GABA Modulators, Mental Depression, neuropsychiatric drugs, SV Health Investors

Draig Therapeutics; $140M Series A; neuropsychiatric drugs; DT-101; depression treatment; AMPA receptor modulator; GABA modulators; biotech funding; Cardiff University; SV Health Investors

FDA Launches New Priority Review Voucher Program Aligned with National Priorities

2 weeks ago talkbio0Tagged Accelerated, Biopharma, CNPV, Drug Approval, national priorities, Priority Review, public health medicine (field), Review [Publication Type], United States Food and Drug Administration, unmet

FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs

IPG Health Leads at Cannes Lions 2025 as Real Chemistry and Ogilvy Health Earn Major Awards

2 weeks ago talkbio0Tagged Agencies, Cannes, Geographic Locations, Grand Prix, Health, Health & Wellness, Health Care Market, IPG, Ogilvy Health, Science of Chemistry, Vaseline, Verification

Cannes Lions 2025; IPG Health; Real Chemistry; Ogilvy Health; healthcare marketing; agency awards; Health & Wellness Lions; Grand Prix; AREA 23; Vaseline Verified