Temporal Concept – Page 4

Vir Biotechnology’s Phase 2 Data for Hepatitis D Combo Regimen Highlights Market Potential

1 month ago talkbio0Tagged Clinical Trials, Combined Modality Therapy, ECLIPSE program, elebsiran, HDV RNA, Hepatitis D Infection, Market, Phase 2, SOLSTICE, tobevibart, Undetectable, Vir Biotechnology

Vir Biotechnology; Phase 2; hepatitis D; combination therapy; tobevibart; elebsiran; SOLSTICE trial; undetectable HDV RNA; market potential; ECLIPSE program

Eisai Expands Leqembi Subcutaneous Label, Accelerates Early U.S. Launch Progress for Alzheimer’s Disease

1 month ago talkbio0Tagged Alzheimer 's disease, at-home injection, dosing, Eisai, expansion, Labels (device), Leqembi, Maintenance, sBLA, starting dose, status - In progress, Subcutaneous Autoinjector, supplemental biologics, United States Food and Drug Administration

Eisai; Leqembi; subcutaneous autoinjector; label expansion; Supplemental Biologics License Application (sBLA); FDA; maintenance dosing; starting dose; early Alzheimer’s disease; at-home injection; launch progress

Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

1 month ago talkbio0Tagged asparagine, Atacicept, autoimmune kidney disease, Blackfoot language, File (record), IGA, IGA Glomerulonephritis, Kidney, Phase 3 trial, Proteinuria, Submission, United States Food and Drug Administration, UPCR, Vera Therapeutics

Vera Therapeutics; atacicept; Phase 3 trial; IgA nephropathy; proteinuria reduction; UPCR; FDA filing; BLA submission; ASN Kidney Week 2025; autoimmune kidney disease

Delaware Court Denies Pfizer’s Bid to Block Novo Nordisk-Metsera Deal

1 month ago talkbio0Tagged Antitrust, Delaware Court, merger agreement, Metsera, Nordisk, Obesity, Pfizer, restraining order, Transitory, United States Federal Trade Commission

Delaware Court; Pfizer; Novo Nordisk; Metsera; temporary restraining order; merger agreement; antitrust; FTC; obesity drugs

Ratio Therapeutics Appoints Marcel Reichen as Chief Strategy Officer

1 month ago talkbio0Tagged Cancer Therapeutic Procedure, Chief Strategy Officer, Drug Industry, Marcel Reichen, Neoplasms, Precision - temporal, radioligand therapy, Radiopharmaceuticals, Ratio Therapeutics, Strategic Growth

Ratio Therapeutics; Marcel Reichen; Chief Strategy Officer; radiopharmaceuticals; oncology; radioligand therapy; pharmaceutical industry; cancer treatment; strategic growth; precision oncology

UCB Wins First FDA Approval for Ultra-Rare Mitochondrial Disease: Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)

1 month ago talkbio0Tagged Approved, Breakthrough Therapy, doxecitine, doxribtimine, Drugs, Orphan, Infrequent, Kygevvi, Mitochondrial Diseases, Pediatric Disorder, Priority Review, Thymidine kinase 2 deficiency, TK2d, UCB, United States Food and Drug Administration

UCB; FDA approval; Kygevvi; mitochondrial disease; Thymidine Kinase 2 deficiency; TK2d; doxecitine; doxribtimine; rare diseases; Orphan Drug; Breakthrough Therapy; Priority Review; Rare Pediatric Disease

ESMO 2025 KEYNOTE-671 Update: Perioperative Pembrolizumab Reinforces NSCLC Standard

1 month ago talkbio0Tagged ESMO Congress, Event-Free Survival, Immunotherapy, KEYNOTE-671, Keytruda, Non-Small Cell Lung Carcinoma, Overall Survival, pembrolizumab, perioperative, Standard of Care

KEYNOTE-671; pembrolizumab; KEYTRUDA; perioperative immunotherapy; NSCLC; overall survival; event-free survival; ESMO Congress; standard of care

Researchers Publish Roadmap of FDA Interactions After Baby KJ’s Groundbreaking Gene Editing Therapy, as FDA Signals New Pathway for Patient-Specific Treatments

1 month ago talkbio0Tagged approval pathway, Baby KJ, CPS1 deficiency, CRISPR gene editing, Disease Gene Therapies, Infrequent, N-of-1 therapies, platform trials, Precision Medicine, Rare Diseases, regulatory roadmap, United States Food and Drug Administration

Baby KJ; CRISPR gene editing; CPS1 deficiency; FDA approval pathway; personalized medicine; rare disease; regulatory roadmap; platform trials; N-of-1 therapies; rare disease gene therapies

BMS Battles Deeply Ingrained Prescribing Habits in Schizophrenia as Cobenfy Misses Q3 Estimates

2 months ago talkbio0Tagged Alzheimer 's disease, Antipsychotic Agents, Cobenfy, Dopamine D2 Receptor, Drug Kinetics, drug market, earnings, Myers Squibb, prescribing habits, Psychotic Disorders, Schizophrenia, Trimonthly, Uptake

Bristol Myers Squibb; Cobenfy; schizophrenia; prescribing habits; dopamine D2 receptor; novel mechanism of action; quarterly earnings; drug market uptake; Alzheimer’s disease psychosis; atypical antipsychotics

Novo Nordisk Launches Surprise Bid for Metsera, Topping Pfizer Offer; Pfizer Alleges Move May Violate Antitrust Law

2 months ago talkbio0Tagged Acquisition, Antitrust, bidding war, Metsera, Novo Nordisk, Obesity, Pfizer, Twice a day, Unsolicited Adverse Event, Weight-Loss Agents

Novo Nordisk; Metsera; Pfizer; acquisition; bidding war; obesity; antitrust; unsolicited bid; weight-loss drugs