Finding – Page 5

Gene Therapy Delivers Long-Term Immune Protection in Children With Rare Immune Disorders

2 months ago talkbio0Tagged Adenosine deaminase deficiency, Clinical Trials, Combined immunodeficiency disease, Congenital leukocyte adherence deficiency, Curative Therapy, gene therapy, immune protection, Leukocyte adhesion deficiency type 1, Long-term, Pediatric immunology, Rare Diseases, Severe (severity modifier)

gene therapy; long-term immune protection; ADA-SCID; severe combined immunodeficiency; LAD-I; leukocyte adhesion deficiency; rare disease; pediatric immunology; clinical trial; curative treatment

Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes

2 months ago talkbio0Tagged ACHIEVE-1, ATTAIN-2, Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Effectiveness, Eli Lilly, Farxiga, Glucagon-Like Peptide 1, Oral cavity, orforglipron, regulatory submission, Safety, semaglutide, Weight Loss

Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety

Unlocking Access: Navigating Pharma’s Regulatory Crossroads – Recent Updates (2025)

2 months ago talkbio0Tagged Access, access strategy, Biosimilars, CRLs, drug importation, drug price, executive actions, Market, Patient access, pharmaceutical regulation, United States Food and Drug Administration

pharmaceutical regulation; market access; drug pricing; FDA transparency; biosimilars; executive actions; market access strategy; drug importation; CRLs; patient access

Regeneron Heads to FDA Seeking Approval for Game-Changing Hearing Loss Gene Therapy

2 months ago talkbio0Tagged Approved, CHORD trial, DB-OTO, Deafness, gene therapy, OTOF gene, Regeneron, United States Food and Drug Administration

Regeneron; hearing loss; gene therapy; DB-OTO; FDA approval; OTOF gene; CHORD trial

Somatix Readies Market Launch of First-of-its-Kind Wearable Medication Compliance Feature

2 months ago talkbio0Tagged Adherence To Medication Regime, AI-enabled, Detection, digital health, Gestures, partnering with, Presenile dementia, Preventive monitoring, Remote, Roche (company), SafeBeing platform, Somatix, Wearable Electronic Devices

Somatix; wearable technology; medication compliance; AI-enabled; gesture detection; remote patient monitoring; SafeBeing platform; dementia; partnering with Roche; digital health

Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

2 months ago talkbio0Tagged amgen, Approved, Cardiovascular Diseases, Cardiovascular event, Cerebrovascular accident, LDL-C, Myocardial Infarction, PCSK9 inhibitor, Primary Prevention, Repatha, United States Food and Drug Administration, VESALIUS-CV trial

Amgen; Repatha; VESALIUS-CV trial; primary prevention; cardiovascular disease; PCSK9 inhibitor; LDL-C; FDA approval; major adverse cardiovascular events; heart attack; stroke

Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress

2 months ago talkbio0Tagged Clinical Trials, collaborative framework, Drug Approval, Employment Termination, Hetlioz, jet lag disorder, lawsuit, Motion Sickness, sNDA, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness

Metsera’s New Obesity Data Raises Efficacy Profile, Key Side Effect Questions for Pfizer After Acquisition

3 months ago talkbio0Tagged aspects of adverse effects, Effectiveness, Glucagon-Like Peptide 1, MET-097i, Metsera, Obesity, Pfizer, Pfizer acquisition, Phase 2 trial, Weight Loss

Metsera; Pfizer; obesity drug; MET-097i; GLP-1; side effects; efficacy; Phase 2 trial; weight loss; Pfizer acquisition

Novartis and Boehringer Ingelheim Launch Direct-to-Consumer Drug Sales, Bypassing Middlemen

3 months ago talkbio0Tagged Boehringer Ingelheim, Cosentyx, Direct-to-Consumer, drug price, DTC, middlemen, Novartis, Patient access, Pharmaceutical Sales, PhRMA, Spiriva Respimat

Boehringer Ingelheim; Novartis; Direct-to-consumer (DTC); Pharmaceutical sales; Middlemen; Drug pricing; Patient access; Cosentyx; Spiriva Respimat; PhRMA

Trump Administration Teases MFN Drug Pricing Rule as Commitment Deadline Looms for Companies

3 months ago talkbio0Tagged Commitment Deadline, direct-to-consumer sales, drug price, executive order, international reference price, Medicaid, MFN, Most-Favored-Nation, Parity, pharmaceutical manufacturers, Prices, Pricing, tariffs, Transplant Registry Unified Management Program

Trump administration; Most-Favored-Nation (MFN) pricing; drug pricing; executive order; pharmaceutical manufacturers; Medicaid; direct-to-consumer sales; price parity; commitment deadline; tariffs; international reference price