expansion – Talk Bio

Eli Lilly Touts ‘Striking’ Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study

2 days ago talkbio0Tagged BRUIN, BTK inhibitor, Chronic Lymphocytic Leukemia, Clinical Trials, CLL, CLL-313, eli lilly, expansion, First line treatment, Jaypirca, Labels (device), Progression-Free Survival

Jaypirca; Eli Lilly; CLL; chronic lymphocytic leukemia; BRUIN CLL-313; progression-free survival; BTK inhibitor; first-line treatment; clinical trial; label expansion

Gilead Unveils New Manufacturing Site in California as Part of $32B U.S. Investment Plan

1 week ago talkbio0Tagged Billion, Biological Factors, California, economic impact, expansion, Foster City, Gilead Sciences, Investments, Manufacturing, Manufacturing Facilities, R&D, Surgical construction, United States

Gilead Sciences; Foster City; California; manufacturing facility; biopharmaceuticals; $32 billion investment; economic impact; expansion; R&D; job creation; U.S. manufacturing

Ionis Builds Case for Wider Tryngolza Use in Severe Lipid Disorders Following Positive Phase 3 Results

1 week ago talkbio0Tagged drug indication, expansion, Familial chylomicronemia syndrome, Hypertriglyceridemia, Ionis Pharmaceuticals, Lipid Metabolism Disorders, Olezarsen, Pancreatitis, Acute, Severe (severity modifier), TRYNGOLZA, United States Food and Drug Administration

Ionis Pharmaceuticals; Tryngolza; olezarsen; severe hypertriglyceridemia; lipid disorder; Phase 3 trial; familial chylomicronemia syndrome; acute pancreatitis; FDA; drug indication expansion

Argenx’s Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis

2 weeks ago talkbio0Tagged AChR-Ab, Adaptation, Argenx, expansion, Labels (device), LRP4 gene, Musk, Myasthenia Gravis, Phase 3, SERON, Seronegative, triple seronegative, United States Food and Drug Administration, Vyvgart

Vyvgart; Argenx; Phase 3; myasthenia gravis; seronegative; ADAPT SERON; AChR-Ab; MuSK+; LRP4+; triple seronegative; FDA label expansion

AbbVie Invests $195 Million in New North Chicago API Manufacturing Site

4 weeks ago talkbio0Tagged AbbVie, alpha 1-antitrypsin, domestic production, expansion, Facility (object), Illinois (geographic location), Investments, Manufacturing, North Chicago, pharmaceutical manufacturing

AbbVie; North Chicago; API manufacturing; $195 million investment; facility expansion; pharmaceutical manufacturing; Illinois; domestic production

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

1 month ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

Lilly’s Mounjaro Matches Cardiovascular Benefit of Trulicity in Landmark Trial, Paving Way for Expanded Approval

1 month ago talkbio0Tagged Cardiovascular system, Diabetes Mellitus, Non-Insulin-Dependent, dulaglutide, eli lilly, expansion, Hemoglobin A1c measurement, MACE-3, Mortality Vital Statistics, Mounjaro, non-inferiority, outcomes, SURPASS-CVOT, Trulicity, United States Food and Drug Administration, Weight Loss

Mounjaro; tirzepatide; Eli Lilly; cardiovascular outcomes; type 2 diabetes; SURPASS-CVOT; Trulicity; dulaglutide; major adverse cardiovascular events (MACE-3); non-inferiority; A1C reduction; weight loss; mortality; FDA expansion

ARTBIO Raises $132M Series B to Advance Alpha Radiotherapy Pipeline and Manufacturing with Pb212

1 month ago talkbio0Tagged AB001, alpha radioligand therapies, AlphaDirect technology, ARTBIO, Cancer Therapeutic Procedure, Clinical Trials, expansion, Manufacturing, Metastatic castration-resistant prostate cancer, PB212, Series B financing

ARTBIO; Series B financing; alpha radioligand therapies; Pb212; AlphaDirect technology; cancer treatment; manufacturing expansion; AB001; metastatic castration-resistant prostate cancer; clinical trials

CDMO Pulse Check: Lonza Posts Major Sales Rebound as Samsung Bio Keeps Revenue Growth Rolling

2 months ago talkbio0Tagged capsule (pharmacologic), CDMO, commercial, expansion, Growth, Lonza, Manufacturing, profit margin, Sales - occupational activity, Samsung Bio

Lonza; CDMO; sales growth; Samsung Bio; 2025 outlook; profit margin; Capsules & Health Ingredients; commercial momentum; manufacturing expansion

Biogen Pledges $2 Billion Manufacturing Investment in North Carolina

2 months ago talkbio0Tagged Antisense Oligonucleotides, Aortic Valve Insufficiency, Automation, Biogen, Biotechnology, expansion, gene therapy, Investments, Manufacturing, North Carolina, Research Triangle Park

Biogen; manufacturing investment; North Carolina; Research Triangle Park; biotechnology; antisense oligonucleotides; gene therapy; automation; AI; expansion