Functional Concept

Former FDA Chiefs Criticize Proposed Vaccine Policy Changes at ACIP Meeting

4 days ago talkbio0Tagged * New England Journal of Medicine*., ACIP, Centers for Disease Control and Prevention (U.S.), Changing, commissioners, COVID19 (disease), Policy, research, Senator Bill Cassidy, United States Food and Drug Administration, vaccine safety regulation, Vaccines, Vinay Prasad ; Center for Biologics Evaluation

former FDA commissioners; CDC; ACIP meeting; vaccine policy changes; COVID-19 vaccines; Vinay Prasad; Center for Biologics Evaluation and Research; vaccine safety regulation; Senator Bill Cassidy; New England Journal of Medicine commentary

mAbxience and HP Drive the Use of Artificial Intelligence in Biomanufacturing and Biosimilar Development

4 days ago talkbio0Tagged Artificial Intelligence, Biological Factors, biomanufacturing, Biosimilars, development aspects, digital twin, Fresenius, Hereditary pancreatitis, mAbxience, Monoclonal Antibodies, Neural Network Simulation

mAbxience; HP; artificial intelligence; biomanufacturing; biosimilar development; digital twin; monoclonal antibodies; neural network models; biologics; Fresenius

FDA Refuses to Release Detailed Data on Claimed COVID Vaccine-Linked Child Deaths in Near Term

5 days ago talkbio0Tagged COVID19 (disease), Data Release, Death of child, Myocarditis, United States Food and Drug Administration, vaccine oversight, Vaccine Safety, Vaccines

FDA; COVID-19 vaccine; child deaths; myocarditis; vaccine safety; Vinay Prasad; data release; vaccine oversight

Recent obesity and IL-6 program updates for Fractyl, Helicore, and Tiziana

5 days ago talkbio0Tagged Autoimmune, Discontinuation (procedure), Fractyl Health, Glucagon-Like Peptide 1, Helicore, interleukin-6, Obesity, REVEAL-1, Revita, Tiziana Life Sciences, weight loss maintenance

Fractyl Health; Revita; REVEAL-1; weight loss maintenance; GLP-1 discontinuation; Helicore; Tiziana Life Sciences; IL-6; autoimmune; obesity

Imvax Shares Positive Phase 2b Data for IGV-001 Glioblastoma Treatment and Plans FDA Meeting

5 days ago talkbio0Tagged Clinical Trials, Glioblastoma, IGF-1R Antisense Oligodeoxynucleotide-treated Autologous Glioma Cells IGV-001, Immunotherapy, Imvax, meeting, Overall Survival, United States Food and Drug Administration

Imvax; IGV-001; glioblastoma; Phase 2b trial; overall survival; FDA meeting; immunotherapy; clinical trial; glioblastoma treatment

OncoPrecision Announces Oral Presentation of ONC001, a First-in-Class CD64-Targeting ADC for Monocytic Leukemia, at the 67th ASH Annual Meeting

6 days ago talkbio0Tagged annual, Antibody-Drug Conjugates, Asymmetric Septal Hypertrophy, CD64-targeting ADC, Leukemia, Myelocytic, Acute, Leukemia, Myelomonocytic, Chronic, meeting, Monocytic leukemia, OncoPrecision, Resistance (Psychotherapeutic)

OncoPrecision; ONC001; CD64-targeting ADC; monocytic leukemia; acute myeloid leukemia; ASH Annual Meeting; antibody-drug conjugate; CMML; therapy resistance

Biocon Biologics Secures Market Entry Date for Denosumab Biosimilars in Europe and Global Markets

6 days ago talkbio0Tagged Amgen settlement, Biocon Biologics, Biosimilars, biosimilars approval, bone health, Commission, denosumab, entry - ActRelationshipCheckpoint, Europe market, European (ethnic group), Evfraxy, Neoplasms, Vevzuo

Biocon Biologics; Denosumab biosimilars; Vevzuo; Evfraxy; Europe market entry; Amgen settlement; biosimilars approval; European Commission; bone health; oncology

Rakovina Therapeutics Announces Q3 2025 Financial Results and Corporate Update

6 days ago talkbio0Tagged AI-powered, ATR Inhibitor, Clinical Nurse Specialists, Conferences, corporate milestones, development expenses, Ditiocarb, Drug Discovery, Eligibility Determination, financial results, Investments, NanoPalm joint-venture, net loss, Penetration, Q3, Rakovina, research

Rakovina Therapeutics; Q3 2025; financial results; net loss; research and development expenses; AI-powered drug discovery; ATR inhibitor; CNS penetration; corporate milestones; NanoPalm joint-venture; investment conference; DTC eligibility

Keytruda Breaks New Ground with FDA Approval for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

1 week ago talkbio0Tagged Adjuvant Therapy, Approved, Clinical Trials, Event-Free Survival, Gene Expression, KEYNOTE-689 trial, Keytruda, Neoadjuvant Therapy, PD-L1, pembrolizumab, perioperative, Squamous cell carcinoma of the head and neck, United States Food and Drug Administration

Keytruda; pembrolizumab; perioperative treatment; head and neck squamous cell carcinoma; HNSCC; FDA approval; KEYNOTE-689 trial; neoadjuvant therapy; adjuvant therapy; PD-L1 expression; event-free survival; clinical trial

Accelerating Breast Cancer Treatment Planning with Agentic AI: Recent Advances and Implementations (2025)

2 weeks ago talkbio0Tagged agentic AI, AI-guided, AWS HealthLake, Clinical Decision Support, DNA Integration, healthcare workflow, Malignant neoplasm of breast, Microsoft Teams, multi-agent systems, Neoplasms, Precision Medicine

agentic AI; breast cancer treatment; oncology; clinical decision support; multi-agent systems; healthcare workflow automation; personalized medicine; AWS HealthLake; Microsoft Teams integration; AI-guided treatment planning