ENTITY – Talk Bio

Recent news on ACIP’s hepatitis B birth‑dose recommendation

22 hours ago talkbio0Tagged ACIP, birth dose, Centers for Disease Control and Prevention (U.S.), Clinical Decision-Making, Hepatitis B, hepatitis B policy change, Immunization Schedule, Infant, pregnancy screening, Vaccination

ACIP; hepatitis B; birth dose; infant vaccination; shared clinical decision-making; CDC immunization schedule; pregnancy screening; hepatitis B policy change

Recent news on Biopharma Sentiment Index (BPSI)

22 hours ago talkbio0Tagged Attitude, Biopharma, Biopharma Sentiment Index, BPSI, drug development sentiment, Endpoints, investing, News [Publication Type], Pharma Industry, Sentiment

Biopharma Sentiment Index; BPSI; Endpoints News; biopharma sentiment survey; drug development sentiment; biotech investing sentiment; pharma industry outlook

Rapport Therapeutics Reports Updated Phase 2a Data for Seizure Drug RAP-219

1 day ago talkbio0Tagged clinical seizure, Epilepsy, focal onset seizures, meeting, Phase 2a Trial, Phase 3 trials, RAP-219, Rapport Therapeutics, seizure drug, United States Food and Drug Administration

Rapport Therapeutics; RAP-219; Phase 2a trial; seizure drug; epilepsy; focal onset seizures; clinical seizure reduction; FDA meeting; Phase 3 trials

Building the Next Generation of Biologics: Inside the Future of Protein Engineering

1 day ago talkbio0Tagged Antibodies, Bispecific, Antibody-Drug Conjugates, cryo-EM, generative biology, high-throughput protein production, manufacturability, mini-proteins, molecular glues, next-generation biologics, PROTACs, protein degraders, protein design, Protein Engineering, Structural Biology

next-generation biologics; protein engineering; bispecific antibodies; antibody-drug conjugates (ADCs); protein degraders; PROTACs; molecular glues; mini-proteins; AI in protein design; manufacturability; structural biology; cryo-EM; high-throughput protein production; generative biology

Crescent Biopharma and Kelun-Biotech Announce Reciprocal Licensing Pact for PD-1xVEGF and ADC Cancer Therapies

1 day ago talkbio0Tagged Antibodies, Bispecific, China, CR-001, Crescent Biopharma, Kelun-Biotech, Licensing, oncology partnership, PD-1xVEGF, Reciprocal, SKB105, therapeutic autologous dendritic cells

Crescent Biopharma; Kelun-Biotech; PD-1xVEGF; CR-001; SKB105; reciprocal licensing; oncology partnership; China; ADC; bispecific antibody

UniQure restates FDA’s negative feedback on Huntington’s trial; Neurimmune expands AstraZeneca alliance

1 day ago talkbio0Tagged AMT-130, antibody collaboration, AstraZeneca, biopharmaceutical partnerships, external control group, Feedback - system communication, gene therapy, Nerve Degeneration, Neurimmune, UniQure, United States Food and Drug Administration

UniQure; AMT-130; FDA feedback; external control group; gene therapy; Neurimmune; AstraZeneca; neurodegeneration; antibody collaboration; licensing deal; biopharmaceutical partnerships

FDA names Tracy Beth Heg as acting CDER chief

2 days ago talkbio0Tagged CDER, Center for Drug Evaluation, Chief, COVID19 (disease), Drug Regulations, Leadership, research, Tracy Beth Heg, U.S. Food and Drug Administration, United States Food and Drug Administration, Vaccine Safety

Tracy Beth Heg; acting CDER chief; FDA leadership; Center for Drug Evaluation and Research; COVID-19 vaccine safety; drug regulation; U.S. Food and Drug Administration

Former FDA Chiefs Criticize Proposed Vaccine Policy Changes at ACIP Meeting

2 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

Bristol Myers Squibb Delays Cobenfy Alzheimer’s Psychosis Trial Readout Due to Site Irregularities

2 days ago talkbio0Tagged ADEPT-2 trial, Alzheimer 's psychosis, Cobenfy, Deferred, Myers Squibb, Phase 3 Clinical Trials, trial site irregularities

Bristol Myers Squibb; Cobenfy; Alzheimer’s psychosis; ADEPT-2 trial; trial site irregularities; Phase III study; delay; 2026

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

3 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