Disease or Syndrome

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

2 days 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

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

2 days 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

2 days 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

FDA names Tracy Beth Heg as acting CDER chief

3 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

3 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

Jesper Høiland Joins Alva Therapeutics’ Board of Directors

4 days ago talkbio0Tagged Alva Therapeutics, board of directors, Clinical Development, Diabetes Mellitus, Non-Insulin-Dependent, incretin secretagogue, Novo Nordisk, Obesity, Oral cavity, pharmaceutical commercialization

Alva Therapeutics; Board of Directors; Novo Nordisk; Type 2 diabetes; obesity; oral incretin secretagogue; clinical development; pharmaceutical commercialization

Jesper Høiland Joins Alva Therapeutics’ Board of Directors

4 days ago talkbio0Tagged Alva Therapeutics, board of directors, Clinical Development, Diabetes Mellitus, Non-Insulin-Dependent, incretin secretagogue, Novo Nordisk, Obesity, Oral cavity, pharmaceutical commercialization

Alva Therapeutics; Board of Directors; Novo Nordisk; Type 2 diabetes; obesity; oral incretin secretagogue; clinical development; pharmaceutical commercialization

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

4 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

Capricor Therapeutics Reports Positive Phase 3 HOPE-3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy, Planning FDA Resubmission

4 days ago talkbio0Tagged Capricor Therapeutics, cardiac function preservation, Clinical Trials, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3 clinical trial, regulatory approval pathway, Rejection, United States Food and Drug Administration, upper limb function

Capricor Therapeutics; Deramiocel; Duchenne muscular dystrophy; HOPE-3 trial; Phase 3 clinical trial; FDA rejection; cardiac function preservation; upper limb function; clinical trial results; regulatory approval pathway