Uncategorized – Page 7

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

1 week 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

1 week 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

1 week 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

1 week 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

1 week 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

Nona Biosciences Appoints Dr. Hongjiang Miao as Chief AI Officer to Advance A³ Strategy and AI-Driven Drug Discovery

1 week ago1 week ago talkbio0Tagged Biotechnology, Chief AI Officer, Drug Development, Drug Discovery, Harbour Mice ® technology, Hongjiang Miao, integrated solutions, Nona Biosciences, Shanghai

Nona Biosciences; Hongjiang Miao; Chief AI Officer; AI-Driven Drug Discovery; biotechnology; Shanghai; drug development; Harbour Mice technology; integrated solutions

Jesper Høiland Joins Alva Therapeutics’ Board of Directors

1 week 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

1 week 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

1 week 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

1 week 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