Pathologic Function

Pfizer Veteran Suneet Varma Named CEO of Phase 3-Ready Biotech Startup Intent Biologics

2 days ago talkbio0Tagged Appointments, biotech startup, CEO, Clinical Trials, Immunology, Inflammation, Intent Biologics, Pfizer vet, Phase 3, Regenerative Medicine, Suneet Varma

Suneet Varma; Pfizer vet; Intent Biologics; CEO appointment; regenerative medicine; Phase 3 clinical trials; biotech startup; inflammation and immunology

FDA Pushes Back Agios’ Pyrukynd Thalassemia Decision to December

7 days ago talkbio0Tagged Agios, decision delay, Liver damage, PDUFA, Pyrukynd, REMS, Thalassemia, United States Food and Drug Administration

FDA; Agios; Pyrukynd; thalassemia; PDUFA; decision delay; REMS; hepatocellular injury

Prothena’s Alzheimer’s Trial Hit by High ARIA-E Rates, Resulting in ‘Non-Competitive’ Profile

2 weeks ago talkbio0Tagged Alzheimer 's disease, amyloid beta antibody, ARIA-E, ASCENT, Cerebral Edema, clinical program, non-competitive profile, Prothena, PRX012, subcutaneous administration

Prothena; PRX012; Alzheimer’s disease; ARIA-E; brain swelling; phase 1 trial; non-competitive profile; amyloid beta antibody; ASCENT clinical program; subcutaneous administration

FDA Begins Daily Publication of Drug Adverse Event Data

2 weeks ago talkbio0Tagged Adverse event, Daily, data modernization, drug safety, FAERS, public health medicine (field), real-time monitoring, United States Food and Drug Administration

FDA; FAERS; adverse event reporting; daily publishing; data modernization; drug safety; real-time monitoring; public health

FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns

3 weeks ago talkbio0Tagged Adverse event, Cessation of life, chikungunya vaccine, Encephalitis, Hospitalization, Ixchiq, license suspension, Safety, United States Food and Drug Administration, Valneva

FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

3 weeks ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

Viking Therapeutics Shares Crash After Obesity Pill VK2735 Delivers 12% Weight Loss, But Side Effects and Discontinuations Raise Concerns

3 weeks ago talkbio0Tagged Adverse event, aspects of adverse effects, Clinical Trials, Contraceptives, Oral, drug efficacy, gastrointestinal, Obesity, Stock Crash, Viking, VK2735, Weight Loss

Viking Therapeutics; VK2735; obesity pill; weight loss; clinical trial; stock crash; side effects; adverse events; gastrointestinal; drug efficacy

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

4 weeks ago talkbio0Tagged Adverse reactions, Advisory Committees, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Childhood, Childhood Vaccines, Jay Bhattacharya, NIH Mouse, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccine Safety, Vaccines

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

CorestemChemon Partners with ATG Lifetech to Expand Organoid and Transcriptomics Capabilities

2 months ago talkbio0Tagged Blood - brain barrier anatomy, CorestemChemon, Drug Discovery, FDA/EMA regulatory pathways, Gene Expression Profiling, heart organoids, Lifetech, liver organoids, lymphocyte immune globulin, anti-thymocyte globulin, Organoids, preclinical CRO, Predictive analytics, Tumorigenicity

CorestemChemon; ATG Lifetech; organoids; transcriptomics; preclinical CRO; drug discovery; predictive analytics; tumorigenicity; FDA/EMA regulatory pathways; liver organoids; heart organoids; blood-brain barrier models

EU Lifts Restriction on Valneva’s Chikungunya Vaccine for Older Adults, Recommends Caution

2 months ago talkbio0Tagged Adverse event, chikungunya vaccine, concerns, Elderly (population group), European Medicines Agency, Ixchiq, label extension, Safety, Valneva

Valneva; Chikungunya vaccine; IXCHIQ; European Medicines Agency; older adults; safety concerns; label extension; adverse events