Effectiveness – Talk Bio

Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

1 week ago talkbio0Tagged Capricor Therapeutics, Cell Therapy, Clinical Trials, data misinterpretation, deramiocel, Effectiveness, Endpoints, HOPE-2 trial, Muscular Dystrophy, Duchenne, Non-Parametric Test, Rejection, Statistical Significance, United States Food and Drug Administration

Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy

Dynavax Highlights Comparable Efficacy and Improved Tolerability of Z-1018 Shingles Vaccine vs. Shingrix

4 weeks ago talkbio0Tagged aspects of adverse effects, Dynavax, Effectiveness, Herpes zoster disease, Immunogenicity (package insert), Shingrix, Vaccines, Z-1018

Dynavax; Z-1018; shingles vaccine; Shingrix; vaccine efficacy; side effects; Phase 1/2 trial; immunogenicity

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

4 weeks ago talkbio0Tagged Clinical Trials, concerns, Effectiveness, factor IX, Failure (biologic function), Friedreich 's ataxia, Rare Diseases, Rejection, Response process, United States Food and Drug Administration, vatiquinone

PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure

HHS Ends BARDA Funding for Future mRNA Vaccine Development, Citing Efficacy Concerns

1 month ago talkbio0Tagged BARDA, CHARGE Syndrome, COVID19 (disease), Effectiveness, Influenza, mRNA Vaccines, project cancellation, public health policy, Robert F. Kennedy, Vaccines

mRNA vaccines; BARDA; Robert F. Kennedy Jr.; vaccine efficacy; HHS; COVID-19; flu; project cancellation; public health policy

Moderna’s Next-Generation COVID Shot Gets FDA Backing With Usage Limitations

4 months ago talkbio0Tagged age restriction, Approved, conditions, COVID19 (disease), Effectiveness, mNEXSPIKE, Moderna, mRNA-1283, next-generation vaccine, respiratory virus season, United States Food and Drug Administration, Vaccines

Moderna; COVID-19 vaccine; FDA approval; mNEXSPIKE; mRNA-1283; next-generation vaccine; respiratory virus season; age restriction; underlying conditions; vaccine efficacy