Effectiveness – Talk Bio

Dyne Therapeutics’ z-rostudirsen Shows Durable Efficacy, Supporting Positive Regulatory Outlook

6 days ago talkbio0Tagged Accelerated, Approved, Biological Markers, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, Effectiveness, Functional improvement, Muscular Dystrophy, Duchenne, regulatory approval, z-rostudirsen

Dyne Therapeutics; z-rostudirsen; DELIVER trial; Duchenne muscular dystrophy (DMD); durable efficacy; regulatory approval; biomarkers; functional improvement; accelerated approval

Moderna Halts Development of CMV Vaccine After Phase 3 Failure

2 weeks ago talkbio0Tagged Clinical trial failure, Congenital Cytomegalovirus Infection, Cytomegalovirus Infections, Effectiveness, Moderna, mRNA-1647 cytomegalovirus vaccine, Phase 3 trial, Vaccines

Moderna; CMV vaccine; mRNA-1647; Phase 3 trial; Congenital cytomegalovirus; Vaccine efficacy; Clinical trial failure

Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes

3 weeks ago talkbio0Tagged ACHIEVE-1, ATTAIN-2, Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Effectiveness, Eli Lilly, Farxiga, Glucagon-Like Peptide 1, Oral cavity, orforglipron, regulatory submission, Safety, semaglutide, Weight Loss

Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety

Metsera’s New Obesity Data Raises Efficacy Profile, Key Side Effect Questions for Pfizer After Acquisition

1 month ago talkbio0Tagged aspects of adverse effects, Effectiveness, Glucagon-Like Peptide 1, MET-097i, Metsera, Obesity, Pfizer, Pfizer acquisition, Phase 2 trial, Weight Loss

Metsera; Pfizer; obesity drug; MET-097i; GLP-1; side effects; efficacy; Phase 2 trial; weight loss; Pfizer acquisition

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

2 months 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

3 months 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

3 months 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

3 months 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

5 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

Moderna Shares Fall as Company Withdraws Flu/COVID-19 Combination Vaccine Application

6 months ago talkbio0Tagged Biologics License Application, Clinical Trials, COVID19 (disease), Effectiveness, Influenza, Moderna, mRNA-1083, Prices, United States Food and Drug Administration, Vaccines, Vaccines, Combined

Moderna; mRNA-1083; combination vaccine; flu; COVID-19; FDA; Biologics License Application; vaccine efficacy; clinical trial; share price