PERSON – Talk Bio

J&J’s Inlexzo Bladder Cancer Therapy Wins ‘Practice-Changing’ FDA Approval

6 hours ago talkbio0Tagged Approved, BCG-Unresponsive, Carcinoma, Drug Delivery Systems, gemcitabine intravesical system, in situ, Inlexzo, Johnson & Johnson, Malignant neoplasm of urinary bladder, New, Non-Muscle Invasive Bladder Neoplasms, SunRISe-1 trial, United States Food and Drug Administration

Inlexzo; FDA approval; bladder cancer; Johnson & Johnson; gemcitabine intravesical system; BCG-unresponsive; non-muscle invasive bladder cancer; SunRISe-1 trial; novel drug delivery; carcinoma in situ

Second MAHA Report Emphasizes Chronic Disease, Tilts at Vaccine Reform

11 hours ago talkbio0Tagged childhood health, childhood vaccine schedule, Chronic disease, Commission, federal directives, Food Policy, MAHA, Prescription Drug Overuse, public health medicine (field), Robert F. Kennedy Jr., Vaccine Reform

MAHA Commission; chronic disease; vaccine reform; Robert F. Kennedy Jr.; childhood health; food policy; medication overuse; public health; federal directives; childhood vaccine schedule

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

1 day 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

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

1 day 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

Trump Administration May Exempt Some Pharma Products from Future Tariffs in Trade Policy Shift

1 day ago talkbio0Tagged active pharmaceutical ingredients, Evaluation, generic pharmaceuticals, pharmaceutical tariffs, reciprocal tariffs, Secretary, Sectioning technique, tariff exemptions, trade policy, Trump administration

pharmaceutical tariffs; tariff exemptions; Trump administration; Section 232 investigation; trade policy; reciprocal tariffs; generic pharmaceuticals; active pharmaceutical ingredients; commerce secretary authority

Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial

2 days ago talkbio0Tagged Accelerated, Antibody-Drug Conjugates, Approved, Breakthrough Therapy, CD276 gene, Co., Daiichi, Deruxtecan, Frequency of Responses, IDeate-Lung01, Identifier, ifinatamab, Overall Survival, Progression-Free Survival, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation