Intellectual Product – Page 4 – Talk Bio

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Amgen, Kyowa Kirin Bolster Safety Profile for Atopic Dermatitis Drug Rocatinlimab

1 month ago talkbio0Tagged amgen, ASCEND trial, Dermatitis, Atopic, Eczema, Kyowa Kirin, Long-term, OX40 receptor, Programs - Publication Format, Rocatinlimab, Rocket, Safety

Amgen; Kyowa Kirin; rocatinlimab; atopic dermatitis; OX40 receptor; ASCEND trial; ROCKET program; long-term safety; eczema

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

1 month 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

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

1 month 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

Japan Wins Exemption for Generics in US-Japan Trade Deal

1 month ago talkbio0Tagged generic pharmaceuticals, Japan, semiconductor supply chains, tariff exemption, TNFRSF19 gene, Transplant Registry Unified Management Program, U.S.

Japan; US Trade Deal; generic pharmaceuticals; tariff exemption; semiconductor supply chains; Trump administration

RFK Jr. Blasts Pharma Industry and Spreads mRNA Vaccine Misinformation During Heated Senate Hearing

1 month ago talkbio0Tagged Centers for Disease Control and Prevention (U.S.), COVID19 (disease), Leadership, mRNA misinformation, Pharma Industry, Policy, public health medicine (field), RFK Jr., Senate hearing, Vaccines

RFK Jr.; Senate hearing; pharma industry; mRNA misinformation; COVID-19 vaccines; public health; vaccine policy; CDC leadership

RFK Jr. Faces Bipartisan Senate Criticism After CDC Shakeup

1 month ago talkbio0Tagged bipartisan criticism, Centers for Disease Control and Prevention (U.S.), director firing, Policy, public health medicine (field), RFK Jr., Senate hearing, Shakeup, Trump administration reforms, Vaccines

RFK Jr.; CDC shakeup; bipartisan criticism; Senate hearing; public health; vaccine policy; CDC director firing; Trump administration reforms

AstraZeneca Ends Manufacturing License at Indian Plant and Exits Site as Part of Global Strategy

1 month ago talkbio0Tagged AstraZeneca, Bangalore plant, Contract agreement, Drug Industry, global strategy, India, Manufacturing, manufacturing license, Site of exit

AstraZeneca; India; manufacturing license; site exit; Bangalore plant; contract manufacturing; global strategy; pharmaceutical industry

Paul Offit, RFK Jr. Critic, Removed from Key FDA Vaccine Panel

2 months ago talkbio0Tagged Advisory Committees, CHARGE Syndrome, Paul Offit, Policy, removal technique, RFK Jr., United States Food and Drug Administration, vaccine panel, Vaccines, VRBPAC

Paul Offit; FDA; vaccine panel; RFK Jr.; removal; vaccine policy; VRBPAC; advisory committee; HHS

AstraZeneca gears up for FDA filing after baxdrostat’s phase 3 hypertension success

2 months ago talkbio0Tagged aldosterone synthase inhibitor, AstraZeneca, baxdrostat, File (record), Hypertensive disease, regulatory approval, United States Food and Drug Administration

AstraZeneca; baxdrostat; hypertension; FDA filing; aldosterone synthase inhibitor; phase 3 trial; regulatory approval

Vinay Prasad Explains FDA’s Revocation of Pfizer’s Covid Vaccine EUA for Children

2 months ago talkbio0Tagged Child, COVID19 (disease), Emergency Situation, Emergency Use Authorization, EUA, Pfizer, Policy, Prasad, risk-benefit analysis, United States Food and Drug Administration, Vaccines

FDA; Pfizer; COVID-19 vaccine; emergency use authorization (EUA); children; Vinay Prasad; vaccine policy; risk-benefit analysis