Qualitative Concept

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

5 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

Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

1 day ago talkbio0Tagged Approved, Biosimilars, Enzeevu, Eylea, launch, Ophthalmology specialty, Patent Settlement, Regeneron, sandoz, United States, United States Food and Drug Administration

Regeneron; Sandoz; Eylea; Enzeevu; biosimilar; aflibercept; patent settlement; FDA approval; U.S. launch; ophthalmology

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

Takeda and Alkermes Detail Strong Clinical Results for Orexin Drugs in Narcolepsy – Head-to-Head Race Accelerates

2 days ago talkbio0Tagged agonists, alixorexton, Alkermes, Cataplexy, Clinical Trials, Daytime Somnolence, Excessive (qualifier value), Maintenance, MWT, Narcolepsy, orexins, oveporexton, Phase 3, Takeda, Wakefulness Test

Takeda; Alkermes; orexin agonists; narcolepsy; oveporexton; alixorexton; clinical trials; Phase 3; excessive daytime sleepiness; cataplexy; maintenance of wakefulness test (MWT)

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

AstraZeneca Escalates EGFR Lung Cancer Rivalry with J&J: Tagrisso Combo Posts Survival Win

2 days ago talkbio0Tagged AstraZeneca, Combined, EGFR-mutated, FLAURA2 trial, Johnson & Johnson, Lazcluze, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, Overall Survival, Pharmacotherapy, Rybrevant, Tagrisso

AstraZeneca; Tagrisso; EGFR-mutated NSCLC; Johnson & Johnson; Rybrevant; Lazcluze; Flaura2 trial; overall survival; lung cancer; chemotherapy combination

FDA Shifts Approach on GLP-1 Compounding: Announces Consumer Green List Instead of Immediate Crackdown

2 days ago talkbio0Tagged Compound, Consumer Safety, Drug shortages, Glucagon-Like Peptide 1, green list, import alert, Regulation, semaglutide, United States Food and Drug Administration

FDA; GLP-1; compounding; green list; drug shortages; semaglutide; tirzepatide; import alert; consumer safety; regulation

FDA Releases Second Batch of Complete Response Letters, Moves to Real-Time Public Disclosure

6 days ago talkbio0Tagged Complete, CRLs, Drug Approval, real-time publishing, regulatory disclosure, Response Letters, Translucent, United States Food and Drug Administration

FDA; Complete Response Letters; CRLs; real-time publishing; drug approvals; transparency; regulatory disclosure

Survival Benefit of Amgen’s Bemarituzumab in Gastric Cancer Attenuates at Final Analysis

6 days ago talkbio0Tagged amgen, Attenuated by (contextual qualifier), bemarituzumab, Benefit, final analysis, FORTITUDE-101, FORTITUDE-102, Malignant neoplasm of stomach, nivolumab, Opdivo, Overall Survival, Zai Lab

Amgen; bemarituzumab; gastric cancer; Phase 3 trial; overall survival; attenuated benefit; final analysis; FORTITUDE-101; FORTITUDE-102; Zai Lab; Opdivo; nivolumab

FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER

6 days ago talkbio0Tagged Accelerated, Approved, CBER, CDER, gene therapy, Hereditary Diseases, Infrequent, RDEP, regulatory guidance, submission program, United States Food and Drug Administration

CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders