July 2025 – Page 12

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

2 months ago talkbio0Tagged Capricor Therapeutics, Cardiomyopathies, Cell Therapy, Clinical Data, Complete, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3, Rejection, Response process, United States Food and Drug Administration

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

Bayer’s Lynkuet (elinzanetant) Wins First-in-World Approval in UK, Challenging Astellas’ Hot Flash Drug

2 months ago talkbio0Tagged Approved, Astellas, Bayer, Elinzanetant, Hot flushes, Lynkuet, Menopause, MHRA, non-hormonal therapy, UK, vasomotor symptom

Bayer; elinzanetant; Lynkuet; menopause; hot flashes; vasomotor symptoms; Astellas; non-hormonal therapy; MHRA approval; UK first approval

Apple Watch AI Model Enhances Health Predictions Using Behavioral Data

2 months ago talkbio0Tagged Aortic Valve Insufficiency, Apple Watch, Behavior, health prediction, Heart, Machine Learning, pregnancy detection, Wearable Behavior Model

Apple Watch; AI model; behavioral data; health prediction; machine learning; Wearable Behavior Model; pregnancy detection; Heart and Movement Study

FDA Commissioner Makary Proposes Fast-Track Drug Review Vouchers Tied to Lower US Prices, Without Detailing Criteria

2 months ago talkbio0Tagged drug price, fast-track approval, Makary, national priority review vouchers, Parity, pilot program, Prices, United States Food and Drug Administration

FDA; Makary; national priority review vouchers; drug pricing; fast-track approval; price parity; pilot program

Moderna’s COVID Vaccine Wins FDA Approval for At-Risk Young Children

2 months ago talkbio0Tagged Approved, At-Risk, Child, conditions, Covid Vaccine, Moderna, Spikevax, United States Food and Drug Administration

Moderna; FDA approval; COVID vaccine; children; at-risk; Spikevax; underlying conditions; full approval

Biopharma Layoffs Continue to Surge in First Half of 2025

2 months ago talkbio0Tagged Biopharma, biotech closures, Increase, Industry, layoffs, trends qualifier

biopharma; layoffs; 2025; workforce reductions; industry trends; biotech closures; year-over-year increase

UnitedHealth Group Names Mike Cotton as New Medicaid CEO in Executive Reshuffle

2 months ago talkbio0Tagged Appointments, Bobby Hunter, CEO, executive changes, Gossypium, government programs, Leadership, Medicaid, UnitedHealth Group

UnitedHealth Group; CEO appointment; Medicaid; Mike Cotton; executive changes; government programs; Bobby Hunter; leadership transition

AbbVie Acquires Rights to Ichnos Glenmark’s Lead Myeloma Antibody (ISB 2001) in $1.93 Billion Deal

2 months ago talkbio0Tagged AbbVie, bis(3-bis(4-chlorophenyl)methyl-4-dimethylaminophenyl)amine, CD3 Antigens, CD38 Antigen, Clinical Trials, Global Licensing, Ichnos Glenmark, ISB, Multiple Myeloma, Neoplasms, Phase 1 (qualifier value), Trispecific Antibody

AbbVie; Ichnos Glenmark; ISB 2001; trispecific antibody; multiple myeloma; biotech deal; CD3; BCMA; CD38; Phase 1 clinical trial; global licensing; oncology

NUCLIDIUM Sees Copper Isotopes as Future of Radiopharmaceuticals, Raises CHF 79M to Advance Clinical Development

2 months ago talkbio0Tagged cancer diagnostics, cancer therapeutics, copper isotopes, Malignant neoplasm of breast, Metastatic Prostate Carcinoma, Neoplasms, Neuroendocrine Tumors, NUCLIDIUM, NuriPro, Radiopharmaceuticals, Series B financing, Theranostics, TraceNET

NUCLIDIUM; copper isotopes; radiopharmaceuticals; Series B financing; Cu-NuriPro; NuriPro; TraceNET; oncology; theranostics; metastatic prostate cancer; neuroendocrine tumors; breast cancer; cancer diagnostics; cancer therapeutics

Pfizer, Astellas’ Xtandi Combo Extends Survival in Early Prostate Cancer

2 months ago talkbio0Tagged Astellas, BCR, biochemical recurrence, Combined Modality Therapy, EMBARK, enzalutamide, leuprolide, Malignant neoplasm of prostate, nmHSPC, non-metastatic, Overall Survival, Pfizer, Xtandi

Pfizer; Astellas; Xtandi; Enzalutamide; prostate cancer; overall survival; combination therapy; leuprolide; non-metastatic hormone-sensitive prostate cancer (nmHSPC); EMBARK study; biochemical recurrence (BCR)