Identifier – Talk Bio

Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease

4 weeks ago talkbio0Tagged access program, Alexander Disease, Antisense Oligonucleotides, Fast Track, Identifier, Improvement, Infrequent, Ionis Pharmaceuticals, nervous system disorder, orphan drug designation, Phase I – III study, Speed, United States Food and Drug Administration, Zilganersen

Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation

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

Precigen Receives FDA Approval for First Immunotherapy for HPV-Related Recurrent Respiratory Papillomatosis

2 months ago talkbio0Tagged Adenovirus Vector, Approved, Episodic, gene therapy, human papillomavirus, Identifier, Immunotherapy, Papzimeos, Precigen, Recurrent respiratory papillomatosis, RRP, United States Food and Drug Administration, zopapogene imadenovec-drba

Precigen; FDA approval; Papzimeos; zopapogene imadenovec-drba; HPV; recurrent respiratory papillomatosis (RRP); immunotherapy; gene therapy; adenoviral vector; Breakthrough Therapy designation

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

2 months ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

Forging the Future of Cell Therapy: Bayer and BlueRock’s Unique Journey

5 months ago talkbio0Tagged Bayer, bemdaneprocel, biotech partnerships, BlueRock Therapeutics, Cell Therapy, Identifier, Parkinson 's disease, Phase 3 trials, Regenerative Medicine, RMAT

cell therapy; Bayer; BlueRock Therapeutics; Parkinson’s disease; bemdaneprocel; biotech partnerships; RMAT designation; Phase 3 trials; regenerative medicine

Neurona nabs $102M to launch pivotal trial of epilepsy cell therapy

7 months ago talkbio0Tagged Cell Therapy, drug-resistant, Epilepsy, Identifier, MTLE, RMAT

MTLE, Epilepsy, Cell Therapy, RMAT, Identifier, drug-resistant

Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA

7 months ago talkbio0Tagged Advanced Manufacturing Technology, Biologics License Application, Cell Shuttle, Cell Therapy, Cellares, Identifier, Investigational New Drugs, production, Technology, United States Food and Drug Administration

Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs

Kura Oncology’s Ziftomenib Achieves Phase 2 Success in AML, Paving Way for Dual-Track Phase 3 Program

9 months ago talkbio0Tagged AML, Breakthrough Therapy, DNA Sequence Rearrangement, Identifier, KMT2A gene, KOMET-001, KOMET-017, Leukemia, Myelocytic, Acute, Menin Inhibitor, Mutation, NPM1, NPM1 gene, Phase 3 trials, Ziftomenib

Ziftomenib, Acute Myeloid Leukemia (AML), NPM1 mutation, KMT2A rearrangement, Phase 3 trials, KOMET-001, KOMET-017, Menin inhibitor, Breakthrough Therapy Designation