ORG – Page 15 – Talk Bio

Sandoz Launches Tyruko (Natalizumab-Sztn), First Tysabri Biosimilar, in US After JCV Assay Delays

4 weeks ago talkbio0Tagged Approved, Biological Assay, Biosimilars, JC Virus, JCV, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, Polpharma Biologics, Progressive, sandoz, Tyruko, Tysabri, United States Food and Drug Administration

Sandoz; Tyruko; Tysabri biosimilar; natalizumab-sztn; multiple sclerosis (MS); biosimilar launch; JCV assay; progressive multifocal leukoencephalopathy (PML); FDA approval; Polpharma Biologics

NewcelX Appoints Jeremy Shefner to Scientific Advisory Board

4 weeks ago talkbio0Tagged ALS, Amyotrophic Lateral Sclerosis, AstroRx ®, Barrow Neurological Institute, Cell Therapy, Clinical Trials, Jeremy Shefner, Neurodegenerative Disorders, NewcelX, Scientific Advisory Board

NewcelX; Jeremy Shefner; Scientific Advisory Board; ALS; AstroRx; neurodegenerative disease; Barrow Neurological Institute; cell therapy; clinical trials

Bright Minds Biosciences Expands Scientific Advisory Board to Include Renowned Experts in Prader-Willi Syndrome (PWS)

4 weeks ago talkbio0Tagged BMB-101, BMB-105, Bright Minds Biosciences, Clinical Trials, Neurodevelopmental Disorders, Prader-Willi Syndrome, PWS, Scientific Advisory Board

Bright Minds Biosciences; Scientific Advisory Board; Prader-Willi Syndrome; PWS; BMB-101; BMB-105; clinical trials; neurodevelopmental disorders

Lunit and Labcorp Partner to Transform Tumor Microenvironment Analysis with AI-Powered Digital Pathology

4 weeks ago talkbio0Tagged Artificial Intelligence, Biological Markers, digital pathology, Discover, Labcorp, Lunit, MET exon 14 skipping mutation, Non-Small Cell Lung Carcinoma, precision oncology, spatial profiling, Tumor Microenvironment

Lunit; Labcorp; artificial intelligence; digital pathology; tumor microenvironment; spatial profiling; biomarker discovery; precision oncology; non-small cell lung cancer (NSCLC); MET exon 14 skipping mutation

Johnson & Johnson Acquires Halda Therapeutics for $3.05 Billion to Add RIPTAC Cancer Drug Platform

4 weeks ago talkbio0Tagged Acquisition, clinical pipeline, Halda Therapeutics, HLD-0915, Johnson & Johnson, Malignant neoplasm of prostate, Neoplasms, RIPTAC, Targeted Protein Degradation

Johnson & Johnson; Halda Therapeutics; acquisition; RIPTAC; HLD-0915; prostate cancer; targeted protein degradation; oncology; clinical pipeline

FDA Imposes Boxed Warning and Restricts Use of Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

4 weeks ago talkbio0Tagged Black Box Warning, ELEVIDYS, gene therapy, Indication restriction, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Post-marketing study, Safety labeling, United States Food and Drug Administration

Elevidys; Sarepta Therapeutics; Duchenne muscular dystrophy; FDA; Boxed warning; Gene therapy; Acute liver failure; Safety labeling; Indication restriction; Post-marketing study

Nuvalent Shares Positive Phase 1/2 ALK Inhibitor Data Rivaling Pfizer’s Lorbrena in Lung Cancer

4 weeks ago talkbio0Tagged ALK Inhibitor, ALKOVE-1 trial, Clinical Trials, CNS activity, Frequency of Responses, Lorbrena, lorlatinib, neladalkib, Non-Small Cell Lung Carcinoma, Nuvalent, Phase 1/2 data, United States Food and Drug Administration

Nuvalent; neladalkib; ALK inhibitor; ALKOVE-1 trial; Phase 1/2 data; non-small cell lung cancer (NSCLC); lorlatinib; Lorbrena; FDA; clinical trial; objective response rate; CNS activity

Lundbeck Fires First Shot in Bidding War With Alkermes Over Sleep Biotech Avadel

4 weeks ago talkbio0Tagged Alkermes, Approved, Avadel, bidding war, CVR, LUMRYZ, Lundbeck, Primary Hypersomnia, sleep biotech, United States Food and Drug Administration

Lundbeck; Alkermes; Avadel; bidding war; sleep biotech; Lumryz; idiopathic hypersomnia; FDA approval; deal; CVR

Pfizer Reduces Stake in BioNTech; Candel Pauses Pancreatic Cancer Program

4 weeks ago talkbio0Tagged Acquisition, BioNTech, Comirnaty, expansion, Metsera, mRNA Vaccine, Pancreatic carcinoma, Pfizer, pipeline

Pfizer; BioNTech; stake reduction; Candel Therapeutics; pancreatic cancer; Comirnaty; mRNA vaccine; Metsera acquisition; pipeline expansion

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

4 weeks ago talkbio0Tagged ARC-EX System, CE Mark, Clearance, hand sensation, Hand Strength, Home Use, Medical Devices, Medical service, neurotechnology, ONWARD, Spinal Cord Injuries, United States Food and Drug Administration

ONWARD Medical; FDA 510(k) clearance; ARC-EX System; home use; spinal cord injury; hand strength; hand sensation; neurotechnology; CE Mark; medical device