Conceptual Entity

Lightning Step and Sunwave Achieve SOC 2 Type II Attestation, Strengthening Security and Trust Across Healthcare Technology

2 weeks ago talkbio0Tagged Biomechanical compliance, Healthcare technology, Lightning Step, Security - service, spindle orientation checkpoint, Sunwave, Type 2

Lightning Step; Sunwave; SOC 2 Type II; Healthcare Technology; Security; Compliance

FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations

1 month ago talkbio0Tagged Cautionary Warning, COVID19 (disease), Marty Makary, mRNA Vaccines, Myocarditis, RFK gene, Safety, United States Food and Drug Administration, vaccine deaths, Vaccines

Marty Makary; FDA; COVID-19 vaccine; myocarditis; vaccine deaths; safety warnings; RFK Jr.; mRNA vaccines

MediView Achieves First CE Mark, Bringing Augmented Reality to European Healthcare

2 months ago talkbio0Tagged augmented, Augmented Reality, CE Mark, clinical visualization, European (ethnic group), GE HealthCare, Health care facility, Interventional radiology, MediView, MediView XR, MediView XR90, reality

MediView; CE Mark; augmented reality; European healthcare; mixed reality; clinical visualization; MediView XR; MediView XR90; GE Healthcare; interventional radiology

Merck Continues Cuts: 204 Employees Laid Off in New Jersey

2 months ago talkbio0Tagged Biopharma Industry, Cautionary Warning, cost-cutting, Dosage Forms, Gardasil, global workforce reduction, Keytruda, layoffs, Merck, New Jersey, Rahway, restructuring

Merck; layoffs; New Jersey; Rahway; pharmaceutical; cost-cutting; restructuring; WARN notice; global workforce reduction; Keytruda; Gardasil; biopharma industry

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

2 months 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

GSK Secures Exclusive Rights to Syndivia’s Preclinical Prostate Cancer ADC in $357 Million Deal

3 months ago talkbio0Tagged asset, GeminiMab technology, Licensing, Malignant neoplasm of prostate, Metastatic castration-resistant prostate cancer, milestone payments, Oncology Pipeline, Preclinical, SmithKline Beecham, Syndivia, therapeutic autologous dendritic cells

GSK; Syndivia; ADC; prostate cancer; metastatic castration-resistant prostate cancer; exclusive licensing; oncology pipeline; GeminiMab technology; milestone payments; preclinical asset

AnaptysBio Announces Strategic Business Split to Create Two Public Companies, Sharpening Asset Focus

4 months ago talkbio0Tagged AnaptysBio, asset, biopharmaceutical development, business split, Immunology, Imsidolimab, Jemperli, public companies, restructuring, royalty management

AnaptysBio; business split; royalty management; biopharmaceutical development; Jemperli; imsidolimab; public companies; immunology treatments; asset value; restructuring

AstraZeneca Plans Direct US Stock Listing While Maintaining UK Headquarters

4 months ago talkbio0Tagged American Depositary Receipts, AstraZeneca, Capital Markets, Drug Industry, headquarters, London, Nasdaq Stockholm, NYSE, shareholders, Stock exchange, U.S., UK

AstraZeneca; US stock listing; NYSE; London Stock Exchange; Nasdaq Stockholm; American Depositary Receipts; capital markets; pharmaceutical industry; shareholders; UK headquarters

FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

4 months ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing

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

4 months 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