Intellectual Product – Page 3

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

2 months ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

2 months ago talkbio0Tagged 2025, Accountability, AI-enabled, clinical oversight, digital health regulation, digital mental health devices, draft guidance, EU, EU AI Act health, Generative AI, Health care facility, Medical Devices, Regulation, Software as a Medical Device, United States Food and Drug Administration

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices

Recent advances in AI for antimicrobial resistance (AMR) prevention and control

2 months ago talkbio0Tagged AI antibiotic discovery, Antibiotics, Antimicrobial Resistance, Diagnostics, Generative AI, GPR182 gene, Health care facility, Machine Learning, Phage Therapy, Stewardship, surveillance aspects

antimicrobial resistance; AI in healthcare; machine learning; antibiotic stewardship; AI antibiotic discovery; phage therapy; rapid diagnostics; AMR surveillance; generative AI

Mindpeak Secures First Patent for Advanced AI Method in Digital Pathology

2 months ago talkbio0Tagged AI model, AI-powered, cell classification, Diagnostics, digital pathology, EU, Histopathological aspects, Legal patent, Mindpeak, oncology diagnostics, Pathology, Precision - temporal, Training Programs, United Kingdom, Validation

Mindpeak; digital pathology; AI-powered pathology; oncology diagnostics; cell classification; histopathology; EU patent; United Kingdom validation; AI model training; precision diagnostics

FDA Signals Higher Efficacy Bar for New CAR‑T Cancer Therapies

2 months ago talkbio0Tagged CAR-T, Cells, Chimeric Antigen Receptor T-Cell Therapy, gene therapy, Hematologic Neoplasms, Neoplasms, Overall Survival, Randomized Controlled Trials as Topic, regulatory standards, superiority trials, United States Food and Drug Administration

FDA; CAR-T; chimeric antigen receptor T-cell therapy; oncology; regulatory standards; superiority trials; randomized controlled trials; overall survival; hematologic malignancies; cell and gene therapy

German Court Blocks Merck’s Subcutaneous Keytruda Over Patent Dispute with Halozyme

2 months ago talkbio0Tagged Antineoplastic Agents, Germany, Halozyme, Keytruda SC, Legal patent, MDASE, Merck, Munich Regional Court, Patent infringement, preliminary injunction, subcutaneous formulation

Merck; Keytruda SC; Halozyme; Germany; patent infringement; preliminary injunction; Munich Regional Court; subcutaneous formulation; cancer drug; MDASE patents

Recent news on Biopharma Sentiment Index (BPSI)

2 months ago talkbio0Tagged Attitude, Biopharma, Biopharma Sentiment Index, BPSI, drug development sentiment, Endpoints, investing, News [Publication Type], Pharma Industry, Sentiment

Biopharma Sentiment Index; BPSI; Endpoints News; biopharma sentiment survey; drug development sentiment; biotech investing sentiment; pharma industry outlook

Former FDA Chiefs Criticize Proposed Vaccine Policy Changes at ACIP Meeting

2 months ago talkbio0Tagged * New England Journal of Medicine*., ACIP, Centers for Disease Control and Prevention (U.S.), Changing, commissioners, COVID19 (disease), Policy, research, Senator Bill Cassidy, United States Food and Drug Administration, vaccine safety regulation, Vaccines, Vinay Prasad ; Center for Biologics Evaluation

former FDA commissioners; CDC; ACIP meeting; vaccine policy changes; COVID-19 vaccines; Vinay Prasad; Center for Biologics Evaluation and Research; vaccine safety regulation; Senator Bill Cassidy; New England Journal of Medicine commentary

mAbxience and HP Drive the Use of Artificial Intelligence in Biomanufacturing and Biosimilar Development

2 months ago talkbio0Tagged Artificial Intelligence, Biological Factors, biomanufacturing, Biosimilars, development aspects, digital twin, Fresenius, Hereditary pancreatitis, mAbxience, Monoclonal Antibodies, Neural Network Simulation

mAbxience; HP; artificial intelligence; biomanufacturing; biosimilar development; digital twin; monoclonal antibodies; neural network models; biologics; Fresenius

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