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Functional Concept

  • Disease or Syndrome
  • ENTITY
  • Functional Concept

Aldeyra hopes new data for dry-eye disease drug will satisfy FDA

2 days ago talkbio0Tagged Aldeyra, Approved, Clinical Trials, Dry Eye Syndromes, New Drug Application, reproxalap, United States Food and Drug Administration

United States Food and Drug Administration, Aldeyra, reproxalap, Approved, Dry Eye Syndromes, Clinical Trials, New Drug Application

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  • ENTITY
  • Functional Concept
  • Geographic Area

Trump, FDA zero in on foreign factories to give domestic sites an edge

3 days ago talkbio0Tagged foreign factories, manufacturers, Transplant Registry Unified Management Program, United States, United States Food and Drug Administration

United States Food and Drug Administration, United States, Transplant Registry Unified Management Program, foreign factories, manufacturers

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  • ENTITY
  • Functional Concept
  • Gene or Genome

Mersana makes Emi-Le the one, laying off 55% of staff to narrow focus to B7-H4 ADC

3 days ago talkbio0Tagged 55%, Antibody-Drug Conjugates, Emi-Le, emiltatug ledadotin, Malignant neoplasm of breast, Mersana, VTCN1 gene

Emi-Le, Mersana, VTCN1 gene, Antibody-Drug Conjugates, emiltatug ledadotin, Malignant neoplasm of breast, 55%

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  • Amino Acid, Peptide, or Protein
  • Biologically Active Substance
  • ENTITY

PTC crashes as win for Novartis-partnered Huntington’s drug fails to convince investors

3 days ago talkbio0Tagged Accelerated, Approved, factor IX, PTC518, United States Food and Drug Administration

factor IX, PTC518, Accelerated, Approved, United States Food and Drug Administration

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  • DATE
  • ENTITY
  • Functional Concept

Capricor shares turn red as FDA plans deramiocel adcomm, likely the first under new commissioner

3 days ago talkbio0Tagged Biologics License Application, Capricor, deramiocel, first, Market, Review [Publication Type], United States Food and Drug Administration

United States Food and Drug Administration, Capricor, deramiocel, Market, Review [Publication Type], Biologics License Application, first

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  • Amino Acid, Peptide, or Protein
  • Biologically Active Substance
  • DATE

PTC’s Novartis-partnered Huntington’s drug disappoints in mid-stage data reveal

3 days ago talkbio0Tagged factor IX, Huntington 's disease, Market, PTC518

PTC518, factor IX, Huntington ‘s disease, Market

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  • Biologically Active Substance
  • DATE
  • ENTITY

FDA lifts clinical hold on Atara’s Epstein-Barr T-cell programme

3 days ago talkbio0Tagged Atara, Atara 's, Ebvallo, Hoist device, Study on Hold, United States Food and Drug Administration

United States Food and Drug Administration, Study on Hold, Atara, Hoist device, Atara ‘s, EBVALLO

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  • Congenital Abnormality
  • Disease or Syndrome
  • ENTITY

J&J’s $130M gene therapy bet flunks rare retinal disease trial

3 days ago talkbio0Tagged bota-vec, Disorder of eye, Failure (biologic function), gene therapy, Infrequent, Investments, Johnson and Johnson, loss treatment, Phase 3, Vision, X-linked retinitis pigmentosa

Johnson & Johnson, gene therapy, bota-vec, X-linked retinitis pigmentosa, Phase 3 failure, vision loss treatment, rare eye disease, $130 million investment

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  • Biologically Active Substance
  • ENTITY
  • Functional Concept

Exclusive: Vertex drops AAV gene therapy research, tRNA therapy partnership

4 days ago talkbio0Tagged Dependovirus, gene therapy, Industry, Partnership, research, Safety, Transfer RNA

gene therapy, Dependovirus, Transfer RNA, Partnership, Industry, research, Safety

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  • DATE
  • ENTITY
  • Functional Concept

Unity disbands workforce as it searches for strategic path forward, while Mammoth cuts 24 roles

4 days ago talkbio0Tagged layoffs

layoffs

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Organizations

Agencies amgen AstraZeneca boehringer ingelheim Centers for Disease Control and Prevention (U.S.) Congress (U.S. Legislature) court Drug Industry European Medicines Agency genentech Government Health care facility Johnson and Johnson Moderna Novavax Partnership Pfizer Pharmacy Benefit Manager Pharmacy facility Roche (company) sandoz sanofi squibb United States Federal Trade Commission United States Food and Drug Administration World Health Organization

Concepts & Ideas

Accelerated Accelerated Approval Access accessibility Approved aspects of adverse effects asset Bankruptcy Benefit Capacity Capital Changing Chinese Language Clearance Clinical Data Combined commercial Complete Compound Contract agreement Cost Effectiveness development aspects Discontinuation (procedure) Diversity Dosage drug price Drug Shortage earnings Economic Inflation Effectiveness Efficiency Expectations Failed Failure (biologic function) Financial cost Financial savings financing characteristics Funding Generalized Health Identifier Improvement Increased Infrequent Legal Legal patent Long-term Moderate (severity modifier) New Drug Application Overall Survival Paroxysmal perioperative Phase 2 Phase 3 Prices Pricing Programs - Publication Format Progression-Free Survival Projections and Predictions Recommendation regulatory Review [Publication Type] rights Risk Series Statistical Significance Study on Hold subcutaneous Submission Symptoms aspect Toxicity aspects trends qualifier Variant Weekly

Procedures

Advice Cancer Therapeutic Procedure Cell Therapy Clinical Research Clinical Trials Combined Modality Therapy Confirmatory Trial Detection Drug Discovery Evaluation Gene Modification gene therapy HIV prevention Immunotherapy Injection of therapeutic agent Medical Research activity patient safety Pharmaceutical Services Pharmacotherapy Phase 2 Clinical Trials Phase 3 Clinical Trials Precision Medicine Prescription procedure Reparative closure research Telemedicine Vaccination

Occupations

Artificial Intelligence biology (field) Biotechnology Drug Development Genetic Medicine Global Health Immunology medical technology Neurology speciality Neuroscience discipline public health medicine (field) Science Science of genetics Technology

Disorders

Achondroplasia Acute onset pain Adverse event Amyotrophic Lateral Sclerosis Angioedemas, Hereditary Aortic Valve Insufficiency Asthma Attention deficit hyperactivity disorder Autoimmune Diseases Brain Neoplasms Burning Mouth Syndrome Cardiomyopathies Cardiovascular Diseases Chronic Kidney Diseases Chronic Obstructive Airway Disease Colorectal Carcinoma COVID19 (disease) Dental Plaque Dermatitis, Atopic Diabetes Diabetes Mellitus, Non-Insulin-Dependent Disease Progression Eczema Epilepsy Esophageal Neoplasms Fibrosis Heart failure Hematologic Neoplasms Hemophilia A Hemophilia B Hereditary Diseases Hypoparathyroidism IGA Glomerulonephritis Infantile Severe Myoclonic Epilepsy Inflammation Inflammatory Bowel Diseases Inflammatory disorder Kidney Diseases leukemia Liver and Intrahepatic Biliary Tract Carcinoma Liver diseases Lung diseases Lupus Nephritis Lymphoma, Follicular Malignant neoplasm of breast Malignant neoplasm of endometrium Malignant neoplasm of lung Malignant neoplasm of prostate Malignant neoplasm of stomach Malignant neoplasm of urinary bladder Malignant Neoplasms Malignant tumor of cervix melanoma Mental Depression Mental deterioration Metabolic Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Multiple Myeloma Multiple Sclerosis Muscular Dystrophy Muscular Dystrophy, Duchenne Nance-Horan syndrome Narcolepsy Neoplasms Nerve Degeneration nervous system disorder Neurodegenerative Disorders Non-Small Cell Lung Carcinoma Nonalcoholic Steatohepatitis Obesity Paroxysmal nocturnal hemoglobinuria Post-Traumatic Stress Disorder Primary Biliary Cholangitis Psoriasis Pulmonary arterial hypertension Pulmonary Hypertension Reduced Schizophrenia Seizures Severe (severity modifier) Small cell carcinoma of lung Solid Neoplasm Spinal Muscular Atrophy Ulcerative Colitis Urinary tract infection Weight Loss

Objects

Arrowhead Facility (object) Investments Labels (device)

Chemicals & Drugs

Agonist agonists Antibiotics Antibodies Antibodies, Bispecific Antibody-Drug Conjugates Antineoplastic Agents Biological Factors Biosimilars BTK Inhibitor Cancer Vaccines Caplyta Clesrovimab Clustered Regularly Interspaced Short Palindromic Repeats Donanemab Dosage Forms Dupixent durvalumab Enhertu Epidermal Growth Factor Receptor Glucagon-Like Peptide-1 Receptor Glucagon-Like Peptide 1 Humira Imfinzi Immunologic Adjuvants Immunostimulating conjugate (antigen) Inhibitor inhibitors Insulin Jemperli Keytruda Lenacapavir Lumateperone Microbicides Midomafetamine Monoclonal Antibodies Mounjaro Nitroglycerin/Sodium Citrate/Ethanol Solution obinutuzumab Ocaliva Opdivo Ozempic patritumab Pediatric brand name pembrolizumab Primary Endpoint Radiopharmaceuticals RNA RNA, Messenger RNA, Small Interfering Rybrevant semaglutide Stelara Tagrisso Tecentriq therapeutic autologous dendritic cells tirzepatide Tremfya Trodelvy Vaccines Wegovy Weight-Loss Agents Zantac

Activities & Behaviors

Acquisition (action) Administration occupational activities Advisory Committees Agreement authorization Automation business career CEO Collaboration competition Continuance of life Drug Approval Industry Leadership Machine Learning Manufacture Mediation Medicare National Security Optimization production Rating (action) Rejection (Psychology) Relations Sales - occupational activity Settlement and Resettlement Success Withdraw (activity)

Geographic Areas

California China Japan Market North Carolina Singapore United States

Phenomena

Emergency Situation Motor function (observable entity) Safety

Living Beings

Adult Child Consumer European (ethnic group) HIV Ira (eukaryote) manager Partner in relationship Pet Animal Plants Plant seeds Respiratory syncytial virus

Anatomy

Cardiovascular system Carvykti Cells Liver Neurosecretory Systems T-Lymphocyte

Physiology

Biological Markers cellular targeting Cessation of life Decision Gene Expression Growth Hearing Immune response Menopause mental health Mutation Practice Experience Response process RNA Interference

Genes & Molecular Sequences

CSHL1 gene K-ras Oncogene PDCD1 gene PREP gene TIGIT gene TYK2 gene
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