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Governmental or Regulatory Activity

  • Governmental or Regulatory Activity
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Congress Passes Slimmed-Down Continuing Resolution, Extends Telehealth Flexibilities and Includes PBM Reform

11 months ago talkbio0Tagged Continuous, Healthcare Package, Medicaid, Medicare, PBM Reform, physiologic resolution, Telehealth Flexibilities

Continuing Resolution, Telehealth Flexibilities, PBM Reform, Healthcare Package, Medicare, Medicaid

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  • Age Group
  • Amino Acid, Peptide, or Protein
  • Biologically Active Substance

Moderna’s RSV Vaccines Face Safety Concerns Over Severe Infections in Infants

11 months ago talkbio0Tagged Advisory Committees, concerns, Infant, Moderna, Respiratory syncytial virus, RNA, Messenger, Safety, United States Food and Drug Administration, Vaccines

Moderna, RSV vaccines, safety concerns, severe infections, infants, mRNA vaccines, FDA, advisory committee

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  • Biomedical Occupation or Discipline
  • ENTITY
  • Governmental or Regulatory Activity

BIOSECURE Act Excluded from US Defense Bill, Offering Reprieve to Chinese Biotechs

11 months ago talkbio0Tagged BIOSECURE, Biotechnology, biotechs, Chinese Language, National Security, U.S.

BIOSECURE Act, Chinese biotechs, US defense bill, biotechnology supply chains, national security concerns

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  • DATE
  • ENTITY
  • Eukaryote

Healthcare M&A and IRA Price Negotiations: Key Trends to Watch Amidst Political Shifts

11 months ago talkbio0Tagged Acquisitions, Drug Industry, drug price, Healthcare M&A, Inflation, Ira (eukaryote), Mediation, Medicare, mergers, Negotiation Program, Prices, trends qualifier

Healthcare M&A, IRA Price Negotiations, Medicare Drug Price Negotiation Program, Inflation Reduction Act, Pharmaceutical Industry Trends, Mergers and Acquisitions Outlook 2024

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  • Disease or Syndrome
  • Governmental or Regulatory Activity
  • Intellectual Product

Biden Administration Proposes Expanded Coverage of Anti-Obesity Medications for Medicare and Medicaid Enrollees

11 months ago talkbio0Tagged Biden administration, Drug Prescriptions, Health Care Reform, Medicaid, Medicare, Obesity

Biden Administration, Obesity Drug Coverage, Medicare, Medicaid, Prescription Drug Costs, Healthcare Reform

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  • Amino Acid, Peptide, or Protein
  • ENTITY
  • Functional Concept

Biopharma Industry Braces for Uncertainty Under Trump’s Second Term: Impact on Vaccines and M&A Deals

11 months ago talkbio0Tagged Biopharma Industry, Changing, FTC, Health Policy, M&A, Policy, Regulation, second, Trump 's, United States Federal Trade Commission, Vaccines

Trump’s second term, Biopharma industry, Vaccine regulation, Robert F. Kennedy Jr., M&A deals, FTC policy changes, Healthcare policy uncertainty

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  • ENTITY
  • Governmental or Regulatory Activity
  • Health Care Related Organization

FDA Raises Safety Concerns Over AstraZeneca’s Andexxa Ahead of Advisory Committee Meeting

12 months ago talkbio0Tagged Advisory Committees, Andexxa, AstraZeneca, concerns, Hemorrhage, reversal agent, Safety, United States Food and Drug Administration

AstraZeneca, Andexxa, FDA, safety concerns, bleeding reversal agent, advisory committee meeting

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  • ENTITY
  • Governmental or Regulatory Activity
  • Intellectual Product

Dr. Mehmet Oz Nominated to Lead Centers for Medicare and Medicaid Services

12 months ago talkbio0Tagged Dr., healthcare leadership, Medicaid, Medicaid Services, Medicare, nomination, ounce, Transplant Registry Unified Management Program

Dr. Mehmet Oz, Medicare, Medicaid, Centers for Medicare and Medicaid Services, Trump nomination, healthcare leadership

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  • DATE
  • ENTITY
  • Governmental or Regulatory Activity

Pharma’s Future at Stake: Trump’s Victory and Its Implications for Drug Pricing Reform

12 months ago talkbio0Tagged 2024, Biopharma, Donald Trump, Drug Industry, Drug Pricing Reform, Inflation, Kamala Harris, Mediation, Medicare, presidential election, Prices

Donald Trump, Kamala Harris, 2024 Presidential Election, Drug Pricing Reform, Inflation Reduction Act, Medicare Price Negotiations, Pharmaceutical Industry, Biopharma.

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  • Disease or Syndrome
  • ENTITY
  • Governmental or Regulatory Activity

FDA Advisory Committee Rejects Lexicon’s Zynquista for Type 1 Diabetes and Chronic Kidney Disease

1 year ago talkbio0Tagged Advisory Committees, Chronic Kidney Diseases, Drug Approval, lexicon, United States Food and Drug Administration, Zynquista

FDA, Lexicon Pharmaceuticals, Zynquista, sotagliflozin, type 1 diabetes, chronic kidney disease, FDA advisory committee, drug approval

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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 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 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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