Idea or Concept – Page 32

Optimizing Pharmaceutical Supply Chains: The Evolving Role of Third-Party Logistics Providers

2 years ago talkbio0Tagged Administration occupational activities, Cold Chain Management, Pharma, Pharmaceutical Supply Chain, Regulatory Compliance, requirements, third-party logistics

Third-Party Logistics (3PL) Providers, Pharmaceutical Supply Chain, Pharma 4.0, Regulatory Compliance, Cold Chain Management, Data Mining and Management, Licensing Requirements

Record-Breaking 323 Medications in Active Shortage in US, ASHP Reports

2 years ago talkbio0Tagged Active shortages, Adderall, American Society of Health-System Pharmacists, Antineoplastic Agents, ASHP, Attention deficit hyperactivity disorder, Drug Enforcement Administration, Drug shortages, Drug supply chains, Generic sterile injectable medications, Policy, Recommendation, Record-high

Drug shortages, US, Record-high, American Society of Health-System Pharmacists (ASHP), 323 medications, Active shortages, Generic sterile injectable medications, Cancer chemotherapy drugs, ADHD medications, Adderall, Drug Enforcement Administration (DEA), Drug supply chains, Policy recommendations

EMA Dispels Link Between GLP-1 Receptor Agonists and Suicidal Ideation Risk New

2 years ago talkbio0Tagged agonists, Continuous, Diabetes, Glucagon-Like Peptide-1 Receptor, Mental association, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, pharmacovigilance activities, Preventive monitoring, Suicidal ideation risk, Weight-Loss Agents

EMA, GLP-1 receptor agonists, Diabetes and weight-loss drugs, Suicidal ideation risk, No causal association, Pharmacovigilance activities, Continued monitoring

Experts Commend Amylyx for Withdrawing ALS Drug Relyvrio Following Trial Failure

2 years ago talkbio0Tagged Amylyx, Amyotrophic Lateral Sclerosis, Market, promise, Relyvrio, Trial failure, Withdraw (activity)

Amylyx, Relyvrio, ALS drug, Trial failure, Market withdrawal, Promise kept

Ipsen Secures Exclusive Rights for Sutro’s Antibody-Drug Conjugate (ADC) Portfolio in a $900 Million Agreement

2 years ago talkbio0Tagged Agreement, Antibody-Drug Conjugates, Exclusive, Ipsen, Sutro

Ipsen, Sutro, Antibody-Drug Conjugate (ADC), $900 million agreement, Exclusive rights

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

2 years ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024

Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges

2 years ago talkbio0Tagged Bankruptcy, Biological Factors, Chapter 11, Assets Sale, development aspects, Eiger, Infrequent, Metabolic Disease Therapy, Operational Wind Down

Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development

FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults

2 years ago talkbio0Tagged Anemia, Approved, Black Box Warning, Chronic Kidney Diseases, Daprodustat, Effectiveness, Hemoglobin concentration result, Jesduvroq, Oral Medication, post-marketing safety, Safety, United States Food and Drug Administration, vadadustat, Vafseo

Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data

Pfizer Continues FDA Approval Expectations for Sickle Cell Disease Therapy Despite Terminating One Phase 3 Trial

2 years ago talkbio0Tagged Antibody/, Approval/, Disease/, Inclacumab/, monoclonal, Pfizer/, Program/, terminated - RoleStatus, Thrive, Trial/ Poor Accrual, United States Food and Drug Administration

Pfizer/ Sickle Cell Disease/ FDA Approval/ Inclacumab/ THRIVE Program/ Monoclonal Antibody/ Terminated Trial/ Poor Accrual

Praxis’ Mid-Stage Triumph Propels Advancement of Novel Epilepsy Drug

2 years ago talkbio0Tagged Adult Focal Onset, concept, Efficacy Study, Epilepsy, Functionally Selective Small Molecule,, Hyperexcitable State, Phase IIa, PRAX-628, Praxis Precision Medicines, Sodium Channel, Success

Praxis Precision Medicines, PRAX-628, Functionally Selective Small Molecule, Hyperexcitable State of Sodium Channels, Adult Focal Onset Epilepsy Treatment, Phase IIa Proof of Concept Study Success, Second Half of 2024 Efficacy Study Planned