Health Care Related Organization – Page 78

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

1 year 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

Bristol Myers Squibb’s Zeposia Misses Mark in Phase 3 Crohn’s Disease Study

1 year ago talkbio0Tagged bristol-myers, Clinical Remission Endpoint Not, Crohn Disease, ozanimod, Unmet Medical Need, YELLOWSTONE Program, Zeposia

Bristol Myers Squibb, Zeposia (ozanimod), Phase 3 Trial Setback, Crohn’s Disease, Clinical Remission Endpoint Not Met, YELLOWSTONE Program, Unmet Medical Need in Crohn’s Treatment

Walgreens Takes $6 Billion Hit from VillageMD Investment Amid Strategic Review

1 year ago talkbio0Tagged Clinic, Cost Savings Plan, Investment Value Decline, Quarter 2, strategic review, VillageMD, Walgreens, Write-down

Walgreens, VillageMD, Quarter 2, $6 billion loss, Write-down, Investment Value Decline, Strategic Review, Cost Savings Plan, Underperforming Clinics Closure

Pfizer Discontinues Phase III Trial for Sickle Cell Treatment Amid Challenges in Patient Recruitment

1 year ago talkbio0Tagged Anemia, Sickle Cell, ClinicalTrials.gov, Grail, inclacumab, Pfizer, Phase 3 Clinical Trials, Poor Accrual, Recruitment Challenges, THRIVE Program

Pfizer, Sickle Cell Disease, Phase III Study, Inclacumab, Poor Accrual, Recruitment Challenges, THRIVE Program, ClinicalTrials.gov, Gene Therapies

AstraZeneca’s Ultomiris Gains FDA Approval for Rare Autoimmune Condition – NMOSD

1 year ago talkbio0Tagged Approved, AstraZeneca, Autoimmune Diseases, dosing, Infrequent, Long-acting C5 complement inhibitor, Neuromyelitis Optica, Rating (action), ravulizumab-cwvz, Reduced, Relapse, Ultomiris, United States Food and Drug Administration, With frequency

AstraZeneca, Ultomiris, ravulizumab-cwvz, FDA Approval, Rare Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD), Long-acting C5 complement inhibitor, Phase 3 CHAMPION-NMOSD Trial, Reduced Relapse Rate, Dosing Frequency

Roche’s Phase III Trial Success with IL-6 Blocker Enspryng Tempered by Modest Outcomes

1 year ago talkbio0Tagged Blocker, disappointment, Enspryng, Expectations, interleukin-6, Myasthenia Gravis, Generalized, Phase 3 Clinical Trials, Roche (company), satralizumab

Roche, IL-6 blocker, Enspryng (satralizumab), Phase III trial, Generalized Myasthenia Gravis (gMG), Disappointment, Expectations

Lonza Acquires Roche’s Massive Biologics Production Facility in Vacaville, California for $1.2 Billion

1 year ago talkbio0Tagged Biologics Manufacturing Site, California, Capacity, CDMOs, Contract Development, genentech, Global Biologics Market, Growth, Large-Scale Commercial Mammalian Products, Lonza, manufacturing organizations, Roche (company), utilization qualifier, Vacaville

Lonza, Roche, Genentech, Biologics Manufacturing Site, Vacaville/ California, $1.2 Billion Deal, Large-Scale Commercial Mammalian Products, Expansion Plans ($561 Million), Capacity Utilization, Contract Development and Manufacturing Organizations (CDMOs), Global Biologics Market Growth