April 17, 2024 – Talk Bio

AbbVie Secures Deal with Medincell for Long-Acting Injectable Platform, Valued up to $1.9 Billion

1 year ago talkbio0Tagged AbbVie, Biotechnology, long-acting injectable platform, Medincell

AbbVie, Medincell, Long-acting injectable platform, Biotechnology, Deal, $1.9 billion

CMS to Increase Reimbursement for New Sickle Cell Gene Therapies through Outcomes-Based Agreements

1 year ago talkbio0Tagged Administrative action, Burden, Casgevy, Cells, Centers for Medicaid and Medicare (CMS) Pnl, Central, CGT, Equitable Access, Fertility, Grail, Increased, Lyfgenia, Medicaid Access, Medicare & Medicaid Services, OBAs, Outcomes-Based Agreements, Reimbursement, sickle cell gene therapies

CMS (Centers for Medicare & Medicaid Services), Sickle Cell Gene Therapies, Increased Reimbursement, Outcomes-Based Agreements (OBAs), Cell and Gene Therapy (CGT) Access Model, Medicaid Access, Casgevy, Lyfgenia, Fertility Preservation Services, Equitable Access, Administrative Burden Reduction

Arrowhead’s Plozasiran Projected to Surpass $700M in Sales by 2032, Addressing Major Unmet Needs in Dyslipidemia Treatment

1 year ago talkbio0Tagged 2032, APOC3 gene, Arrowhead, cellular targeting, Dyslipidemias, Familial chylomicronemia syndrome, FCS, Fetal Bovine Serum, GlobalData, Plozasiran, Projections and Predictions, Sales - occupational activity, SHTG, Triglycerides, Unmet Needs

Arrowhead Pharmaceuticals, Plozasiran, Dyslipidemia, GlobalData, Sales Forecast, $700M, 2032, Unmet Needs, Triglyceride Reduction, APOC3 Targeting, SHTG (Severe Hypertriglyceridemia), FCS (Familial Chylomicronemia Syndrome), Mixed Dyslipidemia

Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing

1 year ago talkbio0Tagged Caplyta, CGI-S, Clinical Global Impression Original Version Questionnaire, clinically, File (record), Intra-Cellular Therapies, Lumateperone, MADRS, MDD, Montgomery-Åsberg depression rating scale, Phase 3 trial, Positive, results, Severities, Statistical Significance, Unipolar Depression, United States Food and Drug Administration

Intra-Cellular Therapies, Caplyta, Lumateperone, Major Depressive Disorder (MDD), Phase 3 Trial, Positive Results, Statistically Significant, Clinically Meaningful, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale for Severity of Illness (CGI-S), FDA Filing

FDA Launches CDER Center for Clinical Trial Innovation (C3TI) to Boost Trial Design and Efficiency

1 year ago talkbio0Tagged C3TI, Center for Drug Evaluation, Center for Drug Evaluation and Research, Clinical Trial Innovation, Clinical Trials, Collaboration, Drug Development, Efficiency, innovation, research, United States Food and Drug Administration

FDA, CDER (Center for Drug Evaluation and Research), C3TI (CDER Center for Clinical Trial Innovation), Clinical trial innovation, Efficiency, Drug development, Trial design, Collaboration

Cullinan Secures $280M in Private Placement to Enter Autoimmune Market

1 year ago talkbio0Tagged autoimmune market, Biotechnology, Cullinan, private placement

Cullinan, Private Placement, $280M, Autoimmune Market, Biotechnology

Intra-Cellular’s Caplyta Shows Promising Results in Major Depressive Disorder Study

1 year ago talkbio0Tagged adjunctive therapy, blockbuster label, Caplyta, Clinical Global Impression Original Version Questionnaire, expansion, Intra-Cellular Therapies, Lumateperone, Major Depressive Disorder, MDD, Montgomery-Åsberg depression rating scale, Montgomery-Asberg Depression Rating Scale Questionnaire, Positive Clinical Trial, Study 501, Unipolar Depression

Intra-Cellular Therapies, Caplyta (lumateperone), Major Depressive Disorder (MDD), Positive clinical trial results, Study 501, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale, Adjunctive therapy, Potential blockbuster label expansion