New Drug Library
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New articles
December 2023
Total ... 75
First approval ... 4
Wainua (eplontersen) granted first-ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN)< AstraZeneca, 21 December 2023
Vertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease - – First-ever approval of a CRISPR-based gene-editing therapy in the U.S. < December 8, 2023
Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH < December 6, 2023
UCB announces European Commission approval of ZILBRYSQ[®]▼ (zilucoplan) for the treatment of adults with generalized Myasthenia Gravis < December 4, 2023
Supplemental approval ... 5
U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data < R/R LBCL 2L, Gilead, December 21, 2023
PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer < Merck, Astellas, December 15, 2023
FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI < December 14, 2023
GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer < December 11, 2023
Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor < Lilly, December 1, 2023
Other regulatory ... 10
Amgen provides regulatory update on status of Lumakras® (sotorasib) - FDA Has Issued New Postmarketing Requirement < December 26, 2023
Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer < Daiichi Sankyo (TSE: 4568) and Merck, December 22, 2023
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) < December 21, 2023
The U.S. FDA has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant < Chronic cough, December 20, 2023
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health phase III study results < Roche, December 19, 2023
FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults< Merck, December 19, 2023
Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) < December 15, 2023
FDA Grants Priority Review To Amgen's Tarlatamab Application For Advanced Small Cell Lung Cancer < BsAb, December 13, 2013
U.S. FDA Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma < December 5, 223
Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer < December 4, 2023
Pivotal studies ... 25
Sanofi announces end of program evaluating tusamitamab ravtansine after a 2L NSCLC Phase 3 trial did not meet a primary endpoint < December 21, 2023
Bristol Myers Squibb Provides Update on RELATIVITY-123 Trial Evaluating the Fixed-Dose Combination of Nivolumab and Relatlimab in Patients with Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer < December 15, 2023
Moderna and Merck Announce mRNA-4157 (V940) in Combination with KEYTRUDA® (pembrolizumab) Demonstrated Continued Improvement in Recurrence-Free Survival and Distant Metastasis-Free Survival in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection < December 14, 2023
Positive Results from Pivotal Trials of CASGEVY™ (exagamglogene autotemcel) Highlighted in Oral Presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition - - Longer-term follow-up data demonstrate consistent and durable response to treatment < SCD, Vertex, December 11, 2023
Analyses of Kite’s Yescarta®CAR T-Cell Therapy Support Curative Potential in Patients With Non-Hodgkin Lymphomas < GILD, December 11, 2023
Novartis investigational iptacopan Phase III study demonstrates clinically meaningful and statistically significant proteinuria reduction in patients with C3 glomerulopathy (C3G) < December 11, 2023
Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone < Sanofi, December 11, 2023
Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3 < BMY, December 11, 2023
Merck and Moderna Initiate INTerpath-002, a Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients with Certain Types of Resected Non-Small Cell Lung Cancer < December 11, 2023
Lilly's Zepbound™ (tirzepatide) achieved additional 6.7% weight loss following a 36-week open-label lead-in period, for a total mean weight loss of 26.0% from study entry over 88 weeks < Obesity, December 11, 2023
Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting < Lilly, December 11, 2023
Updated Odronextamab Data From Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep And Durable Responses And The Potential Of Ctdna To Predict Long-term Outcomes < Regeneron, December 10, 2023
Latest Odronextamab Data In Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses And Overall Maintenance Of Patient-reported Outcomes < Regeneron, December 10, 2023
Incyte And Syndax Present Additional Data From Positive AGAVE-201 Trial At ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses In Chronic Graft-Versus-Host Disease < December 10, 2023
EZHARMIA® Showed Clinically Meaningful and Durable Responses in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL) in VALENTINE-PTCL01 Phase 2 Trial < Daiichi Sankyo, December 9, 2023
Marstacimab Phase 3 Data Presented at ASH 2023 Demonstrate Significant Bleed Reduction in Hemophilia A and B < Pfizer, December 09, 2023
New Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Shows Strong, Durable Treatment Response for Patients with Difficult-To-Treat Relapsed/Refractory (R/R) Follicular Lymphoma (FL) < AbbVie, December 09, 2023
Roche’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation < December 09, 2023
Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions < December 8, 2023
Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates And Depth Of Response In Patients With Heavily Pre-treated Multiple Myeloma < Regeneron, December 7, 2023
Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant < Sanofi, December 7, 2023
Bristol Myers Squibb Announces Phase 3 CheckMate -8HW Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Compared to Chemotherapy in Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer Meets Primary... < December 7, 2023
Merck Announces KEYLYNK-008 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LYNPARZA® (olaparib) for Patients With Metastatic Squamous Non-Small Cell Lung Cancer to Stop for Futility < December 7, 2023
Merck KGaA Provides Update on Phase III Results for Evobrutinib in Relapsing Multiple Sclerosis - Phase III EVOLUTION clinical trials of evobrutinib did not meet their primary endpoints < December 5, 2023
Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation < December 05, 2023
Other R&D ... 15
Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial < GSK, December 18, 2023
Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy < December 13, 2023
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma < JNJ, December 12, 2023
Two Early Studies Evaluating Potential First-in-Class CELMoD™ Agent Golcadomide for the Treatment of Non-Hodgkin Lymphomas Presented at ASH 2023 < BMY, December 11, 2023
Novartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) < December 11, 2023
Treatment with CARVYKTI® (ciltacabtagene autoleucel) Resulted in Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Disease-Specific Symptoms in Patients with Earlier-Line Multiple Myeloma < JNJ, BCMA, December 11, 2023
New Analyses Demonstrate Versatility and Continued Efficacy of TALVEY™ in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma < Janssen, December 11, 2023
New data reinforce the benefit of early preventative treatment with Roche’s Hemlibra for babies with severe haemophilia A < December 10, 2023
Roche's Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment < December 09, 2023
Merck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma < December 8, 2023
Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) < TIGIT, December 7, 2023
New global analysis across five cities shows inequities in adult immunisation uptake, signalling need to redesign local and national policy interventions < GSK, December 6, 2023
Lilly to Present Final Overall Survival Analysis from the MONARCH 3 Study of Verzenio® (abemaciclib) and Additional Results from Its Breast Cancer Portfolio at the 2023 San Antonio Breast Cancer Symposium < December 5, 2023
Discontinuation of STABILIZE-CKD and DIALIZE-Outcomes Phase III trials < Hyperkalemia, AstraZeneca , December 1, 2023
Pfizer Announces Topline Phase 2b Results of Oral GLP-1R Agonist, Danuglipron, in Adults with Obesity - High discontinuation rates, greater than 50%, were seen across all doses compared to approximately 40% with placebo < December 01, 2023
Business & Management ... 16
AstraZeneca to acquire Gracell, furthering cell therapy ambition across oncology and autoimmune diseases - Includes clinical-stage autologous BCMA/CD19 CAR-T therapy targeting haematologic malignancies and autoimmune diseases < M&A, December 26, 2023
Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio - Lead Program, RYZ101, in Phase 3 Development for Treatment of Gastroenteropancreatic Neuroendocrine Tumors and Early-stage Development for Treatment of Small Cell Lung Cancer < M&A, December 26, 2023
Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics - Transaction Delivers KarXT, a First-in-Class M1 / M4 Muscarinic Receptor Agonist, with Differentiated Efficacy and Safety < December 22, 2023
GSK enters exclusive license agreement with Hansoh for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) < December 20, 2023
Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission <Multiple sclerosis, Patents, Biogen, December 19, 2023
Gilead and Compugen Announce Exclusive License Agreement for Novel Pre-Clinical Immunotherapy Program – Gilead Will Have Exclusive Rights to Later Stage Development and Commercialization of Anti-IL18 Binding Protein Antibodies with Potential to Treat Various Tumor Types < IL-18, December 19, 2023
Roche named among top three most sustainable healthcare companies in the Dow Jones Sustainability Indices < December 15, 2023
Merck Ranks No. 1 on Newsweek’s List of America’s Most Responsible Companies 2024 < December 13, 2023
AstraZeneca to acquire Icosavax, including potential first-in-class RSV and hMPV combination vaccine with positive Phase II data < M&A, December 12, 2023
SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1 < EGFRxHER-ADC, China, December 11,2023
Sanofi Pipeline Transformation to Accelerate Growth Driven by Record Number of Potential Blockbuster Launches, Paving the Way to Industry Leadership in Immunology - Ambition to become an immunology powerhouse driven by recent and future launched pharma assets, generating over €10 billion in annual sales by 2030 < December 7, 2023
AbbVie to Acquire Cerevel Therapeutics in Transformative Transaction to Strengthen Neuroscience Pipeline - Transaction valued at a total equity value of approximately $8.7 billion < M&A, December 06, 2023
Johnson & Johnson Announces Key Drivers for Long-Term Competitive Growth at Enterprise Business Review < December 5, 2023
AbbVie and BigHat Biosciences Announce Research Collaboration to Leverage Artificial Intelligence and Machine Learning to Discover Next-Generation Therapeutic Antibodies < December 05, 2023
Merck KGaA Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib < December 4, 2023
Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, including three clinical stage assets with best-in-class potential in obesity and diabetes < December 04, 2023
Reference Room
PHARMACOLOGY
THERAPEUTICS
INDUSTRY
DATABASE
about the Pharma Asset Library
The Library integrates web-based information on pharmaceutical industry,
In the Reading Room at the entrance, visitors can find titles of about fifty new articles released by major pharmaceutical companies in a most recent month. By clicking linked keywords in a title, readers can find the full article at the top of previous articles in a binder of the relevant subject. Readers can also easily find other binders of similar subjects in adjacent shelves.
and offers complete overview of the companies, products, and their pharmacology and/or therapeutics.
The extensive, in-depth data are maintained and updated in inter-linked sections in the library: 1) PHARMACOLOGY CLASS, 2) THEAPEUTIC AREA, 3) INDUSTRY (Companies, Management, Market & Environment), and 4) Database. For ease and speed of access, these data have been categorized and stored under various key sub-titles, such as alliance, M&A, and diversification in the "INDUSTRY" section, and, for example, melanoma on the "THERAPEUTICS AREA, and PD-1 inhibitor in the "PHARMACOLOFY CLASS."
Readers will instantly grasp a change in a whole picture of the industry, which is necessary for making intelligent decisions in management and investment.
The New Drug Library, or Pharma Asset Library, is operated on Google Sites platform with easy-to-use navigation tools designed to help you instantly find the relevant data. The Google navigation system allows you to feel as if you are flying over a target freely and taking snapshots from any angle you wish. The service is available in smart phones and tablets as well as desktop computers.
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