Roche
Dec 05, 2023
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementar...
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Nov 10, 2023
Roche’s Vabysmo Third US Approval Spiced Up the Battle With Regeneron and Bayer’s Eylea
Roche’s Vabysmo secures a new FDA nod for retinal vein occlusion treatment, intensifying the competition with Regeneron and Bayer’s Eylea in the eye medication market. This approval for Vabysmo in RVO adds another shared medical indication for the competing eye medications. Vabysmo’s successful FDA approval for RVO...
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Oct 31, 2023
Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC
FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...
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Sep 05, 2023
Daiichi Sankyo’s Trastuzumab Deruxtecan; ODD to Bexmarilimab for AML; Roche’ Alecensa; Ergomed Aims To Go Private; Tagraxofusp Receives ODD in Japan for BPCDN; FDA Fast Track Designation to Abliva’s KL1333
FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the United States for the treatment of adult patients with unresectable or metastati...
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Jun 29, 2023
GE HealthCare, DePuy Synthes Announced Collaboration; Eko Health Launched CORE 500 Digital Stethoscope; Haemonetics’s NexSys PCS Plasma Collection System; Roche’s Alzheimer’s Disease Cerebrospinal Fluid (CSF) Assays; Medtronic’s MiniMed 780G system; Biodesix’s VeriStrat Blood-Based Host Immune Classifier
GE HealthCare Announced Collaboration with DePuy Synthes to Bring Advanced 3D Precision Imaging Innovation to Spine Practices in the United States On June 21, 2023, GE HealthCare entered into a distribution agreement with DePuy Synthes, the Orthopaedics division of Johnson & Johnson, to bring GE HealthCare’s...
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Jun 20, 2023
FDA Extended the Review Period for Momelotinib; FDA Approves Roche’s Columvi; Avita Medical Obtains FDA Approval of RECELL; FDA Approves Odevixibat for ALGS; TME Pharma Receives IND Approval for NOX-A12; Aldeyra’s Phase 3 INVIGORATE‑2 Trial of Reproxalap
GSK Announces Extension of FDA Review Period for Momelotinib After all, GSK will not hear from the FDA this month about its marketing application for momelotinib as a therapy for anemia in myelofibrosis patients. The pharmaceutical company announced that the US Food and Drug Administration has extended the drug'...
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May 23, 2023
Abbvie-Genmab’s EPKINLY Approval for DLBCL Treatment: The First CD20XCD3 Bispecific Antibody
Abbvie-Genmab’s EPKINLY, the first CD20XCD3 Bispecific Antibody gets US approval for Relapsed/Refractory DLBCL treatment. Roche’s Glofitamab is expected to garner benefits in Europe first. Let's have a glimpse of evolving DLBCL treatment landscape in Relapsed/Refractory setting and if bi-specific as a class can be...
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Apr 28, 2023
Roche’s CD79b ADC POLIVY: Attempt to Change DLBCL Treatment Space
In recent years, the field of oncology has witnessed a remarkable transformation thanks to the groundbreaking innovation of antibody-drug conjugates (ADCs). These game-changing molecules have three key components: an antibody drug, a potent cytotoxic payload, and a specialized linker protein that binds them togethe...
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Mar 14, 2023
Sanofi to Acquire Provention Bio; USFDA Committee Votes in Favor Roche’s Polivy; FDA to Review Mesoblast’s GvHD Drug; FDA Approves Acadia’s Daybue ; FDA Approves Nelarabine Injection; Calliditas’s Nefecon Trial Reuslt in IgA Nephropathy
Sanofi to Acquire Provention Bio for USD 2.9 Billion Sanofi and Provention Bio, Inc., a publicly traded biopharmaceutical company based in the United States focused on intercepting and preventing immune-mediated diseases such as type 1 diabetes (T1D), have agreed to acquire Provention Bio, Inc. for $25.00 per sh...
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Feb 14, 2023
Leo Pharma’s Hand Eczema Clinical Trial Updates; GSK’s PD-1 inhibitor Jemperli Approval; Roche Announces Phase III Result of Vabysmo; FDA Accepts NDA for Aldeyra’s reproxalap; RMAT and Fast Track Designations to IASO Bio’s CT103A; Orphan Drug Designation to Jubilant Therapeutics’s JBI-778
Leo Pharma Announces Positive Results of Phase III Hand Eczema Clinical Trial LEO Pharma A/S, a global leader in medical dermatology, announced that the DELTA 2 trial yielded positive results. DELTA 2 is the second of two pivotal phase III clinical trials involving delgocitinib cream, an investigational topical ...
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