news
Jan 03, 2023
Gilead Buys Out Rights to Cancer Therapy from Jounce; FDA Places Clinical Hold on Biogen’s Orelabrutinib; Pfizer Announces Phase 3 BENEGENE-2 Study Result; FDA Approves MediWound’s NexoBrid; UCB Announces FDA Acceptance of BLA Resubmission for Bimekizumab; FDA Approves TG Therapeutics’ Briumvi
Gilead Buys Out Rights to Cancer Therapy from Jounce for USD 67 Million Gilead Sciences must have liked what it saw in a two-year-old collaboration with Jounce Therapeutics for CCR8-targeting cancer immunotherapy because the company has just agreed to own the program fully. The drug in question, GS-1811 (formerl...
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Dec 27, 2022
Gilead Sciences’ Sunlenca Approval; FDA Approves Roche’s CD20xCD3 Bispecific Antibody Lunsumio; EU Approves AstraZeneca’s Imfinzi Plus Chemo; Pfizer Files Blockbuster Hope Etrasimod for Ulcerative Colitis; FDA Approves Mosunetuzumab for R/F Follicular Lymphoma; FDA Breakthrough Therapy Designation to Adagrasib Plus Cetuximab for KRAS G12C–Mutated Advanced CRC
FDA Approves Gilead Sciences’ Sunlenca Sunlenca, a Gilead Sciences therapy for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, has received FDA approval for the second time of asking. Sunlenca, which is based on the HIV capsid inhibitor lenacapavir, is intended to be...
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Dec 22, 2022
Medtronic’s Hugo Robotic-Assisted Surgery System Trial; Insightec’s Pivotal LIBERATE Clinical Trial; FDA Granted EMA for Thermo Fisher Scientific’s Monkeypox Test; Life Spine’s Trulift Lateral Expandable Spacer System & Lateral Pate System; Fujifilm & Inspirata Announces Asset Purchase Agreement; Abbott Launched SCS System for Chronic Pain
Medtronic Announced First Patient Enrolment for Hugo™ Robotic-Assisted Surgery System in US Clinical Trial On December 15, 2022, Medtronic, a global healthcare technology leader, announced that the first patient was enrolled in the Expand URO US clinical trial for the Hugo™ robotic-assisted surgery...
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Dec 20, 2022
Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result
AbbVie Secures Fourth FDA Approval for Vraylar AbbVie has received its fourth FDA approval for Vraylar, adding major depressive disorder (MDD) adjunctive therapy to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. According to AbbVie, the approval makes Vraylar (cariprazi...
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Dec 15, 2022
BioGX’s ‘pixl’ Portable qPCR Platform; Stryker’s Citrefix Suture Anchor System; Boston Scientific to Acquire Majority Stake of Acotec Scientific; FDA Approved the Dexcom G7 CGM System; Agilent’s NSCLC Liquid Biopsy Companion Diagnostic Test Approval; ClearPoint Neuro’s Prism™ Neuro Laser Therapy
BioGX Announced Ex-US Commercial Launch of ‘pixl™’ Portable qPCR Platform On December 8, 2022, BioGX, a global provider of easy molecular diagnostic solutions, announced the Ex-US commercial release of BioGX's portable pixl™ qPCR real-time PCR platform for use with BioGX CE-IVD approved assays.&nbs...
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Dec 13, 2022
Amgen to Purchase Horizon Therapeutics; IND Clearance to Vertex’s VX-522; FDA Fast-Track Designation for Moleculin’s WP1122; Orphan Drug Designation to Brim’s WP1122; Eisai Presents Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study; UCB Announces Phase 3 Studies for Bimekizumab
Amgen Inc. Agrees to Purchase Dublin-based Horizon Therapeutics Plc. for €24.7 Billion Amgen Inc. has agreed to buy Dublin-based Horizon Therapeutics Plc. for €24.7 billion ($26 billion), in a deal that could face further delays or a breakdown in negotiations. Following Sanofi's withdrawal from the race, c...
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Dec 08, 2022
Olympus Launches New Gynecologic Power Morcellator; Journey Biosciences Launched NaviDKD; GE Board Approves Separation of GE HealthCare; FDA Approval to Enovis’s STAR Ankle; FDA Clearance to Deep Blue Medical’s T-Line Hernia Mesh; NeuroOne Completed Feasibility Study with its OneRF Ablation System
Olympus Launches New Gynecologic Power Morcellator for Its Contained Tissue Extraction System On November 30, 2022, Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, launched the moresolution™ Power Morcellator, manufactured by TROKAM...
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Dec 06, 2022
Nkarta’s Anti-CD19 Allogeneic CAR-NK Cell Therapy, NKX019; Eisai Presents Results of lecanemab for Alzheimer’s Disease; EQRx’s Aumolertinib for EGFR-Mutated NSCLC; FDA Approves Olutasidenib for IDH1-Mutated R/R AML; FDA Orphan Drug Designation to AUM302 for Neuroblastoma; X4 Pharma Announces Results for WHIM Syndrome Drug
FDA Grants Orphan Drug Designation to AUM302 for Neuroblastoma A global clinical-stage biotech company, AUM Biosciences, focused on discovering and developing precision oncology therapeutics, declared that the U.S. FDA has permitted Orphan Drug Designation for AUM302. For the treatment of neuroblastoma, AUM302 i...
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Dec 01, 2022
AnchorDx’s UriFind Bladder Cancer Assay in the US; UroMems Initiates Smart Implant to Treat Stress Urinary Incontinence; FDA 510(k) Clearance to NeuroLogica’s BodyTom 64; CE-IVD Mark Approval to SeekInCure’s Recurrence Monitoring Kit Gets; Ypsomed and CamDiab’s Automated Insulin Dosing System; Boston Scientific to Acquire Apollo Endosurgery
AnchorDx Clinical Trial Enrols First Patient for its UriFind® Bladder Cancer Assay in the US On November 23, 2022, AnchorDx, announced the first patient enrollment for its clinical trials of the UriFind® bladder cancer assay in the United States. The UriFind® bladder cancer assay clinical trial in the U...
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Nov 29, 2022
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer
C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...
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