news
Feb 16, 2023
GI Dynamics’s I-STEP Clinical Study of EndoBarrier; EndoStream’s Clinical Trial for Nautilus™ Intrasaccular System; CE Mark for Ibex’s Galen™ Prostate; Sunrise’s At-home Sleep Apnea Test; Globus Medical Announced Merger with NuVasive; Boston Imaging’s HERA W10 Elite
First Patient Enrolled in I-STEP Clinical Study of EndoBarrier in India On February 13, 2023, GI Dynamics Inc., a medical device company, announced the enrollment of the first candidate in the I-STEP clinical trial in India. The trial aimed to assess the safety and effectiveness of the EndoBarrier® System for gl...
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Feb 09, 2023
LivaNova Launched SenTiva DUO; Candela Launched Matrix System; 3M Launched Medical Adhesive; MONARCH Platform Performed First Kidney Stones Removal Procedure; Biosense Webster Presented Data of HELIOSTAR Balloon Ablation Catheter; FDA 510(k) Clearance to Aspivix’s Cervical Stabilizer Carevix
LivaNova Launched SenTiva DUO, an Implantable Pulse Generator On February 3, 2023, LivaNova PLC, a market-leading medical technology and innovation company launched SenTiva DUO™, an implantable pulse generator (IPG) with a dual-pin header that delivers VNS Therapy™ for the treatment of drug-resista...
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Jan 31, 2023
Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval
FDA Approves Eli Lilly’s Jaypirca for Relapsed Mantle Cell Lymphoma Eli Lilly has received FDA approval for Jaypirca, a non-covalent BTK inhibitor, in relapsed mantle cell lymphoma (MCL) patients who have relapsed after treatment with other drugs in the class. Adult MCL patients who have previously received at l...
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Jan 24, 2023
BeiGene’s Brukinsa Approval; FDA Approval to Seagen’s TUKYSA; NICE Recommends Alnylam’s Amvuttra; FDA Approves Brenzavvy for Type 2 Diabetes; Roche’s Tecentriq to be Filed for Early-stage Liver Cancer; FDA Lifts Hold on Astellas’ Pompe Gene Therapy
FDA Approves BeiGene’s Brukinsa for CLL/SLL BeiGene's Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has been approved by the US Food and Drug Administration. CLL is a common type of leukemia, accounting for approximately 25% of all new cases each year. SLL is...
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Jan 19, 2023
First Patient Enrolled in Kaizen Clinical Study in Japan; Koneksa’s At-Home Mobile Spirometry Clinical Trial; Medcura’s LifeGel™ Absorbable Surgical Hemostat; FDA Clearance to Abbott’s NAVITOR; Enovis’s DynaClip Delta™ and DynaClip Quattro™ bone staples; Bausch + Lomb Acquired AcuFocus
First Patient Enrolled in Kaizen Clinical Study in Japan On January 11, 2023, Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for patients suffering from peripheral and coronary artery disease, announced the initiation of the...
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Jan 10, 2023
Ipsen to Acquire Albireo; Chiesi Farmaceutici to Buy Amryt Pharma; Takeda Presents Phase III Results of TAK-755 for cTTP; ACELYRIN Acquires ValenzaBio; FDA Approves LEQEMBI for Alzheimer’s Disease; Orphan Drug Designation to Lantern Pharma’s LP-284 for MLL
Ipsen to Acquire Albireo for USD 952 Million Ipsen, a French pharmaceutical company, has offered USD 42 per share for the US biotech Albireo and its rare disease treatment Bylvay, continuing a recent spree of merger and acquisition activity. Albireo, a Boston-based business, is valued at USD 952 million under th...
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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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