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Category: Today’s Highlights

Gilead and Eisai Submitted an Application to Japan's PMDA for Approval of Filgotinib for UC

Gilead Sciences and Eisai Pharmaceutical Co Submitted an Application to Japan's PMDA for Filgotinib Galapagos NV ( GLPG )  announced that  Gilead Sciences ( GILD )  and Eisai Pharmaceutical Co ( ESALY )  submitted an application to Japan’s Pharmaceuticals and Medical...

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April 23, 2021

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From Biogen and Eisai: Lecanemab Confirmatory Phase 3 Clarity Met Primary Endpoint for Early Alzheimer’s Disease  

Biogen & Eisai Co and Early Alzheimer's Disease  From Tokyo and Cambridge, Eisai Co., Ltd. and Biogen Inc. ( BIIB ) announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab. The product...

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September 28, 2022

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Celldex Therapeutics Presented Positive Preclinical Data from its TSLP/SCF Bispecific Antibody Program CDX-622 at AAI

Celldex Therapeutics Announcement Celldex Therapeutics ( CLDX ) announced today preclinical data from its CDX-622 bispecific antibody with dual targeting of the alarmin TSLP and stem cell factor ( SCF ), also known as KIT receptor ligand, developed from its...

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May 15, 2023

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Bio-Techne ExoDx Prostate Test is More Accurate in High- and Low-Risk Patients Compared to Standard of Care

Prostate Cancer Prostate cancer is the most common type of cancer found in men, accounting for more than a quarter of all newly diagnosed cancer cases. Early detection is linked to improved survival rates, but typical screening recommendations — such...

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May 18, 2023

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Vertex and CRISPR Therapeutics: The EMA Granted PRIME Designation to CTX001. Read Also: Cassava Sciences Encouraging News

Vertex and CRISPR Granted PRIME Designation from the EMA for CTX001 Vertex Pharmaceuticals ( VRTX ) and CRISPR Therapeutics ( CRSP ) announced that the European Medicines Agency ( EMA ) granted Priority Medicines ( PRIME ) designation to CTX001, an...

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April 26, 2021

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Reata Pharmaceuticals: Good News for the Prohost Pick

Reata Pharmaceuticals Announcement Regarding the NDA for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced that the U.S. Food and Drug Administration ( FDA ) does not plan to hold an advisory committee meeting in connection with its review of...

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October 14, 2022

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Amylyx Pharma Informed European CHMP is Trending Toward a Negative Opinion for Conditional Marketing Authorization of AMX0035 for ALS

Amylyx Pharmaceuticals  Amylyx Pharmaceuticals ( AMLX ) announced an update on the ongoing review of its Marketing Authorization Application ( MAA ) for AMX0035 (taurursodiol]) regarding the treatment of adults with amyotrophic lateral sclerosis ( ALS ) by the Committee...

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May 30, 2023

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Why the UT Southwestern Medical Center is Enrolling Cancer Patients in Phase III TIGeR-PaC Clinical Trial from RenovoRx

UT Southwestern Medical Center and RenovoRx RenovoRx Inc ( RNXT ) announced that the University of Texas ( UT ) Southwestern Medical Center is now enrolling pancreatic cancer patients in the open label, randomized Phase III TIGeR-PaC clinical trial. The...

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June 1, 2023

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Gilead and MacroGenics Announce Oncology Collaboration to Develop Promising Bispecific Antibodies

Gilead Sciences and MacroGenics Collaboration Announcement Gilead Sciences ( GILD ) and MacroGenics ( MGNX ) announced an exclusive option and collaboration agreement to develop MGD024 using MacroGenics DART® platform, and two additional bispecific research programs. The collaboration agreement grants...

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October 17, 2022

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Arbutus Biopharma Doses First Patient in Additional Treatment Arm of Phase 2a Triple Combination Clinical Trial That Includes a PD-1 Monoclonal Antibody Nivolumab

Arbutus Biopharma Announcement Today, June 21, 2023, Arbutus Biopharma ( ABUS ) announced that the first patient has been dosed in the additional treatment arm of the AB-729 Phase 2a triple combination clinical trial, which has been expanded to include...

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June 21, 2023

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