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Archive for the ‘Global News Feed’ Category

Centers for Medicare & Medicaid Services Creates New Codes That Establish Specific Payment for Intravascular Lithotripsy Performed Below the Knee

Saturday, December 5th, 2020

Four New C-Codes for IVL Performed Below the Knee in Hospital Outpatient Setting Four New C-Codes for IVL Performed Below the Knee in Hospital Outpatient Setting

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Centers for Medicare & Medicaid Services Creates New Codes That Establish Specific Payment for Intravascular Lithotripsy Performed Below the Knee

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Y-mAbs and Takeda Announce Exclusive License and Distribution Agreement for DANYELZA® (naxitamab-gqgk) and Omburtamab in Israel

Saturday, December 5th, 2020

NEW YORK and PETACH TIKVA, Israel, Dec. 04, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) (the “Company” or “Y-mAbs”) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer and Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced today that they have entered into an exclusive license and distribution agreement for the registration and commercialization in Israel of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. DANYELZA (naxitamab-gqgk) was approved by the U.S. FDA on November 25, 2020. Additionally, Y-mAbs plans to resubmit the amended BLA for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma to the FDA by the end of 2020 or in early 2021.

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Y-mAbs and Takeda Announce Exclusive License and Distribution Agreement for DANYELZA® (naxitamab-gqgk) and Omburtamab in Israel

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22nd Century Group to Present at 13th Annual LD Micro Main Event Conference

Saturday, December 5th, 2020

WILLIAMSVILLE, N.Y., Dec. 04, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that it will be presenting at the 13th Annual LD Micro Main Event Conference on Monday, December 14, 2020, at 9:20 a.m. ET. James A. Mish, chief executive officer of 22nd Century Group, will be presenting to a live, virtual audience.

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22nd Century Group to Present at 13th Annual LD Micro Main Event Conference

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Zynerba Pharmaceuticals Presents New Data in Two Posters at the 2020 Annual Meeting of the American Epilepsy Society (AES)

Saturday, December 5th, 2020

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Zynerba Pharmaceuticals Presents New Data in Two Posters at the 2020 Annual Meeting of the American Epilepsy Society (AES)

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Valneva – Déclaration d’actions et de droits de vote – NOVEMBRE 2020

Saturday, December 5th, 2020

VALNEVA

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Valneva - Déclaration d’actions et de droits de vote – NOVEMBRE 2020

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Tauriga Sciences Inc. to Further Expand its Product Offerings With Dark Chocolate [20mg] CBD Infused Round Medallions

Saturday, December 5th, 2020

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Tauriga Sciences Inc. to Further Expand its Product Offerings With Dark Chocolate [20mg] CBD Infused Round Medallions

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Novartis announces first data from REACH3 trial showing Jakavi® (ruxolitinib) significantly improved outcomes in patients with…

Saturday, December 5th, 2020

Basel, December 4, 2020 — Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi® (ruxolitinib) significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to best available therapy (BAT)1. The results of REACH3, the first successful, randomized Phase III trial in chronic GvHD, were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH). REACH3 is jointly sponsored by Novartis and Incyte.

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Novartis announces first data from REACH3 trial showing Jakavi® (ruxolitinib) significantly improved outcomes in patients with...

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Virbac : Declaration of the number of shares and voting rights 11/2020

Saturday, December 5th, 2020

DECLARATION OF THE NUMBER OF SHARES AND VOTING RIGHTS

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Virbac : Declaration of the number of shares and voting rights 11/2020

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Galapagos increases share capital through subscription right exercises

Saturday, December 5th, 2020

Mechelen, Belgium; 4 December 2020, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.

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Galapagos increases share capital through subscription right exercises

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Anpac Bio Announces Change of Auditor

Saturday, December 5th, 2020

SAN JOSE, Dec. 04, 2020 (GLOBE NEWSWIRE) -- Anpac Bio-Medical Science Co., Ltd. (“Anpac Bio,” the “Company” or “we”) (ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, announced today the resignation of Ernst & Young Hua Ming LLP ("EY"), which previously was the independent registered public accounting firm of Anpac Bio, on November 3, 2020 and the appointment of Friedman LLP ("Friedman") as the Company's independent registered public accounting firm on December 2, 2020 to conduct the audit for the fiscal year ended December 31, 2020.   The appointment of Friedman has been approved by both the audit committee and the board of directors (the "Board") of the Company. The change was not made due to any disagreements with EY.

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Anpac Bio Announces Change of Auditor

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Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Saturday, December 5th, 2020

WALTHAM, Mass., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company approved the grant of equity awards to two new employees with grant date of December 1, 2020, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with the company. The equity awards were approved on October 27, 2020 and November 16, 2020, in accordance with Nasdaq Listing Rule 5635(c)(4).

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Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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Novartis analyses confirm benefit of Kymriah® with clinically meaningful rates of complete response seen in patients with certain advanced lymphomas

Saturday, December 5th, 2020

Basel, December 5, 2020 — Novartis announced analyses from two separate trials with Kymriah® (tisagenlecleucel) in patients with certain advanced lymphomas. In the interim analysis of the investigational Phase II ELARA study, Kymriah led to a complete response (CR) in 65% of patients with relapsed or refractory (r/r) follicular lymphoma (FL) and an overall response rate (ORR) of 83% after at least three months of follow-up. These patients continued to relapse or have refractory disease despite exposure to numerous lines of therapy (median four prior lines of therapy [range 2-13]) prior to Kymriah infusion1. The second analysis – a 40-month median follow-up from the Phase II JULIET trial – reported that the two-year progression-free survival (PFS) rate was 33% in patients with r/r diffuse large B-cell lymphoma (DLBCL), an important finding given these patients have limited treatment options that provide durable responses2. The JULIET study continued to show the effectiveness and well-characterized safety profile of Kymriah for these patients. These results were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH).

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Novartis analyses confirm benefit of Kymriah® with clinically meaningful rates of complete response seen in patients with certain advanced lymphomas

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Fulcrum Therapeutics Presents Updated Data on Sickle Cell Disease Program at the 62nd American Society of Hematology (ASH) Annual Meeting and…

Saturday, December 5th, 2020

CAMBRIDGE, Mass., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that preclinical data with FTX-6058 for the treatment of sickle cell disease will be presented in three posters at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 5-8, 2020. FTX-6058 is a highly potent small molecule EED inhibitor that induces expression of fetal hemoglobin (HbF). Elevating HbF can compensate for the mutated adult hemoglobin that has been identified as the root cause of several hemoglobinopathies and can ameliorate or eliminate the symptoms of sickle cell disease.

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Fulcrum Therapeutics Presents Updated Data on Sickle Cell Disease Program at the 62nd American Society of Hematology (ASH) Annual Meeting and...

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Editas Medicine Announces Preclinical Data and Large-Scale Manufacturing Process for EDIT-301, in Development for the Treatment of Sickle Cell Disease…

Saturday, December 5th, 2020

Data support novel approach to develop and manufacture a best-in-class, durable medicine for people living with hemoglobinopathies

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Editas Medicine Announces Preclinical Data and Large-Scale Manufacturing Process for EDIT-301, in Development for the Treatment of Sickle Cell Disease...

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Intellia Therapeutics Presents New Preclinical Data Supporting Its CRISPR/Cas9-Engineered TCR-T Cell Treatment for Acute Myeloid Leukemia at the…

Saturday, December 5th, 2020

CAMBRIDGE, Mass., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), is presenting new preclinical data in support of NTLA-5001, the company’s wholly owned Wilms’ Tumor 1 (WT1)-directed T cell receptor (TCR)-T cell therapy candidate for the treatment of acute myeloid leukemia (AML), at the 62nd American Society of Hematology (ASH) Annual Meeting, taking place virtually from December 5-8, 2020. NTLA-5001 capitalizes on how natural T cells recognize and respond to tumors. The target, WT1, is highly overexpressed in AML, a cancer of the blood and bone marrow that is often fatal despite existing treatments (NIH SEER Cancer Stat Facts: Leukemia – AML). The new preclinical data being presented today highlight the faster expansion and superior function of T cells manufactured by Intellia’s proprietary approach, compared to a standard genome editing process. Specifically, NTLA-5001’s lead TCR-T cells resulted in significantly higher anti-tumor activity in mouse models of acute leukemias than that observed in mice treated with cells engineered using the standard process.

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Intellia Therapeutics Presents New Preclinical Data Supporting Its CRISPR/Cas9-Engineered TCR-T Cell Treatment for Acute Myeloid Leukemia at the...

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Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL Study of ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory…

Saturday, December 5th, 2020

SOUTH SAN FRANCISCO, Calif., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced positive initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma (MM). Data were presented at an oral session of the American Society of Hematology (ASH) annual meeting. This study utilizes ALLO-647, Allogene's anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen.

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Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL Study of ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory...

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Kura Oncology Presents First Clinical Data for Menin Inhibitor KO-539 at American Society of Hematology Annual Meeting

Saturday, December 5th, 2020

– Evidence of biologic activity observed in each dose-escalation cohort treated to date –

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Kura Oncology Presents First Clinical Data for Menin Inhibitor KO-539 at American Society of Hematology Annual Meeting

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CRISPR Therapeutics and Vertex Present New Data for Investigational CRISPR/Cas9 Gene-Editing Therapy, CTX001™ at American Society of Hematology…

Saturday, December 5th, 2020

- Beta thalassemia: All seven patients were transfusion independent with 3 to 18 months of follow-up after CTX001 infusion -

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CRISPR Therapeutics and Vertex Present New Data for Investigational CRISPR/Cas9 Gene-Editing Therapy, CTX001™ at American Society of Hematology...

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Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic…

Saturday, December 5th, 2020

Basel, 5 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta®/Venclyxto® (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday 5 December 2020. “These results reinforce the long-term value of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based combinations in CLL, potentially offering patients a significant period of time without treatment following initial therapy,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These data also reflect our ongoing commitment to accelerating clinical advancements for patients by exploring the novel endpoint minimal residual disease as a potential predictor of patient outcomes.” Five-year data from the pivotal phase III MURANO trial continue to show sustained investigator-assessed progression-free survival (PFS) with Venclexta/Venclyxto plus MabThera®/Rituxan® (rituximab). Data, presented in an oral session, showed:

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Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic...

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IGM Biosciences Presents First Clinical Data from IGM-2323 in Non-Hodgkin’s Lymphoma at 2020 ASH Annual Meeting

Saturday, December 5th, 2020

- 9 of 14 Patients Showed Reduction in Tumor Size, Including Two Recently Reported Complete Responses -

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IGM Biosciences Presents First Clinical Data from IGM-2323 in Non-Hodgkin’s Lymphoma at 2020 ASH Annual Meeting

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