News & Updates

New Talk About It Resources Aim to Accelerate Integration of Mental Health into Quality Cancer Care

02/08/2023

BeiGene Releases Report and Launches CancerandMentalHealth.com in Conjunction with World Cancer Day to Help Patients and Caregivers Overcome Barriers to Access Excerpt from the Press Release: BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, has released a report highlighting the challenges cancer patients and caregivers…

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Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Relapsed/Refractory Multiple Myeloma

02/08/2023

BCMA/CD19 dual-targeting FasTCAR-T GC012F has demonstrated deep responses and favorable safety profile in proof of concept clinical studies Company plans to initiate Phase 1b/2 clinical trial in the U.S. in second quarter of 2023 Excerpt from the Press Release: SAN DIEGO Calif., and SUZHOU and SHANGHAI, China, Feb. 3, 2023 /PRNewswire/ — Gracell Biotechnologies Inc. (“Gracell”…

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Varian Receives FDA 510(k) Clearance for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight Imaging Solution and Announces First Patient Treatment

02/07/2023

Achieves CE Mark for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight Excerpt from the Press Release: PALO ALTO, Calif., Feb. 2, 2023 /PRNewswire/ — Varian, a Siemens Healthineers company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as CE mark, for Halcyon® and Ethos™ radiotherapy…

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Rigel Announces Publication of REZLIDHIA™ (olutasidenib) Phase 2 Clinical Results in Blood Advances

02/07/2023

˗ REZLIDHIA induced durable remissions in adult patients with mIDH1 R/R AML Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Feb. 2, 2023 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced a peer-reviewed publication of data in Blood Advances, which summarizes clinical results from the Phase 2 registrational study of REZLIDHIA™ (olutasidenib), a…

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4D Molecular Therapeutics Announces FDA Clearance of IND Application for 4D-150 Genetic Medicine for the Treatment of Diabetic Macular Edema

02/07/2023

Excerpt from the Press Release: EMERYVILLE, Calif., Feb. 02, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, “4DMT”), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced FDA clearance of the Investigational New Drug Application (IND) for 4D-150, an R100 vector-based intravitreal genetic medicine, for the treatment of patients…

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Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG462; Provides Additional Business Updates

02/06/2023

TNG908 granted Orphan Drug Designation in U.S. for the treatment of malignant glioma Excerpt from the Press Release: BOSTON, Jan. 25, 2023 (GLOBE NEWSWIRE) — Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the U.S. Food and Drug Administration…

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Eloxx Pharmaceuticals Announces First Patients Enrolled in Phase 2 Clinical Study Evaluating ELX-02 for the Treatment of Alport Syndrome

02/06/2023

Topline results expected in first half of 2023 Trial sites open in Australia and United Kingdom Excerpt from the Press Release: WATERTOWN, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that the first patients have now been enrolled in…

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Mersana Therapeutics Announces Initiation of Phase 1 Trial of XMT-2056 in HER2-Expressing Tumors

02/06/2023

First Immunosynthen ADC product candidate enters the clinic Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the initiation of…

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Capricor Therapeutics Announces Positive 18-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy Patients

02/03/2023

-Statistically Significant Results in Performance of the Upper Limb PUL 2.0 (p=0.02) Extended to 18 Months, Demonstrating Long-Term Benefit in Skeletal Muscle Function- -Results Continue to Suggest Potential Disease Modification in Duchenne Muscular Dystrophy (DMD)- -Capricor to Host Webinar in Conjunction with Parent Project Muscular Dystrophy (PPMD) Today at 1:00 p.m. ET- Excerpt from the…

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Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in Multiple Sclerosis by Sanofi

02/03/2023

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced that its partner Sanofi has commenced dosing…

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