- Independent Data Monitoring Committee (IDMC) Recommended Continuation of Phase 3 REGAL Trial Without Any Modifications -
See the article here:
SELLAS Life Sciences Announces Positive Recommendation from REGAL Independent Data Monitoring Committee of Galinpepimut-S in Acute Myeloid Leukemia
Technological advances reduce time and increase efficiency for MDD treatment Technological advances reduce time and increase efficiency for MDD treatment
More here:
NeuroStar TMS Receives Expanded Regulatory Approval in Japan
PALO ALTO, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the State of Tennessee added ZTlido® as a preferred agent to the Medicaid Preferred Drug List effective as of October 1, 2023.1 This change has the potential to improve access to ZTlido® for all eligible patients which includes approximately 1,500,000 adult lives between the ages of 19 to 64.1
Continue reading here:
Scilex Holding Company announces the addition of ZTlido® (lidocaine topical system) as a preferred agent to the Medicaid Preferred Drug List (PDL) of...
Holliston, MA, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today announced that it officially executed a Sponsored Research Agreement (SRA) with Hugh Taylor, MD, chair of Obstetrics, Gynecology & Reproductive Sciences at Yale School of Medicine. The program will focus on the use of Harvard Apparatus Regenerative Technology’s cell-based scaffold platform to restore fertility by repairing uterine tissue in a mouse model of uterine damage.
BRISBANE, CALIFORNIA, Dec. 04, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE® platform, today announced the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the development of GTB-3650, a 2nd generation nanobody TriKE® for the treatment of patients with CD33+ leukemia, including relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
See more here:
GT Biopharma Announces IND Submission for GTB-3650 for Treatment of CD33+ Leukemia
PETALUMA, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- RetinalGeniX Technologies Inc. (OTCQB: RTGN) (“RetinalGeniX” or the “Company”), today announced that Dessislava (Dessy) Boneva, M.D. has joined the Company’s Board of Directors.
Read more from the original source:
RetinalGeniX Technologies Inc. Appoints Dessy Boneva, MD, FACS to the Board of Directors
CAMBRIDGE, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, today announced that management will participate in a fireside chat at the H.C. Wainwright 4th Annual Precision Oncology Virtual Conference on Wednesday, December 6, 2023, at 9:30 a.m. ET.
See the article here:
Omega Therapeutics to Participate in the H.C. Wainwright 4th Annual Precision Oncology Virtual Conference
MONT-SAINT-GUIBERT, Belgium, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Celyad Oncology (Euronext: CYAD), a cutting-edge biotechnology company dedicated to pioneering the discovery and advancement of revolutionary technologies for chimeric antigen receptor (CAR) T-cells, announces that its CEO and managing director Georges Rawadi has decided to step down, effective as of Friday December 1, 2023.
SAN FRANCISCO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced that it will host a live webcast to review clinical data from the Phase 1 clinical trials of its Bruton’s tyrosine kinase (BTK) degrader programs, NX-5945 and NX-2127, which are being evaluated in patients with relapsed or refractory B cell malignancies, at 8:30 p.m. PST (11:30 p.m. EST) on Monday, December 11, 2023.
After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgAN to full approval
See the original post here:
Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS
WALTHAM, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the Company will host a virtual key opinion leader (KOL) event on Monday, December 11, at 8:00 a.m. ET to discuss highlights from its poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. Following the prepared remarks, the call will be opened for a live question and answer session. To submit a question, please reach out to questions@lifesciadvisors.com.
See the rest here:
TScan Therapeutics to Host Virtual KOL Event to Discuss Results from Ongoing Phase 1 Trial of TSC-100 and TSC-101 Presented at the 65th ASH Annual...
SOUTH SAN FRANCISCO, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that Bill Newell, Chief Executive Officer, will participate in a virtual fireside chat at the JMP Securities Hematology and Oncology Summit on Wednesday, December 6, 2023 at 2:30 p.m. ET / 11:30 a.m. PT.
Go here to read the rest:
Sutro Biopharma to Participate in the JMP Securities Hematology and Oncology Summit
Daix (France), Long Island City (New York, United States), December 4, 2023 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs, today announced the positive recommendation from the third meeting of the Data Monitoring Committee (DMC) to continue the NATiV3 Phase III clinical trial evaluating lanifibranor in patients with NASH without modification to the trial protocol. The DMC, composed of a group of independent experts, arrived at this recommendation after review of the safety data of patients enrolled in the NATiV3 trial.
See the rest here:
Inventiva announces the positive recommendation of the third DMC of the Phase III clinical trial with lanifibranor in patients with NASH
-Based on preliminary data from ongoing clinical trials, focusing on next-generation CAR T product candidates, CTX112™ targeting CD19 and CTX131™ targeting CD70-
See the article here:
CRISPR Therapeutics Announces Updates to Immuno-Oncology Pipeline and Expansion into Autoimmune Disease
Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15
Read more from the original source:
Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15
PARIS and CAMBRIDGE, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – “Nanobiotix” or the “Company”), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, announces today the closing of the previously announced subscription by Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) for 901,256 additional ordinary shares of the Company, in the form of restricted American Depositary Shares (“ADSs”), for an aggregate amount of $4.8 million, equivalent to €4.6 million1 (the “Remaining Placement Amount”, and the subscription transaction being the “Remaining Placement”), following the approval by the French Ministry of Economy of JJDC Remaining Placement on November 22, 2023, in accordance with the French foreign investment control rules2.
See the rest here:
Nanobiotix Announces Closing of the Remaining $4.8 Million Investment From Johnson & Johnson Innovation – JJDC, Inc.
FOSTER CITY, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (“Notable”) (Nasdaq: NTBL), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced that Thomas Bock, M.D., CEO of Notable Labs, will participate in a fireside chat at the JMP Securities Hematology and Oncology Summit taking place virtually on December 5 – 6, 2023.
See the original post:
Notable Labs to Participate in JMP Securities Hematology and Oncology Summit
Information regarding the total number of voting rights and total number of shares of the Company as of November 30, 2023
Original post:
Information regarding the total number of voting rights and total number of shares of the Company as of November 30, 2023
MELBOURNE, Australia and SAN FRANCISCO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, will be hosting an investor webcast on Wednesday, 6 December 2023 in Australia / Tuesday, 5 December 2023 in the United States. Details are listed below and registration is required.
Read the original post:
Alterity Therapeutics to Host Webcast to Discuss ATH434 Efficacy Data in Primates and Recent Clinical Progress