Medical/Pharmaceuticals
De Motu Cordis (DMC) Applauds ARS Pharma's FDA Approval of Neffy®, Expanding Patient Options to Needle-Free Epinephrine Delivery and Inspiring Confidence in Our Own Development Efforts
BRISBANE, Australia, Aug. 16, 2024 /PRNewswire/ -- De Motu Cordis (DMC) is pleased to acknowledge and enthusiastically commends the recent U.S. FDA approval of ARS Pharma's Neffy®, the first-ever needle-free intranasal epinephrine delivery device for the treatment of anaphylaxis. This groundbrea...
Sanyou Bio's Innovative Intelligent Antibody Design oneClick+ Platform is Officially Launched
SHANGHAI, Aug. 15, 2024 /PRNewswire/ -- On August 16, 2024 (local time), Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. officially announced the launch of the "Sanyou Innovative Intelligent Antibody Design oneClick+ Platform." Sanyou Bio's Innovative Intelligent Antibody Design oneClick+ Platform...
Vimgreen Completes Enrollment of Its Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson's Disease
HANGZHOU, China, Aug. 15, 2024 /PRNewswire/ -- Vimgreen Pharmaceuticals, a science-driven pharmaceutical company focused on the modulation of adenosine signaling, announced today the completion of enrollment of its Phase 2 clinical trial of VG081821AC, a novel adenosine A2A receptor (A2AR) antago...
Ivonescimab (PD-1/VEGF) Received Priority Review from China's NMPA for First-Line Treatment of PD-L1 Positive NSCLC
The Second Indication of Ivonescimab in NSCLC 2L+ EGFRm NSCLC Already Approved in May 2024 HONG KONG, Aug. 14, 2024 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") today announced that the National Center for Drug Evaluation of the State Drug Administration ofthe People's Republic of China...
Qilian International Holding Group Ltd. Announces Trading Ticker Symbol to "BGM"
CHENGDU, China, Aug. 13, 2024 /PRNewswire/ -- Qilian International Holding Group Ltd. ("Qilian" or the "Company") (NASDAQ: QLI), aChina-based pharmaceutical and chemical products manufacturer, announced today that effective onAugust 11, 2024, its Class A ordinary shares will begin trading on the...
Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program
* Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. onJuly 2, 2023 * Adalimumab-aaty's inclusion creates greater accessibility to treatments for Americans with inflammatory conditions...
Mabwell's Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China's NMPA
SHANGHAI, Aug. 12, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) bythe Center for Drug Evaluation (CDE) of China's...
VISEN Pharmaceuticals announced that the Phase 3 PaTHway China Trial of Palopegteriparatide achieved primary and key secondary endpoints in the treatment of adults with hypoparathyroidism
* 77.6% of patients treated with palopegteriparatide in the PaTHway China Trial achieved the primarymulti-component endpoint compared to 0.0% for placebo (p <0.0001) * Palopegteriparatide was generally safe and well-tolerated, with no discontinuations related to study drug. SHANGHAI, Aug. 12...
Actinogen announces achievement of clinically and statistically significant superiority of Xanamem® over placebo on depression in XanaCIDD phase 2a trial
There was a clinically meaningful and persistent improvement depression measured by the key secondary endpoint of MADRS.[1] The primary endpoint of superiority to placebo in a cognitive "attention composite" of three Cogstate computerized tests was not met with large improvements seen in both Xan...
Milestone: Renal Nerve Mapping / Selective Renal Denervation (msRDN) System by SyMap Medical Ltd Approved for Treatment of Uncontrolled Hypertension in China
SUZHOU, China, Aug. 12, 2024 /PRNewswire/ -- On August 6, 2024, the msRDN System (SyMapCath I®/ SYMPIONEER S1®), developed by Suzhou/China-based SyMap Medical Ltd. (SyMap Medical), was approved by the National Medical Products Administration (NMPA) ofChina and granted a Class III Medical Devices ...
IASO Bio Receives U.S. FDA Approval of Investigational New Drug Application for Equecabtagene Autoleucel for Two New Autoimmune Disease Indications
SHANGHAI, NANJING, China and SAN JOSE, Calif., Aug. 12, 2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, today announced that the investigation...
T-MAXIMUM PHARMACEUTICAL Announces Latest Clinical Advances in Allogeneic CAR-T Cell Therapy Breakthrough for Solid Tumors
Summary * T-Maximum Pharmaceutical develops allogeneic CAR-T therapies with a unique CRISPR/Cas9 Gene-Editing platform for solid tumors, provide a solution of two major pain points, GvHD and HvG, aiming to revolutionize cancer. * MT027, the product of target B7H3 received US FDA orphan drug d...
WuXi Biologics and Medigene Enter into a Research Collaboration for Off-the-Shelf TCR-Guided T Cell Engagers
* Partnership leverages Medigene's leadership for T cell receptor (TCR) generation and characterization and WuXi Biologics' unique anti-CD3 mAb, its T cell engager (TCE) platform and proprietary bispecific antibody platform WuXiBody™ * Collaboration is a three-year and potentially multi-TCR p...
WestGene to Advance Clinical Trials Following Dual IND Approvals for World's First EB Virus-Related mRNA Therapeutic Cancer Vaccine
CHENGDU, China, Aug. 7, 2024 /PRNewswire/ -- WestGene Biopharma is proud to announce that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals fromChina's National Medical Products Administration (NMPA) and the US FDA. This unprecedented achievement marks the world's firs...
Concord Medical Regains Compliance with NYSE Minimum Price Requirement
BEIJING, Aug. 7, 2024 /PRNewswire/ -- Concord Medical Services Holdings Limited ("Concord Medical" or the "Company") (NYSE: CCM), a healthcare provider specialized in cancer treatment, research, education and prevention inChina, today announced that it has received a letter from the New York Stoc...
Formosa Pharma and Eyenovia Announce Initiation of Co-Development of Clobetasol Propionate Ophthalmic Suspension, 0.05%, for the treatment of Acute Dry Eye Disease in United States
TAIPEI, Aug. 7, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has signed a non-binding terms agreement with Eyenovia, Inc. ("Eyenovia", NASDAQ: EYEN), whereby the companies will co-develop Clobetasol Propionate Ophthalmic Suspensi...
I-Mab Appoints U.S. Auditor, PricewaterhouseCoopers LLP (PwC)
Engagement is part of I-Mab's commitment to transition to a U.S.-based biotech PwC to serve as independent registered public accounting firm for FY 2024 ROCKVILLE, Md., Aug. 7, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) ("I-Mab", the "Company"), a U.S.-based, global biotech company, exclusively f...
Senhwa Biosciences receives US FDA Study May Proceed letter for the Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors
TAIPEI and SAN DIEGO, Aug. 6, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug A...
Datasea's Digital Technology Subsidiary Selected as Prospective Partner for Future Projects with Subsidiary of China Mobile
The Prospective Partnership with a Subsidiary of China Mobile, one of the World's Largest Mobile Operator, Underscores DTSS' Achievements in 5G-AI Communications BEIJING, Aug. 6, 2024 /PRNewswire/ -- Datasea Inc. (Nasdaq: DTSS) ("Datasea" or the "Company"), a digital technology company incorpora...
Lunit's AI for Tuberculosis Detection Tops in 12-Product Comparative Study
* Lancet Digital Health study highlights Lunit INSIGHT CXR as top performer in TB screening, showing promise for improving detection in high-burden settings SEOUL, South Korea, Aug. 6, 2024 /PRNewswire/ -- Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics,...
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