Medical/Pharmaceuticals
I-Mab Announces Acceptance of IND Application from China NMPA for Phase 2 Clinical Trial of Enoblituzumab in Combination with Pembrolizumab in Solid Tumors
SHANGHAI and GAITHERSBURG, Md., Sept. 28, 2021 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of China Nati...
Xiaobai Maimai Plans to Enter the U.S. Radiation Oncology Services Market
BEIJING, Sept. 28, 2021 /PRNewswire/ -- Xiaobai Maimai Inc. (NASDAQ: HX) ("Xiaobai Maimai", the "Company", or "we"), a social e-commerce platform in China, today announced that it plans to enter the radiation oncology services market in the U.S. The Company recently established We Health Limited...
University Health Network (UHN) Selects Kailo Medical's SonoReview
Quality Improvement via Automated Structured Reporting CALGARY, AB, Sept. 27, 2021 /PRNewswire/ -- Kailo Medical, a leader in medical imaging workflow solutions, today announced that the University Health Network (UHN), a group ofOntario hospitals including Toronto General, Princess Margaret, T...
Harbour BioMed Announces Dosing of First Patient of Batoclimab Phase III Trial in Patients with Generalized Myasthenia Gravis
CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, Sept. 27, 2021 /PRNewswire/ -- Harbour BioMed ("HBM", HKEX: 02142) announced that, the clinical trial of its anti-FcRn antibody, batoclimab (HBM9161), has completed the first dosing of first patient in registrational phase III trial f...
CGBIO to introduce AI-empowered robotic intervention device, with clinical trials
* CGBIO, NDR Medical Technology, forge a partnership in a move to introduce puncture robot technology and collaborate in clinical studies. * CGBIO expects this partnership to gain its stronger competitiveness in the global digital healthcare market beyond the presence as a pioneer of AI based ...
Bo'ao Winhealth Rare Disease Medical Center and Ali Health Jointly Launched the "Global Drug Information Platform for Rare Diseases"
BEJING, Sept. 27, 2021 /PRNewswire/ -- On September 25, 2021 in Beijing, China, the "Global Drug Information Platform for Rare Diseases" was successfully kicked off at Ali Center inBeijing. Jointly built by Bo'ao Winhealth Rare Disease Medical Center and Ali Health, the Platform aims at addressin...
Immunoforge Inc. receives U.S. FDA ODD for Treatment of Polymyositis
SEOUL, South Korea, Sept. 27, 2021 /PRNewswire/ -- Immunoforge (Co-CEOs Sung-min Ahn,Kiho Chang), a company specializing in developing new drugs for rare musculoskeletal diseases, has reported that their new drug candidate PF1801 has received Orphan Drug Designation (ODD) from the U.S. FDA for th...
Senhwa Announces Acceptance of Early Positive COVID-19 Phase II Study Abstract for Presentation at the ISIRV-WHO Conference
* Early Positive Phase 2 efficacy and safety data are both statistically significant and clinically meaningful. * No SAE related to Silmitasertib was reported. * Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against eme...
Clever Culture Systems Appoints Thermo Fisher Scientific as Exclusive US APAS® Distributor
ADELAIDE, Australia, Sept. 27, 2021 /PRNewswire/ -- Australian medical technology company LBT Innovations Limited (ASX: LBT) (LBT or the Company), a leader in medical technology automation using artificial intelligence, is pleased to announce the signing of an exclusive Distribution Agreement for...
Transcenta Received IND Clearance from NMPA of its Anti-sclerostin Monoclonal Antibody TST002
SUZHOU, China, Sept. 26, 2021 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta"), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it received IND clearance on...
Kintor Pharma Announces Brazil's ANVISA Approves Phase III Clinical Trial of Proxalutamide for the Treatment of Hospitalized COVID-19 Patients
SUZHOU, China, Sept. 26, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that onSeptember 22 the Brazilian Health Regulatory Agency (ANVISA) ...
GenScript ProBio and AskGene Enter into a Non-exclusive License of A sdAb Targeting Immune Checkpoint Target
NANJING, China, Sept. 26, 2021 /PRNewswire/ -- On September 26, 2021, GenScript ProBio and AskGene signed a license agreement forGenScript ProBio's single-domain antibody (sdAb) targeting an immune checkpoint target.GenScript ProBio grants a non-exclusive global license to AskGene to use GenScrip...
Boan Biotech to Present the Pre-clinical Data of Its Proprietary CD3+ T-cell Engager Platform and CEA/CD3 Bispecific Antibody at World Bispecific Summit
Sept. 25, 2021, BOSTON /PRNewswire/ -- Boan Biotech, a subsidiary of Luye Pharma Group, will orally present the pre-clinical data of its proprietary CD3+ T-cell engager platform and CEA/CD3 bispecific antibody at World Bispecific Summit 2021. The annual World Bispecific Summit aiming to promote ...
New Drug Application for Cadonilimab (PD-1/CTLA-4 Bi-Specific Antibody) for the Treatment of Relapsed or Metastatic Cervical Cancer Accepted by NMPA
HONG KONG, Sept. 23, 2021 /PRNewswire/ -- Akeso, Inc. (the Company, 9926.HK) announces that the National Medical Products Administration (the NMPA) ofChina has officially accepted the new drug application for the world's first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and d...
Ascentage Pharma's MDM2-p53 Inhibitor Alrizomadlin (APG-115) Granted Fast Track Designation by the US FDA for the Treatment of Relapsed/Refractory Unresectable or Metastatic Melanoma
SUZHOU, China, and ROCKVILLE, MD, Sept 22, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its novel MDM2-p53 inhibitor alrizomadlin (A...
United Imaging Announces FDA Clearance for its Versatile Ultra-Premium Scanner, the uCT® ATLAS
HOUSTON, Sept. 22, 2021 /PRNewswire/ -- United Imaging, a global leader in advanced medical imaging and radiotherapy equipment, announced FDA clearance for the uCT ATLAS, the latest in the company's Computed Tomography (CT) portfolio of scanners and the 25th FDA clearance for the company overall....
Clover's COVID-19 Vaccine Candidate Demonstrates 79% Efficacy Against Delta in Global Phase 2/3 SPECTRA Trial Dominated by Variants of Concern and Interest
* Trial enrolled over 30,000 adult & elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants (Delta was predominant strain) * Primary and secondary efficacy endpoints were successfully met * 100% efficacy against severe COVID-19 & hosp...
Samsung Biologics showcases its newest CDO process platform, S-Cellerate™, at BPI 2021, offering expedited timeline to IND and BLA
INCHEON, South Korea, Sept. 22, 2021 /PRNewswire/ -- Samsung Biologics, a global contract development and manufacturing organization (CDMO), introduced its proprietary technology platform, S-CellerateTM, at the BioProcess International Conference (BPI 2021) to offer clients an integrated and seam...
Asieris Appoints Dr. Alice Chen as Vice President, Discovery Biology and Head of Translational Research
SHANGHAI, Sept. 22, 2021 /PRNewswire/ -- Asieris Pharmaceuticals announced the appointment of Dr.Alice Chen as Vice President, Discovery Biology and Head of Translational Research with effect fromSeptember 20, 2021. She will report to Dr.Kevin Pan, Founder and CEO of Asieris. Alice has over 20 ...
New Therapy to Treat Advanced Small Cell Lung Cancer ZEPZELCA® (lurbinectedin) Approved in Singapore
Highlights: * ZEPZELCA® (lurbinectedin) is the first new therapy approved in Singapore to treat 2L metastatic small cell lung cancer (SCLC) in 20 years * ZEPZELCA provisional approval represents an important advance for adult patients whose metastatic SCLC has progressed on or after platinum-...
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