Biotechnology
FDA purchases digiM I2S software for the assessment of product quality attributes
Reviewers and regulatory researchers to use AI image analytics for process-quality correlation WOBURN, Mass., Jan. 24, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration has placed a purchase order (75F40123P00369) committing to an annual subscription of digiM I2S, a fully integrated ima...
2024-01-24 23:37
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WestGene Spearheads Oncology Breakthroughs at the 3rd mRNA-Based Therapeutics Summit
CHENGDU, China, Jan. 24, 2024 /PRNewswire/ -- Kicking off the New Year with remarkable achievements,Chengdu-based WestGene made a significant impact at the 3rd mRNA-Based Therapeutics Summit inBerlin, Germany. Renowned for her pivotal role in mRNA research, Dr.Xiangrong Song, co-founder and CEO o...
2024-01-24 21:32
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Genome & Company Announces Positive Topline Results from Phase 2 Clinical Trial of Combination of GEN-001 and Bavencio® for the Treatment of Gastric Cancer Poster presented at ASCO GI
* Results showed partial response being confirmed in 7 out of 42 patients * Partial response was observed in 3 out of 8 patients who were previously treated by immunotherapy SEOUL, South Korea, Jan. 24, 2024 /PRNewswire/ -- Genome & Company (KOSDAQ: 314130), a clinical stage biotech leading in...
2024-01-24 21:00
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Seegene Announces Collaboration with Microsoft to Realize 'a World Free from All Diseases'
* Strategic collaboration to open a new chapter in the field of molecular diagnostics that aspires to 'a world free from all diseases and future pandemics' * Digitally enhance Seegene's automated diagnostic reagent development system with the integration of Microsoft Azure AI solutions * A ...
2024-01-24 20:00
2108
Sirnaomics Publishes Novel Mechanism of Action of RNAi Cancer Therapeutic STP707 for Solid Tumors
Study published in NAR Cancer, a leading peer-reviewed journal in the field of nucleic acid therapeutics HONG KONG, Germantown, Md. and SUZHOU, China, Jan. 24, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a l...
2024-01-24 17:49
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Ascletis Announces Dosing of the First Patient in Phase III Clinical Trial of ASC40 (Denifanstat) for Treatment of Acne
HANGZHOU and SHAOXING, China, Jan. 24, 2024 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces dosing of the first patient in Phase III clinical trial of ASC40 (Denifanstat) for treatment of moderate to severe acne vulgaris at Huashan Hospital, Fudan University. This P...
2024-01-24 16:50
1460
PRISM BioLab raises 1.5 billion yen in Series C fundraising to advance technologies and programs targeting protein-protein interactions
Eli Lilly and Company, Santec Holdings Corporation participated in the round TOKYO, Jan. 24, 2024 /PRNewswire/ -- TOKYO, Jan. 24, 2024 /PRNewswire/ -- PRISM BioLab, Co. Ltd. ("PRISM"), a leading discovery and development biotechnology company designing small molecule inhibitors of protein-protei...
2024-01-24 16:00
1165
Onward Therapeutics Announces Enrollment of Phase 1 Clinical Trial of a Novel Bispecific Antibody (OT-A201) Targeting Two Immune Checkpoints
EPALINGES, Switzerland and PARIS, Jan. 24, 2024 /PRNewswire/ -- Onward Therapeutics SA (Onward Therapeutics), a global biotechnology company focused on developing innovative immunotherapies for cancer treatment, today announced that the phase 1 clinical trial of OT-A201 (Study No. A20101), a firs...
2024-01-24 15:00
1223
Harbour BioMed Announces IND Clearance for HBM9027 in the U.S.
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 23, 2024 /PRNewswire/ -- Harbour BioMed (the "Company", HKEX: 02142) announced that the Company has been granted the clearance of Investigational New Drug (IND) from the Food and Drug Administration (FDA) ofthe United States to init...
2024-01-24 12:40
1236
WuXi XDC and Celltrion Sign MOU for Integrated Services for Antibody-Drug Conjugates (ADCs)
SHANGHAI and INCHEON, South Korea, Jan. 23, 2024 /PRNewswire/ -- WuXi XDC(2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on ADC and the other types of bioconjugate market, and Celltrion, Inc. (068270.KS), a leading global biopharmaceutical...
2024-01-24 11:37
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PharmAbcine Announces First Patient Dosed in Phase 1a/b Clinical Trial of PMC-309 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced or Metastatic Solid Tumors
* Initiation of Phase 1a/b clinical trial exploring MTD, RP2D, safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA® * The clinical trial aims to enroll a total of 67 patients across four institutions inAustralia DAEJEON, South Korea, Jan. 23, 2024 /PRNewswire/ ...
2024-01-24 10:01
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Sciwind Biosciences Announces Positive Results from Phase 1 Clinical Trial of XW004, an Oral Formulation of Long-acting GLP-1 Analog Ecnoglutide
* Oral ecnoglutide was safe and well tolerated with gastrointestinal side effects as the most commonly reported adverse events * Study participants receiving up to 30 mg oral ecnoglutide once-daily for 6 weeks achieved a mean body weight reduction of -6.8% from baseline, compared to -0.9% for...
2024-01-24 10:00
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INTREPID Alliance Releases Review of Antiviral Compounds in Clinical Development to Contribute to Collaborative Efforts in Pandemic Preparedness
Global landscape analysis identifies strengths and gaps in R&D pipeline to inform international pandemic preparedness efforts ROME and CAMBRIDGE, Mass., Jan. 24, 2024 /PRNewswire/ -- The INTREPID Alliance, a consortium of innovative biopharmaceutical companies dedicated to accelerating the devel...
2024-01-24 08:22
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Akeso Presented Promising Results of Cadonilimab and Lenvatinib in Combination with TACE in uHCC at 2024 ASCO GI
HONG KONG, Jan. 23, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") today announced that the Company presented the promising phase II results of cadonilimab (a tetravalent PD-1/CTLA-4 bispecific antibody) and Lenvatinib (Len) combined with TACE for the treatment of mi...
2024-01-23 21:00
2841
FDA Grants Breakthrough Device Designation to Amadix´s preventive screening blood test for Colorectal Cancer
* PreveCol®, a blood test for oncological diagnosis, has obtained US recognition for its efficacy in detecting precancerous lesions compared to existing alternatives inthe United States. * Amadix becomes the first European company to announce this recognition for early detection of colorectal...
2024-01-23 18:00
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Gannex's Strategic Partner Sagimet Biosciences Announces Positive Topline Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH
Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial of 168 NASH patients with stage 2 or 3 fibrosis - Primary efficacy endpoints: * NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS (NAFLD A...
2024-01-23 12:17
1355
European Medicines Agency (EMA) Grants Orphan Drug Designation (ODD) to GC Biopharma's Treatment for Sanfilippo Syndrome (Type A)
YONGIN, South Korea, Jan. 22, 2024 /PRNewswire/ -- GC Biopharma Corp. (006280.KS) announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its intracerebroventricular (ICV) Enzyme Replacement Therapy (ERT) candidate, GC1130A, designed for Sanfilippo Syndrome...
2024-01-23 11:53
1235
First Myeloma Patient Treated with CAR-T Successfully Discharged
SHANGHAI, Jan. 23, 2024 /PRNewswire/ -- In another milestone since the implementation of CAR-T therapy at Jiahui, the first myeloma patient treated with CAR-T at Jiahui International Hospital was recently discharged two weeks after infusion. The foreign patient was first diagnosed with multiple ...
2024-01-23 10:19
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NK CellTech Announces FDA Clearance for Clinical Trial of NK010
SHANGHAI, Jan. 22, 2024 /PRNewswire/ -- On January 17, 2024, NK CellTech Co., Ltd. (NK CellTech), a leading biotech company focused on the development of NK cellular therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of NK010, the non-genetically modified ...
2024-01-22 20:10
1300
Telix Highlights Presentations at Upcoming ASCO Genitourinary Cancers Symposium (ASCO GU 2024)
MELBOURNE, Australia, Jan. 22, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces presentations featuring the Company's theranostic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2024) to be he...
2024-01-22 19:00
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