Pharmaceuticals

CHIMERIC THERAPEUTICS ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR CHM 2101, A NOVEL CDH17 CAR T CELL THERAPY FOR ADVANCED GASTROINTESTINAL CANCERS

* FDA IND Clearance for CHM 2101, a novel 3rd generation CDH17 CAR T cell therapy * Anticipated to be the first CDH17 CAR T cell therapy to enter the clinic * Phase 1A clinical trial to initiate patient enrolment in 2024 * Phase 1A clinical trial will enroll patients with advanced Colorecta...

2023-10-31 19:00 2476

iNtRON, Executes Evaluation License and Option Agreement for SAL200

* iNtRON Grants Basilea exclusive right for preclinical evaluation with an undisclosed payment * Basilea has the option to enter into exclusive License Agreement following the evaluation BOSTON and SEOUL, South Korea, Oct. 30, 2023 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON",www.intodeworl...

2023-10-31 12:20 2325

Bridge Biotherapeutics Announces Initiation of Phase 1/2 Clinical Trial of BBT-207 in EGFR-Mutant NSCLC

SEONGNAM, South Korea and NEWTON, Mass., Oct. 30, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis, and inflammation, announced that the company has initiated the Phase 1/2 clinical trial evaluating t...

2023-10-31 07:00 2760

Journal of Thoracic Oncology Published Promising Results of Ivonescimab (PD-1/VEGF Bispecific) as First- or Second-line Therapy for Advanced or Metastatic Immunotherapy Naïve Non-Small-Cell Lung Cancer

HONG KONG, Oct. 30, 2023 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase Ib clinical trial for PD-1/VEGF bispecific antibody ( ivonecimab AK112/SMT112 ) as first- or second-line therapy for advanced or metastatic immunotherapy naïve non-small-cell lung cancer (NSCLC) were p...

2023-10-30 20:00 3597

Foresee Pharmaceuticals to Present at the American Heart Association Annual Meeting Focusing on its ALDH2 activator FP-045 in Pulmonary Hypertension Associated with Interstitial Lung Disease

TAIPEI, Oct. 30, 2023 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announced today that the company will be presenting at the American Heart Association (AHA) 2023 Annual Meeting taking place inPhiladelphia, PA, fromNovember 11-13, 2023. The presentation will focus on Foresee...

2023-10-30 15:18 2279

Lunit Enters into Research Collaboration to Explore the Use of AI to Improve the Effectiveness of Immunotherapy

-       Lunit to support MD Anderson researchers studying immune phenotype biomarkers for pembrolizumab treatment response SEOUL, South Korea, Oct. 27, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced ...

2023-10-27 21:07 4213

Peijia Medical Presents Early Clinical Findings of GeminiOne® TEER Device at TCT 2023

SUZHOU, China, Oct. 27, 2023 /PRNewswire/ -- Peijia Medical Limited (Peijia, (9996.HK)), a leading Chinese medical device player in transcatheter structural heart device and neurovascular device, presented its GeminiOne® TEER technology, along with the early clinical experiences of the device at ...

2023-10-27 20:00 3094

Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India

* The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India  * Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commerc...

2023-10-27 19:47 3449

Chime Biologics and Hope Medicine Enter Manufacturing Agreement to Speed up the Launch of First-in-class Antibody Drug HMI-115 Targeting Endometriosis and Androgenic Alopecia

* Chime Biologics to support the late-stage clinical study and to provide global commercial manufacturing services forHope Medicine's first-in-class monoclonal antibody drug, HMI-115. * The first-in-class mAb will benefit endometriosis and androgenetic alopecia patients. SHANGHAI, Oct. 26, 20...

2023-10-26 22:49 2664

Clarity and PSI kick off SAR-bisPSMA Phase III

SYDNEY, Oct. 26, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, and PSI CRO AG ("PSI"), a global contract rese...

2023-10-26 21:00 3022

HanAll Biopharma Reports Third Quarter 2023 Financial Results and Provides a Business Update

* Sales recorded KRW 33 billion in Q3 2023, an 11 percent increase from the same period in 2022, due to the sustained growth of major products. * 'HL161ANS', HanAll's second anti-FcRn antibody, demonstrated best-in-class potential through the initial outcome of Phase 1 study. * 'HL192', a Nu...

2023-10-26 19:00 2568

Bridge Biotherapeutics Announces Positive Recommendation from the Independent Data Monitoring Committee of the BBT-877 Phase 2a Study in Idiopathic Pulmonary Fibrosis

* The independent data monitoring committee (IDMC) recommended the continuation of the BBT-877 Phase 2a trial based on the initial clinical data from the first 20 participants dosed with theinvestigational product * No safety concerns were raised based on the evaluation of the data presented ...

2023-10-26 07:00 2960

Neuragenex Brings Innovative Fibromyalgia Treatment to Patients Across the US

GULBERT, Ariz., Oct. 25, 2023 /PRNewswire/ -- Neuragenex, the national healthcare provider focused on non-pharmaceutical pain treatment, announced its continued expansion to bring relief to fibromyalgia patients across the country. With clinics now operating in Georgia, Texas, Illinois, Tenness...

2023-10-25 23:23 1849

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

JINAN, China, Oct. 25, 2023 /PRNewswire/ -- On October 22, Qilu Pharmaceutical unveiled the latest findings from a multicenter, single-arm Phase II clinical trial at the European Society for Medical Oncology (ESMO) Annual Congress 2023. This trial studied the use of QL1706 (iparomlimab and tuvonr...

2023-10-25 22:15 2776

First Patient Dosed for MRCT Phase 3 Study on First-Line LS-SCLC of Henlius Anti-PD-1 mAb Serplulimab in Europe

SHANGHAI, Oct. 25, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient inEurope has been dosed in the international multi-centre phase 3 clinical trial (NCT05353257) of the company's self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination ...

2023-10-25 21:15 2771

Good Safety Profile and Antitumor Activity: Oral Presentation of Mabwell's 9MW2821 at 2023 ESMO

Shanghai, Oct. 25, 2023 /PRNewswire/ -- ESMO Congress 2023 was held in Madrid, Spain from October 20-24, the preliminary results of the Phase I/II study of 9MW2821 (Nectin-4 targeting ADC) in patients with advanced solid tumors were reported by Dr.Jian Zhang of Fudan University Shanghai Cancer Ce...

2023-10-25 17:46 2800

Phase Ib/II Results of Akeso's PD-1/CTLA-4 Bispecific Antibody for First-Line Treatment of Advanced Hepatocellular Carcinoma Published at 2023 ESMO

HONG KONG, Oct. 24, 2023 /PRNewswire/ -- Akeso announced poster presentation at the 2023 European Society for Medical Oncology (ESMO) Congress from its cadonilimab ( PD-1/CTLA-4 bispecific antibody) combined with lenvatinib for first-line treatment of Advanced Hepatocellular Carcinoma (HCC). The ...

2023-10-24 20:00 2636

Clinical Trial Application (IND) for BioRay Pharmaceutical's BR105 Injection Receives U.S. FDA Approval

SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced onOctober 7th that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA). This marks BioRay's first ...

2023-10-24 15:05 2076

OBiO Announces Strategic Partnership with Refreshgene to Realize Commercialization of Gene Therapy Product

Visit OBiO at ESGCT 30th Annual Congress in Brussels SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. (OBiO, 688238.SH), a world leading contract development and manufacturing organization for cell and gene therapy, officially announced an agreement with Refreshgene...

2023-10-24 12:05 2660

Certa Therapeutics' FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis

MELBOURNE, Australia, Oct. 23, 2023 /PRNewswire/ -- Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ...

2023-10-23 21:30 2436
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