Biliary tract

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

Retrieved on: 
Saturday, April 6, 2024
Research, Women, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, Oncology, Orbis, Urinary tract infection, Cardiac arrest, Stomatitis, Patient, Stroke, Lung cancer, University, Acute kidney injury, Neoplasm, Therapy, Anemia, Vomiting, Pleural effusion, Cellulitis, Shock (mechanics), Periodic breathing, Colorectal cancer, Abdominal pain, Safety, Immunohistochemistry, Fatigue, ADC, Daiichi Sankyo, Food, IHC, Sepsis, NSCLC, Appetite, Biliary tract, Constipation, NCCN, MD, Priority review, Fatality, Pneumonitis, HER2, ILD, Medication, Pneumonia, AstraZeneca, COVID-19, Biomarker, Diarrhea, Bleeding, MD Anderson Cancer Center, Nausea, Upper respiratory tract infection, Pharmaceutical industry

The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .

Key Points: 
  • The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .
  • In DESTINY-PanTumor02, efficacy was assessed in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.
  • In DESTINY-Lung01, efficacy was assessed in a subgroup of patients (n=17) with centrally confirmed HER2 positive (IHC 3+) non-small cell lung cancer (NSCLC).
  • In DESTINY-CRC02, efficacy was assessed in the subgroup of patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer.

ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial in Participants with Lynch Syndrome and Initiation of Randomized Controlled Phase of the Trial

Retrieved on: 
Wednesday, February 21, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Large intestine, Bangladesh Technical Education Board, Cancer, HNPCC, Medicine, B cell, TTY, DCP, FDA, Safety, Hereditary nonpolyposis colorectal cancer, National Cancer Institute, Vaccine, Risk, Biliary tract, Stomach, Antigen, Ureter, Patient, Pancreas, NK, Clinical trial, Protein, Diagnosis, Translational research, Colorectal cancer, Adenoviridae, Immune system, Brain, Pharmaceutical industry

The study, sponsored by the National Cancer Institute, part of the National Institutes of Health, will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial.

Key Points: 
  • The study, sponsored by the National Cancer Institute, part of the National Institutes of Health, will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial.
  • Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells.
  • The vaccine combination is studying whether activation of dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer occurs.
  • Safety and efficacy of these investigational agents have not been established by any Health Authority, including the FDA.

Olympus Closes the Acquisition of Korean Gastrointestinal Stent Company, Taewoong Medical Co., Ltd

Retrieved on: 
Wednesday, January 24, 2024
Knowledge, Comment, GI, Duodenum, Patient, Esophagus, Stenosis, Name, Medtech, Gastrointestinal disease, Acquisition, Sale, Health, Biliary tract, Pharmaceutical industry

[2]

Key Points: 
  • [2]
    Taewoong Medical offers a variety of medical devices including metallic stents designed for biliary tract, esophagus, colon, and duodenum treatments.
  • Taewoong Medical will join Olympus' Therapeutic Solutions Division, helping Olympus become a comprehensive solutions provider in the GI market with varied GI EndoTherapy solutions by bringing together talent and technology.
  • The addition of Taewoong Medical to Olympus' portfolio will contribute to the company's focus on enhancing patient care pathways.
  • Comment from Kyong-min Shin, President and CEO of Taewoong Medical: "As a leading medical company, Taewoong Medical manufactures a vast range of medical equipment of our own designs.

Kaneka Acquires Japan Medical Device Technology

Retrieved on: 
Wednesday, December 6, 2023
Surgery, Medical Devices, Health, Cardiology, Medical Supplies, Atherosclerosis, Human body, Restenosis, Kaneka, Research, Biliary tract, Artery, Extremities, Esophagus, Metal, Sirolimus, Coronary artery disease, Risk, Corporation, Multimedia, FIH, Duodenum, Thrombosis, Blood, Human, Trachea, Kaneka Corporation, Pharmaceutical industry

Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka)(TOKYO:4118) has acquired all shares of Japan Medical Device Technology Co., Ltd. (Headquarters: Kamimashiki-gun, Kumamoto; President: Shuzo Yamashita) (hereinafter JMDT), a developer and manufacturer of medical devices, on November 30, 2023, and made it a wholly owned subsidiary.

Key Points: 
  • Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka)(TOKYO:4118) has acquired all shares of Japan Medical Device Technology Co., Ltd. (Headquarters: Kamimashiki-gun, Kumamoto; President: Shuzo Yamashita) (hereinafter JMDT), a developer and manufacturer of medical devices, on November 30, 2023, and made it a wholly owned subsidiary.
  • In particular, stenting*1 for the treatment of coronary artery diseases such as atherosclerosis has a market worth 30 billion yen in Japan, and Kaneka is aiming to expand its business in this area.
  • It is a medical device that widens tubular parts of the human body (blood vessels, trachea, esophagus, duodenum, colon, biliary tract, etc.)
  • [Japan Medical Device Technology Co., Ltd.]

Fulgent Shares Data from Two Poster Presentations at SITC 2023 Annual Meeting

Retrieved on: 
Friday, November 3, 2023
Technology, Genetics, Health Technology, Software, Biotechnology, Health, Pharmaceutical, General Health, Oncology, SNV, Taxane, Plasma, Stomach, Paclitaxel, Bladder cancer, Research, Cancer, Poster, HNSCC, Pharmacokinetics, SITC, Immunotherapy, Drug discovery, Biopsy, Annual general meeting, Head and neck cancer, RECIST, Biliary tract, Society, Therapy, Liquid biopsy, Patient, Neoplasm, Prostate, PR, Pharmaceutical industry, Medical imaging, Illumina

Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.

Key Points: 
  • Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.
  • The study calls for the involvement of certified labs, highlighting the need for stringent quality management and regulatory alignment.
  • The poster titled, “FID-007: Nanoencapsulated Paclitaxel Derived from a Novel Nano-Drug Delivery Platform,” highlights progress for Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in various cancers.
  • Preliminary clinical data suggests FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

Retrieved on: 
Wednesday, November 1, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Survival, Patient, Colitis, Nephritis, Cholangiocarcinoma, Incidence, Hypothyroidism, Pneumonitis, NYSE, Food, Progression-free survival, Fatigue, Medicine, Itch, DOR, AST, Pembrolizumab, Cisplatin, Head, Gastrointestinal cancer, MRK, PFS, Fever, University of California, Bile, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HIV disease progression rates, Administration, Rash, Disease, Ascending cholangitis, Merck & Co., Risk, Immunotherapy, ORR, University, Anemia, RECIST, BTC, Hepatitis, Biliary tract, Lymphocyte, ALT, OS, Death, Toxicity, Hematopoietic stem cell transplantation, CI, Pharmaceutical industry, Vaccine, Merck

Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.

Key Points: 
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles.
  • There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%).

ENHERTU® Demonstrated Clinically Meaningful Survival Across Multiple HER2 Expressing Advanced Solid Tumors in DESTINY-PanTumor02 Phase 2 Trial

Retrieved on: 
Monday, October 23, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Principal, Neoplasm, Survival, AstraZeneca, Pneumonitis, Progression-free survival, IHC, American Society of Clinical Oncology, DOR, Thrombocytopenia, HER2, Immunohistochemistry, Congress, PFS, European Society for Medical Oncology, MD, Journal, Society, ADC, Disease, Medicine, TSE, Cancer, American Journal of Clinical Oncology, Annual general meeting, ILD, ORR, Anemia, Biliary tract, Overalls, University, Therapy, Patient, Neutropenia, ASCO, Fatigue, Pharmaceutical industry, Medical imaging, Daiichi Sankyo

Positive results from the ongoing DESTINY-PanTumor02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan) continued to demonstrate clinically meaningful and durable responses, leading to a clinically meaningful survival benefit in previously treated patients across multiple HER2 expressing advanced solid tumors.

Key Points: 
  • Positive results from the ongoing DESTINY-PanTumor02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan) continued to demonstrate clinically meaningful and durable responses, leading to a clinically meaningful survival benefit in previously treated patients across multiple HER2 expressing advanced solid tumors.
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • Median follow-up was 12.75 months as of the data cut-off of June 8, 2023.
  • These clinically meaningful outcomes affirm the interim DESTINY-PanTumor02 results presented earlier this year at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Daiichi Sankyo Showcases Progress in Developing New Standards of Care for Patients with Industry-Leading DXd ADC Portfolio Across Multiple Cancers at ESMO

Retrieved on: 
Monday, October 16, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, Congress, Cancer, Daiichi Sankyo, Abstract, Update, Research, NSCLC, Breast cancer, HR, MD, Biliary tract, TSE, Lung cancer, Survival, R, European Society for Medical Oncology, ESMO, Ovarian cancer, ET, JST, DXD, Brain, Paced Auditory Serial Addition Test, Overalls, ADC, HER2, Patient, Fine chemical, Medical imaging, Pharmaceutical industry, Symposia

Three late-breaking abstracts, including two Presidential Symposia presentations, are among the more than 20 abstracts showcasing Daiichi Sankyo’s leadership and progress in developing new standards of care for patients with cancer.

Key Points: 
  • Three late-breaking abstracts, including two Presidential Symposia presentations, are among the more than 20 abstracts showcasing Daiichi Sankyo’s leadership and progress in developing new standards of care for patients with cancer.
  • Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, October 24, 2023 at 8:00-9:30 am ET / 9:00-10:30 pm JST.
  • Executives from Daiichi Sankyo will provide an overview of the ESMO research data and address questions.
  • Highlights of late-breaking data across Daiichi Sankyo’s DXd ADC portfolio at 2023 ESMO include:

Jazz Pharmaceuticals to Showcase Growing Impact in Solid Tumor Oncology Research at ESMO 2023

Retrieved on: 
Monday, October 16, 2023
Congress, Cancer, Abstract, ORR, Tislelizumab, SCLC, BeiGene, Biliary tract, Jazz Pharmaceuticals, Safety, Dor, Patient, Oncology, ESMO, Lurbinectedin, Quality of life (healthcare), Carcinoma, Protein, PFS, European Society for Medical Oncology, Progression-free survival, HER2, Research, BTC, Nightclub, Pharmaceutical industry

DUBLIN, Oct. 16, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company, along with partners, will present six abstracts including data from trials of bispecific antibody zanidatamab and Zepzelca® (lurbinectedin), as well as the study design for a Phase 1 trial of the pan-RAF inhibitor JZP815, at the European Society for Medical Oncology (ESMO) Congress 2023, taking place in Madrid, Spain, from October 20-24, 2023.

Key Points: 
  • DUBLIN, Oct. 16, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company, along with partners, will present six abstracts including data from trials of bispecific antibody zanidatamab and Zepzelca® (lurbinectedin), as well as the study design for a Phase 1 trial of the pan-RAF inhibitor JZP815, at the European Society for Medical Oncology (ESMO) Congress 2023, taking place in Madrid, Spain, from October 20-24, 2023.
  • "The compelling data being presented at ESMO by Jazz and partners, in particular for zanidatamab in biliary tract and gastric cancers, demonstrate the clinical potential of our solid tumor oncology development programs to raise the standard of care for some of the most difficult-to-treat cancers," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals.
  • "Through our expanding research in solid tumors – including targeted therapies and immuno-oncology – Jazz is advancing novel investigational therapies that target specific proteins like HER2 and important signaling pathways such as the RAS-RAF-MAPK pathway."
  • A poster presentation featuring progression-free survival (PFS) and duration of response (DoR) results from a Phase 1b/2 study of zanidatamab plus chemotherapy in combination with tislelizumab for the first-line treatment of HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC).

Bold Therapeutics Selected as 2023 'Company to Watch' by Life Sciences British Columbia

Retrieved on: 
Thursday, September 14, 2023
LSBC, Vancouver Convention Centre, AACR, Friends, EVP, ASCO, Bayer, Patient, Emphasis (typography), Preclinical development, Trifluridine, CIO, Biliary tract, Therapy, Safety, Pharmaceutical industry

VANCOUVER, BC, Sept. 14, 2023 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company developing novel metallotherapeutics, is announcing its selection by Life Sciences British Columbia (LSBC) for the 2023 'Company to Watch' Honour Roll.

Key Points: 
  • VANCOUVER, BC, Sept. 14, 2023 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company developing novel metallotherapeutics, is announcing its selection by Life Sciences British Columbia (LSBC) for the 2023 'Company to Watch' Honour Roll.
  • This year marks the 25th Annual Life Sciences BC Awards that brings together industry leaders, researchers, investors, and stakeholders to celebrate their remarkable achievements.
  • The ceremony will provide an opportunity to showcase the cutting-edge research, technological advancements, and collaborations that drive innovation in British Columbia's thriving life sciences community and takes place on September 14, 2023 at the Vancouver Convention Centre.
  • Bold Therapeutics' BOLD-100 is a first-in-class metallotherapeutic with a unique multimodal mechanism-of-action.