Fluorouracil

IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models

Retrieved on: 
Tuesday, April 9, 2024
BID, Patient, Fluorouracil, 3D, MIA, Cancer, AACR, TGI, Pancreatic cancer, Paclitaxel, TGA, Annual general meeting, Medical imaging

CAMBRIDGE, Mass., April 09, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting, which the company views as supportive of its ongoing Phase 2a clinical trial of IMM-1-104 in RAS-mutated advanced or metastatic solid tumors.

Key Points: 
  • “We are evaluating a broad range of combinations for a variety of cancer types in our humanized 3D tumor growth assays, together with animal models.
  • The data we are sharing today at AACR clearly demonstrates IMM-1-104’s potential in combination with chemotherapy for pancreatic cancer.
  • IMM-1-104 showed promising combination effects when treated with gemcitabine (GEM), paclitaxel (PAC) or fluorouracil (5FU) in 3D-tumor growth assay (TGA) pancreatic cancer models.
  • IMM-1-104 was synergistic with chemotherapy in animal models of pancreatic cancer.

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 20, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Research, Multiple myeloma, Lung cancer, Partner, NMPA, Growth, NSCLC, CIDP, Partnership, Telephone, GSK, Patient, TED, NASDAQ Biotechnology Index, Epitope, Artificial intelligence, Sale, Myasthenia gravis, Neonatal Fc receptor, Fluorouracil, Graves' ophthalmopathy, Investment, Teclistamab, NBI, National Medical Products Administration, Johnson & Johnson, Drug development, Safety, Chicken, Machine learning, Gastrointestinal cancer, Immunoglobulin G, BLA, Chronic inflammatory demyelinating polyneuropathy, Pharmaceutical industry

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA  

Retrieved on: 
Tuesday, February 13, 2024
Cancer, Neoplasm, Progression-free survival, Caregiver, IPN, EVP, ASCO, Diarrhea, FDA, ADR, Food, Abdominal pain, Pancreatic Cancer Action Network, Hope, Nausea, MBA, Fluorouracil, Vomiting, Dicarboxylic acid, Constipation, Safety, Oxaliplatin, NCCN, Fatigue, PDAC, JD, Patient, Pancreas, Clinical trial, Disease, Phase, UCLA, Pancreatic cancer, Development, Appetite, Category, Pharmaceutical industry

PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).

Key Points: 
  • PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).
  • This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.
  • “The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen," said Christelle Huguet, EVP and Head of Research and Development, Ipsen.
  • In the clinical trial, diarrhea was managed following institutional guidelines and appropriate antidiarrheal medications.9
    *NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

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Tuesday, January 2, 2024
Stomach, Liver, Medical Subject Headings, Diarrhea, Marketing, Prostate cancer, Neck, Prednisolone, Stomatitis, Breast, INN, Cyclophosphamide, HER2, Breast cancer, ATC, Trastuzumab, Hair loss, International, Stomach cancer, Prednisone, Lung cancer, Weakness, Neutropenia, Nausea, Language, Mouth, Cisplatin, Cancer, Inflammation, Head, Testosterone, Neoplasm, Dexamethasone, Neutrophil, Blood, Non-small-cell lung cancer, Capecitabine, European Medicines Agency, Skeleton, Fluorouracil, Doxorubicin, Select, Cell, Patient, Anatomy, Medicine, Anemia, Vomiting, IIA, Prostate, Medical imaging

Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, Stomach, INN, Risk, HER2, Breast, Tissue, Heart, Cancer, Neoplasm, Cardiotoxicity, Infection, Anatomy, Paclitaxel, IIA, Breast cancer, ATC, European, Allergy, Metastasis, Blood, Capecitabine, MBC, EBC, Safety, Heart failure, MGC, Patient, Medical Subject Headings, Agency, European Commission, Cyclophosphamide, Immune system, Docetaxel, Carboplatin, International, Language, Cisplatin, Select, Enzyme inhibitor, Medicine, FISH, Radiation, Lymph, Arm, European Medicines Agency, Fluorouracil, Doxorubicin, Medical device

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

Vizient: Lack of Information Across Supply Chain Exacerbating Oncology Drug Shortage

Retrieved on: 
Wednesday, August 23, 2023
Practice Management, Pharmaceutical, Medical Supplies, Oncology, Health, Hospitals, Supply Chain Management, Retail, Docetaxel, Methotrexate, Cisplatin, Pharmacy, Carboplatin, Trust, Hospital, Patient, Cancer, Fluorouracil, Nursing

A Vizient white paper released today demonstrates how the lack of information about medication access across the supply chain is exacerbating the shortage of seven oncology drugs used to treat a multitude of cancers.

Key Points: 
  • A Vizient white paper released today demonstrates how the lack of information about medication access across the supply chain is exacerbating the shortage of seven oncology drugs used to treat a multitude of cancers.
  • View “Evaluating the impact of the oncology drug shortage.”
    Six antineoplastic oncology medications are in short supply in the United States due to the December shutdown of a manufacturing plant in India — capecitabine, carboplatin, cisplatin, docetaxel, fluorouracil and methotrexate; a seventh, fludarabine, has been in short supply since 2019.
  • “The fulfillment data we reviewed highlights challenges with how product availability and demand fluctuate considerably when a shortage occurs.
  • In April, Vizient conducted a survey of its pharmacy program participants with 32 unique oncology network provider customers responding.

Astellas Submits New Drug Application for Zolbetuximab in Japan

Retrieved on: 
Friday, June 9, 2023
Dicarboxylic acid, Adenocarcinoma, Doctor of Public Health, Capecitabine, MHLW, Neoplasm, Oxaliplatin, NDA, Cancer, Ministry of Health, Labour and Welfare, MBA, Zolbetuximab, MS, CAPOX, Ministry, Death, Patient, GEJ, Immunohistochemistry, Stomach cancer, Fluorouracil, Ministry of Health, Stomach, GLOW, CLDN18, TSE, Pharmaceutical industry, Astellas Pharma, Health

TOKYO, June 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.

Key Points: 
  • If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.
  • "Astellas' submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan."
  • The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.
  • The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

Cardiff Oncology Announces the Appointment of Fairooz Kabbinavar, MD, FACP, as Chief Medical Officer

Retrieved on: 
Thursday, February 2, 2023
CMO, Rashtrasant Tukadoji Maharaj Nagpur University, Harvard University, Journal, Colorectal cancer, MBBS, Compugen (company), Medicine, SVP, Cancer, Patient, University, The New England Journal of Medicine, Research, PLK1, KRAS, FACP, FDA, SAN, Bachelor of Science, Random phase approximation, Puma Biotechnology, CRDF, Beth Israel Deaconess Medical Center, Employment, Folinic acid, Journal of Clinical Oncology, UCLA, Doctor of Philosophy, MD, Pharmaceutical industry, Medical imaging, Textile, Genentech, Fluorouracil, Bevacizumab

SAN DIEGO, Feb. 2, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today announced that it has strengthened its leadership team with the appointment of Fairooz Kabbinavar, MD, FACP, as chief medical officer (CMO).  Dr. Kabbinavar will oversee the clinical development program for the Company's investigational drug onvansertib and will report directly to Chief Executive Officer, Mark Erlander, PhD.

Key Points: 
  • Dr. Kabbinavar will oversee the clinical development program for the Company's investigational drug onvansertib and will report directly to Chief Executive Officer, Mark Erlander, PhD.
  • Dr. Kabbinavar joins Cardiff Oncology with more than 30 years of experience that bridges both the academic and biotech/pharmaceutical sectors.
  • "His experience guiding the development and registration of high-impact oncology drugs adds critical and relevant expertise to the Cardiff team.
  • In connection with Dr. Kabbinavar joining Cardiff Oncology, the Company's Board of Directors approved the grant of non-qualified stock options to purchase 425,000 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan.

Merrimack Pharmaceuticals Extends Section 382 Net Operating Loss Rights Plan

Retrieved on: 
Monday, December 5, 2022
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Security (finance), Fluorouracil, Elevation, Food, Regulation of tobacco by the U.S. Food and Drug Administration, Revenue stream, Patient, Sale, LV, HIV disease progression rates, FDA, Pancreas, Medication, Form 10-Q, Risk, Clinical trial, Organic acid, Plan, NOL, Internal Revenue Code section 409A, Life insurance, Pharmaceutical industry, Ipsen

Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) (the Company or Merrimack), announced today that its Board of Directors (the Board) has extended the Section 382 net operating loss rights plan (the Plan) that was adopted in 2019.

Key Points: 
  • Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) (the Company or Merrimack), announced today that its Board of Directors (the Board) has extended the Section 382 net operating loss rights plan (the Plan) that was adopted in 2019.
  • The Plan is designed to protect the Companys ability to use its valuable net operating loss (NOL) carryforwards and certain other valuable tax attributes.
  • Merrimack is also subject to the risk that it may not have funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements.
  • Forward-looking statements should not be relied upon as representing Merrimacks views as of any date subsequent to the date hereof.

Merrimack Provides Ipsen Report That Onivyde® Regimen Demonstrated Statistically Significant Improvement in Overall Survival in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Retrieved on: 
Wednesday, November 9, 2022
Health, FDA, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Review, Private Securities Litigation Reform Act, PFS, Fluorouracil, Forward-looking statement, LV, U.S. Securities and Exchange Commission, Overalls, Form 10-Q, Elevation, Food, Risk, New Drug Application, Sale, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SEC, Organic acid, HIV disease progression rates, Fast Track, Survival, Clinical trial, Merrimack Pharmaceuticals, Patient, CEO, Security (finance), Progression-free survival, Pancreas, NAPOLI, Medication, FDA, Oxaliplatin, Pharmaceutical industry, Ipsen, Irinotecan

The Ipsen press release indicates that the trial met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm.

Key Points: 
  • The Ipsen press release indicates that the trial met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm.
  • We are encouraged by these results which indicate progress toward a potential future milestone payment from Ipsen, said Gary Crocker, Chairman and CEO of Merrimack Pharmaceuticals.
  • We congratulate the Ipsen team and look forward to continuing to await further public announcements from Ipsen regarding progress with this important program.
  • Merrimacks agreement with Ipsen does not require Ipsen to provide Merrimack with any information on the progress of Onivyde clinical trials that is not publicly available.