Immunoglobulin G

HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 22, 2023
Health, Oncology, CISH, Sequela, Triple-negative breast cancer, FISH, Therapy, Cleavage, HER2, CDK, Bone metastasis, Survival, Clinical trial, Route of administration, Quality of life, Lead, Woman, ERBB2, AstraZeneca, Rated R, IHC, II, Sapporo Medical University, Combination therapy, Route, Daiichi Sankyo, Administration, US, Discovery, ET, Patient, Breast cancer, Risk, DXD, Immunoglobulin G, HR, In situ hybridization, Immunohistochemistry, ADC, Growth, Mortality, Spacecraft, Lymph node, Recurrence, News, III, SERD, DFS, Birth control, Medical imaging, Pharmaceutical industry, Dietary supplement, Fine chemical

This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape.

Key Points: 
  • This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape.
  • Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer.
  • A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines.
  • HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Sensei Biotherapeutics Announces Submission of Investigational New Drug (IND) Application for SNS-101, a Conditionally Active VISTA-Blocking Antibody

Retrieved on: 
Tuesday, March 21, 2023
Sensei, Therapy, Cancer, Pharmacokinetics, Northwest Biotherapeutics, Investigational New Drug, Cytokine release syndrome, Patient, Immunoglobulin G, Risk, VISTA, PD-1, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tumor microenvironment, IND, Food, Pharmaceutical industry

BOSTON, March 21, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of SNS-101, a conditionally active VISTA-blocking antibody, in patients with solid tumors.

Key Points: 
  • BOSTON, March 21, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of SNS-101, a conditionally active VISTA-blocking antibody, in patients with solid tumors.
  • SNS-101 is a conditionally active, human monoclonal IgG1 antibody designed to selectively block the VISTA checkpoint in the tumor microenvironment, which acts as a suppressor of T cells by binding the receptor PSGL-1.
  • Preclinical studies have demonstrated SNS-101’s potential to inhibit tumor growth as monotherapy, significantly enhance the anti-tumor effects of PD-1 blockade, avoid poor pharmacokinetics from target-mediated drug disposition and lower the risk of cytokine release syndrome.
  • Sensei plans to evaluate SNS-101 as a novel treatment for patients with solid cancers, as both a monotherapy and in combination with other therapies.

Jounce Therapeutics Announces Results from Pre-Planned Data Review of INNATE Phase 2 Trial of JTX-8064 and Pimivalimab Demonstrating Deep and Durable Responses in Platinum Resistant Ovarian Cancer

Retrieved on: 
Thursday, March 16, 2023
POC, Therapy, Immunoglobulin G, LILRB2, Pembrolizumab, Neoplasm, Platinum, Patient, PD-L1, RECIST, Ligand, PD-1, Ovarian cancer, Pharmaceutical industry

The INNATE trial evaluates JTX-8064 as a monotherapy and in combination with the PD-1 inhibitor pimivalimab in patients with advanced solid tumors.

Key Points: 
  • The INNATE trial evaluates JTX-8064 as a monotherapy and in combination with the PD-1 inhibitor pimivalimab in patients with advanced solid tumors.
  • A data review was conducted on March 15, 2023 to assess the potential to achieve proof-of-concept (POC) in the ovarian cancer combination cohort of the INNATE trial.
  • In this cohort, 35 patients with third- and fourth-line platinum resistant ovarian cancer were treated with JTX-8064 and Jounce’s PD-1 inhibitor, pimivalimab.
  • The combination was well tolerated with

Labroots Announces Agenda for its 7th Annual Laboratory Automation Virtual Event on March 22, 2023

Retrieved on: 
Thursday, March 16, 2023
Research, UCLA, MSC, Microsoft Exchange Server, Cell, PCR, Molecular biology, Laboratory, Antibody, LR, Community Tool Box, Enzyme, LIMS, GenScript Biotech, Next Level, ELISA, VEGF, Cell isolation, Immunoglobulin G, QC, Microfluidics, Science News, Labroots, Doctor of Philosophy, Q&A, B cell, Science, Therapy, Networking hardware, Laboratory automation, Biological engineering, Automation, Entrepreneurship, Mobile phone, Vaccine, Typesetting

YORBA LINDA, Calif., March 16, 2023 /PRNewswire-PRWeb/ -- Labroots, the leading scientific social networking website, offering premier, interactive virtual events and webinars, is delighted to host its 7th annual Laboratory Automation event on March 22, 2023. This free online event brings together thousands of research scholars, laboratory managers, scientists, and experts from leading academic and industry institutions globally to explore disciplines with emerging topics ranging from microfluidics: current and upcoming technologies, automation and new methods to achieve it, and compliance with laboratory software, LIMS and automation, and cyber security.

Key Points: 
  • YORBA LINDA, Calif., March 16, 2023 /PRNewswire-PRWeb/ -- Labroots , the leading scientific social networking website, offering premier, interactive virtual events and webinars, is delighted to host its 7th annual Laboratory Automation event on March 22, 2023.
  • Panel Presentation sponsored by eLabNext on Lab Automation – Taking Lab Digitization to the Next Level, with live Q&A.
  • Labroots is an approved provider of continuing education programs in the clinical laboratory sciences by the ASCLS P. A.C.E.
  • Participants can use the official hashtag #LRlabauto to follow the conversation and connect with other members of the Laboratory Automation community!

Mammalian Polyclonal IgG Antibody Global Market Report 2023: Growing Prevalence of Standard Laboratory Tests Bolsters Sector - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 16, 2023
Biotechnology, Science, Health, Research, Neoplasm, Syphilis, Prevalence, Antibody, Immunoelectrophoresis, Organization, Epitope, Immunoglobulin G, Conditional sentence, University, Human, COVID-19, IHC, AIDS, Flow cytometry, Immunohistochemistry, Cancer, Hospital, CVD, Government, Anemia, Growth, GSK plc, Viral, Government agency, Acceleration, ELISA, Lyme disease, Mouse, Plasma, Application, Biomarker, Agilent Technologies, USD, Region, Diagnosis, CDC, Western blot, Rabbit, Serum, Autoimmunity, SARS-CoV-2, State, Investment, GenScript Biotech, Animal, Disease, Chip, Incidence, Diabetes, Fine chemical, Pharmaceutical industry, Vaccine, Immunoprecipitation

The "Mammalian Polyclonal IgG Antibody Market by Type, by Product, by Application, by End-user, and by Region - Global Forecast to 2022-2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Mammalian Polyclonal IgG Antibody Market by Type, by Product, by Application, by End-user, and by Region - Global Forecast to 2022-2033" report has been added to ResearchAndMarkets.com's offering.
  • The mammalian polyclonal IgG antibody market size is estimated to be USD 1,347.4 million in 2022 and is expected to witness a CAGR of 5.28% during the forecast period 2023-2033.
  • Furthermore, growing prevalence of standard laboratory tests, government investment, acceleration in institutional and academic research, and affordability of supporting equipment and technology are other factors supporting the market growth.
  • Growing prevalence of standard laboratory tests such as microarray assays, western blot analysis, immunohistochemical, and cell imaging is predicted to propel the mammalian polyclonal IgG antibody market growth during the forecast period.

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Kamada Issues 2023 CEO Letter to Shareholders

Retrieved on: 
Wednesday, March 15, 2023
Acquisition, Data monitoring committee, AAT, CSL Behring, Medical Affairs Bureau, Plasma, TASE, St Saviour's and St Olave's Church of England School, KMDA, Immunoglobulin G, Patient, Physician, Food and Drug Administration, FDA, DSMB, Growth, European Medicines Agency, Safety, SDF, Innova (video game company), Food, Letter, Collection, Fine chemical, Cryptocurrency, Pharmaceutical industry, Video game, Takeda, EU, Kamada, EBITDA

The recently completed 2022 year was a transformational period for Kamada as we embarked on a new and exciting chapter in the Company’s evolution.

Key Points: 
  • The recently completed 2022 year was a transformational period for Kamada as we embarked on a new and exciting chapter in the Company’s evolution.
  • Looking ahead, we expect the momentum from 2022 to extend throughout 2023, with profitability to be further increased as compared to the past year.
  • I am pleased to report that we anticipate continued growth in the portfolio's revenues in 2023 and beyond.
  • Importantly, looking past 2023, based on our multiple catalysts, we continue to project annual double-digit growth in revenues and profits in the foreseeable years ahead.

Kamada Reports Strong Fiscal Year and Fourth Quarter 2022 Financial Results, and Provides 2023 Guidance Representing Significant Profitability Growth

Retrieved on: 
Wednesday, March 15, 2023
Annual report, Acquisition, Table, Three Months, AAT, Webcast, International, Plasma, Pivotal, TASE, Regulation of tobacco by the U.S. Food and Drug Administration, Health Canada, St Saviour's and St Olave's Church of England School, Depreciation, R, KMDA, Immunoglobulin G, EBITDA, Acceleration, Investment, FDA, DSMB, Globalization, G&A, European Medicines Agency, Growth, Internet, Security (finance), Safety, Innova (video game company), Food, S&M, Video game, Cryptocurrency, Rare-earth element, Pharmaceutical industry, Fine chemical, Reinsurance, Insurance, Takeda, Kamada

“Importantly, we expect the momentum from 2022 to extend throughout 2023, with profitability to be further enhanced.

Key Points: 
  • “Importantly, we expect the momentum from 2022 to extend throughout 2023, with profitability to be further enhanced.
  • As such, we are introducing full-year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million.
  • Total revenues during the fourth quarter of 2022 included strong sales from the portfolio of four acquired FDA-approved IgG products.
  • Adjusted EBITDA, as detailed in the tables below, was $7.2 million in the fourth quarter of 2022, as compared to ($1.3) million in the fourth quarter of 2021.

Adagene Announces Poster Presentations on Anti-CTLA-4 SAFEbody®, ADG126, at Upcoming American Association for Cancer Research (AACR) Annual Meeting in April

Retrieved on: 
Tuesday, March 14, 2023
Clinical, Poster, Tumor microenvironment, AACR, ADCP, CD47, Pembrolizumab, SAN, ADCC, Patient, Toxicity, Safety, Policy, IND, Pharmaceutical industry, Medical imaging, Immunoglobulin G

SAN DIEGO and SUZHOU, China, March 14, 2023 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of antibody-based therapies, today announced poster presentations at the upcoming AACR Annual Meeting in Orlando, Florida from April 14-19, 2023.

Key Points: 
  • Two poster presentations on ADG126 SAFEbody will report results of ongoing phase 1b/2 trials of this masked, anti-CTLA-4 therapy in combination with two different anti-PD-1 treatments at multiple dosing regimens (6 mg/kg and 10 mg/kg).
  • Notably, the results of ADG126 in combination with pembrolizumab after repeated dosing to assess late-onset toxicity will also be presented for the first time.
  • The third poster will review the differentiated preclinical profile of ADG153, an anti-CD47 SAFEbody® in IgG1 isotype, currently in the IND-enabling stage.
  • The poster will also include results demonstrating preferential CD47 target engagement by ADG153 in the tumor microenvironment.