pharmaphorum

NOVEMBER 6, 2022

The potential of monoclonal antibodies (mAbs) as therapies is indisputable. Naturally, the pharma industry has seen an explosion of mAbs in the pipeline, which has led to the evolution of new methods for improving and refining the antibody pipeline. AI for accelerated antibody discovery.

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Antibody Drugs Protein Life Science 123

XTalks

DECEMBER 4, 2024

The company’s lead candidate, ENV105, is an antibody targeting CD105, which is implicated in cancer cell resistance to various treatments. Dr. Yu has also led numerous clinical trials. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Drugs 59

Drugs Life Science Clinical Trials Clinical Trials 59

XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Antibody 98

XTalks

NOVEMBER 21, 2024

The test, the first of its kind approved for over-the-counter (OTC) use in the US, detects antibodies for Treponema pallidum , the bacterium responsible for syphilis. Using a single drop of blood, it delivers highly accurate results, with clinical trials showing a 99.5 percent accuracy rate for negative cases and 93.4

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Bacterium Antibody Manufacturing Pharmacy 104

BioSpace

MAY 14, 2024

Armed with a $300 million commitment from Blackstone Life Sciences and a former Merck monoclonal antibody, Uniquity Bio is starting Phase II clinical trials in asthma and chronic obstructive pulmonary disease.

Life Science 79

Life Science Clinical Trials Clinical Trials Antibody 79

XTalks

DECEMBER 31, 2024

Imlifidase is an enzyme that works by cleaving immunoglobulin G (IgG) antibodies, thereby halting the immune-mediated damage that characterizes GBS. The first-in-class IgG cleaving enzyme has shown promise in other applications, including kidney transplantation and antibody-mediated rejection.

Life Science 52

Life Science Clinical Trials Antibody Clinical Trials 52

Pharmaceutical Technology

JUNE 9, 2023

Co-led by Venrock Healthcare Capital Partners (Venrock) and Enavate Sciences, the financing round has seen participation from new investors Wellington Management and Bain Capital Life Sciences. It is also preparing for a swift transition to Phase III development.

Clinical Development 147

Clinical Development Development Life Science Clinical Trials 147

XTalks

MARCH 10, 2025

Omalizumab is an anti-IgE antibody that works by blocking the effects of IgE, a key driver in many allergic reactions. In a global Phase III clinical trial, 619 adult patients were enrolled and received either 150 mg or 300 mg of omalizumab-igec every four weeks.

Allergies 66

Allergies FDA Approval Antibody Trials 66

BioTech 365

JANUARY 4, 2021

Tiziana Life Sciences plc (“Tiziana” or the “Company”) – Tiziana announces completion of the clinical trial with nasally administered Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19 patients in Brazil Tiziana Life Sciences plc (“Tiziana” … Continue reading (..)

Life Science 40

Life Science Clinical Trials Clinical Trials Antibody 40

XTalks

DECEMBER 10, 2024

Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5 This aligns with previous studies, reinforcing its potential as a well-tolerated treatment option. percent platelet response in a study published in The New England Journal of Medicine.

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Trials Protein Clinical Development Drugs 104

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. One year post-vaccination, antibody levels remained strong, with geometric mean titers well above the required protective threshold. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccine Vaccination Trials 59

XTalks

APRIL 1, 2025

Related: Niktimvo (Axatilimab) Approved as First-in-Class Therapy for Chronic GVHD More on Itolizumabs Clinical Data Itolizumab is a humanized anti-CD6 monoclonal antibody that targets the CD6-ALCAM pathway involved in T cell activation and trafficking. The risk limits the number and type of patients who receive HSCT.

Immune Response 94

Immune Response Trials Licensing Licensing 94

XTalks

APRIL 2, 2025

Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fordyce discuss new innovations in therapies for autoimmune diseases like IgA nephropathy and the work he is leading at Vera Therapeutics.

Life Science 59

Life Science Clinical Development Development Trials 59

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN.

Trials 101

Trials Clinical Trials Clinical Trials Antibody 101

XTalks

APRIL 9, 2025

XTALKS WEBINAR: Driving Efficiency and Quality in Clinical Trials Through AI & Innovation Live and On-Demand: Tuesday, May 27, 2025, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how AI is revolutionizing the efficiency and quality of clinical trials.

FDA Approval 59

FDA Approval Clinical Trials Clinical Trials Trials 59

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

JULY 25, 2022

Later lines of treatment can include monoclonal antibodies, tyrosine kinase inhibitors and antibody-drug conjugates (ADCs). XTALKS WEBINAR: Discussing the Concerns within Clinical Research in Oncology and In-Home Healthcare. ADCs consist of an antibody attached to a cytotoxin that is delivered to targeted cells.

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

XTalks

AUGUST 10, 2022

Ayesha also talked about the FDA approval of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science FDA Approval Drugs Licensing 52

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

Drug Delivery Systems 111

Drug Delivery Systems Dermatology Drug Delivery Antibody 111

pharmaphorum

JANUARY 13, 2021

The Series B fundraiser follows the FDA’s decision to grant Breakthrough Therapy designation last month for a combination of its lead immune-oncology therapies IO102 and IO103, with anti-PD-1 monoclonal antibodies for patients with metastatic melanoma.

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Vaccine Vaccination Development In-Vivo 95

The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Phase1b/2 clinical study to be conducted in the United States and several European countries. . Phase1b/2 clinical study to be conducted in the United States and several European countries. and Europe.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

NOVEMBER 30, 2020

Shailubhai will provide updates on the Company’s proposed move from AIM to the Standard Segment of the Main Market of the London Stock Exchange, ongoing clinical trials, as well as other recent developments in Tiziana Life Sciences. About Tiziana Life Sciences. NEW YORK and LONDON, Dec.

Life Science 40

Life Science Antibody Clinical Trials Clinical Trials 40

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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Clinical Trials Clinical Trials Gene Trials 52

XTalks

MARCH 20, 2024

When it comes to leadership in clinical trials today, what qualities are necessary to navigate the evolving landscape of clinical research effectively? Continue reading to explore effective leadership in clinical trials. Can you begin by telling us about your experience in clinical research?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

MAY 20, 2021

Switzerland’s Numab has raised 100 million Swiss francs – around $110 million – in Series C financing to develop bispecific antibodies for cancer and inflammation, with Novo Noldings and HBM Partners co-leading the investor syndicate. The post Numab raises $110m to develop cancer bispecific antibodies appeared first on.

Antibody 52

Antibody Development Clinical Development Life Science 52

pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. Six months after one dose of Convidencia, recipients have about 70% of the antibodies that dose delivered.

Vaccine 138

Vaccine Vaccination Development Immune Response 138

XTalks

JANUARY 6, 2025

However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies. These inhibitors make managing bleeding episodes more challenging, increasing the risk of severe complications such as joint damage, chronic pain and life-threatening hemorrhages. Hympavzi is administered once weekly.

FDA Approval 105

FDA Approval Antibody Drugs Clinical Trials 105

XTalks

FEBRUARY 12, 2025

Current PCSK9 inhibitors on the market include Regenerons monoclonal antibody Praluent (alirocumab), Amgens Repatha (evolocumab) and Novartiss Leqvio (inclisiran), which is a small RNA interference (siRNA) therapy designed to lower LDL-C. This gives lerodalcibep an edge to approved PCSK9 inhibitors.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

XTalks

MAY 29, 2024

Recognized on May 30 each year, World MS Day brings together global communities, healthcare professionals and life sciences industries to share stories, raise awareness and support those affected by multiple sclerosis (MS). These seek to protect the nervous system from MS damage and slow disease progression.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

Advarra

MARCH 21, 2023

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. This is how the product achieves its therapeutic effect.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Karl Ziegelbauer, Almirall’s chief scientific officer, in the press release.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

XTalks

AUGUST 30, 2022

The CMA is for adult patients who do not have a history of factor VIII inhibitors and who do not have detectable antibodies to adeno-associated virus serotype 5 (AAV5). Some examples of hemophilia A medications are: Hemlibra (emicizumab), an antibody for the treatment of hemophilia A in adult and pediatric patients.

Gene Therapy 98

Gene Therapy Gene Clinical Trials Clinical Trials 98

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. percent in the 68-week STEP-1 clinical trial.

Trials 104

Trials Drugs Clinical Trials Clinical Trials 104

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. The company partners with small and large biopharma and medical device and diagnostic companies to optimize early clinical development through excellence in study design and execution.

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110