XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. Datroway leverages DXd technology to precisely target cancer cells.

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Antibody FDA Approval HR Trials 105

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

FEBRUARY 5, 2025

That was followed by a full approval for the same patient subset in December 2022, making it the first FDA-approved monoclonal antibody to treat COVID-19. In June 2021, the FDA granted emergency use authorization (EUA) for Actemra to treat hospitalized COVID-19 patients. It also has EUA for children aged between two and 18.

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FDA Approval Marketing Antibody Immune Response 102

Fierce Pharma

NOVEMBER 30, 2023

The sizzling antibody-drug conjugate (ADC) field is at the center of another major life sciences deal. | The sizzling antibody-drug conjugate field is at the center of another major life sciences deal. Hoping to redeem itself following the epic Rova-T failure, AbbVie is shelling out $10.1

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Life Science Antibody Drugs 122

Pharmaceutical Technology

APRIL 5, 2024

Caris Life Sciences has entered a collaboration with Merck KGaA for the development of antibody-drug conjugates (ADCs) for cancer.

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Development Life Science Antibody Drugs 130

XTalks

FEBRUARY 21, 2025

Antibody-drug conjugates (ADCs) have emerged as one of the most promising advancements in precision oncology, combining targeted delivery with the potency of traditional chemotherapies. Over the last decade, ADCs have gained significant traction, with more therapies being approved and a rapidly expanding development pipeline.

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Antibody Drugs Development Research 52

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. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Kairos is developing therapeutics that reverse cancer drug resistance in cancers such as prostate and lung cancer.

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Drugs Life Science Clinical Trials Clinical Trials 59

XTalks

APRIL 24, 2024

Sensei Biotherapeutics specializes in creating conditionally active antibodies engineered to operate specifically within the acidic tumor microenvironment, enhancing the immune system’s ability to combat cancer. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science Antibody Development Engineer 52

BioSpace

MARCH 14, 2021

Nearly five years to the day after striking the deal, AVEO Oncology and CANbridge Life Sciences announce the termination of their collaboration and licensing agreement for AVEO’s AV-203.

Life Science 86

Life Science Antibody Licensing Licensing 86

XTalks

NOVEMBER 4, 2020

It has long been known that mothers greatly influence the development of the growing fetus by not only providing nutrients through the placenta, but also a growing list of biological elements including beneficial antibodies, gut bacteria and now, allergies. They reported their findings last week in the journal Science.

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Allergies Antibody In-Vitro Development 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. NOWDiagnostics’ First To Know Syphilis Test circumvents these barriers with a convenient, in-home solution offering results in just 15 minutes. percent for positive cases.

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Bacterium Antibody Manufacturing Pharmacy 104

XTalks

MAY 25, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab’s Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two or more lines of systemic therapy.

Antibody 98

Antibody FDA Approval Drugs Trials 98

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.

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Life Science Clinical Trials Clinical Trials Antibody 79

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. Originally approved by the FDA over two decades ago for the treatment of moderate to severe persistent asthma, Xolair recently also gained approval for managing food allergies.

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Allergies FDA Approval Antibody Trials 66

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 Antibody Clinical Trials Clinical Trials 52

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.

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Life Science Clinical Development Development Trials 59

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.

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Clinical Development Development Life Science Clinical Trials 147

XTalks

MAY 2, 2022

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The main pathological markers of AD are beta-amyloid (A?) plaques and neurofibrillary tangles, which accumulate between and inside neurons, respectively, disrupting their function.

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Clinical Trials Clinical Trials Antibody Trials 98

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.

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Antibody Clinical Trials Clinical Trials Medicine 52

XTalks

APRIL 11, 2025

Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). The FDA has approved Jobevne (bevacizumabnwgd) , a biosimilar to Avastin (bevacizumab). This marks BioconBiologics seventh biosimilar cleared for use in the US.

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Antibody Marketing Clinical Trials Clinical Trials 59

pharmaphorum

JULY 18, 2022

You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. CD4s are present to stimulate B cells, so they keep producing antibodies, whereas CD8 or inner cells go after infected cells, killing them before the virus spreads.

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Vaccine Vaccination Development Immune Response 138

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

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.

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Immune Response Trials Licensing Licensing 94

XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

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FDA Approval Antibody Sales Protein 66

XTalks

DECEMBER 20, 2024

Importantly, patients switching from Stelara to Steqeyma maintained stable anti-drug antibody (ADA) levels, demonstrating consistent immune responses to the drug over time. Safety results were also strong, with low rates of side effects and no serious issues that led to stopping treatment.

FDA Approval 52

FDA Approval Immune Response Antibody Marketing 52

pharmaphorum

JANUARY 12, 2024

Discover the top six key takeaways from JP Morgan's 2024 conference, focusing on dealmaking trends in big tech, life science, AI, and advancements in cell and gene therapies, as well as the future of Antibody-drug conjugates (ADCs). Stay informed with the latest industry insights.

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Gene Therapy Life Science Antibody Gene 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.

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Antibody Trials Clinical Trials Clinical Trials 52

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.

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FDA Approval Antibody Drugs Clinical Trials 105

XTalks

APRIL 7, 2021

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

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Antibody Immune Response Radiology Marketing 102

XTalks

JANUARY 6, 2021

Researchers at the National Institutes of Health (NIH) in the US have isolated small antibodies called “nanobodies” from a llama named Cormac that can block the SARS-CoV-2 coronavirus. Nanobodies are about a quarter of the size, and approximately one tenth of the weight, of a typical human antibody.

Antibody 105

Antibody Protein Bacteria In-Vitro 105

XTalks

OCTOBER 12, 2021

The research team, led by Dr. Ritu Chakravarti, assistant professor in the UToledo College of Medicine and Life Sciences, and the paper’s lead author, was investigating 14-3-3? antibodies in the knockout (KO) rats. In rescue experiments, supplementation of the antibodies through passive immunization did not suppress arthritis.

Vaccine 105

Vaccine Vaccination Research Immune Response 105

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

pharmaphorum

SEPTEMBER 30, 2022

Although the sticker shock that was at first associated with Yervoy (ipilimumab) in 2011 – in the early days of immuno-oncology monoclonal antibodies – has fallen by the wayside, especially in light of CAR-Ts and other “one and done” cell and gene therapies, the field of non-orphan oncology remains a target for cost savings by payers. [NB:

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Life Science Marketing Drugs Production 98

BioSpace

APRIL 3, 2024

Amid a flurry of deals in the antibody-drug conjugate space, Merck KGaA is getting in on the action with a partnership with Caris Life Sciences to accelerate the discovery and development of first-in-class ADCs for oncology.

Life Science 52

Life Science Development Antibody Drugs 52

XTalks

JANUARY 20, 2025

From Bristol-Myers Squibbs monumental acquisition of Celgene to Pfizers recent purchase of Seagen, these deals illustrate the strategies and ambitions driving innovation in life sciences. The deal aligned with Pfizers strategic focus on advancing precision medicine and expanding its presence in the high-growth oncology market.

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Marketing Botox Life Science Pharma Companies 104

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

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.

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Drug Delivery Systems Dermatology Drug Delivery Antibody 111