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

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

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

DECEMBER 5, 2024

Amgens randomized, double-blind, placebo-controlled Phase II study enrolled 592 adults with obesity or overweight conditions, defined by a body mass index (BMI) of 30 or 27, respectively, with at least one obesity-related comorbidity.

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Trials Drugs Clinical Trials Clinical Trials 104

XTalks

DECEMBER 5, 2024

Amgen’s randomized, double-blind, placebo-controlled Phase II study enrolled 592 adults with obesity or overweight conditions, defined by a body mass index (BMI) of ≥30 or ≥27, respectively, with at least one obesity-related comorbidity.

Trials 96

Trials Drugs Clinical Trials Clinical Trials 96

XTalks

JANUARY 17, 2024

In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

pharmaphorum

APRIL 7, 2021

billion DKK ($672 million) from AbbVie after the companies struck an R&D deal to research epcoritamab, a bispecific antibody targeting CD3 and CD20 that the biotech developed in-house. Genmab has four technology platforms to draw from, with the most established being bispecific antibodies which target two receptors at once.

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Antibody Life Science Development Drugs 91

Worldwide Clinical Trials

MAY 30, 2024

Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography. Additionally, researchers are investigating T-cell stimulants (Tregs) and cell-derived neurotrophic growth factor agonists.

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Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

NOVEMBER 1, 2020

This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. The clinical data from this trial is expected to available by the end of this year. Brazil has reported almost 5.5M Forward-Looking Statements.

Clinical Trials 40

Clinical Trials Clinical Trials Antibody Life Science 40

pharmaphorum

JULY 20, 2021

Gilead Sciences just forged even closer ties with its cancer drug partner Arcus Biosciences, enticing the biotech’s chief medical officer Bill Grossman to a new role as its head of oncology clinical research. billion last year to claim ownership of magrolimab, a CD47-targeting antibody in trials for blood cancers.

Antibody 40

Antibody Clinical Research Drugs Clinical Development 40

The Pharma Data

SEPTEMBER 28, 2021

“Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. Merck has the industry’s largest immuno-oncology clinical research program.

Hormones 52

Hormones Medicine Clinical Research Research 52

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Oral therapy data presented at ASH. CellCentric, a U.K-based Professional reception of the findings.

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Development Drugs Clinical Development Antibody 52

The Pharma Data

DECEMBER 14, 2020

Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is headquartered in New York City.

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Clinical Trials Clinical Trials Clinical Development Antibody 40

The Pharma Data

AUGUST 10, 2021

“The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. Merck has the industry’s largest immuno-oncology clinical research program.

Clinical Research 52

Clinical Research Trials Licensing Licensing 52

The Pharma Data

APRIL 8, 2021

“Since its first approval in renal cell carcinoma nearly two years ago, KEYTRUDA has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Trials 52

Trials Clinical Development Antibody Clinical Research 52

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

Development 52

Development Gene Therapy Engineer Life Science 52

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. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Billion by 2025. Shailubhai, K.,

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

JUNE 25, 2021

Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinical development program, which includes over 20 clinical studies and more than 4,000 patients.

HR 52

HR Trials Clinical Research Research 52

The Pharma Data

JULY 15, 2021

“These highly anticipated event-free survival results in this TNBC population build upon earlier findings from the KEYNOTE-522 trial and further support the potential use of KEYTRUDA in these patients,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

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HR Trials Clinical Development Clinical Research 52

The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. VBL is currently advancing its lead anti-MOSPD2 candidate through IND-enabling studies.

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The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. This vision is what defines us and guides our research, clinical development and partnerships. Wainberg, M.D., Wainberg, M.D.,

Trials 52

Trials HR Containment Development 52

The Pharma Data

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. O’Day has been a principal investigator for more than 200 clinical trials. Before GSK, Rosén was senior vice president, U.S. and global medical affairs at Aimmune Therapeutics, Inc.

Genomics 40

Genomics Genome Medicine Life Science 40

Pfizer

FEBRUARY 16, 2023

GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development. Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

XTalks

DECEMBER 4, 2020

Since CKD is a broad diagnosis that can have a variety of underlying causes, a beneficial focus of current research strategies has been to identify biomarkers and develop diagnostics that can help stratify patients into clinically relevant categories and help guide their management.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 52

The Pharma Data

OCTOBER 27, 2020

Under the agreement, during the option period, Molecular Partners will conduct Phase 1 clinical trials for MP0420, expected to begin in November 2020, and perform all remaining preclinical work for MP0423 and Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials.

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Development Protein Manufacturing Medicine 40

The Pharma Data

JUNE 26, 2021

Part of the industry leading EXPLORER clinical research program, EINSTEIN-Jr is the largest study completed to date evaluating the treatment of pediatric patients with VTE, and UNIVERSE is the first clinical trial to examine a DOAC for the prevention of thromboembolism in congenital heart disease post-Fontan pediatric patients.

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Doctor Doctors Medicine Clinical Trials 52

The Pharma Data

MARCH 23, 2021

“There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We

HR 52

HR FDA Approval Containment Genomics 52

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Merck has the industry’s largest immuno-oncology clinical research program.

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The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Presentation Topic: Clinical Trials. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program.

Trials 52

Trials Clinical Trials Clinical Trials Vaccination 52

XTalks

SEPTEMBER 14, 2020

Moderna, for one, recently reported positive results in older adults between 56 and 71, as well as those 71 years of age and older, who reportedly mounted levels of neutralizing antibodies against the SARS-CoV-2 virus after two doses of its vaccine that were comparable to those seen in younger adults. Johnson & Johnson’s COVID-19 Vaccine.

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Vaccine Vaccination Antibody Life Science 92