Clinical Trials, Dermatology and Immune Response

Health Canada to review Arcutis’ roflumilast cream NDS for plaque psoriasis

Pharmaceutical Technology

JULY 12, 2022

A validated target in dermatology, PDE4 is an enzyme that induces overactive immune responses. The NDS submission by Arcutis is based on positive findings from the company’s pivotal Phase III programme and two long-term open-label clinical trials.

Dermatology

Dermatology Immune Response Trials Clinical Trials

Leqselvi Can Achieve Nearly 90% Scalp Hair Coverage in Severe Alopecia Areata Patients

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

Immune Response

Immune Response Dermatology Clinical Trials Clinical Trials

Next Generation Complement Therapeutics: Potential Life-Changing Therapies for Multiple Rare Disorders

Roots Analysis

MARCH 3, 2022

The complement-targeted therapeutics inhibit complement activation, thereby reducing tissue inflammation and dampening the adaptive immune response to foreign and tissue antigens. Broad Clinical Trial Landscape. Next Generation Complement Therapeutics – Current Market Landscape. Next Generation Complement Therapeutics.

Drug Delivery Systems

Drug Delivery Systems Marketing Immune Response Dermatology

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Lilly’s lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials

The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. About Atopic Dermatitis.

Trials

Trials Dermatology Bioavailability Medicine

Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

The Pharma Data

OCTOBER 9, 2021

“While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases. About Ulcerative Colitis.

Trials

Trials Immune Response Dermatology Clinical Trials

World Psoriasis Day 2024: New Treatments and Research Trends

XTalks

OCTOBER 24, 2024

In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. In this blog, we break down some of the latest innovations in psoriasis treatment, including biosimilars, AI-driven diagnostics and the growing role of family care.

Research

Research Dermatology Clinical Trials Clinical Trials

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Gene Therapy

Gene Therapy Vaccine Vaccination Trials

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

JULY 23, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Hormones

Hormones Trials Genome Genomics

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

The Pharma Data

MARCH 11, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials

Trials Hormones Genome Genomics

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials

Trials Hormones Clinical Trials Clinical Trials

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials

Trials Hormones Clinical Trials Clinical Trials

New Sotyktu Commercial for Plaque Psoriasis: Living Life Without a “Filter”

XTalks

JUNE 10, 2024

Related: Sotyktu (deucravacitinib) Gets FDA Approval for Moderate-to-Severe Plaque Psoriasis Sotyktu’s effectiveness stems from its selective inhibition of tyrosine kinase 2 (TYK2), a key enzyme involved in the pathogenesis of many immune-mediated inflammatory diseases. More About Psoriasis About 7.55

Immune Response

Immune Response Dermatology Clinical Trials Clinical Trials

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

The Pharma Data

APRIL 28, 2021

Additional analyses evaluated response rates across a broad population, and the impact of Dupixent on disease extent and severity, quality of life (QoL), and itch. About Rilzabrutinib Rilzabrutinib is an oral, reversible covalent, Bruton’s tyrosine kinase (BTK) inhibitor being investigated for the treatment of immune mediated diseases.

Dermatology

Dermatology Trials Clinical Trials Clinical Trials

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

FDA Approval

FDA Approval Containment Hormones Dermatology

Unloxcyt Wins FDA Approval for Advanced Skin Cancer, Set to Compete with Keytruda

XTalks

DECEMBER 18, 2024

The approval was based on findings from pivotal Phase I and Phase II clinical trials, which demonstrated significant response rates and a favorable safety profile in patients with advanced cSCC. Oliviero noted that Unloxcyt has a couple of differentiating features that set it apart from other checkpoint inhibitors on the market.

FDA Approval

FDA Approval Antibody Immune Response Marketing

Top 10 Best-Selling Immunology Drugs by Recent Sales Data

XTalks

JANUARY 2, 2025

Why it sold so well: Skyrizi, an interleukin-23 (IL-23) inhibitor, has shown clinical efficacy in treating moderate-to-severe plaque psoriasis and active psoriatic arthritis. Skyrizis targeted mechanism of action and long-lasting effectiveness have positioned it as a leading choice among modern biologics in dermatology.

Sales

Sales FDA Approval Drugs Marketing

Clinical Research Informer

Health Canada to review Arcutis’ roflumilast cream NDS for plaque psoriasis

Leqselvi Can Achieve Nearly 90% Scalp Hair Coverage in Severe Alopecia Areata Patients

Webinars

Trending Sources

Next Generation Complement Therapeutics: Potential Life-Changing Therapies for Multiple Rare Disorders

Webinars

Lilly’s lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials

Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

World Psoriasis Day 2024: New Treatments and Research Trends

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

New Sotyktu Commercial for Plaque Psoriasis: Living Life Without a “Filter”

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Unloxcyt Wins FDA Approval for Advanced Skin Cancer, Set to Compete with Keytruda

Top 10 Best-Selling Immunology Drugs by Recent Sales Data

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