Antibody, Clinical Trials, Dermatology and Medicine

Lebrikizumab Could Soon Be a New Treatment for Atopic Dermatitis

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 Most TEAEs were mildly or moderately severe and resulted in a low frequency of treatment discontinuation.

Dermatology

Dermatology Antibody Clinical Trials Clinical Trials

Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

MAY 19, 2023

Clinical response was observed after just two weeks in some cases. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology. A maintenance study showed the same effects at 52 weeks. In patients with severe symptoms, a dosage of 30mg can be considered.

FDA Approval

FDA Approval Dermatology Sales Clinical Trials

Positive data from two Phase 3 Dupixent® (dupilumab) trials in prurigo nodularis published in Nature Medicine

The Pharma Data

MAY 15, 2023

Positive data from two Phase 3 Dupixent ® (dupilumab) trials in prurigo nodularis published in Nature Medicine Positive results from two Phase 3 Dupixent ® (dupilumab) trials in adults with uncontrolled prurigo nodularis have been published in Nature Medicine. Gil Yosipovitch, M.D.

Medicine

Medicine Trials Dermatology FDA Approval

New dermatitis treatment shows promising long-term results

Drug Discovery World

DECEMBER 13, 2022

A novel, patient-tailored monoclonal antibody therapy has shown promise in treating moderate to severe atopic dermatitis. . Patients who participated in a clinical trial of rocatinlimab showed positive results while taking the drug and up to 20 weeks after stopping therapy, Mount Sinai researchers have reported in The Lancet. .

Dermatology

Dermatology Clinical Trials Clinical Trials Antibody

Risk adjusted net present value: What is the current valuation of Novartis’s Gevokizumab?

Pharmaceutical Technology

FEBRUARY 18, 2023

Gevokizumab is a monoclonal antibody commercialized by Novartis, with a leading Phase I program in Metastatic Renal Cell Carcinoma. According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. The company offers generic medicines and biosimilars through Sandoz.

Generic Pharmaceutical

Generic Pharmaceutical Dermatology Antibody Development

SLAS2024: Day One Highlights

Drug Discovery World

FEBRUARY 5, 2024

Williams discussed the advantages of the company’s ‘disease agnostic’ small molecule degraders, and its success so far in translating results from preclinical to clinical tests in dermatology, inflammation and oncology indications. One company having a busy event is Tecan, with several product launches across the business.

Gene Therapy

Gene Therapy Life Science Production Dermatology

Spevigo Becomes First Treatment Option for Generalized Pustular Psoriasis Flares

XTalks

SEPTEMBER 22, 2022

Clinical Trial Behind Spevigo. The efficacy of Spevigo (spesolimab) was determined based on the results of the Effisayil 1 double-blind, randomized, Phase II clinical trial. The novel, selective monoclonal antibody spesolimab behind Spevigo reduces flares in individuals by inhibiting interleukin-36 (IL-36) signalling.

FDA Approval

FDA Approval Clinical Trials Clinical Trials Dermatology

Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly’s Lebrikizumab Atopic Dermatitis Monotherapy Trials

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s

Trials

Trials Clinical Trials Clinical Trials Medicine

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. 1-4 The U.S.

Dermatology

Dermatology Trials Bioavailability Medicine

Janssen Initiates First-of-its-Kind Clinical Study to Bridge Critical Gaps in Care for People of Color with Moderate to Severe Plaque Psoriasis

The Pharma Data

MARCH 23, 2022

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities. 11 TREMFYA is approved in the U.S.,

Dermatology

Dermatology Clinical Research Research Medicine

Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps

The Pharma Data

MARCH 15, 2022

The sBLA submitted to the FDA by AstraZeneca included data from the OSTRO Phase III trial, which met both co-primary endpoints with a safety profile consistent with the known profile of the medicine. 1 The CRL requested additional clinical data and the Company is working closely with the FDA regarding next steps.

Trials

Trials Medicine Licensing Licensing

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

The Pharma Data

AUGUST 1, 2021

Saphnelo is a first-in-class type I interferon receptor antibody and the only new medicine in over a decade for patients with systemic lupus erythematosus . This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often debilitating disease.”. 12,13,14,15.

Trials

Trials Clinical Development Antibody Dermatology

Health Canada approves DUPIXENT® (dupilumab injection) as the first biologic for the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years

The Pharma Data

MAY 18, 2021

DUPIXENT ® is the only biologic medicine approved to treat atopic dermatitis for this patient population. Melinda Gooderham , Dermatologist and Medical Director at the SKiN Centre for Dermatology. AD, the most common form of eczema, is an inflammatory disease classified by dry, itchy skin. . ” About DUPIXENT ®.

Production

Production Dermatology Medicine 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

These and other data from real-world settings and clinical trials, including the Dupixent open-label extension (OLE) trials, will be presented at the American Academy of Dermatology (AAD VMX 2021), April 23-25, and at the 20 th European Society for Pediatric Dermatology Annual Meeting (ESPD 2021), May 12-14.

Dermatology

Dermatology Trials Clinical Trials Clinical Trials

Tezepelumab regulatory submission accepted and granted FDA Priority Review in the US for the treatment of patients with asthma

The Pharma Data

JULY 8, 2021

Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials. Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.

Trials

Trials Medicine Sales Clinical Trials

New spesolimab data show clinically significant improvement in patients with generalized pustular psoriasis (GPP) flares

The Pharma Data

MARCH 28, 2022

Boehringer Ingelheim announced today new data from the pivotal Effisayil™ 1 trial presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting in Boston. of patients had no visible pustules after the 12-week trial duration and 81.3% About the EffisayilTM 1 clinical trial. had clear/almost clear skin.

Dermatology

Dermatology Trials Contract Manufacturing Medicine

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

Sales

Sales Manufacturing FDA Approval Life Science

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. Clinical Phase 1/2 study results demonstrated never before observed fold rises of RSV neutralizing antibodies; a fold rise of 15.2 Internal Medicine.

Vaccination

Vaccination Vaccine Gene Therapy 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

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. confirmatory trial for the accelerated approval. See additional selected indications for KEYTRUDA in the U.S.

FDA Approval

FDA Approval Containment Hormones Dermatology

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

The Pharma Data

JULY 23, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients. endocrinopathies and dermatologic reactions) are discussed below.

Hormones

Hormones Trials Genome Genomics

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

The Pharma Data

MARCH 11, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients. endocrinopathies and dermatologic reactions) are discussed below.

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

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. About Opdivo. Immune-Mediated Encephalitis.

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

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. About Opdivo. Immune-Mediated Encephalitis.

Trials

Trials Hormones Clinical Trials Clinical Trials

How GSK, Chiesi Farmaceutici, Regeneron/Sanofi, Novartis, and AB Science are trying to benefit patients afflicted with Inadequately Controlled Asthma?

Delveinsight

AUGUST 13, 2020

In February 2020, GSK announced the acceptance of regulatory submission seeking an additional indication for the use of Trelegy Ellipta for the treatment of asthma in adults by the European Medicines Agency (EMA). REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis.

Antibody

Antibody Medicine Trials Development

Clinical Research Informer

Lebrikizumab Could Soon Be a New Treatment for Atopic Dermatitis

Treatment options for Crohn’s disease expand after Rinvoq approval

Trending Sources

Positive data from two Phase 3 Dupixent® (dupilumab) trials in prurigo nodularis published in Nature Medicine

New dermatitis treatment shows promising long-term results

Risk adjusted net present value: What is the current valuation of Novartis’s Gevokizumab?

SLAS2024: Day One Highlights

Spevigo Becomes First Treatment Option for Generalized Pustular Psoriasis Flares

Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly’s Lebrikizumab Atopic Dermatitis Monotherapy Trials

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

Janssen Initiates First-of-its-Kind Clinical Study to Bridge Critical Gaps in Care for People of Color with Moderate to Severe Plaque Psoriasis

Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

Health Canada approves DUPIXENT® (dupilumab injection) as the first biologic for the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years

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

Tezepelumab regulatory submission accepted and granted FDA Priority Review in the US for the treatment of patients with asthma

New spesolimab data show clinically significant improvement in patients with generalized pustular psoriasis (GPP) flares

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

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

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

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

How GSK, Chiesi Farmaceutici, Regeneron/Sanofi, Novartis, and AB Science are trying to benefit patients afflicted with Inadequately Controlled Asthma?

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