Antibody, Dermatology, FDA Approval and Trials

Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval

FDA Approval Dermatology Sales Clinical Trials

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 The safety of this trial was consistent with previously reported atopic dermatitis trials.

Dermatology

Dermatology Antibody Clinical Trials Clinical Trials

Spevigo Becomes First Treatment Option for Generalized Pustular Psoriasis Flares

XTalks

SEPTEMBER 22, 2022

On September 1, 2022, Boehringer Ingelheim Pharmaceuticals announced in a press release that the US Food and Drug Administration (FDA) approved Spevigo (spesolimab-sbzo) intravenous injections for GPP flares in adults. Spevigo is the first approved treatment option for GPP in adults. Clinical Trial Behind Spevigo.

FDA Approval

FDA Approval Clinical Trials Clinical Trials Dermatology

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. Results from the trials were the basis for the U.S.

Medicine

Medicine Trials Dermatology FDA Approval

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. About Lebrikizumab. Source link: [link].

Trials

Trials Clinical Trials Clinical Trials Medicine

GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study.

FDA Approval

FDA Approval Antibody DNA Hormones

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

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales

Sales Manufacturing FDA Approval Life Science

First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma

The Pharma Data

MARCH 18, 2022

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab 1. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 months (95% CI: 3.4

Antibody

Antibody HR Dermatology Trials

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S., For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies.

Sales

Sales Production Antibody Development

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval

FDA Approval Containment Trials Genome

Boehringer bags first approval for rare skin disease drug

pharmaphorum

SEPTEMBER 2, 2022

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. It is also under review by regulators in Europe, with a decision expected before the end of the year.

Drugs

Drugs Antibody FDA Approval 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

SAR440340 History: Regeneron and Sanofi are currently studying REGN3500 in respiratory and dermatological diseases where inflammation is thought to play an underlying role. REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis. Key abstracts/Posters: #Poster716.

Antibody

Antibody Medicine Trials Development

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. in these patients.

FDA Approval

FDA Approval Containment Hormones Dermatology

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

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Trials

Trials Hormones Clinical Trials Clinical Trials

Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis

The Pharma Data

OCTOBER 9, 2021

Currently there are no FDA-approved treatments for EoE. In EoE, a Phase III trial is planned. Patients are often treated with corticosteroids to manage inflammation. Amgen collaboration In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for tezepelumab.

Drugs

Drugs Sales Medicine Dermatology

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

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

Trials

Trials Hormones Clinical Trials Clinical Trials

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

The Pharma Data

MARCH 23, 2021

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

HR

HR FDA Approval Containment Genome

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

The Pharma Data

MARCH 11, 2021

In 2017, Opdivo was granted accelerated approval by the FDA as a single agent for patients with HCC who have been previously treated with sorafenib. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

Trials

Trials Hormones Genome Genomics

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

The Pharma Data

JULY 23, 2021

Opdivo was first granted this indication in 2017 under the FDA’s accelerated approval program, making it the first immunotherapy agent to be approved for use in this setting. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

Hormones

Hormones Trials Genome Genomics

Clinical Research Informer

Treatment options for Crohn’s disease expand after Rinvoq approval

Lebrikizumab Could Soon Be a New Treatment for Atopic Dermatitis

Trending Sources

Spevigo Becomes First Treatment Option for Generalized Pustular Psoriasis Flares

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

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

GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

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

First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma

Amgen Reports Second Quarter 2021 Financial Results

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

Boehringer bags first approval for rare skin disease drug

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

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

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

Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis

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

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

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

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

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