Antibody, Clinical Development and Dermatology

Sanofi wagers $400m on miRecule muscular dystrophy therapy

pharmaphorum

OCTOBER 5, 2022

Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule. The aim will be to identify promising candidates in areas of “unmet patient need.”

RNA

RNA Genetics Dermatology 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

Sanofi continues on path to industry leadership in Immunology with Dupixent® (dupilumab) as key driver

The Pharma Data

MARCH 28, 2022

The focus of the event is on Dupixent ® (dupilumab), a key growth driver, and Sanofi’s rapidly advancing pipeline, highlighting dermatological, respiratory and gastrointestinal diseases as priority therapeutic areas. Two complementary candidates for COPD , developed in collaboration with Regeneron, targeting distinct subpopulations.

Medicine

Medicine Sales Clinical Development Development

BioSpace Movers & Shakers, Dec. 18

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

Development Gene Therapy Engineer Life Science

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

1-2 Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin-13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13R?1/IL-4R? These studies are part of the comprehensive clinical development program for lebrikizumab in AD evaluating more than 2,000 patients.

Trials

Trials Clinical Trials Clinical Trials Medicine

US companies drive 2023 drug launches positioned for blockbuster success by 2028

Pharmaceutical Technology

MAY 30, 2023

Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut. which is the licensee of lebrikizumab, recently reported favourable outcomes for lebrikizumab through a novel secondary analysis of the Phase III clinical development programme.

Drugs

Drugs Sales Antibody Dermatology

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

The Pharma Data

JULY 23, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Hormones

Hormones Trials Genome Genomics

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

The Pharma Data

MARCH 11, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials

Trials Hormones Genome Genomics

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

The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Clinical Phase 1/2 study results demonstrated never before observed fold rises of RSV neutralizing antibodies; a fold rise of 15.2 for RSV A and 18.0

Vaccine

Vaccine Vaccination Gene Therapy Trials

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 ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials

Trials Hormones Clinical Trials Clinical Trials

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

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 32.44

Sales

Sales Manufacturing FDA Approval Life Science

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 ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials

Trials Hormones Clinical Trials Clinical Trials

Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer

The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Graham earned an M.D.,

Life Science

Life Science Antibody In-Vivo In-Vitro

Almirall demonstrates resilient performance year to date despite COVID-19 impacts

The Pharma Data

NOVEMBER 8, 2020

Ilumetri ® sales grew +125% year-on-year and Seysara ® showed Net Sales performance improvement quarter-on-quarter following clinically relevant FDA label improvement. “Our solid results confirm that we are on the right track to strengthen our leadership position in the medical dermatology space. .

Dermatology

Dermatology Sales Marketing Production

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 . Saphnelo Saphnelo (anifrolumab) is a fully human monoclonal antibody that binds to subunit 1 of the type I IFN receptor, blocking the activity of type I IFNs. 7,8,9,10,11.

Trials

Trials Clinical Development Antibody Medicine

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. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval

FDA Approval Containment Hormones Dermatology

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

Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

HR

HR FDA Approval Containment Genome

Clinical Research Informer

Sanofi wagers $400m on miRecule muscular dystrophy therapy

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

Trending Sources

Sanofi continues on path to industry leadership in Immunology with Dupixent® (dupilumab) as key driver

BioSpace Movers & Shakers, Dec. 18

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

US companies drive 2023 drug launches positioned for blockbuster success by 2028

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

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

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

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

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

Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer

Almirall demonstrates resilient performance year to date despite COVID-19 impacts

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

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

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

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