Antibody, Containment and Dermatology - Clinical Research Informer

Top 2020 Biopharma M&A Deals

The Pharma Data

DECEMBER 30, 2020

billion acquisition of immuno-oncology company Forty Seven and its lead asset, magrolimab, a monoclonal antibody in the clinic for several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). It began in May with the $4.9 Magrolimab targets CD47.

Antibody

Antibody Allergies Branding Dermatology

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

Mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell [i]. About JEMPERLI (dostarlimab-gxly) JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.

FDA Approval

FDA Approval Antibody DNA Hormones

Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

All participants randomized to receive either 4,200 mg of bamlanivimab, Lilly’s neutralizing antibody, or placebo. VP-102 is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidim delivered by way of a single-use applicator. Non-COVID-19-Related. BT-001 is based on the patented Invir.IO

Trials

Trials Allergies In-Vitro Antibody

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen’s Leadership in Novel Treatments for Autoimmune Diseases

The Pharma Data

AUGUST 19, 2020

The transaction will include full global rights to nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody. In autoantibody-driven diseases, the body’s antibodies attack or damage its own proteins, cells and tissues, often with devastating consequences. Investors and Momenta Pharmaceuticals, Inc.

Production

Production Dermatology Development Containment

TAKHZYRO® (lanadelumab) for Hereditary Angioedema Patients to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress

The Pharma Data

JULY 11, 2021

Department of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin in Berlin, Germany. TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity. All antibody titres were low. Markus Magerl, M.D., About TAKHZYRO ® (lanadelumab). Interactions.

Allergies

Allergies Antibody Recombinant DNA Technology Production

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases

The Pharma Data

AUGUST 19, 2020

The transaction will include full global rights to nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody. In autoantibody-driven diseases, the body’s antibodies attack or damage its own proteins, cells and tissues, often with devastating consequences. Investors and Momenta Pharmaceuticals, Inc.

Production

Production Dermatology Development Containment

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

The Pharma Data

JULY 23, 2021

OPDIVO ® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Hormones

Hormones Trials 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

Clinical Phase 1/2 study results demonstrated never before observed fold rises of RSV neutralizing antibodies; a fold rise of 15.2 Disclosure Notice: The information contained in this release is as of September 15, 2020. for RSV A and 18.0 Inflammation and Immunology.

Vaccination

Vaccination Vaccine Gene Therapy Trials

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

The Pharma Data

MARCH 11, 2021

OPDIVO ® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Trials

Trials Hormones Genome Genomics

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

XTalks

AUGUST 2, 2023

It contains the antiviral medications nirmatrelvir and ritonavir. 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. Pfizer’s total global revenue from Paxlovid was $18.93 billion in 2022.

Sales

Sales Manufacturing FDA Approval Life Science

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 ® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

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 ® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

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

Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

Life Science

Life Science Antibody In-Vivo In-Vitro

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

The Pharma Data

JULY 8, 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. 1) as determined by an FDA-approved test.

FDA Approval

FDA Approval Containment Trials Genome

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

Delveinsight

AUGUST 13, 2020

It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis.

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. This indication is approved under accelerated approval based on tumor response rate and durability of response.

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. 1] as determined by an FDA-approved test.

HR

HR FDA Approval Containment Genome

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. IR main line: Tel.: +33

Dermatology

Dermatology Trials Clinical Trials Clinical Trials

Clinical Research Informer

Top 2020 Biopharma M&A Deals

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

Trending Sources

Clinical Catch-Up: January 18-22 | BioSpace

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen’s Leadership in Novel Treatments for Autoimmune Diseases

TAKHZYRO® (lanadelumab) for Hereditary Angioedema Patients to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases

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

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) Hepatocellular Carcinoma U.S. Indication

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

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

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

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

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

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

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

Stay Connected