Drug Discovery World

APRIL 11, 2024

In clonogenic assay, BRCA2-deficient DLD1 cells were ~15-fold more sensitive to FEN1 inhibition than their isogenic BRCA2-wild-type counterparts (EC50 of 350nM and 5µM, respectively), confirming the increased susceptibility of HR deficient cancer cells to FEN1 inhibition. LAE119 is a potent and selective PARP1 inhibitor and PARP1-DNA trapper.

HR 52

HR Antibody In-Vitro DNA 52

XTalks

AUGUST 10, 2022

Enhertu is an antibody-drug conjugate (ADC) consisting of Roche’s Herceptin (trastuzumab), a monoclonal antibody against HER2 (human epidermal growth factor receptor 2), and the topoisomerase I inhibitor deruxtecan. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.

FDA Approval 98

FDA Approval HR Hormones Antibody 98

XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

FDA Approval 101

FDA Approval Drugs Sales Development 101

Drug Discovery World

FEBRUARY 21, 2023

The FDA has granted expanded approval for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) for patients with HR-positive/HER2-negative metastatic breast cancer who have received hormonal therapy and at least two additional therapies in the metastatic setting.

HR 52

HR Hormones Sales Antibody 52

XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. It is a CDK 4/6 inhibitor that is taken in combination with other hormonal therapies to stop the growth of cancer and healthy cells.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

APRIL 7, 2021

months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months (HR: 0.51; 95% CI: 0.41-0.62; Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. months from 1.7 0.54; p<0.0001).

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

JANUARY 4, 2021

months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). TIGIT and PD-L1 are proteins that play a role in suppression of the immune system. Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

APRIL 14, 2021

Trodelvy is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer. More information on TROPiCS-04 is available at [link]. About Trodelvy.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. Isolated growth hormone deficiency. ?

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]). The BTK protein sends important signals that tell B cells to mature and produce antibodies. Isolated growth hormone deficiency. ?

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.; A decision from the EC is expected in 2022.

Vaccination 40

Vaccination Vaccine Production Sales 40