The Pharma Data

FEBRUARY 8, 2021

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). About Metastatic Castration-Sensitive Prostate Cancer.

HR 52

HR Hormones Development Production 52

XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2

HR 52

HR Hormones FDA Approval Antibody 52

XTalks

AUGUST 10, 2022

HER2-low is characterized by the presence of some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive. Prior to the approval of Enhertu, patients in the latter IHC/ISH category were not eligible for HER2-targeted therapies and mainly got endocrine therapy (if HR-positive disease) or chemotherapy.

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FDA Approval HR Hormones Antibody 98

XTalks

MARCH 22, 2021

Maverick’s COBRA platform is used to engineer protein-based therapies that target T cells in the tumor microenvironment to trigger their activation. The therapies are designed to induce T cell-mediated killing specifically at the tumor site while sparing healthy cells and tissue.

Life Science 110

Life Science Development Marketing Gene Expression 110

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

Pfizer

JANUARY 27, 2023

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

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Marketing Production Drugs Licensing 75

The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints.

HR 52

HR Trials In-Vitro Manufacturing 52

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

AUGUST 30, 2021

KEYTRUDA Now Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer. KEYTRUDA Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer. months (95% CI, 7.6-11.3)

Hormones 52

Hormones HR Trials Protein 52

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

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

FDA Approval 52

FDA Approval Drugs Sales Development 52

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Microsomal triglyceride transfer protein inhibitor: lomitapide. Immunosuppressants: voclosporin.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

DECEMBER 13, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Microsomal triglyceride transfer protein inhibitor: lomitapide. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

Drugs 110

Drugs Licensing Licensing Production 110

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. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. No dosage adjustment is needed in patients with mild renal impairment.

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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

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001).

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). chief medical officer and head of Global Product Development. “We

Immune Response 52

Immune Response Medicine Protein Gene 52

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

Pfizer

NOVEMBER 23, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Microsomal triglyceride transfer protein inhibitor: lomitapide. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

The Pharma Data

APRIL 14, 2021

Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial. A global, randomized Phase 3 confirmatory clinical trial TROPiCS-04 (NCT04527991) is underway and is also intended to support global registrations. More information on TROPiCS-04 is available at [link]. About Trodelvy.

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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. vs. 11.4%) (p < 0.0001).

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. 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]).

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

In February 2021, Pfizer and BioNTech announced results from an in vitro study published in NEJM that demonstrated sera from individuals immunized with BNT162b2 neutralize SARS-CoV-2 with the South African variant spike protein. The study investigated the full set of South African variant (also known as B.1.351

Vaccination 40

Vaccination Vaccine Production Sales 40