pharmaphorum

JUNE 17, 2022

Developed by Pfizer, Paxlovid was granted emergency use authorization (EUA) to treat COVID-19 patients based on the EPIC-HR study which showed it reduced the risk of hospitalization or death by almost 90 percent. The active drug is nirmatrelvir, a protease inhibitor, which helps keep the SARS-CoV-2 protein from replicating.

Drugs 104

Drugs Clinical Trials Clinical Trials HR 104

The Pharma Data

JANUARY 14, 2021

“The FIGHT trial results demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a significant reduction in the risk of disease progression and death in gastric cancer patients whose tumors overexpress FGFR2b.”. HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87).

Trials 52

Trials HR Containment Development 52

Drug Discovery World

MARCH 24, 2023

Efti As a first-in-class soluble LAG-3 protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is positioned to improve clinical outcomes from standard-of-care chemotherapy. Its activation of APCs (e.g., The first patient is expected to be enrolled early in the second quarter of the 2023 calendar year.

Trials 52

Trials Immune Response HR Clinical Development 52

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 High risk was specifically defined as women (any menopausal status) and men with resected HR+, HER2- invasive early breast cancer with either ?4

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. Internationally, revenue reached $355.7

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

SEPTEMBER 10, 2021

Patients treated with a short course of five cycles of tremelimumab, an anti-CTLA4 antibody, over 16 weeks in addition to Imfinzi and chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options (based on a hazard ratio [HR] of 0.77; 95% CI 0.65-0.92; 0.92; p=0.00304). Median OS was 14.0

HR 52

HR Trials Immune Response Medicine 52

The Pharma Data

AUGUST 9, 2021

The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events. The data will be presented at an upcoming medical meeting and shared with health authorities.

Trials 52

Trials Medicine Development Clinical Trials 52

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). For more information about ERLEADA ® , visit www.ERLEADA.com. *©

HR 52

HR Hormones Development Production 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. Internationally, revenue reached $355.7

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

DECEMBER 4, 2020

Recently, Medpace hosted an informative webinar on CKD and how new developments in our understanding of the disease are helping to shape more effective clinical research programs. Watch this free webinar to learn more about CKD from Medpace’s medical and clinical operations experts. Developed in 1999 2. Expressed in mL/min/1.73m 2.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 52

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. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Drugs 110

Drugs Licensing Licensing Production 110

Pfizer

DECEMBER 20, 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. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Drugs 69

Drugs Licensing Licensing Containment 69

The Pharma Data

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. 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). All rights reserved.

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

JUNE 18, 2021

months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]); with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; VENCLYXTO ® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. After a median follow-up of more than four years (52.4

Medicine 40

Medicine HR Trials Production 40

The Pharma Data

APRIL 23, 2021

Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). Venclyxto blocks the BCL-2 protein and works to help restore the process of apoptosis. The median OS was 14.7 months (95% CI: 11.9,

Medicine 40

Medicine In-Vitro Antibody Branding 40

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. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 6.45 percent increase from the $9.13

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 24, 2020

The safety and efficacy of Oxlumo are also being evaluated in the ongoing ILLUMINATE-C Phase 3 clinical trial in patients of all ages with advanced PH1, including patients on dialysis. 0.514 mmol/24 hr/1.73 0.771 mmol/24 hr/1.73 Visit OXLUMO.com for more information, including full Prescribing Information.

FDA Approval 52

FDA Approval Production RNA Medicine 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. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. No dosage adjustment is needed in patients with mild renal impairment.

Marketing 75

Marketing Production Drugs Licensing 75

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

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. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

The Pharma Data

APRIL 14, 2021

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. Beyond the regulatory approvals of Trodelvy in the U.S., About the TROPHY U-01 Study.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 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. 1 Additionally, at 6.5

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. The study investigated the full set of South African variant (also known as B.1.351

Vaccination 40

Vaccination Vaccine Production Sales 40