Containment, FDA Approval and HR - Clinical Research Informer

Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

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. What does this Approval Mean for Breast Cancer Patients? months in HR+/HER2- Patients The average five-year rate of survival is 30 percent in HR+/HER2- patients.

HR

HR Hormones FDA Approval Antibody

The regulatory round-up: Eight key FDA decisions

Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

FDA Approval

FDA Approval In-Vivo Gene Editing Drugs

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

FDA Approval

FDA Approval Production Trials Clinical Trials

The US biosimilar market: Predictions for 2021

pharmaphorum

JANUARY 28, 2021

There is also current legislation in Congress (HR 8190) that aims to open the door to interchangeability within the biosimilar market – specifically starting with insulin products. If passed, HR 8190 would allow insulin biosimilar products to receive automatic interchangeability upon FDA approval.

Marketing

Marketing Insulin HR Production

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

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

HR

HR FDA Approval Containment Genome

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

The Pharma Data

AUGUST 22, 2021

1 Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo (Hazard Ratio [HR] 0.70, 95% CI: 0.57 n=142) for placebo; Opdivo reduced the risk of disease recurrence or death by 45% (HR 0.55, 95% CI: 0.39 months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3 to 13.9]). to 0.86; P =0.0008).

Drugs

Drugs HR FDA Approval Trials

Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

APRIL 7, 2021

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months vs. 6.9

HR

HR Genotype FDA Approval Genotoxicity

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

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

Sales

Sales Manufacturing FDA Approval Life Science

Janssen Announces Treatment with ERLEADA

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). ERLEADA ® received U.S.

HR

HR Hormones Development Production

Trodelvy® for the Treatment of Metastatic Urothelial Cancer

The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Beyond the regulatory approvals of Trodelvy in the U.S., FOSTER CITY, Calif.–(BUSINESS

Genotype

Genotype Containment FDA Approval Genotoxicity

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

The Pharma Data

JANUARY 15, 2021

Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicityEnhertu. 4.3] (HR=0.47; 95% CI 0.31-0.71) Related Articles: Enhertu (fam-trastuzumab deruxtecan-nxki) FDA Approval History. 0.88; p=0.0097) at a pre-specified interim analysis with a median OS of 12.5

Medicine

Medicine Trials Antibody HR

Pembrolizumab by Merck for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval

Pharmaceutical Technology

MARCH 2, 2023

Keytruda is also indicated as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for any platinum-containing chemotherapy.

FDA Approval

FDA Approval Containment Development Genome

Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer

The Pharma Data

JANUARY 4, 2021

months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). They are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status or. They have tried chemotherapy that contains platinum and it did not work or is no longer working.

Immune Response

Immune Response Medicine Protein Gene

Pfizer Responds to Research Claims

Pfizer

JANUARY 27, 2023

In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. Most of this work is conducted using computer simulations or mutations of the main protease–a non-infectious part of the virus.

Research

Research Vaccination Vaccine Drugs

Janssen Presents Results from Phase 3 ACIS

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). 2 ERLEADA ® received U.S.

HR

HR In-Vitro Development Clinical Trials

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). Casirivimab and imdevimab injection is not FDA approved for any use. The results passed the futility analysis (p<0.3 log 10 copies/mL for combined doses).

Antibody

Antibody Trials Production Clinical Trials

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

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

Medicine Production FDA Approval Trials

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). View source version on businesswire.com : [link]. Amy Rose 212.733.7410.

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

The regulatory round-up: Eight key FDA decisions

Trending Sources

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The US biosimilar market: Predictions for 2021

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

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

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

Janssen Announces Treatment with ERLEADA

Trodelvy® for the Treatment of Metastatic Urothelial Cancer

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

Pembrolizumab by Merck for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval

Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer

Pfizer Responds to Research Claims

Janssen Presents Results from Phase 3 ACIS

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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