The Pharma Data

APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

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Drug Target Review

NOVEMBER 17, 2023

NK cells are among the front line of protection from infected and abnormal cells as part of the ‘innate immune response’. They recognise ‘cell stress molecules’ on the surface of infected, old, injured and cancerous cells without the need for complex pre-stimulation signals of the adaptive immune system (eg, T cells).

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Therapies Cell Biology Clinical Trials Trials 118

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

AUGUST 17, 2021

Applications based on positive results from the Phase 3 CheckMate -648 trial, in which both Opdivo -based combinations demonstrated a significant survival benefit over chemotherapy alone. Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -648 trial. About CheckMate -648.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.

Trials 52

Trials Treatment Immune Response Clinical Trials 52

The Pharma Data

MARCH 31, 2023

As the first positive Phase 3 trial with an immunotherapy-based combination in the neoadjuvant setting, the results from CheckMate -816 have already contributed valuable knowledge to the scientific community studying resectable NSCLC. Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -816 clinical trial.

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Trials Clinical Trials Treatment Immune Response 40

The Pharma Data

MARCH 29, 2022

Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer.

Treatment 52

Treatment Clinical Trials Trials Immune Response 52

The Pharma Data

SEPTEMBER 8, 2021

CheckMate -743 remains the only Phase 3 trial to show a survival benefit with first-line immunotherapy treatment in patients with MPM. First-line nivolumab + cabozantinib vs sunitinib in patients (pts) with advanced renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy in the CheckMate 9ER trial. Dr. Camillo Porta.

Research 52

Research Immune Response Treatment Trials 52

The Pharma Data

APRIL 9, 2021

today announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab) plus chemotherapy or Opdivo plus Yervoy (ipilimumab ) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). About CheckMate -648.

Clinical Trials 52

Clinical Trials Trials Immune Response Treatment 52

The Pharma Data

APRIL 16, 2021

Approval based on Phase 3 CheckMate -9ER trial results showing Opdivo in combination with Cabometyx significantly improved overall survival and doubled median progression-free survival and objective response rates compared to sunitinib. professor of medicine and urology department head, Jena University Hospital. vs. 27.1%).

Treatment 52

Treatment Trials Clinical Trials Immune Response 52

Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. A healthy immune system is naturally primed to eliminate malignant and abnormal cells through a synchronised and dynamic interplay between adaptive and innate immunity.

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Research Therapies Immune Response Clinical Trials 130

The Pharma Data

JULY 8, 2021

8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8) 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8)

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. during 2015-2016. The indication for preventing pneumonia caused by S.

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Vaccine FDA Approval FDA Disease 52

The Pharma Data

OCTOBER 28, 2020

We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomized controlled Phase 3 trial is positive.”. The dosing regimen in the Phase 3 is the same as in the pilot trial.

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Treatment Trials Production Disease 40

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies 52

Therapies Trials Disease Treatment 52

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

Treatment 52

Treatment Trials Therapies Clinical Trials 52

The Pharma Data

JUNE 30, 2021

Approval based on Phase 2 CheckMate -142 trial results showing nearly two-thirds of patients responded to the Opdivo plus Yervoy combination with durable responses observed. Results from the CheckMate -142 trial at minimum follow-up of 46.9 achieving a complete response. CheckMate -142 Efficacy and Safety Results.

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

MARCH 11, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.

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Treatment Trials Therapies FDA Approval 52

Drug Discovery World

SEPTEMBER 29, 2022

In 2015, after a 15-year effort to vaccinate against rubella virus (which is usually administered at the same time with vaccines against measles and mumps), the Americas were declared free of endemic transmission of rubella 13. . The immune response to human CMV. The potential future of mRNA in CMV prevention . Cheeran, M.

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SugarCone Biotech

MAY 28, 2019

Iovance has successfully exploited these findings and shown efficacy in late-stage clinical trials using patient-derived TILs to treat melanoma and cervical cancer. Jounce Therapeutics and Immune-Onc showed preclinical data at SITC 2020 on their anti-LILBR2 (ILT-4) programs, and there are additional efforts underway.

Immune Response 52

Immune Response Therapies Engineering Regulations 52

The Pharma Data

MAY 13, 2021

To date, more than 225,000 individuals participating in clinical trials and vaccination initiatives have received at least the first dose of the Johnson & Johnson Ebola vaccine regimen, including 180,000 who have been fully vaccinated. Pregnant women and HIV-positive adults who are otherwise healthy are permitted to enroll in the program.

Vaccine 52

Vaccine Virus Pharmaceutical Companies Clinical Trials 52

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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Vaccine Trials Pharmaceutical Companies Immune Response 40

The Pharma Data

JULY 8, 2021

In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., 2) variants during the study period.

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Vaccine Immune Response Pharmaceutical Companies Disease 52

The Pharma Data

JULY 6, 2021

In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., 2) variants during the study period.

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Vaccine Immune Response Clinical Trials Hospitals 52