The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757).

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Broad Institute

OCTOBER 11, 2023

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA.

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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.

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Agency IQ

OCTOBER 6, 2023

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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FDA Biosimilars Science Production 52

Codon

MAY 22, 2023

Verve already started a Phase 1b trial in New Zealand last July. halted a Verve trial in the U.S. 🧪 From the Lab Other wet-lab papers worth checking out. (* = Recommended) *A temperature-sensitive genome-editing tool — which uses Cas9 — enhances adoptive T-cell therapy upon mild heating. Read more in STAT.

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The Pharma Data

DECEMBER 21, 2020

DFS results in the overall trial population of patients with Stage IB-IIIA disease showed Tagrisso reduced the risk of disease recurrence or death by 80% (HR 0.20; 95% CI 0.15-0.27; The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting. 0.23; p<0.0001).

Treatment 52

Treatment Trials Disease FDA 52

Codon

MAY 22, 2023

Verve already started a Phase 1b trial in New Zealand last July. halted a Verve trial in the U.S. 🧪 From the Lab Other wet-lab papers worth checking out. (* = Recommended) *A temperature-sensitive genome-editing tool — which uses Cas9 — enhances adoptive T-cell therapy upon mild heating. Read more in STAT.

DNA 52

DNA Engineering Science Trials 52

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] 1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). percent in the control arm.

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Pharmaceutical Companies Treatment Clinical Trials Trials 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. Summary of Presentations.

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Research Immune Response Treatment Trials 52

Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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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.–(

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Treatment Trials Therapies Clinical Trials 52

The Pharma Data

OCTOBER 25, 2020

FDA approval. In a sample of charts from 56 patients with SCD, voxelotor increased hemoglobin by more than 1 g/dL on average and decreased hemolysis markers to a degree consistent with the randomized controlled HOPE trial results. . Details of the ASCAT presentations are as follows: Wednesday , Oct.

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The Pharma Data

JUNE 26, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring. EINSTEIN-Jr is the largest pediatric study completed to date for the treatment of VTE.

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Doctors Hospitals Clinical Trials Treatment 52

Drug Discovery World

FEBRUARY 22, 2024

According to Alzheimer’s Research UK (ARUK): “In the UK, dementia was the leading cause of death in 2022 and has been the leading cause of death for women since 2011 – maintaining its position throughout the Covid-19 pandemic. For example, it can take up to it three years to recruit enough participants for a dementia clinical trial.

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Agency IQ

SEPTEMBER 22, 2023

Traditionally, FDA has interpreted the need for “well-controlled investigations” to mean at least two clinical trials for new drugs, or applications for supplemental indications. Three drugs were approved based on no pivotal trials (such as in cases where an approval leveraged literature on use of the drug).

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