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.

Disease 112

Disease Clinical Trials Therapies Science 112

The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

FDA Approval 52

FDA Approval FDA Hospitals Clinical Trials 52

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

SEPTEMBER 8, 2021

Updated Phase 3 CheckMate -577 disease-free survival (DFS) results for adjuvant Opdivo treatment vs. placebo for patients with resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy (CRT). On March 25, 2011, the U.S. Summary of Presentations. Abstract Title. Presentation. Session Title.

Research 52

Research Immune Response Treatment Trials 52

Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability.

FDA 40

FDA Science Trials Clinical Trials 40

The Pharma Data

OCTOBER 25, 2020

FDA approval. 28 Abstract Session: New Therapies Real-World Effectiveness of Voxelotor for the Treatment of Sickle Cell Disease: A Chart Review Study Presenter: Kenneth Bridges, M.D., Details of the ASCAT presentations are as follows: Wednesday , Oct. GBT Time: 11 a.m. 4 – 7.

Treatment 40

Treatment Disease FDA FDA Approval 40

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.

Doctors 52

Doctors Treatment Hospitals Clinical Trials 52

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%

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

DECEMBER 21, 2020

Tagrisso was recently granted Breakthrough Therapy Designation for patients in the early-stage disease setting by the US FDA. 2011:29;2121-27. Related Articles: Tagrisso (osimertinib) FDA Approval History. J Clin Oncol. Ellison G, et al. Cancer Discov. 2014;4(9):1046-1061. Source: AstraZeneca.

Treatment 52

Treatment Trials Disease FDA 52

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). Tax Petition.

Biosimilars 52

Biosimilars Production Treatment FDA 52

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Treatment 52

Treatment Trials Therapies Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. percent of patients in the combination arm versus 56.2 10 months. [iv]

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Codon

MAY 22, 2023

. 🧪 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. Nature Nanotechnology. Read *A feedback system controls the relative populations of microbes in a community. This is bad.

DNA 58

DNA Engineering Science Trials 58

Codon

MAY 22, 2023

. 🧪 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. Nature Nanotechnology. Read *A feedback system controls the relative populations of microbes in a community. This is bad.

DNA 52

DNA Engineering Science Trials 52

Broad Institute

NOVEMBER 6, 2024

Earlier this year, the researchers shared their first translational results, describing the immune cell response underlying colon inflammation in patients undergoing ICI therapy. These are home-run, breakthrough therapies, and quite an amazing success story. How did you go about launching this effort?

Research 131

Research Immune Response Hospitals Therapies 131

Drug & Device Law

SEPTEMBER 19, 2022

604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. 2022 WL 3927868, at *4 (citing In re Incretin-Based Therapies Prods.

Regulations 10

Regulations FDA Approval Drugs FDA 10