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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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.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C. Jazz believes that FDA precedent precludes that position and thus FDA departed from established policy, which FDA denied ever existed.

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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.

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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.

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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]

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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.

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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.

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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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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.

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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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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.

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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.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. In short, all studies found no significant difference between phenylephrine and placebo.

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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?

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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.

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