The Pharma Data

JANUARY 19, 2021

TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. TC-110 is in a Phase I/II trial for CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).

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Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. The changes to the EMA’s Fee Regulation (Regulation (EC) No 297/95) could be adopted during this month’s planned plenary meeting. The European Parliament is set to vote during the plenary meeting on December 12.

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The Pharma Data

AUGUST 3, 2021

The R&D pipeline in Human Pharma comprises more than 60 new substances and around 100 clinical and pre-clinical projects. This pipeline has the potential to deliver up to 15 medicines for approval by 2025. More than 60 million patients worldwide suffer from this disease, approx.

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Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents.

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The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; Regular approval by the U.S. months [95% CI 9.6-14.3] months [95% CI 6.9-10.7] with chemotherapy.

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Early scientific advice, either formal or informal, can shape pivotal study design early in the development process.

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Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. Figures Figure by South Rampart Pharma, illustrating the properties of SRP-001.

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Protease Inhibitor Program.

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Agency IQ

AUGUST 9, 2024

The actual legal definition of a Phase 3 study can be found at 21 CFR 312.21 , and the DAP authority references this specific definition: “Phase 3 studies are expanded controlled and uncontrolled trials. Global trials, enrollment targets, and how to account for a DAP population Quick definition: What are the enrollment goals?

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The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. We expect 2021 will mark a number of key clinical and commercial milestones. COPENHAGEN, Denmark, Jan. Morgan Healthcare Conference. “In ?. .

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FDA Law Blog: Drug Discovery

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. DAPs for clinical trials are not new inventions, as previously mentioned; however, the new mandates under FDORA are designed to shift these plans from “should” to “must.”

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Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. During the lead-in period, all patients are assigned to the reference product followed by randomization to either the “switching arm” or “non-switching arm” of the study. Recently, the FDA has openly supported doing away with the interchangeable distinction.

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Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. That said, FDA has not done nothing in 2024 related to clinical trial diversity.

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