Drug Target Review

NOVEMBER 6, 2023

Before joining AstraZeneca, he served as the Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center (MSKCC) and led a laboratory focused on drug development for patients with lymphoid malignancies. 2013); 108(3): 479-485. Cancers (Basel). 2022;14(9):2182. Published 2022 Apr 27. Br J Cancer.

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Drug Target Review

NOVEMBER 1, 2023

I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre. The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. Acta Cryst.

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The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

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Drug Target Review

SEPTEMBER 26, 2023

Within the field of drug safety hiPSC-cardiomyocytes are now routinely used for early identification of cardiac liabilities in drug discovery. The CiPA initiative aims to engineer an assay to assess the proarrhythmic potential of new drugs with improved specificity compared to current methods.

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The Pharma Data

JANUARY 13, 2021

Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people. Lancet Respir Med 2013. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date. About the study. Patient Population: 45 hospitalized patients with COVID-19. . Franciosi LG, et al.,

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The Pharma Data

JANUARY 7, 2021

About ASP-1929 Since 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. is moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] However, development for these indications was discontinued. [2]

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The Pharma Data

NOVEMBER 29, 2020

(NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive interim efficacy results, as well as additional safety and immunogenicity data, for its prophylactic Cytomegalovirus (CMV) vaccine candidate HB-101. 1 Gilbert C and Boivin G.

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Agency IQ

OCTOBER 20, 2023

FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.

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The Pharma Data

DECEMBER 15, 2020

months that we observed in this trial. These positive efficacy results across all endpoints give us a high degree of confidence in their repeatability in a randomized trial and we plan to meet with the regulatory authorities in order to agree on the fastest pathway forward in this indication. Kenilworth, N.J. , Kenilworth, N.J. ,

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The Pharma Data

DECEMBER 27, 2020

Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials. Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

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LifeSciVC

OCTOBER 13, 2022

At the same time, there are more gene therapies in development overall than antibodies, with 39 Phase 3 trials ongoing and several companies expected to file for approvals over the next 12 months. Now is the time to invest in this space — here are several factors to consider as you weigh your options. million price.

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FDA Law Blog: Drug Discovery

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. See AgencyIQ’s analysis on EMA’s draft guidance on clinical trials to treat depression ].

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Codon

APRIL 9, 2024

After successful testing on animals, Tu and her colleagues volunteered to test the drug sample on themselves, spending a week in a Beijing hospital to do so. Department of Defense administered mefloquine, the synthetic drug developed at Walter Reed in the U.S., Meanwhile, on the other side of the Pacific, the U.S.

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NIH Director's Blog: Drug Development

SEPTEMBER 18, 2014

These factors make large-scale clinical trials particularly challenging. To help address this problem, the NIH is working with an existing network of infectious disease clinical trials experts—the Antibacterial Resistance Leadership Group (ARLG)—and private industry to expand our ability to conduct clinical trials on new antibiotics.

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H1 Blog

NOVEMBER 29, 2023

Breaking the Barriers: How Inaccurate Trial Records Are Delaying Drug Development and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.

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Drug Target Review

JANUARY 16, 2025

These drugs, including grazoprevir and vaniprevir, were the result of macrocyclisation of acyclic precursors. 7 Another more recently developed macrocyclic drug is the oral PCSK9 inhibitor MK-0616, which Merck produced to combat atherosclerotic cardiovascular disease. 8 Why are there not more macrocyclic drugs?

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SugarCone Biotech

MAY 28, 2019

This was an interesting finding and one that I think remains under-appreciated by the immuno-oncology drug development field. Not by coincidence the list overlaps with the phases of the tumor-immunity cycle ( Chen & Mellman, 2013 ). Fifth: associated lymphoid tissues and organs.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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Agency IQ

DECEMBER 15, 2023

This includes questions about the scope of the rule itself and the FDA’s plan for implementation and more granular questions about implications for specific product types, including companion diagnostics (CDx) or LDTs used in drug development as clinical trial assays.

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