Codon

SEPTEMBER 29, 2024

The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. The 2025 genetic network paper fit that bill exactly. 2024 Statistical models of organisms have existed for decades.

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LifeSciVC

JANUARY 16, 2024

recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Join the club. Additional trials (e.g.,

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. Five Predictions for the Drug Development Industry in 2024 1. Stakeholders across the drug development sphere will unlock the transformative potential of AI.

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Agency IQ

JUNE 21, 2024

CBER’s Peter Marks offers insights on a new Rare Disease Hub, upcoming accelerated approval guidance This week, PETER MARKS, director of FDA’s Center for Biologics Evaluation and Research (CBER), spoke at several sessions of the Drug Information Association (DIA) annual meeting.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024.

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LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Drug development is a long process, and patients are waiting. An adverse event or serious adverse event (SAE) that turns out NOT to be related to the drug may take a while to sort out.

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Clinical Trials Trials Disease Treatment 69

Conversations in Drug Development Trends

MAY 23, 2024

The Critical EU-CTR Transition Deadline The three-year transition period for clinical trials authorized under the CTD that are expected to continue beyond the critical deadline of 30 January 2025 are required to transition to the new EU-CTR via a transition application through the CTIS.

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Trials Clinical Trials Therapies Treatment 52

Agency IQ

JULY 7, 2023

This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025. Regulators at EMA have outlined their intent to “enable” RWE and “establish its value for regulatory decision-making” by 2025.

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Vial

APRIL 18, 2024

Yet, hereditary and age-related retinal diseases present challenges, often leading to progressive vision loss and potential blindness. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

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Clinical Trials Trials Treatment Clinical Research 52

Perficient: Drug Development

SEPTEMBER 8, 2023

link] Center for Disease Control and Prevention (CDC). Healthcare Workers Plan To Leave Their Positions By 2025. References: AARP. Promoting Health for Older Adults. link] Gartner. What’s New in Artificial Intelligence from the 2022 Gartner Hype Cycle. link] Forbes. New Survey Shows That Up To 47% Of U.S.

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Nurses Disease 59

Agency IQ

JULY 22, 2024

Since the 1990s, the FDA’s acceptance of single pivotal trials has become more common , especially due to the agency’s expanded reviews of products intended to treat, cure or prevent rare diseases or life-threatening conditions for which there is an unmet clinical need. population.

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Clinical Trials Trials Science FDA 52

Conversations in Drug Development Trends

NOVEMBER 13, 2024

I was diagnosed with Type 1 diabetes, an autoimmune disease where the pancreas stops producing insulin, unlike Type 2 diabetes, where the body doesn’t produce enough or use it properly. The disease doesn’t wait for convenience—it can disrupt sleep, work, and even life events. That was the day my life changed.

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Hospitals Clinical Trials Doctors Nurses 64

The Pharma Data

DECEMBER 2, 2020

million aggregate principal amount of 7.25% convertible senior notes due 2025 (the “notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The notes will mature on December 1, 2025, unless earlier repurchased, redeemed or converted.

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The Pharma Data

DECEMBER 2, 2020

The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Forward Looking Statements.

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Production Drug Development Therapies Research 40

Agency IQ

JULY 28, 2023

But according to AgencyIQ’s user fee program performance tracker linked above and the FDA’s PDUFA VII user fee commitments, CDER and CBER committed to perform an “assessment of hiring and retention” with experience in HR operations “to conduct a targeted assessment of the hiring and retention of staff for the human drug review program.”

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Agency IQ

JULY 8, 2024

The information below includes the event type and whether the meeting can be attended by the public (Open) or not (Closed). For delegated acts, the co-legislators usually have two months to object to the proposals but cannot amend them. For implementing acts, the Commission is required to consult with a committee before adoption.

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New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 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] Drug Discovery. nM vs. 24.0 nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. intended use population. population demographics. population in light of the U.S. role in global health.

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FDA Clinical Trials Disease Trials 59

FDA Law Blog: Drug Discovery

JANUARY 23, 2023

The report bore out what many in the industry and academia already knew—while some sponsors were able to recruit subjects that reflected the distribution of the disease in the population in terms of age and sex, participation by racial minorities and other socially disadvantaged subgroups was lacking.

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FDA Trials Clinical Trials Drugs 59

Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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Agency IQ

FEBRUARY 2, 2024

BY LAURA DIANGELO, MPH | JAN 30, 2024 10:25 AM CST Diagnostic regulation: A quick overview Diagnostics products are those intended to identify, signal or detect a specific health condition, infection or disease, or monitor a person’s health or health status. The diagnostics landscape in the U.S.: In-house tests (similar to LDTs in the U.S.,

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FDA Laboratories Regulations Production 40

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. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

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Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

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FDA Laboratories Regulations Clinical Trials 40

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Similarly, more than 90% of people in the United States with sickle cell disease are Black, with an estimated three to nine percent being Hispanic or Latino.

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Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. 2 The biomarker development pipeline involves multiple stages, including discovery, analytical validation, clinical validation and regulatory qualification. only about 0.1

Drug Development 52

Drug Development Regulations Laboratories FDA 52

Agency IQ

JUNE 28, 2024

For these programs, “the sponsor’s enrollment goals…for each study should consider how individual clinical studies may fit into an overall clinical development program” and how the individual studies would generate data “consistent with the incidence or prevalence in the disease population for the program.” What about rare diseases?

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