Agency IQ

JULY 28, 2023

In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward This week, the FDA issued four new contract notices that highlight agency priorities in meeting user fee commitments, ongoing work in oncology dose optimization, and continued commitment to addressing the opioid crisis.

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Drug Discovery World

JUNE 29, 2023

Recently, the US Food and Drug Administration (FDA) published new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs. EVX-101 is a sustained-release tablet formulation of 5-hydroxytryptophan (5-HTP), the natural precursor to serotonin, and low-dose carbidopa.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Listen here. Watch it now. The Altascientist : Issue No.

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PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 21 U.S.C. §

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

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Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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Drug Discovery World

SEPTEMBER 26, 2022

In terms of the benefits drug repurposing can bring, Jackson says that if “done right, a drug developer has an opportunity to reduce overall drug development risk through some of these repurposing strategies.” . “In The post Highs and lows of drug repurposing appeared first on Drug Discovery World (DDW).

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Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs. These include: FDA (U.S.)

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

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Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

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Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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The Pharma Data

NOVEMBER 6, 2020

We appreciated the opportunity to share our data with the Advisory Committee, and we will continue to work with the FDA as it completes its review of our application.”. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. CAMBRIDGE, Mass. and TOKYO, Nov. About Alzheimer’s Disease.

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. The Company plans to initiate a Phase 2 trial within the next several months. “We

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Drug Discovery World

APRIL 12, 2023

This paid-for advertorial by CN Bio appeared in DDW Volume 24 – Issue 2, Spring 2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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Drug Discovery World

JANUARY 20, 2023

This paid-for advertorial by CN Bio appeared in the SLAS 2023 Supplement, Volume 24 – Issue 1, Winter 2022/2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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The Pharma Data

NOVEMBER 5, 2021

With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

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The Pharma Data

SEPTEMBER 7, 2021

Volunteers for the trial are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, based in Eatontown, New Jersey.

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Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. link] [3] FDA Review application number 216059Orig1s000 for Jaypirca (pirtobrutinib (Loxo-305)). link] [4] FDA prescribing information for INPEFA TM (sotagliflozin). Drug Metab Dispos. Xenobiotica.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products.

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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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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Agency IQ

AUGUST 16, 2024

FDA solidifies its advice on dose optimization for oncology products Just over a year after it released the draft guidance, the FDA has finalized its guidance on dose optimization for oncology products. The FDA also noted the shifting considerations for evaluating toxicity in modern products meant for long-term or chronic use.

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The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Pharmacokinetics Pharmacokinetics examines the absorption, distribution, metabolism, and excretion properties of a drug.

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The Pharma Data

AUGUST 29, 2020

First-in-class LNP023 – which potently and selectively targets factor B, part of the immune system’s alternative complement pathway 3,4,5 – is also in development for several renal conditions with complement system involvement . The FDA and EMA have granted orphan drug designations to LNP023 for the treatment of PNH and C3G.

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Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.

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Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. In addition, these models at the current state are better for short term tests, over a week or two and cannot be used for acquiring data from long term drug exposures.

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. For now, we haven’t included all documents previously released by the FDA in draft form unless specifically included on the agency’s draft agendas. New on CDRH’s guidance agenda. Priority A List.

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Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. To learn more about Altasciences, visit altasciences.com.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the success of a 505(b)(2) application hinges on a tailored development strategy that carefully considers the specific characteristics of the newly proposed drug product, and the nature of the changes made in comparison to a prior US FDA-approved listed drug (LD) or the drug reported in literature.

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Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. Since its inception, OCE has initiated an extensive list of initiatives and has taken the lead on over forty guidances published by FDA.

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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