Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

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The Premier Consulting Blog

JUNE 8, 2023

This includes identifying the necessary information to streamline the development program, outlining the bridging strategy, and determining the most appropriate listed drug, if applicable. This assessment should consider critical issues from multiple perspectives and define the regulatory strategy.

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Drug Target Review

MAY 7, 2024

For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences. At Debiopharm, he has overseen both preclinical and clinical pharmacology of assets from phase I to III.

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DrugBank

FEBRUARY 9, 2023

Read the paper Jörn Lötsch Biomedical scientist at the Goethe - University Frankfurt am Main, Germany Research Focus: Knowledge discovery by combining artificial and human intelligence for information reduction of biomedical data with a focus on data science, pain, and clinical pharmacology.

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The Pharma Data

FEBRUARY 15, 2022

Please see Important Safety Information, including BOXED WARNING, at the end of this press release for further safety information regarding enfortumab vedotin. Neoadjuvant cisplatin-based chemotherapy, which is intended to shrink tumors prior to surgery, prolongs survival in patients with MIBC.

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New Drug Approvals

DECEMBER 24, 2023

. “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85” WHO Drug Information.

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Alta Sciences

SEPTEMBER 20, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. These data inform the construction of disease mechanistic models used to generate a synthetic control arm for use in the trial.

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The Pharma Data

NOVEMBER 1, 2020

For more information, please visit our website, www.missiontherapeutics.com , or follow us on Twitter or LinkedIn. Suhail’s initial industry experience was at Pfizer, where he spent 12 years, initially in Sandwich, UK and then at Global R&D Headquarters in Connecticut, USA. View source version on businesswire.com: [link]. Source link.

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The Premier Consulting Blog

NOVEMBER 4, 2023

Key to the IND opening studies is that the CMC information is sufficient to support the safety of the drug substance and drug product and establish the phase-appropriate quality of the drug product. This will allow for initial evaluation and/or monitoring of the safety of the product.

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Alta Sciences

MAY 15, 2023

Integrated Clinical Sites Accelerate Timelines Well-suited and qualified clinical pharmacology units (CPUs) for early phase trials are getting more expensive to run due to the growing complexity of required clinical procedures, and the precision around participants to be recruited.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

Unlike the traditional 505(b)(1) pathway, which requires extensive original investigations, the 505(b)(2) pathway allows developers to rely on information contained in published literature and/or from studies not conducted by the applicant, which can significantly reduce development time and cost.

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The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. For more information, please visit www.sagerx.com.

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The Pharma Data

NOVEMBER 8, 2020

For information on Absorption Systems’ comprehensive contract services, applied research programs and proprietary test systems, please visit www.absorption.com. www.pharmaron.com. View source version on businesswire.com: [link].

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Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. There’s also a requirement for the FDA to “promptly” post this information publicly.

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The Pharma Data

OCTOBER 1, 2021

The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.

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Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

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Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process. MAM technology (e.g.,

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Agency IQ

FEBRUARY 23, 2024

Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.” We need to factor those in to think about whether a PRO outcome in a small trial is going to be informative or not.”

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Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. the drug and device) of the combination product.

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Agency IQ

JUNE 2, 2023

We’re expecting that there are a lot of companies that aren’t aware of this requirement, but we’re also expecting that this information will be hugely helpful to the FDA and its ability to even know what it regulates. government’s way of informing stakeholders of the regulations that are under active development.

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Metabolite Tales Blog

JULY 5, 2023

We await to see what other biotransformation data emerges on synthetic macrocycles as more information is publicly disclosed as they advance through development. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. LC-MS data indicated that the acyl glucuronide did not undergo acyl migration under physiological conditions [16].

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Metabolite Tales Blog

JULY 5, 2023

We await to see what other biotransformation data emerges on synthetic macrocycles as more information is publicly disclosed as they advance through development. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. LC-MS data indicated that the acyl glucuronide did not undergo acyl migration under physiological conditions [16].

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The Pharma Data

DECEMBER 17, 2020

The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise. Source link.

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The Pharma Data

FEBRUARY 8, 2021

In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”. v] ERLEADA ® is being studied in five Phase 3 clinical trials. ERLEADA ® IMPORTANT SAFETY INFORMATION.

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Agency IQ

DECEMBER 1, 2023

However, the revision provided much more detail given the amount of information on Covid-19 that was gained between May 2020 and February 2021. While the concept of quantitative systems pharmacology (QSP) has been around for several decades, the prospect of actually using these models in regulatory applications is still quite new.

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Agency IQ

DECEMBER 11, 2023

For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.” For instance, patient information derived from medical records may not be complete or accurate.

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Agency IQ

JUNE 16, 2023

Another addition is an advanced notice of proposed rulemaking that seeks to “obtain information related to recalls of products subject to the jurisdiction of the FDA.” For proposed and final rules with near-term planned actions, the FDA is generally more likely to release regulations when it says it plans to.

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Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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The Anticancer Fund

JUNE 7, 2022

Subscription Would you like to stay informed about the latest news on drug repurposing in oncology? Also notable is that the majority of the new use patents are held by pharma companies, and that they maintain (pay to renew) their portfolio. You can easily subscribe to this newsletter by clicking here.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Alta Sciences

FEBRUARY 19, 2025

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. FDA provided information on the comparative sales of cold medicines in the U.S. The communication strategy should include clear information on alternatives, according to the panel.

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Agency IQ

FEBRUARY 12, 2024

to analyze data, generate summaries of certain information, or other tasks of interest to companies in the interest of efficiencies. A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice.

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