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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Metabolite Tales Blog

JULY 5, 2023

Synthetic macrocycles in oncology Pactritinib is a multi-kinase JAK2/FLT3 inhibitor used for the treatment of primary and secondary myelofibrosis, approved by the FDA in 2022. Ayushi Jain and Khalid Mumtaz, 2022. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. of parent drug exposure respectively. Chen et al.,

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Metabolite Tales Blog

JULY 5, 2023

Synthetic macrocycles in oncology Pactritinib is a multi-kinase inhibitor used for the treatment of primary and secondary myelofibrosis and was approved by the FDA in 2022. Ayushi Jain and Khalid Mumtaz, 2022. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. Journal of Medicinal Chemistry, 66 (8), 5377-5396.

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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. Overall, 2022 phenylephrine retail sales reached $1.8 FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine. billion for pseudoephedrine.

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Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine?

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Agency IQ

FEBRUARY 23, 2024

The discussions in this workshop incorporated the content of a draft guidance document on the topic released by the FDA in 2023, as well as the information shared in another series of workshops co-hosted by the FDA and the American Society of Clinical Oncology (ASCO), which occurred in 2022 and 2023.

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Agency IQ

OCTOBER 6, 2023

FDA’s approval volume seems to have recovered from a dip in FY 2022, driven mostly by biologics Now that the government’s – and the FDA’s – fiscal year has come to a close, AgencyIQ has reviewed all novel drug approvals for FY 2023. Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products.

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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.

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The Premier Consulting Blog

JUNE 18, 2023

Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials. A similar draft guidance document for drug development is in process.

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. Was supposed to be finalized as of June 24, 2022. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts. The Agenda is typically updated twice per year, and it was last released in early January 2023.

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The Pharma Data

MARCH 8, 2022

Dr. Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice. Molecular Therapy – Nucleic Acids, 2022. doi: 10.1016/j.omtn.2022.02.008.

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Agency IQ

DECEMBER 11, 2023

While Project Beyond Breakthrough (anticipated to launch its pilot program at the end of 2022) and Project Site Selector (slated to host several meetings in 2023) never quite materialized, others like Project FrontRunner , Project Optimus , and Project Orbis saw frequent mentions throughout the year.

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Alta Sciences

JULY 31, 2024

Dr. David Nguyen , General Manager and Medical Director of Altasciences’ Los Angeles clinical pharmacology unit, says: “Having a diverse medical team working with a diverse participant population can lead to a rewarding experience for both.

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Eye on FDA

JANUARY 5, 2022

FDA has scheduled the first advisory committee meetings of 2022. But before heading into 2022, it is perhaps time to take stock of AdComms and what they did or did not do during 2021. Fewer Meetings. First and foremost is that as noted earlier this year (See August 5, 2021 FDA Adcomms – Is FDA Getting Less Advice?

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Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. The latest update, announced this week, is known as the Spring 2023 Unified Agenda. Of those 51, just four are new to the Agenda, having never before been made public.

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Agency IQ

JULY 28, 2023

In a September 2022 blog post , Califf acknowledged the broad scope of the crisis, saying ,“The opioid crisis has evolved beyond prescription opioids into a broader drug overdose crisis, largely driven by illicit fentanyl and its analogs. Read the full AgencyIQ analysis here.

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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. November is packed with regulatory and industry meetings.

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The Anticancer Fund

JUNE 7, 2022

10 June 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. It is one of the focus areas of the Anticancer Fund. Below, we have listed recent findings about the repurposing of generic drugs in oncology.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

FEBRUARY 15, 2024

Draft published December 2022. CDRH Final 12/29/2023; overdue FDA must issue final guidance no later than one year after the close of the public comment period for the draft guidance.

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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.

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST 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

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Drug Target Review

NOVEMBER 27, 2024

2022 Apr 26;9:878942. Clinical Pharmacology & Therapeutics. 2022 Mar 5;112(1):69–80. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. References Hendrikse NM, Llinares Garcia J, Vetter T, et al. Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond.

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Agency IQ

JULY 12, 2024

provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. For example, the FDA does not have a proposed rule listed that would change how it regulates animal testing requirements following the passage of the FDA Modernization Act 2.0 The agency has come under fire from the bill’s sponsors for its inaction on this topic.

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