2022 and Clinical Pharmacology - Drug Discovery Digest

What recent paediatric guidelines mean for drug developers

Drug Discovery World

JULY 25, 2023

General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022. The guidance covers three main areas: clinical pharmacology considerations, ethical considerations, and the paediatric study plan design including points to consider.

Drug Development

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Preparing the next generation of drug discovery scientists

Drug Discovery World

NOVEMBER 29, 2022

After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. Due to this approach, the Clinical Pharmacology degree has various features that make it different to other courses that are currently available. Starting with the drug.

Clinical Pharmacology

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

JULY 4, 2023

However, a more detailed look into the clinical data suggests that there is room for further dose optimisation, and this is exemplified by the small molecule drug Sotorasib. 2022 Nov 14 [cited 2023 Apr 6];40(11):1255–63. Translational and Clinical Pharmacology [Internet]. 2022 [cited 2023 Feb 10];30(2):71.

Small Molecule

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New strategy for COVID-19 prophylaxis?

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.

Clinical Pharmacology

Clinical Pharmacology Immune Response RNA Virus

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Alta Sciences

SEPTEMBER 20, 2023

In development since 2022, the project has so far seen the completion of safety assessment utilizing intranasal administration at Altasciences’ nonclinical site in Columbia, MO. A cardiovascular study was also completed at Altasciences’ nonclinical facility in Scranton, PA.

Virus

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FDA Advisory Committee Review of 2021

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?

FDA

FDA Clinical Pharmacology Vaccine Production

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. .; Viney, Nicholas J.; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. 88 (12): 5389–5398. doi : 10.1111/bcp.15468.

Clinical Trials

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Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients with Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy

The Pharma Data

FEBRUARY 15, 2022

– La te-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium –. Data from this late-breaking abstract will be included in an oral presentation (Abstract 435) at the 2022 ASCO Genitourinary Cancers Symposium (ASCO GU) on February 18. Astellas Pharma Inc. Astellas”) and Seagen Inc.

Clinical Pharmacology

Clinical Pharmacology Trials Treatment Therapies

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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.

FDA

FDA Biosimilars Science Production

In Silico Modeling Unveils a New Era in Rare Disease Drug Development

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.

Drug Development

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Re-assessing the risks of drug-induced arrhythmias during drug discovery

Drug Discovery World

AUGUST 15, 2023

The pre-clinical pharmacological effects observed in such experimental model systems need to translate meaningfully into human clinical data to guide effective decision making in drug discovery. 2022) Nature Reviews Drug Discovery, 21: 915–931. Journal of Cardiovascular Pharmacology, 20: S96-105 Aktas et al.

Drugs

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Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. Nasdaq: SAGE) and Biogen Inc. Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S.

Treatment

Treatment Clinical Pharmacology Drugs Biosimilars

Metabolism of macrocyclic drugs

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.,

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

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.

Metabolic Stability

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Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

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.

Science

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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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.

FDA

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

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.

Science

Science FDA Clinical Trials Clinical Pharmacology

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

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.

FDA

FDA Pharmacokinetics Clinical Pharmacology Government

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

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.

FDA

FDA Science Regulations Compliance

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

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.

FDA

FDA Science Clinical Trials Trials

Latest news on drug repurposing in oncology #16

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.

Clinical Trials

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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

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.

Science

Science FDA Trials Clinical Pharmacology

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

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.

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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.

FDA

FDA Science Biosimilars Production

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

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.

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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.

Regulations

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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.

FDA

FDA Science Regulations Production

Drug Discovery Digest

What recent paediatric guidelines mean for drug developers

Preparing the next generation of drug discovery scientists

Trending Sources

Antibody Drug Conjugates: windows of opportunity

New strategy for COVID-19 prophylaxis?

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

FDA Advisory Committee Review of 2021

Eplontersen

Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients with Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

In Silico Modeling Unveils a New Era in Rare Disease Drug Development

Re-assessing the risks of drug-induced arrhythmias during drug discovery

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Latest news on drug repurposing in oncology #16

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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