Clinical Development, Clinical Pharmacology and Trials

News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.”

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Clinical Development

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

Clinical Trials

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

Clinical Trials

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Biomarker identification in the realm of rare diseases

Drug Target Review

MAY 7, 2024

AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. By leveraging AI technologies, we could create a more accessible and equitable approach to clinical trials, breaking down barriers to participation and ensuring diverse representation among participants.

Disease

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Top 10 Life Science Resources

Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read it now. The Altascientist : Issue No. Read or listen now. Listen here.

Science

Science Clinical Trials Pharmacokinetics Pharmacy

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

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. Food & Drug Administration.

Treatment

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Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

The Pharma Data

OCTOBER 1, 2021

Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. CESTidentified through 52 weeks of knowledge.

Disease

Disease Laboratories Clinical Pharmacology Treatment

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

Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.

Science

Science FDA Clinical Trials Clinical Pharmacology

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

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

The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

Drug Development

Drug Development Disease Clinical Trials Drugs

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

Clinical Trials

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology

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

Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. These issues are especially apparent in treatments that are intended for chronic use.

FDA

FDA Science Clinical Trials Trials

BioSpace Movers & Shakers, Oct. 16

The Pharma Data

OCTOBER 15, 2020

OncoSec Medical – Sanda Aung was named chief clinical development officer for OncoSec Medical Incorporated. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. Nardi previously served as vice president of Worldwide Manufacturing at Iradimed Corporation.

Pharmaceuticals

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Drug Discovery Digest

News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Trending Sources

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Biomarker identification in the realm of rare diseases

Top 10 Life Science Resources

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)

Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

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

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

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

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

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

BioSpace Movers & Shakers, Oct. 16

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