2019, Clinical Pharmacology, Disease and Trials

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. Providing a broad view.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Drug Development

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

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al.,

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al.,

Metabolic Stability

Metabolic Stability Drugs FDA Approval 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 Pharmacy

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

Agency IQ

JUNE 2, 2023

July 1, 2023 MDUFA Finalize the draft guidance, “Content of Premarket Submissions for Device Software Functions,” by 18 months from close of the comment period.

FDA

FDA Science Regulations Compliance

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

Drug Discovery World

AUGUST 15, 2023

Cardiovascular diseases are the leading cause of death globally. A more recent analysis has illustrated how both assay validity and reproducibility correlate across a population of simulated screening and disease models 2. Unexpected late-stage failures in drug development are, of course, the costliest.

Drugs

Drugs Clinical Pharmacology Disease Engineering

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

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. 2 ERLEADA ® received U.S.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Trials

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

Agency IQ

SEPTEMBER 29, 2023

This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.

FDA

FDA Science Regulations Production

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

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA

FDA Science Biosimilars Production

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

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

FDA

FDA Science Regulations Production

Drug Discovery Digest

Preparing the next generation of drug discovery scientists

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

Trending Sources

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

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

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

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

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

Janssen Presents Results from Phase 3 ACIS

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

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 November 2023

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

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