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.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

The Pharma Data

AUGUST 28, 2020

Dr Matthias Liechti, a Professor of Clinical Pharmacology at the University of Basel and head of the research lab that will be working on the study, said: “The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer lasting effects than standalone psilocybin or LSD.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Therapies 52

Drug Target Review

AUGUST 7, 2024

The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation. This increases the chances of success in clinical trials and commercialisation, leading to better patient outcomes and a more competitive pharmaceutical industry.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

Eye on FDA

AUGUST 4, 2021

When Breakthrough Therapy (BT) designation is granted, then the drug gets Fast Track status and receives more intensive guidance – which can begin as early as Phase I clinical trials. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

FDA 122

FDA Clinical Pharmacology FDA Approval Therapies 122

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 59

Disease Clinical Trials Clinical Pharmacology Trials 59

Alta Sciences

JULY 25, 2024

Discover some of the nonclinical requirements for moving dermal studies into Phase I clinical trials, including formulation considerations, species selection, and ideal candidates for transdermal drug delivery systems (TDDS). The Altascientist: Issue No. Read or listen now. Watch the webinar. the UK, or the EU. View the podcast.

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

Alta Sciences

JANUARY 23, 2024

With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City. “It

Clinical Pharmacology 40

Clinical Pharmacology Clinical Trials Drug Development Clinical Research 40

Alta Sciences

MAY 15, 2023

Starting at formulation, through to preclinical testing, clinical manufacture, early phase clinical trials, and bioanalysis up to Phase IV, Altasciences' Proactive Drug Development Solution offers an innovative and seamlessly integrated drug development journey, with mulitple points of entry.

Drug Development 52

Drug Development Clinical Trials Laboratories Compounding Pharmacies 52

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. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

Alta Sciences

OCTOBER 30, 2023

Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now. Read the fact sheet. Read or listen now. Listen here.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

The Premier Consulting Blog

JUNE 8, 2023

The goal is to minimize regulatory and execution risks through a well-defined clinical, clinical pharmacology, nonclinical, and CMC (chemistry, manufacturing, and controls) development plan and a time and cost analysis for market entry. This robust plan will form the foundation of your pre-IND meeting preparation and discussion.

Clinical Pharmacology 52

Clinical Pharmacology FDA Drug Development Clinical Trials 52

The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Image GettyImages-897885148_pharmacy.jpg Tags Clinical Trials Regulatory Excellence - Licenses for Schedule I through IV drug substances. Fully equipped to support all types of IP administration forms.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Alta Sciences

OCTOBER 9, 2024

Altasciences’ integrated, full-service solutions include preclinical safety testing , clinical pharmacology and proof of concept , bioanalysis , program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Trials 40

Alta Sciences

AUGUST 28, 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. Learn more about the company at www.ischemix.com.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

The Pharma Data

FEBRUARY 15, 2022

In addition to this trial, enfortumab vedotin is being investigated as a monotherapy and in combination with other therapies in clinical trials across lines of treatment and stages of bladder cancer. Senior Vice President and Head of Late-Stage Development at Seagen.

Clinical Pharmacology 52

Clinical Pharmacology Trials Treatment Therapies 52

The Pharma Data

DECEMBER 17, 2020

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. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

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.

Treatment 52

Treatment Drugs Clinical Pharmacology Clinical Development 52

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 40

FDA Science Clinical Trials Trials 40

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

DECEMBER 1, 2023

Furthermore, the guidance offered a list of updated clinical outcome measures and offered insight on FDA’s evolving view of decentralized clinical trials and the use of real-world data to supplement trials. The FDA has streamlined its recommendations for sponsors enrolling patients in clinical trials.

FDA 40

FDA Clinical Trials Trials Vaccine 40

The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund. Pan Pantziarka is Programme Director Drug Repurposing of the Anticancer Fund.

Drugs 40

Drugs Clinical Trials Trials Treatment 40

Agency IQ

OCTOBER 6, 2023

Under the 351(k) pathway, 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.

FDA 52

FDA Biosimilars Science Drugs 52

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. Both trials showed no difference between phenylephrine and placebo.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

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]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

The Pharma Data

FEBRUARY 8, 2021

v] ERLEADA ® is being studied in five Phase 3 clinical trials. 2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea and fracture. All rights reserved.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

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 40

Science Biosimilars FDA Production 40

Agency IQ

JUNE 2, 2023

Start Date End Date Event Event Type Center 06/05/2023 06/09/2023 Regulatory Education for Industry (REdI) Annual Conference 2023 Virtual CDER 06/07/2023 06/08/2023 Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development Public CDER 06/07/2023 06/08/2023 RDEA Pilot Program 2023 Public Workshop Workshop (..)

FDA 40

FDA Science Regulations Production 40

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.” Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

OCTOBER 27, 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 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 8, 2024

Start Date End Date Event Event Type Center 07/10/2024 07/10/2024 Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method Webcast CDRH 07/10/2024 07/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care” Webcast (..)

FDA 40

FDA Science Regulations Production 40

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Treatment 52

Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40