Drug Discovery World

SEPTEMBER 13, 2024

The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. Following a six-week off-drug period, for assessment of pharmacokinetics, Part A was followed by an open-label extension (Part B). All endpoints were met. All endpoints were met.

Pharmacokinetics 147

Pharmacokinetics Drugs Treatment FDA 147

Drug Discovery World

DECEMBER 22, 2023

Neuroscience drug discovery company Sapient Therapeutics successfully completed Part B of the Phase I trial comparing its CBD therapy SAP021 with Epidiolex. When SAP021 was given with food the data were in alignment with both our expectations from Part A of the study and with previously published trial results.

Pharmacokinetics 130

Pharmacokinetics Clinical Development FDA Trials 130

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 80

Trials Clinical Trials Regulations FDA 80

Drug Discovery World

JANUARY 23, 2023

As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics. Additionally, the clinical trial period will be considerably shorter than that required for new drug development.

FDA Approval 130

FDA Approval FDA Drugs Pharmacokinetics 130

Drug Discovery World

FEBRUARY 14, 2024

The post Data shows restored motor function in mouse models of Parkinson’s disease appeared first on Drug Discovery World (DDW).

Disease 147

Disease Clinical Trials Pharmacokinetics Trials 147

Drug Discovery World

JULY 25, 2023

As such, guidance from the FDA and EMA on paediatric drug development and long-term safety is greatly appreciated, particularly given the unique challenges presented by this vulnerable population. General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Together, the tools estimate how a drug may impact diverse outcomes of interest to drug developers: general cellular health, pharmacokinetics, and heart and liver function.

Pharmacokinetics 84

Pharmacokinetics Molecular Biology Drugs FDA 84

Agency IQ

AUGUST 16, 2024

The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways On August 9, Lykos Therapeutics received a Complete Response Letter (CRL) from FDA stating the agency will not currently approve its application for midomafetamine (MDMA) to treat post-traumatic stress disorder.

FDA 40

FDA Trials Regulations Therapies 40

The Premier Consulting Blog

APRIL 15, 2024

However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety. It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

Drug Discovery World

APRIL 10, 2023

BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.

Pharmacokinetics 130

Pharmacokinetics FDA Approval Hospitals Treatment 130

Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

FDA 40

FDA Clinical Trials Vaccine Trials 40

Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. Typical clinical development timelines for anticancer drugs average an estimated 6.7

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 52

Drug Discovery World

JUNE 29, 2023

Recently, the US Food and Drug Administration (FDA) published new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs. The Phase IIa proof-of-concept trial will evaluate short-term changes in anxiety-related patient reported outcomes in approximately 50 healthy volunteers.

Drugs 130

Drugs Pharmacokinetics Trials FDA 130

Drug Discovery World

DECEMBER 4, 2023

“Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.” The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs.

Therapies 130

Therapies Treatment Pharmacokinetics Clinical Development 130

Agency IQ

AUGUST 11, 2023

FDA looking to beef up its remote assessments with artificial intelligence According to a new FDA contract notice, the agency is interested in procuring a new artificial intelligence-based Optical Character Recognition system to extract data from PDFs obtained during remote regulatory assessments. What does the FDA want to do, anyways?

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

The ChEMBL-og

APRIL 16, 2024

71 out of the 882 newly added EMA drugs are only authorised by EMA, rather than from other regulatory bodies e.g. FDA. Progress has been made towards standardising drug and clinical candidate pref_names (in MOLECULE_DICTIONARY.PREF_NAME) whereby an approved drug name (FDA /EMA) is assigned in the first instance, if available.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Packaging 108

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. Watch it now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

PPD

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials.

Clinical Research 98

Clinical Research Research Clinical Trials Trials 98

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. FDA-2024-N-0007. FDA-2023-N-2850. 89 FR 61474.

Pharmacokinetics 52

Pharmacokinetics FDA Production Drugs 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. We look forward to working with the FDA to bring ABP 798 to market.”. Although much of the U.S.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

MAY 5, 2021

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). . It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . controlled trial had not received previous systemic therapy for metastatic disease. New approvals. blind, placebo?controlled

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 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. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Ionis Pharmaceuticals.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

The Pharma Data

NOVEMBER 8, 2020

Food and Drug Administration (FDA) in terms of PDUFA dates. Here’s a look at some of the upcoming target action dates on the FDA’s calendar. . The company is also still conducting a Phase III trial in the adult ADHD patient population. The sNDA was built on data from the Phase III CANDOR trial.

FDA 52

FDA Trials Pharmaceuticals Pharmacokinetics 52

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

Clinical Trials 52

Clinical Trials Vaccine Trials Medical Schools 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Food and Drug Administration (FDA). Working with experienced providers can help clients build data sets that satisfy current and future FDA requirements.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

Drug Discovery World

APRIL 3, 2024

We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. Obtaining these results will allow us to reach a key milestone of the project: approval from the health authorities to test CM-352 in a Phase I clinical trial.

Therapies 130

Therapies Laboratories Pharmacokinetics Treatment 130

Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

Production 130

Production Pharma Companies Clinical Trials FDA 130

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 21 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. Additionally, this review excluded pharmacokinetic and animal studies.

Marketing 59

Marketing FDA Regulations Pharmacokinetics 59

Drug Discovery World

SEPTEMBER 26, 2022

Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. . However, challenges remain.

Pharmaceutical Companies 130

Pharmaceutical Companies Drugs Pharmaceuticals Clinical Trials 130

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. BOSTON, Jan.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Small Molecule 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] Food and Drug Administration (FDA). 1] It is taken by mouth. [1]

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. The Company plans to initiate a Phase 2 trial within the next several months. “We The Company also plans to initiate a Phase 2 trial in hospitalized patients suffering from agitation associated with delirium within the next several months.

Treatment 52

Treatment Trials FDA Hospitals 52