Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. As clinical trial design becomes more dynamic and adaptive, studies require more complex statistics and more specialized biostatisticians to ensure study data are relevant and scientifically valid.

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Trials Clinical Trials FDA Approval Animal Testing 52

Drug Discovery World

NOVEMBER 10, 2023

CAN-2409 in non-metastatic pancreatic cancer Candel Therapeutics reported on initial positive interim data from its Phase II clinical trial of CAN-2409 that showed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC). The estimated overall survival rate was 71.4%

Pharmacokinetics 130

Pharmacokinetics Clinical Trials Immune Response Treatment 130

Drug Discovery World

JANUARY 9, 2023

A PI3Kδ inhibitor, IOA-244 ( roginolisib) is being investigated in the DIONE-01 trial, a two-part, first-in-human Phase I study. Part A of the study investigated the safety and pharmacokinetics of continuous daily dosing of IOA-244 at 10, 20, 40 and 80mg. .

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FDA Drugs Pharmacokinetics Trials 130

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. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

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Drug Discovery World

NOVEMBER 15, 2022

Initial results show a dose-proportional pharmacokinetic (PK) profile and good tolerability with no serious adverse events reported. . The drug is under development for Treatment Resistant Depression and Alcohol Use Disorder and was assessed in combination with psychological support in 44 psychedelic-naïve participants. .

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Pharmacokinetics Treatment Drugs Trials 130

Drug Discovery World

JUNE 12, 2023

Those are the beginning of additional manufacturing, scale of chemistry pharmacokinetics, pharmacology assays, development bioanalytical assays, and then moving forward toxicology work to start the initial clinical trials. Then, we move forward with what are called Investigational New Drug enabling studies.

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Research Clinical Trials Doctors Assay Development 130

Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 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

Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. FDA no longer needs to require animal tests before human drug trials [Internet].

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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.

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Therapies Laboratories Pharmacokinetics Treatment 130

Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? There will probably already be some clinical data for the drug in question and this can save both time and money, as the company can secure regulatory approval without lengthy and costly early-stage clinical trials.

Clinical Pharmacology 100

Clinical Pharmacology Clinical Trials Drugs Trials 100

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. “We

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Pharmaceuticals Trials Pharmacokinetics 40

The Pharma Data

DECEMBER 28, 2020

The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. To date, there are no approved drugs to treat NASH.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Treatment 40

The Pharma Data

JANUARY 3, 2021

This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. The last patients in the trial received their final dose on 21 December 2020. The topline data from the trial is expected to be available in January 2021. NEW YORK and LONDON, Jan.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Drug Target Review

SEPTEMBER 25, 2024

At TOLREMO, we have developed a proprietary modular phenotypic screening platform that leverages transcriptional reprogramming events associated with non-genetic resistance to deliver new chemical scaffolds and identify novel resistance regulators. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet].

Small Molecule 105

Small Molecule Regulations Therapies Treatment 105

The Pharma Data

OCTOBER 25, 2020

The Company plans to initiate a Phase 2 trial within the next several months. “We An exploratory endpoint of this trial will be to determine the overall clinical improvement after drug administration using the Clinical Global Impression – Improvement Scale (“CGI-I”).

Treatment 52

Treatment Trials FDA Hospitals 52

The Pharma Data

NOVEMBER 17, 2021

The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. Encyclopedically, an estimated2.8

Treatment 52

Treatment Marketing Clinical Trials Biosimilars 52

The Pharma Data

DECEMBER 9, 2020

SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Hospitals 52

Hospitals Pharmacokinetics Treatment Trials 52

Drug Discovery World

SEPTEMBER 9, 2024

Study details The Phase I study was a two-part trial in 78 healthy volunteers investigating safety, tolerability, pharmacokinetics and pharmacodynamic target engagement endpoints across a range of separate dose levels.

Treatment 147

Treatment Pharmacokinetics Small Molecule Trials 147

The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm. controlled trial had not received previous systemic therapy for metastatic disease.

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52

The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM. and in Europe.

Trials 52

Trials Disease Treatment Regulations 52

The Pharma Data

APRIL 11, 2021

” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). In this cohort, the most common treatment-emergent adverse events of any grade (?20%) About LIBRETTO-001.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Government 52

Government Long-Term Care Facilities Hospitals Treatment 52

Agency IQ

AUGUST 11, 2023

In AgencyIQ’s thinking, the contract notice could also indicate that the FDA is working to build out its capabilities related to its new authority to conduct RRAs of facilities involved in clinical trials. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

The Pharma Data

SEPTEMBER 26, 2021

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA.

Treatment 40

Treatment Clinical Trials Virus Pharmacokinetics 40

Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

FDA 40

FDA Trials Regulations Therapies 40

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. Once metabolized, which occurs quickly with a half-life of approximately 1.5

Science 40

Science FDA Clinical Trials Pharmacy 40

The Pharma Data

OCTOBER 14, 2021

About MS PATHS Biogen sponsored the MS PATHS (Partners Advancing Technology and Health Solutions) network to foster collaboration between leading MS centers in the U.S. and Europe to help transform patient care by generating standardized data from a diverse, real-world patient population.

Vaccine 52

Vaccine Therapies Immune Response Disease 52

The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

Production 40

Production Trials Treatment Pharmaceuticals 40

The Pharma Data

AUGUST 19, 2021

The majority of treatment-related adverse events (AEs) were Grade 1-2. All events were Grade 1-2. 1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) as the primary endpoint. 1 The median time to first response was 4.1 months (range, 1.6–9.9).

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

Laboratories 52

Laboratories Production Treatment Disease 52

The Pharma Data

JULY 27, 2021

. “Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

Production 52

Production Clinical Trials Government Disease 52

The Pharma Data

APRIL 16, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

AUGUST 29, 2020

LNP023 also demonstrated a favorable safety and tolerability profile with no serious treatment-related infections or thromboembolic events. Following the cut-off date for the presented data, one participant, who had severe lymphopenia at study entry, discontinued treatment due to a serious adverse event (AE) of lymphoproliferative disorder.

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