The Pharma Data

MARCH 25, 2022

Artificial intelligence is now used to map evidence and trends in traditional medicine and to screen natural products for pharmacokinetic properties. For more information, see: who.int/initiatives/who-global-centre-for-traditional-medicine/ . There has been a rapid modernization of the ways traditional medicine is being studied.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

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New Drug Approvals

OCTOBER 24, 2023

“The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78” WHO Drug Information. June 2019). 369 (3): 311–317.

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Agency IQ

DECEMBER 1, 2023

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. However, the revision provided much more detail given the amount of information on Covid-19 that was gained between May 2020 and February 2021. drug-drug interactions) and intrinsic factors (e.g.,

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here. IMPORTANT IBRANCE® (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION.

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The Pharma Data

MARCH 25, 2021

“Real-world evidence is increasingly used to complement traditional randomized clinical trial data to better understand a therapy’s effectiveness in routine clinical practice and inform treatment decisions,” said Angela DeMichele, M.D., Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here.

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The Pharma Data

APRIL 27, 2021

Additional information about Takeda’s EAP is available here. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). For more information, visit www.takedaoncology.com. For more information, visit [link].

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The Pharma Data

APRIL 11, 2023

A focus of the presentation will be on the target engagement results and pharmacokinetics from its ongoing monotherapy dose-escalation study to explore a potential optimal dose and schedule to effectively inhibit AhR.

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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. SOURCE: Hepion Pharmaceuticals, Inc. .

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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.

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The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. For further information, please contact: Stephen Kilmer Hepion Pharmaceuticals Investor Relations Direct: (646) 274-3580 skilmer@hepionpharma.com.

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The Pharma Data

AUGUST 29, 2020

About the Study NCT03439839 is a Phase II, multicenter, open-label, sequential 2-cohort trial to assess the safety, efficacy, tolerability and pharmacokinetics/pharmacodynamics of LNP023 in PNH patients (cohort 1: n=10) with active hemolysis despite treatment with eculizumab.

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The Pharma Data

OCTOBER 25, 2020

This trial is a multicenter, randomized, double-blind, placebo-controlled, ascending, dose-finding, adaptive Phase 2 study designed to evaluate the safety, pharmacokinetics and efficacy of BXCL501 in intensive care unit patients experiencing agitation associated with delirium, including COVID-19 patients. Forward-Looking Statements.

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The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. NASH Investor Event Information. For more information, please visit: www.poxelpharma.com. About PXL770.

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The Premier Consulting Blog

JULY 31, 2024

Regulatory Pathway 505(b)(2) versus 505(b)(1) In the US, novel new small molecule drug products, including some peptides, are regulated, and approved by the FDA under the Federal Food, Drug, and Cosmetic Act (the “Federal FD&C Act”) under two key regulatory pathways: Section 505(b)(1) and Section 505(b)(2) NDAs.

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Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. Generation by phage display and characterization of drug-target complex-specific antibodies for pharmacokinetic analysis of biotherapeutics.

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The Pharma Data

JULY 21, 2021

For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-Looking Statement of Merck & Co.,

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LifeSciVC

APRIL 24, 2024

For KLK5 and KLK7 as well as their endogenous regulator (LEKTI, encoded by SPINK5 ) and one of their substrates (filaggrin, FLG ) there is evidence that KLK5 and 7 up-regulation is pathogenic and down-regulation protective in epidermal barrier dysfunction (especially for Atopic Dermatitis). in the case of CFTR for Trikafta).

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Agency IQ

DECEMBER 11, 2023

So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans. This includes the specific format and content of the plans, such as the rationale for enrollment goals (e.g., Policy-wise, this is still a work in progress.

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Agency IQ

AUGUST 9, 2024

Per Section 3602 of the Consolidated Appropriations Act, this guidance should include information about the specific format and content of the plans, such as the rationale for enrollment goals (e.g., The guidance also includes a section describing the process for sponsors to seek a waiver from the DAP requirements.

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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.

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The Pharma Data

APRIL 26, 2022

Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults. Related Information. Patients in this pediatric phase 2/3 trial received Veklury for up to 10 days.

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The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4. Disclaimer and Forward-Looking Statements.

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The Pharma Data

JANUARY 19, 2021

The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. For more information about Aptorum Group, please visit www.aptorumgroup.com. About ALS-4. Disclaimer and Forward-Looking Statements.

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Agency IQ

FEBRUARY 23, 2024

The discussions in this workshop incorporated the content of a draft guidance document on the topic released by the FDA in 2023, as well as the information shared in another series of workshops co-hosted by the FDA and the American Society of Clinical Oncology (ASCO), which occurred in 2022 and 2023.

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PPD

JUNE 20, 2023

The staff transfer team at the PPD clinical research business of Thermo Fisher Scientific provides transfer success rates that average nearly 90% for FSP engagements and are experts in Acquired Rights Directive laws and regulations.

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The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME.

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Alta Sciences

JULY 31, 2024

Additionally, age-related physiological changes can alter the pharmacokinetics and pharmacodynamics of drugs, often reducing the body's ability to metabolize or eliminate certain medications, which may result in prolonged presence in the system. Discover how drug developers, researchers, and regulators are ensuring this happens.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition.

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Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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Agency IQ

AUGUST 16, 2024

Today, though, patients, clinicians, and regulators expect more. Pharmacokinetic (PK) sample and analysis planning: Generally, the recommendations in the final guidance are nearly identical to those contained in the draft, with a few exceptions.

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The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. For further information please visit www.gsk.com/about-us.

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The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. . .

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The Pharma Data

JANUARY 21, 2021

Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, Vocabria, or rilpivirine. Please see full Prescribing Information. EDURANT ® Important Safety Information. Please see full Prescribing Information for more details. . DRUG INTERACTIONS.

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