Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” Industry wants its products reviewed quickly, efficiently and predictably. Without sufficient resources, the FDA is unable to do so. FDA has previously worked with ACMT.

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LifeSciVC

APRIL 24, 2024

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. To impart “gain-of-function” pharmacology, consider inducing or up-regulating expression (e.g.,

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The Pharma Data

MARCH 25, 2022

To date, 170 of the 194 WHO Member States have reported the use of traditional medicine, and their governments have asked for WHO’s support in creating a body of reliable evidence and data on traditional medicine practices and products. May the global centre at Jamnagar help in providing the best healthcare solutions to the world.”.

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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 FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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Vial

MARCH 15, 2024

Examples of vendors include: Laboratories : CROs often collaborate with specialized laboratories for various purposes, such as sample analysis or pharmacokinetic studies, among others. These collaborations with external vendors are aimed at accessing specialized expertise, technologies, or resources that they may not have in-house.

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Agency IQ

AUGUST 11, 2023

The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management. In a new contract notice , FDA seeks sources that could furnish “ThinkTrends Software Support for Optical Character Recognition (OCR) PDF Extraction.”

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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.

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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. The road to research on psychedelic products is paved with obstacles.

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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

JULY 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies,” said Levi Garraway, M.D., About Roche’s response to the COVID-19 pandemic.

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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. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition.

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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.

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The Pharma Data

APRIL 27, 2021

The review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners. Takeda has established an Expanded Access Program (EAP) ( NCT04535557 ) for patients in the U.S.

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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. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products.

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The Pharma Data

MAY 17, 2023

Roche’s Chief Medical Officer and Head of Global Product Development. BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia.

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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. BioXcel Therapeutics, Inc.

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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. You should not place undue reliance on these statements.

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The Pharma Data

FEBRUARY 8, 2021

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Food and Drug Administration (FDA). 2,3 In the U.S.,

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New Drug Approvals

JANUARY 9, 2024

In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. Blood, 1, 4307-4312, 1997; The transcriptional non-selective cyclin-dependent kinase inhibitor flavopiridol induces apoptosis in multiple myeloma cells through transcriptional repression and down-regulation of Mcl-1; (Gojoet al.,

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Agency IQ

AUGUST 16, 2024

FDA solidifies its advice on dose optimization for oncology products Just over a year after it released the draft guidance, the FDA has finalized its guidance on dose optimization for oncology products. The MTD represents the point at which the serious toxicities outpace the therapeutic benefits of these products.

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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 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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The Pharma Data

MARCH 25, 2021

Chief Development Officer, Oncology, Pfizer Global Product Development. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. 2,3 In the U.S.,

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The Pharma Data

JULY 21, 2021

There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties.

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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

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. Imeglimin , Poxel’s first-in-class lead product, targets mitochondrial dysfunction. NASH Investor Event Information.

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Agency IQ

AUGUST 9, 2024

At a high level, the guidance laid out a policy whereby sponsors of certain products would voluntarily submit a Race and Ethnicity Diversity Plan as part of their development program that would outline and justify their approach to recruiting and retaining a “representative” research population. What programs or products need a DAP?

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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. The Food and Drug Omnibus Reform Act (FDORA) gave FDA new statutory authority and responsibilities.

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The Pharma Data

APRIL 26, 2022

The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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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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Agency IQ

JUNE 9, 2023

Before a drug or biological product can be moved into clinical studies, sponsors must conduct nonclinical studies to demonstrate the product is reasonably safe and that its pharmacological effects and mechanisms of action are sufficiently characterized. Nonclinical studies encompass much more than just animal studies. Pivotal (i.e.,

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The Pharma Data

JANUARY 19, 2021

This milestone supports the transition of Aptorum Group to a clinical-stage company and reflects the potential of our scientific rigor and novel approach of our products. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

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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.” Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

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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.

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New Drug Approvals

SEPTEMBER 29, 2024

gingivalis infection led to the appearance of bacterial DNA in the brain, increased brain Aβ42 production, neuroinflammation, and hippocampal degeneration. The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. In the same study, they show that in mice, oral P. All volunteers with AD had P.

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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. The review of the data is being carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Review will support a formal Marketing Authorisation Application. GlaxoSmithKline plc and Vir Biotechnology, Inc.

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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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