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. patients with renal, hepatic, or cardiovascular concerns).

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Drug Target Review

SEPTEMBER 25, 2024

2022 Dec 12 [cited 2024 Sep 4];22(3):213–34. A phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of TT125-802 in patients with advanced solid tumors. References 1.Jin Jin H, Wang L, Bernards R. Nature Reviews Drug Discovery [Internet]. Available from: [link] 2.Bell

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The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2022 sales of USD 9.2

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New Drug Approvals

DECEMBER 24, 2023

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. 330 (15): 1448–1458. doi : 10.1001/jama.2023.18688. 2023.18688. PMC 10540057. PMID 37768671. Diep, John K.; Yu, Rosie Z.;

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DrugBaron

FEBRUARY 7, 2022

Another common pitfall in medicinal chemistry is optimise one characteristic at once: find super-potent molecules, then try and ‘fix’ the pharmacokinetics and then try and improve the pharmaceutical properties and so on. A video of the whole discussion is also available on the RxCelerate Youtube channel.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1]

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The Premier Consulting Blog

JANUARY 31, 2023

On November 1, 2022, the U.S. Pharmacokinetic and systemic exposure data is also important to consider. Source: ICH S1B(R1), August 2022. 2022 Jan;35(1):53-73. The information should be relevant according to six key WoE factors: target biology, secondary pharmacology, previously conducted studies (e.g., J Toxicol Pathol.

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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. The onsite launch of the new WHO global centre for traditional medicine in Jamnagar, Gujarat, India will take place on April 21, 2022.For Source link: [link].

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Metabolite Tales Blog

JANUARY 23, 2024

The bigger picture An analysis of the metabolism of most commonly prescribed drugs in 2022 [2] revealed that of the 89 subject to drug metabolism, 75% were cleared via phase I mechanisms, with nearly half of these metabolised by CYP3A4. Pharmacokinetics and Metabolism of Nirmatrelvir. 2] Iversen et al., Basic Clin Pharmacol Toxicol.

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Drug Target Review

SEPTEMBER 19, 2023

The organoid technology recreates different disease scenarios in addition to the healthy models with age specific phenotypes and enables recreating drug specific Pharmacokinetics that is more relevant to human in vivo system.

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The Pharma Data

OCTOBER 27, 2020

million Series A gives it the capital to take their PRTX007 candidate into a short-term pharmacokinetic, pharmacodynamic and tolerability study, followed by a clinical proof-of-concept in an acute viral disease setting. The bladder cancer therapy is expected to be in the clinic by 2022. The company’s $27.4

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Practical Cheminformatics

JANUARY 8, 2024

In 2022, several papers , including one of ours , showed the promise of active learning approaches in drug discovery. In our 2022 paper , we evaluated 5 different ML models and saw minimal differences in performance. The ML model can predict the remaining molecules' free energies and prioritize the next set of free energy calculations.

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Alta Sciences

APRIL 17, 2024

According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. In 2022, a GIP-GLP-1R coagonist, tirzepatide, used to treat people with T2D, was found to produce significant weight loss and was also approved for treatment of obesity.

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New Drug Approvals

OCTOBER 24, 2023

July 2022). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . “Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. 401 (10383): 1159–1171. PMID 36871574. ^

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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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New Drug Approvals

JANUARY 31, 2024

citation needed ] The pharmacokinetic properties of obeldesivir and improved was first published by Chinese researchers in May 2022. References ^ “Clinical Trials Register” ^ “Gilead touts Veklury resilience against mutated coronavirus, plots phase 3 for new COVID oral antiviral” 19 October 2022. ^ Cho, A.;

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Agency IQ

AUGUST 9, 2024

While the new version of the guidance is greatly expanded as compared to an earlier version from 2022, it has left plenty of important questions unanswered. In this piece, AgencyIQ answers some of the most common questions we’ve received about the guidance – and raise a few of our own. What happens if you don’t meet your goals?

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Agency IQ

DECEMBER 11, 2023

BY LAURA DIANGELO, MPH | DEC 4, 2023 2:46 PM EST Diversity in clinical research: Guidance and statute In April 2022, the FDA issued a new draft guidance document on diversity in clinical research programs. FDORA was passed into law in December 2022 as part of the end-of-year 2023 federal spending bill.

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Metabolite Tales Blog

DECEMBER 13, 2023

8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. J Pharm Biomed Anal. 22(5):803-11; [link] [10] Glucuronidation and UGT isozymes in bladder: new targets for the treatment of uroepithelial carcinomas? Sundararaghavan VL, Sindhwani P, Hinds TD Jr. Oncotarget.

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Agency IQ

AUGUST 11, 2023

The FDA issued a draft guidance on RRAs outside of the Covid-19 PHE context in July of 2022, which stated that all RRA-associated documents should be submitted in electronic format, and even paper documents should be scanned as searchable Portable Document Format (PDF) files for submission.

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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. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. billion euros.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity. billion for pseudoephedrine.

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Metabolite Tales Blog

MARCH 1, 2023

2018, 26, 965-972 [link] 4a Pharmaceutics, 2022, 14, 1001 [link] 5 Phys. 2010, 75, 9, 3141–3143 [link] 22 Clin Pharmacokinet. 2017, 30, 1, 13–37 [link] 2a Drug Metab. 2006 , 34, 145-51 [link] 3 Drug Metab. 1980, 8, 34-38 [link] 4 J. Food Drug Anal. 2000, 2, 195-201 [link] 6 Biochem. 1966 98, 266-277 [link] 7 Metabolites.

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The Pharma Data

APRIL 8, 2021

We expect data from the studies in 2022. This includes the number of infants able to sit without support for 5 and 30 seconds, a key motor milestone not normally seen in the natural course of the disease, as well as data on event-free survival and reduced hospitalisations. Huntington’s Disease (HD).

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The Pharma Data

NOVEMBER 4, 2020

The Company expects to report topline results from the THRIVE-AA1 trial in 2022. Selective incorporation of deuterium into known molecules has the potential, on a case-by-case basis, to provide better pharmacokinetic or metabolic properties, thereby enhancing their clinical safety, tolerability or efficacy.

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Agency IQ

MAY 17, 2024

For the in vivo portion, the guidance states that applicants should conduct: 1) An in vivo pharmacokinetics (PK) study in fasting condition for both product strengths with healthy volunteers, and 2) an in vivo comparative clinical endpoint or pharmacodynamic (PD) study with patients.”

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The Pharma Data

JANUARY 10, 2021

. Ascendis anticipates completion of enrollment in foresiGHt, a global phase 3 trial evaluating the safety and efficacy of lonapegsomatropin in adult patients with GHD, by late 2021 or early 2022. . . . •. ?. . . •.

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New Drug Approvals

JANUARY 9, 2024

For drug development, it is typically advantageous to employ individual stereoisomers as they exhibit marked differences in pharmacodynamic, pharmacokinetic, and toxicological properties. Inhibitors of CDK7 are currently being developed for the treatment of cancer. mol) in THF (700mL) at -78 °C over a period of 30 min.

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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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The Pharma Data

OCTOBER 27, 2020

In October 2020 , we completed a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. our initial phase 1 study of OreniPro , which has since been completed. We also recommenced startup activities for the ADVANCE CAPACITY study of ralinepag.

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Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

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The Pharma Data

FEBRUARY 12, 2022

(Nasdaq GILD) moment blazoned new data from an interim analysis of its ongoing, Phase2/3 single arm, open- marker study to estimate the safety, tolerability and pharmacokinetics of Veklury ® (remdesivir) in pediatric cases rehabilitated with COVID-19 with periods ranging from 28 days to lower than 18 times.

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New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. Results were expected in May 2022. 2022 Oct;31(10):987-993.

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The Premier Consulting Blog

APRIL 25, 2023

In silico population pharmacokinetic (popPK) and physiologically-based pharmacokinetic (PBPK) modeling can reduce or eliminate certain clinical studies, as was done with the 505(b)(2) approval of the long-acting injectable Aristada® (aripiprazole lauroxil). [8] 8] US Food and Drug Administration (FDA).

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Agency IQ

JULY 28, 2023

In a September 2022 blog post , Califf acknowledged the broad scope of the crisis, saying ,“The opioid crisis has evolved beyond prescription opioids into a broader drug overdose crisis, largely driven by illicit fentanyl and its analogs. Read the full AgencyIQ analysis here.

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The Anticancer Fund

APRIL 1, 2022

1 April 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. It is one of the focus areas of the Anticancer Fund. Below, we have listed recent findings about the repurposing of generic drugs in oncology.

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The Pharma Data

JANUARY 26, 2021

Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. Patent protection until 2039. UPPSALA, Sweden , Jan. ” OX124 is planned to enter a pivotal bridging study in Q2 2021.

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