The Pharma Data

NOVEMBER 9, 2021

Data will be presented on the safety and efficacity of Epclusa ® (400 mg sofosbuvir/ 100 mg velpatasvir) in a broad range of people, including those withco-morbidities (PO-0940, 0927).

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The Pharma Data

MARCH 9, 2021

and Shionogi Limited as shareholders, presented positive data from its phase IIa proof-of-concept study of the investigational maturation inhibitor GSK3640254 (GSK’254). These findings were presented today at the (virtual) 2021 Conference on Retroviruses and Opportunistic Infections (CROI). log 10 and -2.0

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biobide

SEPTEMBER 29, 2023

However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model.

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The Pharma Data

JULY 11, 2021

3 These data are being presented at the 2021 European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress in Krakow, Poland and Madrid, Spain. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. percent and a median reduction of 98.2

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The Premier Consulting Blog

APRIL 15, 2024

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. For example, if the nonclinical data presented in the PIND briefing document lacks information on the potential toxicity profile of the drug (e.g.,

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BMG Labtech

MARCH 11, 2024

In drug development and discovery, ELISAs are useful to quantify drug concentrations in biological samples where they find applications in studies of drug efficacy, pharmacokinetics, and pharmacodynamics. If more analyte is present in the sample, increasing amounts of detection antibody and signaling enzyme bind to the analyte.

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The Premier Consulting Blog

AUGUST 8, 2024

For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., patients with renal, hepatic, or cardiovascular concerns).

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Drug Target Review

SEPTEMBER 25, 2024

5 Here, the original oncogene is still present but the transdifferentiated cancer cells are less dependent on it. Investigating non-oncogene resistance as a parallel defense mechanism used by cancer cells to evade therapies could therefore present a significant opportunity to address drug resistance more comprehensively.

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Alta Sciences

OCTOBER 30, 2023

34: Toxicokinetics, Pharmacokinetics, and Pharmacodynamics Take a closer look at the collection and use of pharmacokinetic (PK) and pharmacodynamic (PD) data in early phase drug development, as well as the critical role of nonclinical toxicokinetic (TK) studies in guiding early phase clinical trials. Watch the video. Watch it now.

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The Pharma Data

APRIL 4, 2023

The HCF formulation is presented in the same auto-injector as currently available to patients, aiming for an enhanced yet familiar patient experience. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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The Pharma Data

JULY 6, 2021

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. Ab stract # PB0526 Fitusiran population pharmacokinetic and pharmacodynamic (PopPK/PD) modeling to support revised dose, dosing regimens and dose mitigation scheme.

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DrugBank

MARCH 7, 2024

Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges. Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options.

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PPD

JULY 29, 2024

This blog presents examples that demonstrate how AI can be used throughout the drug development process, with a specific focus on patient enrollment. AI has the capability to analyze and forecast the pharmacokinetic (PK) profiles of drugs following their administration.

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Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs. These changes can impact staffing requirements throughout the study.

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Drug Target Review

NOVEMBER 1, 2023

2,8-10 However, the number of compounds with satisfying pharmacokinetic parameters (PKD) are limited, with most unable to cross the blood-brain barrier or go sufficiently deep into a malignant tumour. Pleotropic Roles of Autotaxin in the Nervous System Present Opportunities for the Development of Novel Therapeutics for Neurological Diseases.

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The Pharma Data

APRIL 22, 2023

Nasdaq: GILD) today announced positive results from several COVID-19 clinical and real-world evidence studies being presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Veklury® (Remdesivir) Efficacy and Safety Profile Further Demonstrated in Vulnerable Patient Populations Gilead Sciences, Inc.

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The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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Agency IQ

SEPTEMBER 15, 2023

According to the FDA’s agenda, linked above, and the meeting minutes , Leslie Hendeles, Randy Hatton, and Jonathan Shuster of the University of Florida gave presentations supporting the assertions they had made in their petition. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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The Pharma Data

NOVEMBER 5, 2021

The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting. With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

Additionally, this review excluded pharmacokinetic and animal studies. FDA often presents PMRs to applicants as a required condition of drug approval. This review was limited to drugs with approved New Drug Applications (NDAs); biologics and vaccines were excluded.

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Drug Target Review

JUNE 6, 2023

In the context of a tumour microenvironment, Tregs are often present in high numbers, preventing an effective immune response to the tumour. 2 After activation by an antigen presenting cell, a T helper cell segregates the cytokines. Some approaches have already reached the clinical trial stage, with others not far behind.

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The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. P-tau217 in blood showed promise as additional biomarker of efficacy- Donanemab treatment led to 24% lowering of P-tau217 from baseline.

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Agency IQ

MAY 17, 2024

A Supervisory Regulatory Health Project Manager within the FDA’s Office of Generic Drugs (OGD), KAREN BENGTSON, explained that PSUB meetings should be used to “present unique or novel data or information that will be included in an ANDA submission.” Meetings run about one hour total and should flow according to the applicant’s presentation.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. On-Demand Oral Presentation OAB0304.

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Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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The Pharma Data

SEPTEMBER 1, 2020

These data (Presentation #P0217) will be presented at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. At the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, Bristol Myers Squibb and collaborators will present 15 clinical and non-clinical abstracts that reinforce the breadth and depth of the company’s research in MS.

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The Pharma Data

SEPTEMBER 8, 2021

today announced that data from its migraine portfolio will be presented at the International Headache Congress 2021, held jointly this year by the International Headache Society and the European Headache Federation, from September 8-12. The company will share a total of 23 abstracts, including two oral presentations and one abstract lecture.

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The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The company anticipates submitting study results for presentation at an upcoming medical congress.

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New Drug Approvals

OCTOBER 24, 2023

1 Therefore, S1P receptor modulators like etrasimod were investigated in treating immune-mediated diseases like ulcerative colitis where a high level of inflammatory T cells is present in the gastrointestinal tract, thus causing diffuse mucosal inflammation. twitter +919321316780 call whatsaapp EMAIL.

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The Pharma Data

MARCH 13, 2021

If approved, lanadelumab will be available to patients in Japan as a pre-filled syringe presentation. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. 1 Most treatment-emergent adverse events (98.5%) were mild to moderate in severity. Interactions.

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The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. We look forward to discussing these data with global health authorities.

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The ChEMBL-og

JUNE 13, 2023

In these assays, tissues were not present in the cell-based experiments and the cell source tissue had been incorrectly used to populate the tissue field. Formula: STANDARD_VALUE / MW_FREEBASE * 10^6 where STANDARD_VALUE is in ug.mL-1 1 and MW_FREEBASE in g/mol The tissue annotation was removed from approx. 50,000 legacy assays.

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PerkinElmer

JUNE 3, 2022

2 In the present study, the researchers report that PF-07321332 demonstrated potent inhibition in FRET M pro assays representing M pro from all coronavirus types known to infect humans. 2 PF-07321332, which is now being tested in clinical trials, 3 is a nitrile-containing derivative of PF-00835231.

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Chemical Biology and Drug Design

AUGUST 18, 2024

The present work systematically gives a comprehensive review in current developments of benzimidazole–oxadiazole hybrid compounds in the whole range of medicinal chemistry and the perspectives that they hold for future research. Benzimidazole and oxadiazole cores can either be fused or incorporated using either functional groups/bonds.

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