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.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

PPD

MAY 11, 2023

Historically, the elderly have been under-represented in clinical trials that include study participants 18 years of age and older. However, due to the pharmacokinetic and pharmacodynamic physiological changes that come with age and the presence of multi-morbidity, this type of extrapolation is not entirely appropriate.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

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. Abstract 2361.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

SEPTEMBER 1, 2020

The trial included 2,494 patients who had previously completed a Phase 1, 2 or 3 Zeposia clinical trial and who had an average treatment time of 35.4 These data (Presentation #P0217) will be presented at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. Presentation Number: P0217. Presentation Topic: Clinical Trials.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

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). “The

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

LifeSciVC

OCTOBER 10, 2024

At the congress, we were thrilled to share some of the clinical data emerging from our Phase 1 program , an ongoing study evaluating our potent and selective investigational CBL-B inhibitor, HST-1011, in patients with advanced solid tumors.

Therapies 63

Therapies Clinical Development Pharmacokinetics Treatment 63

The Pharma Data

AUGUST 29, 2020

Basel, August 29, 2020 — Novartis today announced new Phase II data for LNP023, an investigational oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), presented at the virtually held 2020 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting.

Treatment 52

Treatment Disease Small Molecule Production 52

The Pharma Data

NOVEMBER 4, 2020

New CTP-543 Data Presented in Late-Breaking News Session at EADV 2020. Initial data from an ongoing long-term, open label extension study with CTP-543 were presented in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Virtual Congress on October 29, 2020.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

The Premier Consulting Blog

JULY 31, 2024

Clinical Pharmacology in Drug Development Clinical pharmacology in drug development covers all aspects of interaction between humans and drugs. Clinical pharmacology studies include both in vitro studies using human biomaterials and in vivo human studies and are focused on characterizing pharmacokinetics (PK) (e.g.,

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 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. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78. Harth S, Ten Haaf A, Loew C, et al.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

DECEMBER 13, 2020

The Phase 2a results will be submitted for presentation at an upcoming scientific meeting. The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. NASH Investor Event Information.

Trials 52

Trials Disease Treatment Pharmacokinetics 52

The Pharma Data

DECEMBER 5, 2020

The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Use of Retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older.

Research 52

Research Therapies Treatment Trials 52

The Pharma Data

APRIL 8, 2021

Additional presentations on investigational programmes, including Alzheimer’s disease and Huntington’s disease, help advance scientific understanding of neurological disorders. Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.”

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

The Pharma Data

MARCH 5, 2021

The data in the publication include key findings previously presented at the 2020 American Society of Hematology (ASH) Annual Meeting. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. chief medical officer of Loxo Oncology at Lilly. The primary endpoint for Phase 2 is ORR.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Presentation at J.P. Pipeline Updates.

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

NOVEMBER 11, 2020

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As Viruses work by infecting host cells and hijacking the cell’s replication machinery.

Treatment 52

Treatment Small Molecule Virus Pharmacokinetics 52

Drug Target Review

JULY 1, 2024

Can you discuss the single-cell transcriptomic analysis presented in the paper and its implications for understanding the pain-relief mechanisms of SRP-001? SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

Alta Sciences

APRIL 17, 2024

They work by binding to specific sequences of nucleotides present within the mRNA structure and can induce mechanisms that either decrease, restore, or modify protein expression. Several small molecule GLP-1R agonists, such as oral orforglipron, are in late-stage clinical development. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Therapies 52

The Pharma Data

MARCH 8, 2021

We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “We

Trials 52

Trials Clinical Trials Pharmacokinetics Research Laboratories 52

Metabolite Tales Blog

JANUARY 23, 2024

Interestingly RA103488 is formed by ω-hydroxylation of the C16 lipid tail by CYP4F2 and has pharmacological activity similar to zilucoplan, However, since it is present at a much lower concentration compared to the parent drug the contribution of RA103488 to pharmacological activity is predicted to be low. link] [9] Patent EP1242061B1.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

Agency IQ

AUGUST 16, 2024

Even though chemotherapies, both as monotherapy and in combination with other products, have become a mainstay in the treatment of most cancers today, they present many drawbacks. Furthermore, these products present risk for serious harm if administered incorrectly.

Production 40

Production FDA Science Clinical Trials 40

The Pharma Data

MARCH 17, 2021

This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. The detailed data were presented at the virtual 17th St. The abstracts presented at St. Gallen International Breast Cancer Conference.

Trials 52

Trials Therapies Treatment Pharmacokinetics 52

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

SEPTEMBER 15, 2020

New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Metabolite Tales Blog

APRIL 4, 2023

A poster presentation at the 2022 ISSX meeting on metabolism of MRTX849 revealed three circulating metabolites, M11, M55a and M68, at > 10% following a single oral dose. The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Acta Pharm Sin B. 2018 Sep;8(5):721-732.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

JUNE 9, 2023

However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product. For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development.

FDA 40

FDA Small Molecule Science Immune Response 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety.

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

DECEMBER 11, 2023

OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings. months, according to the GSK presentation. To start, age was repeatedly mentioned by OCE presenters at meetings in 2023 and was featured in several guidance documents published by OCE as well.

FDA 40

FDA Science Clinical Trials Trials 40

The Pharma Data

MARCH 20, 2023

The data were presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, March 19-22, 2023. The longer-term results of this study add to the robust body of findings from our broad clinical trial programme evaluating Evrysdi across a variety of ages, disease severities and treatment histories.”

Pharmacokinetics 40

Pharmacokinetics Treatment Clinical Trials Trials 40

The Pharma Data

MARCH 16, 2021

These data will be presented at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference taking place from March 15-18. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. and 10%, respectively), nasopharyngitis (21.7%

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

The Pharma Data

MARCH 30, 2021

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Maintenance of Orphan Drug Designation was recently confirmed by the Committee for Orphan Medicinal Products based on the assumption of Evrysdi’s significant benefit over existing treatments. About FIREFISH.

Treatment 52

Treatment Clinical Trials Pharmacokinetics Trials 52

The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. Results will be presented at the virtual CHEST Annual Meeting this weekend.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52

The Pharma Data

SEPTEMBER 27, 2020

The data were presented at the virtual 25th International Annual Congress of the World Muscle Society. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. months later. None of these were attributed by the investigator as related to Evrysdi.

Pharmacokinetics 52

Pharmacokinetics FDA Approval Treatment Clinical Trials 52

Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. representative population.

FDA 40

FDA Science Clinical Trials Production 40