Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Additionally, keeping sites, principal investigators (PIs), and patients informed of changes and updates can present challenges.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. ZYTIGA ® is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8.

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The Pharma Data

APRIL 11, 2023

The presentation highlights the synergistic anti-cancer effects of a PSMA (prostate-specific membrane antigen)-actinium-225 conjugate in combination with darolutamide in preclinical prostate cancer models. Data from all three areas of scientific focus will be showcased during this year’s meeting.

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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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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 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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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A PMR is a study “that sponsors are required to conduct under one or more statutes or regulations,” whereas a PMC is a study “that a sponsor has agreed to conduct, but that are not required by a statute or regulation” (see FDA Webpage, Postmarketing Requirements and Commitments: Introduction ).

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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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Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. The single-cell transcriptomic analysis in the Sci Reports paper 1 provides insights into SRP-001’s pain-relief mechanisms.

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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.

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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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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. June 2019). 369 (3): 311–317. 118.254268.

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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. Read the full AgencyIQ analysis here.

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Metabolite Tales Blog

DECEMBER 13, 2023

Conversely, and interestingly, UGTs present in the bladder can protect against accumulation of toxins since they are highly expressed on the surface of bladder tissue, particularly in females where it is postulated that the lower incidence of bladder cancer is related to increased UGT isoform activity. J Pharm Biomed Anal. Oncotarget.

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The Pharma Data

DECEMBER 23, 2020

Vocabria is intended for adults who are virologically suppressed on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. Following the acquisition, the arivis5D content platform will be rebranded to neuronOS.

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New Drug Approvals

SEPTEMBER 29, 2024

According to a company press release and a poster presentation at the 2018 CTAD conference, healthy adults received 25, 50, or 100 mg COR388 or placebo every 12 hours for 10 days; AD patients took 50 mg or placebo every 12 hours for 28 days. The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar.

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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. Dermavant’s tapinarof is one such friend.

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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.

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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. countries. “And

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The Pharma Data

APRIL 27, 2021

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). About the Phase 1/2 Trial. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

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The Anticancer Fund

JUNE 7, 2022

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). This pharmacokinetic study (n=9) compared half-dose erlotinib (75 mg/day) with the HIV drug ritonavir (200 mg/day) with full-dose erlotinib (150 mg/day).

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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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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. The Phase 2a results will be submitted for presentation at an upcoming scientific meeting. NASH Investor Event Information.

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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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Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. months, according to the GSK presentation.

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Agency IQ

FEBRUARY 2, 2024

The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. This collaboration examining trial formats involved “numerous discussions with regulators, including the US FDA and the EMA Innovation Task Force,” as well as workshops.

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Agency IQ

FEBRUARY 23, 2024

In between, panelists and presenters also discussed alternative designs for dose-finding trials and creative strategies for evaluating and modeling early clinical data. All panels featured at least one representative from the FDA to offer the regulatory perspective on the discussions at hand. . …

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Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

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New Drug Approvals

JANUARY 9, 2024

The present invention is directed to methods of preparation of compound of formula (I) that is useful for inhibiting Cyclin-dependent kinase 7 (CDK7) and for treating diseases or disorders mediated thereby. In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. 1004-1014, 2004). Konig et al.,

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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. CBER-regulated products are no longer within scope of the guidance. Furthermore, nonhuman primates are not required nor indicated in the new guidance for any studies.

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The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients.

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Alta Sciences

DECEMBER 31, 2024

The issue also features a drug-drug interaction case study, in which the effects of two doses of a sponsors investigational product on the pharmacokinetics of multiple oral doses of clopidogrel, and a single dose of warfarin in healthy adult subjects were evaluated. The Altascientist, Issue 7, pg.

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FDA Law Blog: Biosimilars

MAY 21, 2024

The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration.

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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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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. Today, though, patients, clinicians, and regulators expect more.

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The Pharma Data

MARCH 30, 2021

It is vital that we work together with health authorities, regulators and industry to ensure we can get this medicine to the patients who need it as soon as possible.’’. Roche is working closely with reimbursement and assessment bodies in European countries to enable broad and rapid access to patients in need.

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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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