Drug Target Review

OCTOBER 3, 2024

In light of these key developments, the need for flexible yet highly specific and sensitive tools that provide vital information on a drug’s safety and efficacy are essential to help determine the best drug candidates for preclinical and clinical progression. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78.

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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 For more information, visit www.selvarx.com. Source link.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. For more information, visit www.scynexis.com. The study will be conducted in South Africa.

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Metabolite Tales Blog

JANUARY 23, 2024

[link] [3] FDA prescribing information for daprodustat. link] [5] FDA prescribing information for fezolinetant. link] [10] FDA prescribing information for gepirone. Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7 It can also potentially drive up net costs of the research.

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PPD

MAY 11, 2023

Some of the considerations include: Obtaining informed consent of parents or legal guardians and patient assent, when appropriate. Sharing information about the research, including risk and benefits, tailored to the patient’s level of understanding.

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The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”. Important Safety Information. See below forU.S. Long- term Treatment With Vemlidy in HBV.

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The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. **In 2018, Janssen Biotech, Inc. RYBREVANT™ IMPORTANT SAFETY INFORMATION 7. In 2018, Janssen Biotech, Inc.

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The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development.

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Metabolite Tales Blog

APRIL 4, 2023

The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Identification of the Clinical Development Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer. Acta Pharm Sin B. 2018 Sep;8(5):721-732. link] [3] Bauman et al., J Am Acad Dermatol.

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The Pharma Data

DECEMBER 29, 2020

” The Phase III clinical development program consists of three studies, the BRIDGE study, the BALANCE study and the BRIGHT study. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Galactosidase-A enzyme.

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The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. For more information, please visit www.bioxceltherapeutics.com. Contact Information: BioXcel Therapeutics, Inc. Forward-Looking Statements. www.bioxceltherapeutics.com.

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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

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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. For more information, please visit www.ascendispharma.com.

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PPD

JUNE 20, 2023

Does your CRO leverage data-backed intelligence to accelerate your clinical development strategy? A strong CRO partner will also talk through your holistic data strategy early, pinpointing milestones at which data could expedite development and approval. Make sure your CRO stays ahead of the curve.

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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.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. .

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The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. These results, along with a mathematical model-informed approach have supported the currently ongoing dose expansion for BAY 2416964.

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The Pharma Data

MARCH 17, 2021

In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes. IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib). 30-89 mL/min).

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Agency IQ

SEPTEMBER 22, 2023

We have more information on the seven types of confirmatory evidence below ). The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinical development process.

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Agency IQ

AUGUST 9, 2024

Per Section 3602 of the Consolidated Appropriations Act, this guidance should include information about the specific format and content of the plans, such as the rationale for enrollment goals (e.g., For products under an IDE, DAP information must be submitted with the IDE. What programs or products need a DAP?

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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The Pharma Data

APRIL 11, 2021

i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION FOR RETEVMO ® (selpercatinib). Please see full Prescribing Information for Retevmo. 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity.

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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

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

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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.

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. 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.

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Agency IQ

DECEMBER 11, 2023

For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.” For instance, patient information derived from medical records may not be complete or accurate.

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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. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

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The Pharma Data

JULY 21, 2021

For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-Looking Statement of Merck & Co.,

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The Pharma Data

APRIL 8, 2021

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. These data may help advance the understanding of HD and inform future treatment approaches for this rare, neurological condition. Spinal Muscular Atrophy (SMA).

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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.

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The Pharma Data

DECEMBER 13, 2020

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. For more information, please visit: www.poxelpharma.com.

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Agency IQ

AUGUST 16, 2024

The MTD approach evaluates only a few patients at each dose, utilizes a short observation period to observe dose-limiting toxicities (DLTs), and provides limited information on safety beyond DLTs, making it challenging to get a realistic picture of long-term safety and tolerability.

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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. The enrollment goals should be informed by the estimated prevalence or incidence of the disease or condition in the U.S.

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The Pharma Data

MAY 7, 2021

About the Sotrovimab Clinical Development Program. For further information please visit www.gsk.com/about-us. Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. About Vir Biotechnology.

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