LifeSciVC

OCTOBER 10, 2024

In spite of somewhat arduous clinical development pathways, these data sets are now providing some cautious optimism for each mechanism’s potential to drive benefits for NSCLC patients. Changes in both proximal measures of CBL-B inhibition and downstream measures of its ability to activate the immune system.

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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.,

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Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. We are currently selecting our lead IL-18 variant on the basis of potency for the IL-18 receptor, optimal pharmacokinetic profile and in vivo efficacy for inhibiting tumour growth.

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws.

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The Pharma Data

APRIL 7, 2022

Sisunatovir significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. Food and Drug Administration (FDA).

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Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved.

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The Pharma Data

MARCH 5, 2021

Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK). Overall Response Rate (ORR) and Duration of Response, as determined by appropriate histology-specific response criteria).

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Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

DECEMBER 14, 2020

The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. “With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic.”

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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 Cofounder and Chief Scientific Officer of Selva Therapeutics.

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Treatment Small Molecule Virus Pharmacokinetics 52

The Pharma Data

OCTOBER 27, 2020

Sirnaomics is the only biopharma conducting R&D and clinical development in the field of RNAi therapeutics in both the U.S. Primmune aims to advance the development of their novel orally-administered, small molecule toll-like receptor 7 agonists as therapeutic-adjuvants for acute viral diseases and cancer.

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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.

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The Pharma Data

DECEMBER 13, 2020

Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan. Zai Lab is leading clinical development in its territory. “We That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

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FDA Biosimilars Clinical Trials Licensing 52

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s).

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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. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

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The Pharma Data

NOVEMBER 5, 2021

About the study NCT03832114 is a Phase II, open- marker, two cohort,non-randomized study assessing the efficacity, safety and pharmacokinetics of iptacopan in cases with C3 glomerulopathy (C3G) ( cohort A) and cases who have experienced order transplantation and have posterior C3G rush in the transplanted organ ( cohort B).

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Disease Treatment Pharmacokinetics FDA 52

The Pharma Data

NOVEMBER 8, 2020

The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia.

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. ‘SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

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Trials Engineering Pharmacokinetics Therapies 40

Drug Target Review

JULY 1, 2024

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. He is spearheading the scientific and clinical development and fundraising of South Rampart Pharma and technology development efforts.

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Treatment Clinical Trials Therapies Molecular Biology 59

Alta Sciences

APRIL 17, 2024

Our experts align the appropriate bioanalytical approach with the goals of the oligonucleotide drug development program, based on its size/type, the sensitivity and specificity required, as well as throughput needed based on the preclinical or clinical phase of the drug in development. Asia, and Europe.

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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

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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.”.

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Disease Clinical Trials Treatment Pharmacokinetics 52

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. 8] , [9] , [10] , [11] , [12]. **In 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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The Pharma Data

MARCH 26, 2021

About the VIR-7831 Clinical Development Programme. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation for at least 24 hours or death within 29 days of randomisation.

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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.

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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. Pipeline Updates. •. .

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Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Pharmacokinetics and Metabolism of Nirmatrelvir. [link] [9] Patent EP1242061B1. link] [10] FDA prescribing information for gepirone. link] [11] Zheng et al., Blood 129(13): 1823-1830.

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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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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.”. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

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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. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer.

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The Pharma Data

JANUARY 3, 2021

The pharmacokinetics of nasally administered Foralumab will also be evaluated. Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected.

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