Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. CARMIEL, Israel and BOSTON , Dec.

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Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

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Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

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.” The post Trends in Oncology Study Design, from Optimus to Endpoints appeared first on Worldwide Clinical Trials.

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Clinical Trials Trials Pharmacokinetics FDA 83

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Read the fact sheet. Read or listen now. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days. ” About Hepion Pharmaceuticals.

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Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. cell and gene therapies), with other therapeutic areas then pushing it further. Barriers to Enrollment Recent findings indicate significant barriers to enrolling patients remain in clinical trials.

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Trials Clinical Trials FDA Approval Therapies 52

DrugBank

APRIL 3, 2025

Despite this significant commitment of time and resources, many drug candidates fail in clinical trials, with safety and toxicity concerns being one of the leading causes. Historically, many drug candidates have been discontinued during late-stage clinical trials due to unforeseen toxicities.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

The Pharma Data

MARCH 5, 2021

” In addition to the Phase 1/2 BRUIN clinical trial, Loxo Oncology at Lilly plans to initiate four global, randomized Phase 3 studies for pirtobrutinib in 2021, three in CLL and one in MCL. About the BRUIN Phase 1/2 Trial. The trial includes a Phase 1 dose escalation phase and a Phase 2 dose expansion phase.

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Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

JULY 12, 2021

These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. HIV Recent Infection Test-Based Incidence as a Counter-Factual for New PrEP Trials. Abstract 2361. Abstract 709.

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Pharmacokinetics Clinical Trials Trials Treatment 52

New Drug Approvals

DECEMBER 24, 2023

“Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. 12 (1): 267–287. doi : 10.1007/s40120-022-00414-z. PMC 9837340. PMID 36525140. Coelho, Teresa; Marques, Wilson; Dasgupta, Noel R.; PMC 10540057.

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Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

Drug Target Review

OCTOBER 24, 2023

Could you elaborate on the drug being developed by Microbiotica to stimulate cancer patients to respond favourably to immune checkpoint inhibitor therapy? It is likely the combination of these mechanisms of action that will make MB310 an effective therapeutic. How does it work and what are the potential benefits?

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Treatment Pharmaceuticals Pharmacokinetics Trials 122

The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., P6: Neuromuscular Disorders and Clinical Trials. Following U.S. Huntington’s Disease (HD).

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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., in liver, in CNS)? with antibodies), or correction (e.g., in the case of CFTR for Trikafta).

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The Pharma Data

MARCH 22, 2021

GENERATION HD1 is the largest clinical trial in Huntington’s disease to date and we do know that the data generated will significantly advance our understanding of huntingtin-lowering as a potential treatment approach. About tominersen and the clinical trials. said Levi Garraway, M.D., About Roche in Neuroscience.

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Disease Clinical Trials Pharmacokinetics Treatment 52

The Pharma Data

NOVEMBER 26, 2020

Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. Galactosidase-A enzyme.

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New Drug Approvals

APRIL 19, 2025

elimination half-life (min) cardio-selectivity (1/2) metabilization Landiolol 4 250 pseudocholinesterases Esmolol 9 30 ery-esterases Metoprolol 420 3 cytochrom P2D6 (Leber) History The beneficial effects of landiolol have been demonstrated in over sixty clinical trials (pubmed search -August 2018). IV -Blocker max. 32 (2): 828.

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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. Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014.

Therapies 52

Therapies Pharmacokinetics Treatment RNA 52

The Pharma Data

JANUARY 19, 2021

This small molecule therapy is presently in Phase 1 clinical trial for mild to moderate Alzheimer’s disease (AD), which is supported by a NIA R01 grant in healthy aged volunteers. CLARKSVILLE, Md., 20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. , There is a great need for a disease-modifying treatment for the 5.3

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Disease Small Molecule Clinical Trials Therapies 40

The Pharma Data

NOVEMBER 5, 2020

As we had previously indicated, we believe an SVR24 rate of at least 15% would have marked a meaningful first advance in HBV finite therapy, but preliminary results have shown that we will fall short of that mark. ABI-H0731 is a first-generation core inhibitor that is typically administered with NrtI therapy. Assembly Biosciences, Inc.

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Virus Clinical Trials Therapies Pharmacokinetics 40

The Pharma Data

APRIL 11, 2023

Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.

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The Pharma Data

JUNE 28, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections, dietary restrictions, and regular laboratory monitoring. EINSTEIN-Jr. About the EINSTEIN-Jr. Study The randomized, open-label phase III EINSTEIN-Jr.

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The Pharma Data

DECEMBER 15, 2020

16, 2020 (GLOBE NEWSWIRE) — Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that Diabetes Care has published data for the Phase I clinical trial of AT247, its ultra-rapid acting insulin product candidate.

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The Pharma Data

DECEMBER 15, 2020

Daratumumab induced substantial clinical responses in the patients. The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints. Small Molecule Inhibitors. Receptor Inhibitors.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

OCTOBER 27, 2020

“Once we’re in the clinic, we will continue to add multiple programs into the clinic with no rate abatement, or speed abatement, in the next five- to 10-year horizon.” . Former Sarepta Therapeutics executive Bo Cumbo left to launch his new gene therapy company, AavantiBio, with a $107 million Series A. AavantiBio . Sirnaomics.

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Small Molecule Immune Response Clinical Development Therapies 52

The Pharma Data

DECEMBER 14, 2020

AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. 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.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

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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Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

DECEMBER 27, 2020

Phase I Trial. phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. This trial also investigates the food effect on ASC42 exposure.

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Trials Pharmacokinetics Clinical Trials Therapies 40

The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. G&A Expenses.

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Pharmaceuticals Clinical Trials Trials Treatment 52

The Pharma Data

JULY 23, 2021

This approval is based on results from a multicenter, open-label, actively controlled clinical trial evaluating DALVANCE in pediatric patients from birth to less than 18 years of age with ABSSSI and 3 pharmacokinetic studies. This analysis evaluated an early clinical response at 48 to 72 hours based on achieving a ?

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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Drug Development Treatment FDA Approval Drugs 52

The Pharma Data

OCTOBER 18, 2020

The 450mg starting dose in AML patients was selected because that dose, when administered to CLL patients being treated in a separate Phase 1 a/b trial, appeared safe, well tolerated and achieved plasma exposure levels that effectively inhibited phospho-FLT3 activity, which is a key driver of AML.”. About CG-806.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

DECEMBER 9, 2020

SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. The study will be conducted in South Africa. President and Chief Executive Officer of SCYNEXIS.

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Hospitals Pharmacokinetics Treatment Trials 52

New Drug Approvals

APRIL 18, 2025

2] History Crinecerfont’s approval is based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic congenital adrenal hyperplasia. [2] 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] 1 December 2024.

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