Drug Discovery World

APRIL 8, 2024

It is progressing to Phase I clinical trials with JD Bioscience. Beyond its therapeutic potential and pharmacokinetic attributes, including over 60% oral bioavailability, compound 11c exhibits hepatocyte and plasma stability, minimal cytotoxicity, and low cytochrome P450 inhibition.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

cyclosporine A) is currently at pre-registration stage with the FDA, following results from late-stage clinical trials that demonstrated CyclASol significantly reduced corneal and conjunctival staining, and improved ocular dryness compared with vehicle. Novaliq’s CyclASol (0.1%

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BioTech 365

MARCH 10, 2021

Venatorx Pharmaceuticals Expands Anti-Infective Portfolio with HBV Candidate Venatorx Pharmaceuticals Expands Anti-Infective Portfolio with HBV Candidate VNRX-9945 Selected as 3rd Generation Hepatitis B Virus Orally Bioavailable CpAM; Clinical Trial Application and Phase 1 Planned for Second Quarter 2021 MALVERN, Pa.–(BUSINESS

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Drug Discovery World

MARCH 3, 2023

Trial design The placebo-controlled, Phase IIa, proof-of-concept trial will evaluate short-term changes in anxiety-related patient reported outcomes in approximately 50 healthy volunteers. Chief Medical Officer at PureTech.

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Drug Discovery World

JULY 27, 2022

Recursion’s therapy REC-4881 is an orally bioavailable non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients. . FAP is a rare tumour syndrome in which hundreds or thousands of precancerous colorectal polyps grow in the body.

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Camargo

FEBRUARY 10, 2021

This blog post will discuss how PK modeling can contribute to sample size estimation, a key aspect of a clinical trial protocol. The results of the population analysis reveal the average relative bioavailability of the test to reference.

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Drug Discovery World

NOVEMBER 29, 2023

The development of Ketamir-2 is being led by Dr Adam Kaplin, MIRA’s President and Chief Scientific Officer, who served as the Johns Hopkins site Principal Investigator for multi-centre pivotal clinical trials, leading to the approval of an intranasal left-handed ketamine molecule Spravato.

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Drug Discovery World

NOVEMBER 27, 2023

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor. Apollomics extends its full support and congratulations to Avistone on this significant achievement,” said Guo-Liang Yu, Chairman and Chief Executive Officer of Apollomics.

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XTalks

FEBRUARY 3, 2023

Aditya Bardia, MD, MPH, director of Breast Cancer Research at Mass General Cancer Center, associate professor at the Medicine Department at Harvard Medical School and principal investigator for the EMERALD trial, in the same press release statement. Orserdu is available in the form of 345 mg tablets to be taken once a day with food.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

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Roots Analysis

MARCH 2, 2022

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs.

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Pharmaceutical Technology

JANUARY 25, 2023

This is due to the complicated mechanism of induced protein degradation and due to large molecular weight and size, leading to issues associated with solubility, permeability, and bioavailability.”

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The Pharma Data

DECEMBER 29, 2020

Cybin is developing technologies and delivery systems, aiming to improve bioavailability, to potentially achieve the desired medicinal effects of psychedelics at low dosage levels. The new delivery systems are expected to be studied through clinical trials to confirm safety and efficacy.

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Cloudbyz

MARCH 5, 2024

Here are some of the complexities encountered in clinical research for each: Biologics : Immunogenicity: Biologics have a higher risk of inducing immune responses, which can affect efficacy, safety, and pharmacokinetics. Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics.

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XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinical trials underscored the favorable tolerability profile of Vevye.

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pharmaphorum

NOVEMBER 9, 2022

If these mitochondrial therapeutics were to be successful in clinical trials, they would be the first disease-modifying medicine to actually prevent or delay progression of these diseases. Currently, the treatments available only provide management of symptoms of chronic neurodegenerative disorders.

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Delveinsight

JANUARY 7, 2021

The immunotherapy pipeline is led by an in-licensed EP4 antagonist that Ikena is testing combined with Keytruda in phase 1b/2 colorectal and non-small cell lung cancer clinical trials. Eli Lilly backed Terns Pharmaceuticals now has two NASH candidates in clinical trials. IND-enabling studies are underway.

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Camargo

JULY 8, 2021

Researchers at the University of Southern California in conjunction with the National Cancer Institute are currently conducting a Phase II clinical trial of the MAOI phenelzine in prostate cancer patients and have announced in an interim study publication that it has thus far demonstrated efficacy. .

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The Pharma Data

MARCH 11, 2021

Lilly will present findings from a post-hoc safety analysis of the Phase 1/2 LIBRETTO-001 trial, the largest clinical trial in patients with RET -altered cancers. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Session Type: Clinical Trials Plenary Session.

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX: CALTX) (NASDAQ: CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

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The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. 1-4 The U.S. .

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The Pharma Data

JANUARY 3, 2021

The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services.

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The Pharma Data

DECEMBER 1, 2020

The SDS is a patient-rated scale that was designed to assess functioning in work, social life, and family life, and is among the most commonly used functional impairment scales in depression clinical trials. Clinical response on the SDS (defined as a total score of ?12) 12) after treatment with AXS-05 was achieved by 37.1%

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Roots Analysis

JANUARY 28, 2024

Pharmaceutical Research: Big data analytics can be applied in various areas of pharmaceutical research, including drug discovery and development, precision medicine , clinical trial optimization, pharmacovigilance and drug safety, supply chain optimization, and real-time monitoring and surveillance.

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Drug Discovery World

JULY 25, 2023

The guidance is for pharmaceutical companies conducting paediatric clinical trials in the EU using the PIP procedure. This guidance outlines a pilot program for sPIPs to encourage early dialogue and optimise the design of paediatric clinical trials. They are required for orphan drugs but not for biosimilars.

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The Pharma Data

NOVEMBER 26, 2020

The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services.

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The Pharma Data

OCTOBER 21, 2020

Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinical trial for advanced solid tumors in 2021. We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., SAN MATEO, Calif., and CAMBRIDGE, Mass.,

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The Pharma Data

NOVEMBER 22, 2020

EZEPROGIND, which is kicking off phase 2a trials, is a bioavailable neurotrophic inducer. It was tested on 88 healthy human subjects throughout three phase 1 clinical trials and has demonstrated excellent tolerability, with no adverse effects.

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The Pharma Data

DECEMBER 8, 2020

Kura’s most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma.

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The Pharma Data

NOVEMBER 19, 2020

These compounds have demonstrated high potency in inhibiting the activity of the M pro protease as well as promising oral bioavailability and blood plasma levels in animal studies. Several compounds are being further optimized for preclinical studies. Details can be found at this link.

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Roots Analysis

SEPTEMBER 1, 2023

The platform utilizes electronic health records (EHRs) to generate real-world datasets that can be used to identify outcomes for those typically underrepresented or not represented in clinical trials. Streamlining Supply Chain Management The digital field is making a relevant move in the pharmaceutical industry in more than one field.

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Delveinsight

JULY 30, 2020

Another player in the race to advance ALD market size is Minoryx Therapeutics who recently announced the beginning of the registration-enabling Phase 2 NEXUS trial to evaluate the safety and efficacy of leriglitazone in pediatric patients with early-stage cerebral ALD (cALD), the acute form of X-linked adrenoleukodystrophy (X-ALD).

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Drug Discovery World

OCTOBER 25, 2023

JV: A key bottleneck in the research and development of a drug is the lengthy experimentation that is required to gain the confidence to run clinical trials. MT: How does AI and ML accelerate the drug discovery process? Explainability and visibility into the “black box” of AI and ML technology is a significant challenge.

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Pharmaceutical Technology

NOVEMBER 24, 2022

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.

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Pharmaceutical Technology

FEBRUARY 13, 2023

By associating molecular properties with in-silico absorption, distribution, metabolism, excretion, and toxicity (ADMET) models, we can significantly increase the robustness of candidate selection, which subsequently reduces the failure rate during clinical trials.

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The Pharma Data

DECEMBER 3, 2020

Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HSCT. 4, 2020 11:00 UTC. About Maribavir. Maribavir is an investigational treatment that has not been approved for use by the U.S.

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FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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