Pharmaceutical Technology

JANUARY 17, 2023

OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1). We currently plan to file an Investigational New Drug (IND) application with the FDA later this year to support the initiation of a Phase I clinical trial. “We

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Pharmaceutical Technology

MAY 8, 2023

The small molecule Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa has been specially designed for delivering sustained BTK protein inhibition by optimising bioavailability, half-life, and selectivity.

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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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Drugs Bioavailability Clinical Trials Clinical Trials 52

Pharmaceutical Technology

AUGUST 30, 2022

The companies initially signed a partnership last year and developed the first Dispersome drug product, which is readied for upscaling, GMP production and clinical trials in humans. Reduced solubility and low bioavailability affect a huge number of solid drug products, especially tablet formulations on the market.

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Development Drugs Bioavailability Production 130

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. The trial will be conducted using a validated clinical model that simulates social anxiety. Chief Medical Officer at PureTech.

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Bioavailability Trials Clinical Trials Clinical Trials 52

Drug Discovery World

NOVEMBER 27, 2023

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor. Apollomics is in active discussion with the US Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for vebreltinib based on clinical data from the SPARTA trial and Avistone’s KUNPENG trial in China.

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Bioavailability Clinical Trials Clinical Trials Trials 52

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. This gap in the market is what the late-stage pipeline therapies are currently targeting.

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Development Drugs Clinical Trials Clinical Trials 147

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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Bioavailability Clinical Trials Clinical Trials Trials 52

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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Production Bioavailability In-Vivo Bioequivalency 133

Delveinsight

AUGUST 25, 2020

Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial. The results announced that the spartalizumab combo stumbled in the trial and failed to hit the primary endpoint of investigator-assessed progression-free survival in melanoma.

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Trials Bioavailability Drugs Protein 52

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

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Trials Drug Delivery Drugs Gene 83

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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Bioavailability Clinical Trials Clinical Trials Drugs 52

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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Development Bioavailability Clinical Trials Clinical Trials 52

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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Drug Discovery World

DECEMBER 16, 2022

The proceeds from the financing will support the ongoing multiple-ascending dose trial of STC-15 and further facilitate Storm as we advance our pipeline of products.” .

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RNA Immune Response Bioavailability Development 52

The Pharma Data

MARCH 8, 2021

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally-bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. About Molnupiravir.

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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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Clinical Trials Clinical Trials FDA Approval Trials 97

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. . Almirall S.A.’s

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Dermatology Trials Bioavailability Medicine 40

pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. Along with knee osteoarthritis, Grünenthal also plans to test resiniferatoxin in other joints affected by the condition.

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Drugs Bioavailability Trials Clinical Development 52

The Pharma Data

DECEMBER 1, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). AXS-05 was well tolerated in the COMET trial.

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Trials Clinical Trials Clinical Trials Production 52

pharmaphorum

JULY 22, 2021

The company said other companies were also looking at the orally bioavailable drug, but Pfizer emerged as an ideal partner for ARV-371. Arvinas has previously signed PROTAC-based research collaborations with Bayer , Roche’s Genentech unit and Merck & Co/MSD although the latter deal expired last year.

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Protein Hormones Bioavailability Drugs 110

Cloudbyz

MARCH 5, 2024

Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics. Oral Bioavailability: Developing small molecules that are effectively absorbed when administered orally, while also being stable in the digestive system, can be complex.

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Camargo

DECEMBER 22, 2021

This is a key factor in designing Phase 2 and 3 trials. Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence. Clinical Pharmacology. Clinical Safety and Efficacy.

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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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Protein Drug Delivery Drugs Drug Delivery Systems 52

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. About Molnupiravir.

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Clinical Trials Clinical Trials Bioavailability Trials 52

pharmaphorum

JANUARY 16, 2023

They include a once-monthly form of paliperidone called LY03010 that has shown comparable bioavailability with Johnson & Johnson’s Invega Sustenna in a pivotal trial and has a slightly simpler regimen in the induction therapy stage.

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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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Protein Bioavailability Development Scientist 130

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. Cautionary Notes and Forward-Looking Statements.

Life Science 52

Life Science Bioavailability Clinical Trials Clinical Trials 52

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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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. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology.

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Gene Silencing Drug Delivery FDA Approval RNA 97

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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Camargo

SEPTEMBER 30, 2021

While formulation changes for an ongoing program may improve stability, they might also impact the bioavailability, toxicokinetic profile, or toxicology – potentially rendering all previous work void and irrelevant and costing the program money and time. Trial Master File plan. Species Selection. Project management plan.

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Development Research Manufacturing In-Vivo 201

Camargo

AUGUST 22, 2021

3.1.1: Bioavailability Study Reports. A trial summary dataset (ts.xpt) containing the study start date in YYYY-MM-DD format is present. 2.3.2: Repeat-Dose Toxicity. 2.3.4: Carcinogenicity. 3.1.2: Comparative BA and BE Study Reports. 3.3.1: Healthy Subject PK and Initial Tolerability Study Reports. Validation Code. Code 1734.

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XTalks

APRIL 11, 2023

By avoiding the stomach entirely, there is increased bioavailability and more sustained relief from symptoms. In terms of novel treatment options, the ASPro-PD Phase III trial is investigating ambroxol’s (ambroxol hydrochloride) potential to slow the progression of Parkinson’s disease.

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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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RNA Clinical Trials Clinical Trials Bioavailability 52

Delveinsight

AUGUST 10, 2020

Boehringer Ingelheim is worth mentioning here, as it is presenting key posters and studies on Ofev’s SENSCIS Trial and INBUILD Trial. Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. Ofev (Nintedanib) Facts.

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Drugs Trials Bioavailability FDA Approval 52

The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). 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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