Pharmaceutical Technology

MAY 2, 2023

The orally bioavailable small molecule EGFR inhibitor ERAS-801 demonstrated significant central nervous system (CNS) penetration in animal trials. This newly granted status helps Erasca to facilitate the development and review of ERAS-801, thereby accelerating the therapy’s reach to patients. “To

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Pharmaceutical Technology

NOVEMBER 18, 2022

It was specifically designed to provide targeted and sustained BTK protein inhibition by optimising bioavailability, selectivity, and half-life. The regulatory approval is based on the data obtained from two Phase III clinical trials, SEQUOIA and ALPINE.

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XTalks

DECEMBER 5, 2022

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Last year, Pfizer struck a $6.7

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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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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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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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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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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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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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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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XTalks

JUNE 27, 2024

Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand. Their focus is on improving drug solubility and bioavailability with powerful amorphous dispersion technologies, such as KinetiSol for poorly soluble compounds.

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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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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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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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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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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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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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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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Pharmaceutical Technology

MARCH 21, 2023

Just before the Covid-19 pandemic, there were 60 ongoing clinical trials with cannabis-based products, with the majority being tested for pain or psychosis. So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i].

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Pharmaceutical Technology

AUGUST 3, 2022

If clinical trials prove successful, that same process should then be scaled to commercial manufacturing. Milling is a central part of powder processing, as this is where coarse particles are broken down into smaller ones for a variety of processability, bioavailability, reactivity, and safety-related reasons.

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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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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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pharmaphorum

FEBRUARY 25, 2021

Earlier this month Chiesi and Protalix reported results from another trial called BRIDGE which showed a decrease in patients with moderately or fast progressing kidney disease following the switch from Replagal.

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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. . Almirall S.A.’s

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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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XTalks

OCTOBER 2, 2024

If successful, this trial could pave the way for a New Drug Application (NDA) submission. With positive outcomes in preclinical models, EB-003 has confirmed oral bioavailability, adding to its therapeutic potential. This development highlights a growing interest in neuroplastogens as alternative mental health treatments.

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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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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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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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Pharmaceutical Technology

MAY 10, 2023

Within the pharmaceutical industry, it is critical to measure particle size as it influences surface area and porosity, impacting a drug’s bioavailability, effectiveness, and shelf life. Alternatively, they can come as a product component of formulations such as cleaning agents and polymers.

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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. Cautionary Notes and Forward-Looking Statements.

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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

OCTOBER 25, 2022

Dosing is not left up to physicians; it is built into the FDC product and based on clinical trial results. As a result, FDC products may help prevent medication errors and enable better control of dosing. The goal of combination drug treatment is not only the delivery of two or more therapeutic agents that have different mechanisms of action.

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XTalks

SEPTEMBER 24, 2024

Flatt Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.

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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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pharmaphorum

JANUARY 29, 2021

While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable. Tanezumab and Regeneron’s fasinumab are the last drugs standing in the hard-to-target nerve growth factor (NGF) inhibitor class, which has seen several candidates fall by the wayside over the years because of tolerability issues.

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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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