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Jotrol overcomes these barriers using patented micellar technology, enhancing bioavailability and enabling therapeutically effective doses. Proceeds from the IPO will propel key initiatives, including the Phase II clinicaltrial of Jotrol in Parkinson’s disease.
CellCentric is developing inobrodib, an orally bioavailable drug that is transitioning into Phase II clinicaltrials in multiple indications. Both have stellar experience and track records in oncology research and development.
XTALKS WEBINAR: GLP-1 Agonist Development: Endpoint Strategies to Help Differentiate Your Drug Live and On-Demand: Tuesday, February 25, 2025, at 11am EST (4pm GMT/UK) Register for this free webinar to learn how innovative digital and imaging endpoints can maximize the value of GLP-1 clinicaltrials. in its Phase Ib trial.
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 clinicaltrial. “We
Brukinsa is a small-molecule Bruton’s tyrosine kinase (BTK) inhibitor specially designed for delivering sustained and targeted BTK protein inhibition by optimising bioavailability, half-life, and selectivity. The regulatory approval for the BTK inhibitor to treat CLL was based on Phase III SEQUOIA and ALPINE clinicaltrials.
cyclosporine A) is currently at pre-registration stage with the FDA, following results from late-stage clinicaltrials that demonstrated CyclASol significantly reduced corneal and conjunctival staining, and improved ocular dryness compared with vehicle. Novaliq’s CyclASol (0.1%
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.
The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. . The companies initially signed a partnership last year and developed the first Dispersome drug product, which is readied for upscaling, GMP production and clinicaltrials in humans.
Mobasher Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinicaltrials. It was engineered to have high potency, bioavailability and kinase selectivity that led to improved efficacy and safety in B-cell malignancies.
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
This blog post will discuss how PK modeling can contribute to sample size estimation, a key aspect of a clinicaltrial protocol. The results of the population analysis reveal the average relative bioavailability of the test to reference.
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.
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?
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 clinicaltrials.
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 clinicaltrial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).
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.
Researchers at the University of Southern California in conjunction with the National Cancer Institute are currently conducting a Phase II clinicaltrial of the MAOI phenelzine in prostate cancer patients and have announced in an interim study publication that it has thus far demonstrated efficacy. .
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.”
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 clinicaltrials. This feedback is crucial in shaping clinicaltrials and ensuring new therapies fit seamlessly into existing treatment regimens.
If clinicaltrials 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.
(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). Clinical response on the SDS (defined as a total score of ?12)
The clinicaltrials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinicaltrials underscored the favorable tolerability profile of Vevye.
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.
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 clinicaltrials to confirm safety and efficacy.
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 clinicaltrials. Eli Lilly backed Terns Pharmaceuticals now has two NASH candidates in clinicaltrials. IND-enabling studies are underway.
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 clinicaltrial. Session Type: ClinicalTrials Plenary Session.
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 clinicaltrial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. 1-4 The U.S. . Almirall S.A.’s
Dosing is not left up to physicians; it is built into the FDC product and based on clinicaltrial results. As a result, FDC products may help prevent medication errors and enable better control of dosing.
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 clinicaltrials for biologics.
In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.
If these mitochondrial therapeutics were to be successful in clinicaltrials, 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.
XTALKS WEBINAR: Enhancing Efficiency in Early-Phase Oncology Trials: Strategies for Accelerating Data Flow Live and On-Demand: June 24, 2024, at 11am EDT (4pm BST/UK) Register for this webinar today to gain insights into how you can navigate and overcome data flow challenges in early-phase oncology clinicaltrials.
At least 13 ADCs have been approved by the US Food and Drug Administration (FDA) to treat a wide range of cancers cancers, including breast cancer, B-cell lymphoma, urothelial cancers and more, and there is an acceleration ADC entering Phase III clinicaltrials.
Lenti D , under development by bluebird bio , is the company’s investigational cell-based therapy and currently under Phase II/III trial- Starbeam (NCT01896102) in CALD patients, an extension of Starbeam trial (NCT02698579), and the ALD-104 Phase 3 trial (NCT03852498).
Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinicaltrial 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.,
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.
The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e., About Maribavir.
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.
Pharmaceutical Research: Big data analytics can be applied in various areas of pharmaceutical research, including drug discovery and development, precision medicine , clinicaltrial optimization, pharmacovigilance and drug safety, supply chain optimization, and real-time monitoring and surveillance.
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 clinicaltrials. Streamlining Supply Chain Management The digital field is making a relevant move in the pharmaceutical industry in more than one field.
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 ClinicalTrial Authorization (CTA) in the EU. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.
It was specifically designed to provide targeted and sustained BTK protein inhibition by optimising bioavailability, selectivity, and half-life. Currently, Brukinsa is being assessed in a broad clinical programme as monotherapy and along with other therapies for the treatment of several B-cell malignancies.
Livornese — Last month, Congress took a big step towards improving clinicaltrial 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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