Pharmaceutical Technology

AUGUST 30, 2022

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 clinical trials in humans.

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XTalks

SEPTEMBER 19, 2024

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 clinical trials. It was engineered to have high potency, bioavailability and kinase selectivity that led to improved efficacy and safety in B-cell malignancies.

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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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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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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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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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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

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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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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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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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 feedback is crucial in shaping clinical trials and ensuring new therapies fit seamlessly into existing treatment regimens.

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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). Clinical response on the SDS (defined as a total score of ?12)

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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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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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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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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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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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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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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.

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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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Roots Analysis

MAY 21, 2024

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.

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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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XTalks

MAY 23, 2024

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 clinical trials.

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XTalks

AUGUST 8, 2024

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 clinical trials.

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Delveinsight

JULY 30, 2020

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).

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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

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

DECEMBER 3, 2020

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.

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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

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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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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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

NOVEMBER 18, 2022

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.

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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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