XTalks

FEBRUARY 3, 2023

This approval follows the promising results of the Phase III EMERALD global clinical trial published in the Journal of Clinical Oncology. Unlike fulvestrant, elacestrant is not only orally bioavailable, but it has also demonstrated longer steady-states and works as a better combination partner with inhibitor agents like CDK4/6.

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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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Pharmaceutical Technology

AUGUST 3, 2022

Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market. A lack of clinical efficacy is the most common reason for failure, but the development of substandard formulations with ‘poor drug-like properties’ is another recurrent issue.

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Pharmaceutical Technology

JANUARY 25, 2023

According to Atul Tiwari , Head-Discovery Service Solutions at Syngene “Realising the scientific and market potential of this area, we made proactive and early efforts to establish new models, platforms, identifying new ligases, ligands and establishing the ADME-PK correlations of the PROTACs.

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Pharmaceutical Technology

OCTOBER 25, 2022

As the number of FDC products in development and coming to the market increase, the pharmaceutical industry is looking to FDCs as a promising strategy to repurpose, repackage, and expand indications for existing and novel therapeutic agents. As a result, FDC products may help prevent medication errors and enable better control of dosing.

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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 Proteins and Peptides Market (4th Edition).

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Delveinsight

SEPTEMBER 8, 2021

As per DelveInsight’s report on Benlysta (Belimumab) market forecast , the sale of Belimumab has kept on increasing year after year. There are several SLE therapies in the pipeline that are under investigation in different phases of clinical trials for the treatment of Systemic Lupus Erythematosus. Anifrolumab (MEDI-546).

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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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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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Clinical Trials Clinical Trials Bioavailability Trials 52

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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Clinical Trials Clinical Trials Trials Development 52

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

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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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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Delveinsight

JULY 30, 2020

The global Adrenoleukodystrophy market size for the forecast period 2020-30, which was estimated to be USD 922.43 In patients with CALD, Adrenoleukodystrophy market offers two therapies, namely Lorenzo’s oil and haematopoietic stem cell transplantation (HSCT) , using either umbilical cord stem cells or bone marrow stem cells.

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Hormones Marketing Gene Trials 52

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

NOVEMBER 26, 2020

This novel nanoparticle formation technology provides hope for improving the possibilities and probabilities of developing better medicines for patients and it expands Nanoform’s reach into the growing biological market. Finnish time. About Nanoform. Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806.

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Containment Medicine Development Bioavailability 52

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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Roots Analysis

SEPTEMBER 1, 2023

By charting new waters and creating uncontested market spaces, companies can differentiate themselves and unlock unprecedented growth opportunities. In this blog post, I’ll explore how pharma / biotech companies can leverage the blue ocean and red ocean strategy to make waves in the market.

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Drug Delivery Marketing Drug Delivery Systems Drugs 52

The Pharma Data

JANUARY 3, 2021

The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services. . +46 7686 650 11. Finnish time.

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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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Trials Clinical Trials Clinical Trials Production 52

XTalks

AUGUST 30, 2022

The webinar also featured Kelsey Carter, MS, Clinical Trial Manager at Medpace who discussed the site, operational and regulatory challenges for neuroscience trials with direct CNS administration along with the strategies to mitigate these challenges. Why is it Difficult to Develop CNS Therapeutics? Figure 3 ).

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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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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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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

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). by sex, age or by genetic variations).

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Clinical Trials Clinical Trials Development Drugs 59

Pharmaceutical Technology

FEBRUARY 23, 2023

How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably. The micronized capsule was progressed to Part 2 of the study and showed a linear increase in exposure (AUC) up to 800 mg, establishing safety margins for future clinical testing.

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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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