Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Results from the PROVENT Phase III trial showed a significant reduction in the risk of developing symptomatic Covid-19 and that the protection continued for at least six months.

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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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pharmaphorum

AUGUST 16, 2022

The US regulator has started a priority review of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC) based on the results of the PROpel trial. months and 16.6 months, respectively. months and 16.6 months, respectively.

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XTalks

NOVEMBER 9, 2022

Lilly is also working towards an obesity treatment form of tirzepatide, with trials currently underway to evaluate its weight loss effects. GLP-1 receptor agonists, or incretin (metabolic hormones) mimetics, are analogs of the GLP-1 peptide hormone that binds to the GLP-1 receptor to regulate blood sugar levels by boosting insulin secretion.

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Insulin Hormones FDA Approval Sales 98

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

JANUARY 22, 2023

The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. Egetis is banking on tiratricol, an oral small molecule that restores dysfunctional thyroid hormone signalling, to be the first drug approved for this condition. In clinical trials, the drug showed a 3.8-point

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pharmaphorum

AUGUST 15, 2022

In the space of a couple of months, Gilead Sciences’ Trodelvy impact on overall survival (OS) in the TROPICs-02 trial in advanced breast cancer has gone from a trend to a statistically significant improvement, raising its chances of approval in a new indication.

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XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Drug Discovery World

MAY 9, 2024

RA: Tell us how OXE103 works? MW: OXE103 (ghrelin) is a 28 amino acid neuro-peptide hormone that crosses the blood brain barrier and is responsible for maintaining brain energy homeostasis and neuroprotection related to neuronal cell preservation, axonal connectivity and decreased inflammation.

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Drug Discovery World

DECEMBER 19, 2023

Despite VMS, or hot flushes, being a common symptom of menopause, until now, hormone replacement therapy (HRT) was the only treatment. Lack of scientific advancement Before menopause, there is a balance between oestrogen, and the protein neurokinin B (NKB), which regulates the brain’s temperature control centre.

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pharmaphorum

AUGUST 18, 2022

Astellas remains on course to be the first drugmaker to bring a new non-hormonal therapy for symptoms of menopause to market, after the FDA started a review of its orally-active neurokinin-3 (NK3) receptor antagonist fezolinetant. Around a third of women report severe VMS, which can last ten years or more after the last menstrual period.

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Camargo

AUGUST 18, 2021

In general, they run in parallel to clinical trials depending on the target populations, typically starting around Phase I and finishing prior to the end of Phase III. Timing : GLP regulations require that most drug development programs include at least one study per segment. Considerations for DART Studies.

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XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It was also given FDA priority review.

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FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). at 50,039 codified at 21 C.F.R.

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Roots Analysis

AUGUST 31, 2023

Type of Gene Regulation Based on the type of transcription factor ( activators / repressors ), gene regulation has been categorized into positive and negative gene regulation. Negative Gene Regulation: Repressor is a protein molecule that initiates negative regulation.

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pharmaphorum

JULY 19, 2022

The trial had enrolled 309 patient out of a target population of 525, who had not progressed after first-line induction therapy. No new safety signals were observed with Lynparza in the trial, said the statement, and the safety profiles of both the monotherapy and combination arms were generally consistent with previously reported studies.

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pharmaphorum

AUGUST 8, 2022

The US regulator has approved Nubeqa (darolutamide) in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), adding to its earlier indication in non-metastatic castration-resistant prostate cancer (nmCRPC). billion) blockbuster.

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pharmaphorum

JUNE 8, 2022

The UK medicines regulator has awarded Alnylam’s RNAi-based therapy zilebesiran for hypertension an ‘innovation passport ‘, a designation designed to speed up NHS access to promising new medicines. The study is enrolling adults whose blood pressure is not adequately controlled by standard medicines.

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Drug Discovery World

AUGUST 21, 2023

Semaglutide manufacturer Novo Nordisk reported earlier this month that the drug reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity, as shown in the SELECT trial. GLP-1 is a hormone that is produced naturally in the brain and the gut in response to food ingestion.

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Clinical Trials Clinical Trials Trials Drugs 52

XTalks

JUNE 27, 2022

The BRAF gene regulates cell growth, proliferation and apoptosis. Both Tafinlar and Mekinist target the RAS/RAF/MEK/ERK pathway , which regulates cell growth and survival; however, each affects different kinases. Tafinlar and Mekinist Combination Clinical Trial Results.

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Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

MARCH 23, 2023

Hormonal contraceptives, and other drugs like clomiphene, eflornithine have been reported to ameliorate symptoms. As per GlobalData, practitioners typically turn to five drugs to treat PCOS ; the main drug is metformin, accounting for almost a quarter of trials (24.7%). GlobalData is the parent company of Pharmaceutical Technology.

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pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

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Dermatology Drugs Hormones FDA Approval 52

XTalks

MARCH 13, 2024

XTALKS WEBINAR: Addressing Ophthalmology Clinical Trial Design and Effective Data Monitoring Committee Strategies On-Demand: Thursday, February 8, 2024 Register for this free webinar gain insights into statistical data strategies for ophthalmology clinical trials and learn best practices for establishing and reporting ophthalmic data.

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Drug Discovery World

APRIL 4, 2023

Read more: FDA clears in vivo gene editing therapy for trials in US RRx-001, EpicentRx Most recently, the FDA granted Fast Track Designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients.

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Drug Discovery World

AUGUST 21, 2023

However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited. The regulator had already approved the combination treatment in advanced cancers the previous year. TVEC is approved to treat advanced, late-stage melanoma.

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XTalks

MAY 20, 2022

The injection is intended to regulate blood sugar, in conjunction with diet and exercise, in adults with type 2 diabetes. Related: Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial. In trials involving other diabetes medications, patients who received Mounjaro had lowering of HbA1c by 0.5

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The Pharma Data

NOVEMBER 11, 2021

The positive CHMP opinion is based on results from the STEP phase 3a clinical trial programme. Across the trials in people with obesity or overweight without type 2 diabetes, an average weight loss of 17-18% 1 sustained over 68 weeks was reported for those treated with Wegovy. Food and Drug Administration (FDA).

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pharmaphorum

OCTOBER 12, 2022

Gilead Sciences will hear back from the FDA in February next year about its marketing application for Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer, billed by the drugmaker as a key new indication for the drug.

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The Pharma Data

AUGUST 30, 2021

New Kisqali ® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2? Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. 19, 2:10 PM CEST]. Abstract Title.

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XTalks

NOVEMBER 9, 2023

Zepbound contains mimetics of the GLP-1 and GIP hormones that regulate appetite and blood sugar. Zepbound’s approval was based on data from two Phase III trials with 2,519 patients who had obesity or overweight with at least one weight-related condition. The larger of the two trials enrolled adults without diabetes.

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Roots Analysis

MAY 21, 2024

These are the vital structural component of cells, which help in cell functioning and regulation of building body tissues. However, continuous regulation of the cellular proteome is essential for maintaining the right balance of different proteins necessary for normal cellular function, survival, and proliferation.

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Protein Marketing Development Antibody 40

The Pharma Data

MARCH 27, 2021

The CHMP opinion is based on the results of a phase 3 trial published last year in the New England Journal of Medicine, which demonstrated a significant reduction in Body Mass Index (BMI) Standard Deviation Score (SDS), and reduction in BMI, body weight and other weight? About the phase 3 trial (NCT02918279).

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Medicine Trials Hormones Clinical Trials 52

The Pharma Data

JANUARY 19, 2021

The analysis of 23 small trials found that low-carb diets worked better than other eating plans in helping people lose weight and send their type 2 diabetes into remission. The vast majority have type 2 diabetes — which arises when the body loses its sensitivity to the blood-sugar-regulating hormone insulin. TUESDAY, Jan.

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The Pharma Data

APRIL 11, 2023

Based on these data, a first-in-human trial with BAY 2965501 in patients with advanced solid tumors was initiated and is currently enrolling patients. For the first time, Bayer will present the design of the clinical trial and the preclinical activity profile of the inhibitor in human epidermal growth factor receptor 2 (HER2) mutant NSCLC.

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