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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Clinical Trials Clinical Trials Trials In-Vitro 98

BioSpace

OCTOBER 7, 2020

Pfizer and Opko Health reported their Phase III clinical trial of somatrogan met the primary endpoint compared to Genotropin (somatropin) for treating children 3 to 18 years of age with growth hormone deficiency.

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Hormones Trials Clinical Trials Clinical Trials 75

Pharmaceutical Technology

JUNE 1, 2023

On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations. Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines. Trials peaked at 115 in 2018 before declining to 91 last year.

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FDA Approval Hormones Trials Clinical Trials 244

Pharmaceutical Technology

FEBRUARY 9, 2023

Ibutamoren mesylate is under clinical development by Lumos Pharma and currently in Phase II for Growth Hormone Deficiency. According to GlobalData, Phase II drugs for Growth Hormone Deficiency have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. It is administered orally.

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Hormones Drugs Clinical Trials Clinical Trials 100

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients. in trial subjects versus those who received ADT plus docetaxel.

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Hormones Clinical Trials Clinical Trials Licensing 246

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 23, 2024

Semaglutide (sold as Wegovy and Ozempic) and tirzepatide (sold as Zepbound and Mounjaro) are the most well known in the class of drugs that mimic hormones to reduce feelings of hunger. Drugs like Ozempic are very effective at helping most people who take them lose weight. But does weight come back when you stop using […]

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Doctors Doctor Hormones Drugs 185

Pharmaceutical Technology

JULY 8, 2022

The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%

FDA Approval 246

FDA Approval HR Drugs Hormones 246

XTalks

SEPTEMBER 2, 2020

VK2809 is a novel, oral small molecule thyroid hormone receptor beta agonist that has selectivity for liver tissue. VK2809 and the VOYAGE Trial. Results from the trial showed that patients that were administered VK2809 demonstrated a statistically significant 45.4 Related: Six of the Latest NASH/NAFLD Webinars. mg daily; 2.5

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Clinical Trials Clinical Trials Trials Insulin 98

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 14, 2022

If you’re someone who has to deal with a period regularly, you’re probably all too familiar with just how much your energy levels can change throughout your cycle thanks to hormonal fluctuations.

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Hormones Clinical Trials Clinical Trials Clinical Research 188

Medical Xpress

JANUARY 10, 2023

For men with early-stage prostate cancer being managed by active surveillance, adding the hormonal agent apalutamide may lower the rate of positive biopsies during follow-up, suggests a preliminary clinical trial in the Journal of Urology.

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Hormones Clinical Trials Clinical Trials Trials 75

Medical Xpress

DECEMBER 8, 2022

In patients with hormone receptor (HR)-positive, HER2-negative tumors resistant to aromatase inhibitors, addition of the investigational AKT inhibitor capivasertib to fulvestrant (Faslodex) doubled the median progression-free survival compared with placebo plus fulvestrant in the phase III CAPItello-291 clinical trial, according to results presented (..)

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Hormones HR Clinical Trials Clinical Trials 75

BioTech 365

MARCH 17, 2021

Global Growth Hormone Deficiency Clinical Trials Review, H1 2021 Report – ResearchAndMarkets.com Global Growth Hormone Deficiency Clinical Trials Review, H1 2021 Report – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Growth Hormone Deficiency – Global Clinical Trials Review, H1, 2021” clinical trials has (..)

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Hormones Clinical Trials Clinical Trials Trials 40

Medical Xpress

APRIL 28, 2023

The patient-reported outcomes (PROs) of the phase 3 NRG Oncology clinical trial RTOG 0815 comparing dose-escalated radiotherapy (RT) alone to dose-escalated RT combined with short-term (6 months) androgen deprivation therapy (STAD) indicate that the addition of STAD did not significantly impact urinary or bowel quality of life but did significantly (..)

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Clinical Trials Clinical Trials Trials Hormones 74

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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Insulin Hormones Drugs Clinical Trials 182

pharmaphorum

OCTOBER 17, 2022

Bayer has added another clinical trial to its extensive phase 3 programme for oral neurokinin antagonist elinzanetant, hoping to show that it can treat vasomotor symptoms (VMS) in breast cancer patients. The post Bayer extends elinzanetant trials to include breast cancer appeared first on. There are around 2.3

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Trials Hormones Clinical Trials Clinical Trials 111

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 10, 2023

Available through a collaboration with the consumer-initiated testing business of Quest Diagnostics and Proov, maker of at-home fertility and hormone tests, the Proov Confirm PdG test is the first and only FDA-cleared […]

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Hormones Clinical Trials Clinical Trials Trials 159

Medical Xpress

FEBRUARY 10, 2023

A prohibition against puberty blocking hormones and gender-affirming surgeries for minors in Florida was tightened further after a board overseeing doctors eliminated an exception for clinical trials Friday at the request of Florida Gov. Ron DeSantis' administration.

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Doctors Doctor Hormones Clinical Trials 97

XTalks

DECEMBER 6, 2024

In a highly anticipated head-to-head trial of Eli Lillys Zepbound (tirzepatide) and Novo Nordisks Wegovy (semaglutide), Zepbound has come out on top as it helped trial participants lose significantly more weight than Wegovy over an 18-month period. Patients treated with Zepbound achieved an average weight loss of 20.2

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Trials Clinical Trials Clinical Trials Marketing 98

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.

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Trials Drugs Clinical Trials Clinical Trials 96

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.

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Trials Drugs Clinical Trials Clinical Trials 96

STAT News

JULY 13, 2022

A new study , published Wednesday in the New England Journal of Medicine, found that the hormone erythropoietin did not improve survival and other outcomes in newborns with hypoxic-ischemic encephalopathy. Another clinical trial of erythropoietin is ongoing in Australia. Read the rest…

Hormones 98

Hormones Clinical Trials Clinical Trials Doctors 98

Pharmaceutical Technology

SEPTEMBER 28, 2022

The approvals include Keytruda plus chemotherapy as neoadjuvant treatment and then continued as a single agent for adjuvant treatment post-surgery in hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients. This approval is based on KEYNOTE-564 trial data.

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Antibody Clinical Trials Clinical Trials Hormones 147

STAT News

MARCH 21, 2023

A new obesity treatment being developed by Altimmune met goals for weight loss in a mid-stage clinical trial, but the data showed it doesn’t have a leg up on other popular drugs on the market.

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Hormones Drugs Clinical Trials Clinical Trials 98

Advarra

JUNE 30, 2023

The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible for Medicaid in April 2022. However, a year has passed with no further updates on this letter or Medicaid beneficiaries enrolling in clinical trials.

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Clinical Trials Clinical Trials Trials Hormones 52

XTalks

NOVEMBER 29, 2023

David Cameron, Chair of the Breast International Group (BIG) , we delve into the landscape of breast cancer research today, clinical trials and the incorporation of the patient voice in breast cancer research. Breakthroughs in Treatment BIG has been at the forefront of numerous clinical trials.

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Clinical Trials Clinical Trials Trials Research 52

XTalks

JULY 17, 2024

Sweden-based biotech Camurus shared positive Phase III trial data for CAM2029, one of its lead candidates, in patients with the rare hormonal disorder acromegaly. Due to its ability to mimic somatostatin, octreotide is used to treat various conditions associated with excessive hormone production.

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Trials Hormones Clinical Trials Clinical Trials 59

Pharmaceutical Technology

FEBRUARY 27, 2023

The regulatory approval is based on the data obtained from the multi-centre, double-blind, placebo-controlled, randomised Phase III ARASENS clinical trial. The trial assessed the safety and efficacy of oral darolutamide plus ADT and chemotherapy docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC) patients.

Hormones 130

Hormones Trials Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

JULY 8, 2024

Hormonal Status : A body’s hormones, such as levels of reproductive hormones and thyroid function, can impact tissue responses to radiation therapy. Our expertise spans a wide range of therapeutic areas, from oncology to neurology, leveraging advanced imaging techniques and innovative trial designs.

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Hormones Regulation Clinical Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 9, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. MK-0677 is active growth hormone secretagogue that acts on the growth hormone secretagogue receptor in the anterior pituitary to stimulate the release of growth hormone.

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Hormones Clinical Trials Clinical Trials Drugs 100

Pharmaceutical Technology

DECEMBER 21, 2022

This approval is based on findings from the multicentre, double-blind, randomised, placebo-controlled, 12-month Phase III ATOM clinical trial. The trial analysed the safety and efficacy of 80μg abaloparatide in men with osteoporosis. Abaloparatide is a parathyroid hormone-related peptide [PTHrP(1-34)] analog.

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Hormones Clinical Trials Clinical Trials Trials 130

XTalks

JANUARY 9, 2024

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues.

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Hormones Antibody Trials Production 105

XTalks

OCTOBER 23, 2024

Unlike drugs that alter metabolism or appetite by interacting with hormones, the pill functions entirely mechanically. In Oxford Medical’s first-in-human trials, conducted in a diverse patient group, data shows that the pill is well-tolerated, with no significant adverse events reported.

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Production Hormones Drugs Trials 104

BioTech 365

SEPTEMBER 23, 2020

23, 2020 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced that it has filed a Clinical Trial Notification (CTN) with the … Continue reading → COPENHAGEN, Denmark, Sept.

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Clinical Trials Clinical Trials Trials Hormones 40

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. Verifying the biomarker’s clinical validity for use as a surrogate endpoint in rare disease research is another hurdle which is generally a longer-term goal. Acromegaly.

Trials 98

Trials Gene Hormones Clinical Trials 98

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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Trials Drugs FDA Approval Clinical Trials 98

Pharmaceutical Technology

JULY 25, 2022

AstraZeneca noted that the sBLA is based on findings from the randomised, open-label Phase III DESTINY-Breast04 clinical trial of Enhertu in priorly treated subjects with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease.

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HR Hormones Clinical Trials Clinical Trials 130

Pharmaceutical Technology

MARCH 6, 2023

Verzenio along with endocrine therapy (ET) has received approval as an adjuvant treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) adult patients who are at a high recurrence risk.

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FDA Approval HR Hormones Clinical Trials 130