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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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

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 76

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 71

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 149

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 73

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 17, 2023

New research by our team has identified sensitivity to a hormone made in abundance by the developing pregnancy, GDF15, […] Sickness in pregnancy, or hyperemesis gravidarum, is common and is thought to affect seven out of ten women at some time in their pregnancy. But, until recently, very little has been known about why it happens.

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Hormones Research Development Clinical Trials 212

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

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

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

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

The pill, called Opill – the brand name for the tablet formulation of norgestrel – is an oral contraceptive containing only progestin hormone, which helps prevent pregnancy […]

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Hormones Containment Branding Drugs 177

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

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 94

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. months compared with 5.1 months for the chemotherapy arm.

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FDA Approval HR Clinical Trials Clinical Trials 264

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

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 9, 2022

Millions around the world must inject the crucial hormone underneath their skin several times a day to keep their glucose levels in balance. The most effective way for people with diabetes to deliver insulin is also incredibly intrusive.

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Insulin Hormones Scientist Clinical Trials 190

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…

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Hormones Clinical Trials Clinical Trials Doctors 98

Drug Discovery World

DECEMBER 9, 2022

A new type of targeted medicine has shown ‘remarkable’ benefits for patients with advanced breast cancer in a major Phase III clinical trial. . The drug capivasertib combined with hormone therapy doubled the time it took for cancer to progress in people with advanced forms of the most common type of breast cancer. .

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Trials Hormones Drugs Genetics 52

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 Genetics 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

XTalks

JANUARY 23, 2024

Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development. This rare endocrine disorder, characterized by inadequate secretion of growth hormone from the pituitary gland, has profound impacts on physical and sometimes cognitive development.

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Development Hormones Drugs Trials 72

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 158

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

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.

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Hormones Trials Clinical Trials Clinical 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

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 122

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%

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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

XTalks

FEBRUARY 21, 2024

Recently, Eli Lilly revealed promising results from a mid-stage trial, indicating that its popular drug, tirzepatide (marketed as Zepbound and Mounjaro for weight loss and diabetes, respectively), may be an effective treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).

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Clinical Trials Clinical Trials Trials Insulin 59

Drug Discovery World

APRIL 10, 2024

Some of the current optimism may be related to the nearly two decades of experience we now have with certain incretin hormone therapies based on glucagon-like peptide receptor agonists (GLP-1 RA), which modulate appetite, satiation and food intake and have revolutionised treatment for type 2 diabetes.

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Clinical Trials Clinical Trials Trials Hormones 52

The Pharma Data

AUGUST 28, 2020

A new breast cancer drug, called TTC-352, can halt the spread of the disease and is safe according to a Phase 1 clinical trial. The drug is being developed and tested by researchers at the University of Illinois at Chicago and is a type of hormone therapy, which targets oestrogen receptor-positive types of breast cancer.

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Hormones Trials Drugs Pharmacy 52

XTalks

OCTOBER 25, 2023

Dr. Neal-Perry spoke about some of the latest trial data for fezolinetant that was presented at the recent Annual Meeting of The Menopause Society. This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies.

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Life Science Trials FDA Approval Hormones 52

Pharmaceutical Technology

JUNE 1, 2023

In addition, the FDA previously rejected Intercept’s OCA NDA, with the federal agency issuing a complete response letter (CRL) requesting longer-term post-interim analysis efficacy and safety data from the ongoing pivotal Phase III REGENERATE trial (NCT02548351) in June 2020. risk reduction compared with placebo).

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Clinical Trials Clinical Trials Trials Hormones 130

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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Pharmaceutical Technology

JUNE 5, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Rezvilutamide is indicated for the treatment of metastatic hormone sensitive prostate cancer. Rezvilutamide overview Rezvilutamide is an antineoplastic agent.

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Medicine Hormones Production Clinical Trials 100

Pharmaceutical Technology

JUNE 5, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Rezvilutamide is indicated for the treatment of metastatic hormone sensitive prostate cancer. Rezvilutamide overview Rezvilutamide is an antineoplastic agent.

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Medicine Hormones Production Clinical Trials 100

JAMA Internal Medicine

JUNE 20, 2021

Recent clinical trials and a meta-analysis demonstrate no symptomatic benefit from treatment with levothyroxine among nonpregnant adults with subclinical hypothyroidism (defined as an elevated thyrotropin level with normal serum thyroid hormone levels).

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