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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Pharmaceutical Technology

MAY 15, 2023

The drug’s application was based on clinical data from the BRIGHT SKY program , which included the SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142) trials. Prior to Veozah’s approval, available treatments for hot flashes included hormone replacement therapy, which consisted of either combined oestrogen and progestogen or oestrogen.

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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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Pharmaceutical Technology

JULY 13, 2022

Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer. An oral, non-steroidal and selective CYP11A1 inhibitor, ODM-208 is currently being analysed in a Phase II trial in mCRPC patients. As per the agreement, the companies will jointly develop and market ODM-208.

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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

Fierce Pharma

JULY 17, 2024

Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer (mHSPC).

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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

JUNE 13, 2023

The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

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Pharmaceutical Technology

JULY 18, 2024

The Phase III trial evaluating Nubeqa in patients with metastatic hormone-sensitive prostate cancer met its primary endpoint.

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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. months compared with 16.8

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pharmaphorum

MARCH 23, 2021

That’s looking increasingly likely thanks to the trial data just announced, which shows the drug significantly improved overall and progression-free survival compared with standard care in PSMA-positive metastatic castration-resistant prostate cancer. The five-year survival rate for patients with mCRPC is approximately 15%.

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pharmaphorum

AUGUST 4, 2022

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The post Keytruda fluffs its lines in prostate, liver cancer trials appeared first on.

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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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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

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

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

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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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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Medical Xpress

DECEMBER 8, 2022

The next-generation selective estrogen receptor degrader (SERD) camizestrant improved progression-free survival, compared with fulvestrant (Faslodex), in patients with hormone receptor-positive, HER2-negative breast cancer in the phase II SERENA-2 trial, according to results presented at the San Antonio Breast Cancer Symposium, held December 6-10, (..)

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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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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. It focuses on advancing drugs for the treatment of diabetes and other serious chronic conditions, including hemophilia, human growth hormone (HGH) disorders, rare blood and rare endocrine diseases, and obesity.

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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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pharmaphorum

JULY 17, 2024

Bayer has the result it was hoping for in the phase 3 ARANOTE trial of Nubeqa in metastatic, hormone-sensitive prostate cancer (mHSPC), a key part of its plan to build the drug into a €3 billion-a-year blockbuster.ARANOTE compared Nubeqa (darolutamide) to placebo given with standard androgen deprivation therapy (ADT) and showed a significant improvement (..)

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pharmaphorum

FEBRUARY 21, 2022

In contrast, up to 55% of all patients with breast cancer have tumours with a HER2-low score, as defined in the DESTINY-Breast04 trial, and approval in this group could unlock $3 billion in additional sales for Enhertu, according to analysts at Credit Suisse. AZ paid a hefty $1.4 AZ paid a hefty $1.4

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Medical Xpress

NOVEMBER 11, 2022

A Monash University-led trial of a new drug known as Q-122 therapy significantly reduced the number and severity of hot flashes and night sweats in women who have been diagnosed with breast cancer. It also improved their sleep and had no serious adverse effects.

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Hormones Trials Drugs 98

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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pharmaphorum

MAY 20, 2021

NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. Hormone relapsed disease has stopped responding to hormone therapy and is usually treated with ADT alone or with Bayer’s Nubeqa (darolutamide) and ADT.

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pharmaphorum

DECEMBER 3, 2021

Just released results from the ARASENS trial show that adding Nubeqa (darolutamide) to docetaxel chemotherapy and androgen deprivation therapy (ADT) to switch off testosterone production helps men with castration-sensitive prostate cancer (CSPC).

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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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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

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

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

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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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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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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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

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. Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. Acromegaly. Prevalence: 50 to 70 people per 1 million.

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