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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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. AstraZeneca stated that its NDA is being reviewed under Project Orbis.

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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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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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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. Lerner researchers developed a novel artificial intelligence platform to identify potential drugs for COVID-19, finding melatonin to be a promising candidate.

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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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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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The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. MONDAY, Dec. Food and Drug Administration announced Friday.

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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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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

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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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.

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The Pharma Data

DECEMBER 21, 2020

The Phase III study was conducted as an open-label trial with patients receiving either an Orgovyx pill daily or injections of Abbvie’s Lupron as an injection every three months. Because prostate cancer is fueled by testosterone production, both drugs decrease levels of the hormone in the body. .

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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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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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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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Medical Xpress

APRIL 28, 2023

However, this decline in quality of life was temporary and there were no clinically meaningful differences in quality of life between treatment arms by one year after the initiation of treatment.

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pharmaphorum

SEPTEMBER 6, 2022

The health technology assessment (HTA) authority said that the PARP inhibitor “is not cost-effective at its current price” as a treatment for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed after prior hormonal therapy.

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Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

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XTalks

DECEMBER 18, 2024

CAH is a group of rare genetic disorders affecting the adrenal glands, which produce essential hormones like cortisol, aldosterone and androgens. The most common form of CAH, 21-hydroxylase deficiency, disrupts hormone production, leading to cortisol deficiency and an overproduction of androgens.

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pharmaphorum

DECEMBER 12, 2022

The San Antonio Breast Cancer Symposium (SABCS) has highlighted some of the most promising clinical research being undertaken by drugmakers in the category, with AstraZeneca leading the charge with a trio of major trial readouts. The post SABCS: Pharmas show their working in HR+/HER2- breast cancer appeared first on.

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pharmaphorum

JULY 22, 2021

The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors – so are hormone sensitive – but test negative for HER2 receptors that would make them candidates for treatment with drugs like trastuzumab. billion in backloaded milestone payments.

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Scienmag

SEPTEMBER 29, 2020

20-year research breakthrough offers new hope for high risk patients with HR+ breast cancer A new treatment for breast cancer patients with hormone receptor (HR+) early stage disease who are at a high risk of recurrence has been shown to reduce the risk by 25%, according to a study led by The Royal Marsden NHS […].

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XTalks

JANUARY 23, 2024

Rare diseases, often overlooked in the broader medical research field, affect a small percentage of the population yet carry a significant burden for those diagnosed and their families. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development.

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XTalks

SEPTEMBER 12, 2024

XTALKS WEBINAR: How Decentralized and Rapid NGS Testing Can Overcome Challenges in Oncology Trials Live and On-Demand: Friday, October 25, 2024, at 1pm EDT (10am PDT) Register for this free webinar to gain insights into key considerations when managing oncology biomarker-driven trials and more.

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pharmaphorum

AUGUST 11, 2020

At the beginning of this year, KaNDy completed a phase 2b trial of its first-in-class drug NT-814, showing activity against symptoms of the menopause such as hot flashes and night sweats. A phase 3 trial is expected to begin in 2021 and the company says that the compound could generate peak sales of more than a billion euros globally.

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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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XTalks

MARCH 7, 2024

Other issues include medical systems that can often be dismissive of women’s health concerns or experiences, and historically less research on women’s health, which together, can lead to late diagnoses or misdiagnoses. Experts discuss the therapeutic landscape, treatment gaps, regulatory considerations and clinical trial strategies.

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Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged. Allergenics.

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pharmaphorum

OCTOBER 11, 2020

Pfizer already makes big revenues from its breast cancer drug Ibrance, but a late-stage trial failure has set back its hopes of even loftier sales – and set up a challenge from Eli Lilly’s rival drug Verzenio. The post Ibrance trial failure dashes Pfizer’s growth hopes for the drug appeared first on.

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XTalks

DECEMBER 13, 2024

Zealand Pharma has commenced its global Phase IIb ZUPREME-1 trial, enrolling the first participant to evaluate petrelintide, a long-acting amylin analog, as a potential investigational treatment for people with overweight or obesity. And among its many obesity drugs in clinical trials, Eli Lillys amylin analog eloralintide is in Phase II.

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XTalks

NOVEMBER 10, 2021

GlaxoSmithKline (GSK) unveiled positive safety and efficacy data for its oral anemia drug daprodustat from five pivotal trials for the drug last week. Two of the five trials focused on non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) patients, and detailed data from these trials was shared at the nephrology meeting.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company operates research and development, clinical operation centers in China, and the US. Adlai Nortye is headquartered in Hangzhou, Zhejiang, China.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Orgovyx, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.

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