XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). It is a complication of Graves disease, an immune system condition that causes the thyroid gland to make excess amounts of thyroid hormone.

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XTalks

JANUARY 29, 2025

Related: Eli Lillys Zepbound Approved as First Treatment for Obstructive Sleep Apnea The commercial describes Zepbounds mechanism of action as a dual receptor against that works by activating two naturally occurring hormone receptors in [the] body [GLP-1 and GIP-1]. Its changing how much weight I lose, up to 48 lbs, he says.

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XTalks

JANUARY 30, 2025

Novartis has spent three decades advancing breast cancer treatments, focusing on hormone receptor-positive (HR+), HER2-negative breast cancer, the most common subtype. Last year, the FDA approved Kisqali (ribociclib) to reduce the risk of recurrence in HR+/HER2- early breast cancer. Novartis dedicated approximately $0.47

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XTalks

MARCH 18, 2025

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. Janus kinase one (JAK1) plays a central role in the signaling pathways of several inflammatory cytokines.

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XTalks

FEBRUARY 21, 2025

In the gut, these receptors prompt the release of hormones such as cholecystokinin and GLP-1, which together signal satiety. In a Phase II trial involving patients with hyperphagia, ARD-101 was well tolerated and achieved an approximate eight-point reduction in hunger scores. The competitive landscape is equally dynamic.

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XTalks

MAY 17, 2023

Astellas Pharma recently announced the US Food and Drug Administration (FDA) approval of their new medication, Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. Hormone replacement therapy is thought to be one of the most effective treatments for vasomotor symptoms.

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pharmaphorum

FEBRUARY 1, 2021

If approved by the European Commission in the coming weeks, Kesimpta will offer patients with relapsing disease a treatment option that can be self-administered every month through an auto-injector pen.

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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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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 10, 2021

Related: GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer. In the ASCEND trials, Daprodustat was comparable to Amgen’s Aranesp (darbepoetin alfa), an erythropoiesis-stimulating agent (ESA), with respect to heart safety. What is Daprodustat?

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XTalks

AUGUST 22, 2024

Yorvipath, developed using Ascendis Pharma’s TransCon technology, is the first and only approved treatment for hypoparathyroidism, marking this approval as a major milestone. Hypoparathyroidism arises when the parathyroid glands fail to produce enough parathyroid hormone (PTH) or when the PTH produced is ineffective.

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Delveinsight

JANUARY 5, 2021

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon. Pfizer and Opko had joined hands in 2014 to develop somatrogon , a pediatric growth hormone deficiency (GHD) drug. Recent results from Phase III clinical studies support the duo’s regulatory submission for somatrogon.

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Hormones FDA Approval Drugs Trials 52

XTalks

FEBRUARY 21, 2024

There are currently no FDA-approved drug therapies for MASH, and the disease is characterized by excess fat accumulation and inflammation in the liver, which leads to liver scarring or fibrosis. Clinical Trials for MASH Treatment The tirzepatide trial involved approximately 190 adults with MASH at different stages.

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XTalks

OCTOBER 25, 2023

Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause.

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XTalks

SEPTEMBER 17, 2020

Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed.

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XTalks

JUNE 27, 2022

Novartis’ Tafinlar and Mekinist received FDA approval for the treatment of unresectable or metastatic solid tumors with the BRAF V600E mutation. Tafinlar and Mekinist Combination Clinical Trial Results. The safety and efficacy of the Tafinlar and Mekinist combination therapy was evaluated in three clinical trials.

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Clinical Trials Clinical Trials Trials Gene 52

Find Me Cure

OCTOBER 13, 2019

There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. CDK4/6 inhibitors are used alongside hormone therapy. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials.

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Delveinsight

DECEMBER 7, 2020

Development in the technology has made it possible for solutions to surface, primarily related to R&D, clinical trials, and diagnostics and treatment, as well as patient management, leading to even more significant innovative potential and promise for AI in the industry.

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XTalks

MAY 10, 2023

The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. Lupkynis was the first FDA-approved oral medication specifically indicated for the treatment of LN. What Is the Theme of World Lupus Day 2023?

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Drugs Clinical Trials Clinical Trials Antibody 52

The Pharma Data

JUNE 28, 2021

Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide FDA-approved for the treatment of type 2 diabetes. SURPASS-2 was a 40-week, randomized, open-label trial comparing the efficacy and safety of tirzepatide to semaglutide as an add-on to metformin in adults with type 2 diabetes.

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Clinical Trials Clinical Trials Insulin Hormones 52

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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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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XTalks

JULY 6, 2023

Pfizer has been going strong on the approval front, having secured its fifth US Food and Drug Administration (FDA) approval in the past five weeks, with the most recent being for the company’s once-weekly human growth hormone analog Ngenla (somatrogon-ghla).

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XTalks

NOVEMBER 12, 2024

Pancreatic cancer occurs when cells in the pancreas, a vital organ responsible for producing enzymes and hormones, begin to grow uncontrollably. Targeted therapies and clinical trials also offer potential treatment avenues for those diagnosed with the disease.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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XTalks

FEBRUARY 19, 2021

Evofem Biosciences announced the launch of their new national campaign called, “Get Phexxi,” designed to raise awareness about the company’s non-hormonal birth control method. In May 2020, the US Food and Drug Administration (FDA) approved Phexxi , a non-hormonal contraceptive for women.

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XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Mounjaro and Ozempic are both FDA approved for glycemic control in adults with type 2 diabetes, in combination with diet and exercise.

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Pharmaceutical Technology

JUNE 1, 2023

Additionally, panellists expressed doubts regarding Intercept’s use of a surrogate endpoint in its clinical trial. Specifically, the FDA questioned “how the magnitude of changes in these surrogate endpoints may translate to meaningful changes in clinical outcomes”.

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XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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pharmaphorum

DECEMBER 1, 2021

Sanofi said it would also apply its mRNA vaccine platform – acquired along with Translate Bio earlier this year – to find other acne vaccine candidates that could start clinical trials in 2023. Origimm’s expertise in the skin microbiome and antigen discovery will be central to that effort, it added.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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FDA Approval Drugs Sales Development 52

XTalks

FEBRUARY 3, 2023

Until now, fulvestrant was the only other selective estrogen receptor degrader (SERD) therapy approved for ER+ breast cancer, delivered via intramuscular injections. This approval follows the promising results of the Phase III EMERALD global clinical trial published in the Journal of Clinical Oncology.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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XTalks

NOVEMBER 2, 2020

This includes compromising the functioning of the adrenal glands, which can potentially lead to adrenal insufficiency, resulting in inadequate production of steroid hormones. In the trial, more than half of Fasenra patients were completely weaned off of oral steroids, compared with 19 percent for the placebo group.

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Pharmaceutical Technology

MARCH 2, 2023

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. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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pharmaphorum

DECEMBER 23, 2020

In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1 There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. months, compared with 6.7 Neurology on the march.

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XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

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