XTalks

AUGUST 10, 2022

The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo. This is the first approved therapy for patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. Enhertu Trial Data. Of the trial participants, females made up 99.6

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FDA Approval HR Hormones Antibody 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. GLP-1 agonists were first developed as diabetes treatments. percent and 22.5

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Trials Drugs FDA Approval Clinical Trials 98

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. The post Sanofi snaps up acne vaccine developer Origimm Bio appeared first on. Photo by Scott Webb on Unsplash.

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Vaccination Vaccine Development Hormones 105

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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Hormones FDA Approval Drugs Clinical Trials 95

XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data.

FDA Approval 101

FDA Approval Drugs Sales Development 101

pharmaphorum

SEPTEMBER 15, 2021

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva.

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Hormones Drugs FDA Approval Sales 98

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. That study isn’t due to read out until 2026, according to the ClinicalTrials.gov database.

Trials 52

Trials HR Hormones Drugs 52

XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data.

FDA Approval 52

FDA Approval Drugs Sales Development 52

pharmaphorum

JANUARY 26, 2023

Prostate cancer has proved an elusive target for cancer immunotherapies, and Merck & Co’s checkpoint inhibitor Keytruda is the latest to fall short in the disease in a phase 3 trial. It remains ongoing with updated results due in the coming months.

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Hormones Trials FDA Approval Clinical Development 59

Drug Discovery World

DECEMBER 22, 2022

A new drug based on the active ingredient Lutetium-177 PSMA-617 has been approved by the European Commission for the treatment of metastatic prostate cancer carrying the surface molecule PSMA (prostate specific membrane antigen). . It had already received FDA approval for the United States in March of this year.

Drugs 52

Drugs Clinical Trials Clinical Trials Hormones 52

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

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 mL subcutaneous solution (2 mg/1.5 billion in Q4 2022.

Sales 52

Sales Insulin FDA Approval Drugs 52

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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Trials Gene Hormones Clinical Trials 98

pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

Drugs 98

Drugs Hormones FDA Approval Licensing 98

XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. billion to $1.28

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HR FDA Approval Gene Trials 98

Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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Antibody Marketing Drugs Licensing 98

Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

FDA Approval 52

FDA Approval In-Vivo Gene Editing Drugs 52

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. The doublet is working together on developing SCONE , a small capacity, disposable device.

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Hormones FDA Approval Trials Drugs 52

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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HR Hormones FDA Approval Antibody 52

The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

FDA Approval 52

FDA Approval Medicine Clinical Trials Clinical Trials 52

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. The topline results hold even more significance after the rejection of AstraZeneca and FibroGen’s oral anemia med roxadustat by the US Food and Drug Administration (FDA) in August.

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Trials Hormones Drugs FDA Approval 97

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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Clinical Trials Clinical Trials FDA Approval Trials 97

The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

FDA Approval 52

FDA Approval Hormones Production Drugs 52

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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Research Hormones Protein Regulation 98

pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster. Most men with mHSPC will eventually progress to CRPC, which has poor survival prospects.

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Sales Hormones FDA Approval Marketing 59

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Ozempic was approved in 2017 and Wegovy in 2021.

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FDA Approval Manufacturing Drugs Pharmacy 59

Find Me Cure

OCTOBER 13, 2019

If you follow our blog you know that we at FindMeCure take updating our readership on treatments in development very seriously. 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. Rosenberg, M.D.

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Development DNA Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 2, 2020

Results from the world’s largest steroid sparing trial in severe asthma patients conducted to date show that AstraZeneca’s Fasenra (benralizumab) can eliminate the use of maintenance oral corticosteroids (OCS) in OCS-dependent asthma patients. Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., PONENTE Trial.

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Trials FDA Approval Hormones Drugs 94

pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

Dermatology 52

Dermatology Drugs Hormones FDA Approval 52

XTalks

JUNE 10, 2024

Efruxifermin is a novel Fc-FGF21 fusion protein designed to emulate the activity of native FGF21, an endogenous hormone that regulates metabolism and alleviates cellular stress. MASH is intricately linked to cardiovascular, kidney and metabolic disorders. No serious adverse events related to the drug were reported.

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Insulin Life Science Regulation Hormones 52

Drug Discovery World

APRIL 23, 2024

Although not a test to diagnose concussion, a biomarker test developed by Abbott Laboratories helps to determine whether a patient should receive a CT scan to rule out haemorrhage. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI.

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Drugs Development Life Science Hormones 59

pharmaphorum

OCTOBER 26, 2022

Those who develop psoriatic arthritis are saddled with joint pain and inflammation. Food and Drug Administration approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist and the first FDA-approved steroid-free topical medication in its class. When this hormone is suppressed, response to stressors (e.g.

Hormones 98

Hormones FDA Approval Doctors Doctor 98

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. The company is currently preparing for further clinical trials in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).

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Marketing Pharma Companies Development Hormones 94

pharmaphorum

DECEMBER 23, 2020

The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1

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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. In addition, combination therapies may reduce the potential development of additional mutations that make cancer more difficult to treat and could help reduce the risk of drug resistance.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

XTalks

MAY 20, 2022

Related: Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial. Like Mounjaro, Novo Nordisk’s Ozempic is also a GLP-1 receptor agonist and in a head-to-head trial last year, Lilly’s drug trumped Novo’s. The dose is adjusted as tolerated to meet blood sugar goals. percent more than semaglutide, 0.9

Insulin 52

Insulin Life Science Drugs Sales 52

Delveinsight

DECEMBER 7, 2020

For instance, the shortage of healthcare professionals can be tackled by creating better diagnostic and treatment procedures, integrating solutions developed by physicians worldwide, and providing them seamlessly over a platform accessed by all practicing physicians. In May 2018, Ava raised about $30 million in a Series B round.

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Protein Insulin Hormones FDA Approval 56