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.

Hormones 130

Hormones Trials Clinical Trials Clinical Trials 130

XTalks

OCTOBER 25, 2023

Genevieve Neal-Perry, MD, PhD Professor and Chair Department of Obstetrics and Gynecology UNC School of Medicine It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms, which include hot flashes and night sweats, associated with menopause.

Life Science 52

Life Science Trials FDA Approval Hormones 52

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. Novo Nordisk overview Novo Nordisk, a subsidiary of Novo Holdings AS, is a healthcare company focused on discovering, developing, and manufacturing of innovative biological medicines.

Insulin 182

Insulin Hormones Drugs Clinical Trials 182

pharmaphorum

APRIL 25, 2022

Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears to be another blow to the emerging oral selective oestrogen receptor degrader (SERD) class.

Trials 69

Trials Hormones HR Sales 69

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

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

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…

Hormones 98

Hormones Clinical Trials Clinical Trials Doctors 98

Drug Discovery World

NOVEMBER 7, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new indication for anastrozole, to prevent breast cancer in post-menopausal women at moderate or high risk of developing the disease.

Hormones 52

Hormones Drugs Development Trials 52

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.

Hormones 52

Hormones FDA Approval Containment Medicine 52

pharmaphorum

FEBRUARY 18, 2022

Bayer now says it expects to make €3 billion in sales for its prostate cancer treatment Nubeqa, up from an earlier estimate of €1 billion, after reviewing new data for the drug in metastatic hormone-sensitive tumours. compared to standard therapy alone.

Sales 98

Sales Drugs Hormones Pharma Production 98

The Pharma Data

JUNE 2, 2023

“These additional data on Verzenio and Jaypirca build on the evidence supporting the role each of these medicines play in improving the treatment paradigms for patients with node-positive, high risk early breast cancer and covalent BTK inhibitor pre-treated relapsed or refractory MCL, respectively,” said David Hyman, M.D.,

HR 52

HR Hormones Medicine Trials 52

The Pharma Data

MARCH 20, 2023

We are therefore delighted that patients in China will now have a new treatment option for metastatic hormone-sensitive prostate cancer that delays disease progression, extends survival and maintains quality of life”, said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology SBU at Bayer.

Hormones 40

Hormones Trials Sales Development 40

Pharmaceutical Technology

MAY 31, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also provides digital therapeutic solutions through its e-health division, WeHealth Digital Medicine. It invests a substantial amount of revenue in R&D, particularly in France and Hungary.

Generic Drugs 100

Generic Drugs Hormones Manufacturing Development 100

Drug Discovery World

NOVEMBER 15, 2023

The drug has also been approved (as Mounjaro) for weight loss by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. We have drawn on advice from the independent Commission on Human Medicines in coming to our decision, and as with all products, will keep the safety of Mounjaro under close review.”

Trials 52

Trials Hormones Medicine Drugs 52

The Pharma Data

FEBRUARY 21, 2022

All patients in the trial received a HER2 test, and the results were centrally confirmed. 4 Currently, chemotherapy remains the only treatment option both for patients with HR-positive tumours following progression on endocrine (hormone) therapy, and for those who are HR-negative.5.

HR 52

HR Trials Hormones Antibody 52

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.

Hormones 90

Hormones Drugs FDA Approval Sales 90

The Pharma Data

MARCH 27, 2023

The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. About Kisqali ® (ribociclib) Kisqali has consistently demonstrated overall survival benefit while preserving or improving quality of life across three Phase III trials 3 – 1 4.

HR 40

HR Trials Hormones Research 40

pharmaphorum

JUNE 20, 2022

The new advice means that around 4,000 people with hormone receptor-positive, HER2-negative, node-positive early breast cancer who are considered at high risk of recurrence after surgery can receive Verzenios (abemaciclib) in combination with standard hormone therapy, said the agency.

Hormones 114

Hormones Medicine Drugs Production 114

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. Its investigational medicinal products comprise R-107, R-131 and R-147. The company offers consumer, prescription and automation products.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

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. Its investigational medicinal products comprise R-107, R-131 and R-147. The company offers consumer, prescription and automation products.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

The Pharma Data

DECEMBER 9, 2020

9, 2020 — More women with early-stage breast cancer may be able to safely skip chemotherapy after having surgery, according to initial results from a major clinical trial. The trial, conducted in nine countries, found that adding chemotherapy to hormone-blocking drugs brought no added benefit to a particular group of patients.

Hormones 52

Hormones Trials Medicine 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 results were also published in the New England Journal of Medicine at the same time. Roxadustat was also flagged by the FDA for an increased risk of blood clots. percent versus 26.7

Trials 97

Trials Hormones Drugs FDA Approval 97

The Pharma Data

MARCH 23, 2023

The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

Hormones 40

Hormones Trials Branding Development 40

Drug Discovery World

DECEMBER 19, 2023

Astellas’ Veoza (fezolinetant) will soon be available to some women in the UK suffering from vasomotor symptoms (VMS) associated with menopause following approval by the Medicines and Healthcare Regulatory Agency (MHRA). Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in Europe ranging from 56% to 97%.

Hormones 59

Hormones Clinical Trials Clinical Trials Medicine 59

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).

Hormones 67

Hormones Clinical Trials Clinical Trials Trials 67

pharmaphorum

NOVEMBER 27, 2022

The approval comes after presentation of data from the ARASENS phase 3 clinical trial at the 2022 ASCO GU Cancers Symposium in February 2022, together with simultaneous publication of the results in The New England Journal of Medicine. reduced risk of death.

Clinical Trials 89

Clinical Trials Clinical Trials Hormones Medicine 89

The Pharma Data

MARCH 23, 2021

Bagsværd, Denmark, 23 March 2021 – New results from the STEP phase 3a clinical trial programme demonstrated weight loss with investigational treatment of once-weekly subcutaneous semaglutide 2.4 In the STEP 4 trial, study participants who reached the maintenance dose of semaglutide 2.4 for the trial product estimand (2) ).

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

Drug Discovery World

OCTOBER 19, 2022

This announcement comes approximately a year after the Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK licence for E4/DRSP. . The marketing authorisation is based on outcomes from two Phase III randomised control trials. .

Containment 52

Containment Hormones Medicine Production 52

pharmaphorum

MAY 16, 2022

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. And, in trials comparing Mounjaro to other diabetes medications, individuals who received 15mg of Mounjaro had lowering of their HbA1c by 0.5%

FDA Approval 108

FDA Approval Insulin Drugs Hormones 108

Delveinsight

DECEMBER 29, 2020

Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist. Audentes Therapeutics’ ASPIRO Trial Free to Proceed. The ASPIRO trial is a two-part, open-label ascending dose study, and is examining the safety and preliminary efficacy of AT132 in children with XLMTM younger than five years old.

Trials 52

Trials Drugs Hormones Radiology 52

Drug Discovery World

MARCH 24, 2023

There have also been positive trial results announced in prostate cancer, pancreatic cancer and breast cancer.

Drugs 52

Drugs Hormones Trials Research 52

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 Clinical Trials 98

Drug Discovery World

OCTOBER 18, 2023

In an early clinical trial, researchers showed that blocking the messages cancer uses to hijack white blood cells can re-sensitise a subset of advanced prostate cancers to treatment – shrinking tumours or halting their growth. It’s hugely rewarding to see our theory proven in a trial of patients with this disease.

Research 64

Research Drugs Hormones Trials 64

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. The list also included melatonin. This is particularly encouraging since African-Americans have been hit hard by the novel coronavirus.

Research 98

Research Hormones Protein Regulation 98

pharmaphorum

JULY 14, 2022

The antibody-drug conjugate (ADC) was turned down by NICE in draft guidance published earlier this year, leading to concerns of a disparity in access to the drug as the Scottish Medicines Consortium (SMC) had already cleared its use. The post NICE backs two new breast cancer drugs for NHS use appeared first on.

Drugs 92

Drugs Hormones Genome Genomics 92

XTalks

FEBRUARY 3, 2023

Aditya Bardia, MD, MPH, director of Breast Cancer Research at Mass General Cancer Center, associate professor at the Medicine Department at Harvard Medical School and principal investigator for the EMERALD trial, in the same press release statement. Mutations in the ESR1 , however, have contributed to the rise of endocrine resistance.

Clinical Trials 97

Clinical Trials Clinical Trials FDA Approval Trials 97

XTalks

FEBRUARY 6, 2023

Erythropoietin is a hormone that is produced by the kidneys and signals the body to make red blood cells. Clinical Trial Outcomes The FDA approval of Jesduvroq is based on results from the Phase III ASCEND-D trial , which were published in the New England Journal of Medicine. How Does Jesduvroq ( daprodustat) Work?

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

Drug Discovery World

AUGUST 31, 2022

Triple-negative breast cancer is invasive breast cancer that does not respond to hormonal therapy medicines or the current medicines that target the HER2 protein. It is usually more aggressive, harder to treat, and more likely to recur than cancers that are hormone receptor-positive or HER2-positive.

Hormones 52

Hormones Doctors Doctor Clinical Trials 52