Advarra

JUNE 30, 2023

The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible for Medicaid in April 2022. However, a year has passed with no further updates on this letter or Medicaid beneficiaries enrolling in clinical trials.

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Clinical Trials Clinical Trials Trials Hormones 52

XTalks

NOVEMBER 29, 2023

David Cameron, Chair of the Breast International Group (BIG) , we delve into the landscape of breast cancer research today, clinical trials and the incorporation of the patient voice in breast cancer research. Breakthroughs in Treatment BIG has been at the forefront of numerous clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

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.

Hormones 88

Hormones Production FDA Approval Marketing 88

XTalks

JANUARY 23, 2024

Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development.

Development 72

Development Hormones Drugs Trials 72

Pharmaceutical Technology

FEBRUARY 24, 2023

(LAI-287 + semaglutide) is under clinical development by Novo Nordisk and currently in Phase III for Type 2 Diabetes. According to GlobalData, Phase III drugs for Type 2 Diabetes have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. Buy the report here.

Insulin 182

Insulin Hormones Drugs Clinical Trials 182

Pharmaceutical Technology

FEBRUARY 9, 2023

According to GlobalData, Phase I drugs for Turner Syndrome have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Ibutamoren mesylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Hormones 100

Hormones Clinical Trials Clinical Trials Genetics 100

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials In-Vitro 98

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.

Hormones 95

Hormones FDA Approval Drugs Clinical Trials 95

Drug Discovery World

FEBRUARY 20, 2024

One example is that the model can circumvent the difficulties in demonstrating in vivo drug efficacy which arise because of mouse specific metabolism issues. Gates Foundation grant to accelerate global drug discovery appeared first on Drug Discovery World (DDW). A key stage of compound progression. The post $2.3m

Drugs 52

Drugs In-Vivo Hormones Development 52

Drug Discovery World

MAY 6, 2024

Food and Drug Administration (FDA). The company’s lead therapeutic peptide candidate is currently in a Phase III clinical trial for the treatment of hypoparathyroidism. Amolyt Pharma has announced that its lead therapeutic peptide candidate, eneboparatide, has been granted fast track designation by the U.S.

Hormones 52

Hormones Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. In these subjects, the median progression-free survival (PFS) following Enhertu treatment was 9.9

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

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.

Hormones 246

Hormones Clinical Trials Clinical Trials Licensing 246

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. The post Bayer triples sales forecast for prostate cancer drug Nubeqa appeared first on.

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Sales Drugs Hormones Pharma Production 98

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). A prior orchiectomy or receipt of gonadotropin-releasing hormone (GnRH) analogs was also necessary.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

Drug Discovery World

DECEMBER 9, 2022

A new type of targeted medicine has shown ‘remarkable’ benefits for patients with advanced breast cancer in a major Phase III clinical trial. . The drug capivasertib combined with hormone therapy doubled the time it took for cancer to progress in people with advanced forms of the most common type of breast cancer. .

Trials 52

Trials Hormones Drugs Genetics 52

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). . The post New prostate cancer drug approved in Europe appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs Clinical Trials Clinical Trials Hormones 52

Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase I drugs for Liver Failure (Hepatic Insufficiency) does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Rezvilutamide LoA Report. Buy the report here.

Medicine 100

Medicine Hormones Production Clinical Trials 100

Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase III drugs for Prostate Cancer have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Rezvilutamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Medicine 100

Medicine Hormones Production Clinical Trials 100

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. The post CHMP clears way for EU approval of Novartis’ MS drug appeared first on.

Drugs 98

Drugs Hormones FDA Approval Clinical Trials 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.

Hormones 105

Hormones Antibody Trials Production 105

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.

Research 64

Research Drugs Hormones Trials 64

pharmaphorum

JULY 14, 2022

In a statement , the health technology assessment (HTA) organisation said that the two drugs were backed after an agreement with the two developers on pricing that will make them an option for around 3,450 NHS patients. “Both represent another step in delaying chemotherapy, allowing people to stay well for longer,” she added.

Drugs 99

Drugs Hormones Genome Genomics 99

pharmaphorum

MAY 16, 2022

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. 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.

FDA Approval 113

FDA Approval Insulin Drugs Hormones 113

Pharmaceutical Technology

MAY 31, 2023

According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Sym-021’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

Generic Drugs 100

Generic Drugs Hormones Manufacturing Development 100

pharmaphorum

AUGUST 11, 2020

Bayer is to buy UK-based KaNDy Therapeutics in a deal worth more than $800 million, adding the biotech’s menopause drug to its women’s health pipeline. 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.

Drugs 96

Drugs Hormones Marketing Trials 96

Pharmaceutical Technology

JUNE 6, 2023

Ecubectedin is a small molecule commercialized by Pharma Mar, with a leading Phase II program in Hormone Sensitive Breast Cancer. According to Globaldata, it is involved in 5 clinical trials, which are ongoing. The drug candidate is a marine-derived compound. It is administered through intravenous route.

Hormones 100

Hormones In-Vitro Genotype Bacteria 100

pharmaphorum

AUGUST 18, 2022

Astellas remains on course to be the first drugmaker to bring a new non-hormonal therapy for symptoms of menopause to market, after the FDA started a review of its orally-active neurokinin-3 (NK3) receptor antagonist fezolinetant. The post Astellas files menopause drug fezolinetant in US, setting up Feb verdict appeared first on.

Hormones 52

Hormones Drugs Clinical Trials Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). According to GlobalData, Phase I drugs for Genital Warts (Condylomata Acuminata) have a 91% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). According to GlobalData, Phase I drugs for Cervical Intraepithelial Neoplasia (CIN) have a 92% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Drug Discovery World

APRIL 23, 2024

Michael Wyand, PhD, Chief Executive Officer/Director, Oxeia Biopharmaceuticals explains why there’s a need for new drugs to treat traumatic brain injuries. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI. It’s an exciting time in the field of concussion drug development.

Drugs 59

Drugs Development Life Science Hormones 59

Pharmaceutical Technology

FEBRUARY 27, 2023

According to GlobalData, Phase I drugs for Relapsed Multiple Myeloma have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Enzalutamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Hormones 113

Hormones Contract Manufacturing Manufacturing Development 113

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. There are around 2.3

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Trials Hormones Clinical Trials Clinical Trials 111

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.

Hormones 52

Hormones Trials Drugs Pharmacy 52

pharmaphorum

MAY 13, 2022

Ryeqo (relugolix/estradiol/norethisterone acetate) – originally developed by Myovant – is the first drug in the class to be approved for NHS use in this indication, offering another option to treatment with injectable GnRH drugs used for women with moderate to severe symptoms. Pfizer agreed a $4.2

Drugs 64

Drugs Hormones Marketing Clinical Trials 64

Pharmaceutical Technology

FEBRUARY 23, 2023

According to GlobalData, Phase II drugs for Mantle Cell Lymphoma have a 34% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Buparlisib hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Hormones 130

Hormones Development Drugs Clinical Trials 130

Drug Discovery World

JUNE 7, 2023

Positive primary endpoint data from Novartis’ pivotal Phase III NATALEE trial has been presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

HR 52

HR Drugs Hormones Trials 52

pharmaphorum

MAY 27, 2021

Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids. . Combining it with the hormonal drugs reduces side effects – such as bone loss – that can result from reducing oestrogen levels.

Hormones 98

Hormones Sales Marketing Drugs 98