STAT News

MARCH 21, 2023

A new obesity treatment being developed by Altimmune met goals for weight loss in a mid-stage clinical trial, but the data showed it doesn’t have a leg up on other popular drugs on the market. Continue to STAT+ to read the full story…

Hormones 98

Hormones Drugs Clinical Trials Clinical Trials 98

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

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy. On July 13, 2023, the U.S.

Hormones 180

Hormones Containment Branding Drugs 180

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

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

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). Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

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

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. The post Bayer extends elinzanetant trials to include breast cancer appeared first on. There are around 2.3

Trials 111

Trials Hormones Clinical Trials Clinical Trials 111

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

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. in trial subjects versus those who received ADT plus docetaxel.

Hormones 246

Hormones Clinical Trials Clinical Trials Licensing 246

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

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.

Sales 98

Sales Drugs Hormones Pharma Production 98

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

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

XTalks

OCTOBER 25, 2023

Dr. Neal-Perry spoke about some of the latest trial data for fezolinetant that was presented at the recent Annual Meeting of The Menopause Society. This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies.

Life Science 52

Life Science Trials FDA Approval Hormones 52

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

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

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 62

Research Drugs Hormones Trials 62

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).

Clinical Trials 59

Clinical Trials Clinical Trials Trials Insulin 59

Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, panellists expressed doubts regarding Intercept’s use of a surrogate endpoint in its clinical trial. risk reduction compared with placebo).

Clinical Trials 130

Clinical Trials Clinical Trials Trials Hormones 130

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 115

FDA Approval Insulin Drugs Hormones 115

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

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 98

Drugs Hormones Marketing Trials 98

Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

HR 130

HR Hormones Clinical Trials Clinical Trials 130

Drug Discovery World

APRIL 10, 2024

With this heightened interest, insight into the current state of obesity research and its future direction is particularly valuable. An ICON survey of over 100 drug development professionals in obesity research revealed optimism about future therapies, with a significant shift towards combination treatments for obesity and its comorbidities.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Hormones 52

Pharmaceutical Technology

MARCH 6, 2023

The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. In the trial, Verzenio along with ET reduced disease recurrence risk by 35% compared to ET alone.

FDA Approval 130

FDA Approval HR Hormones Clinical Trials 130

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

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

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

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 104

Drugs Hormones Genome Genomics 104

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

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.

Drugs 57

Drugs Development Life Science Hormones 57

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

JUNE 6, 2023

A targeted drug combination for patients with a type of ovarian cancer could be nearly twice as effective as the next best treatment, according to interim results from a Phase II study. Responses to the drug combination were particularly promising in those with a KRAS mutation, with 60% of patients experiencing significant tumour shrinkage.

Drugs 52

Drugs Research Hormones Trials 52