Phase III trial

T cells attack a cancer cell
#Assay development optimisation & technology #Cancer immunotherapy #Cancer research #Immuno-oncology #Immunotherapy #Oncology #Phase III trial

New podcast: The consistency and value of immunotherapy

This is the latest episode of the free DDW narrated podcast, titled “How technology is impacting drug discovery”, which covers two articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. They are called: Immunotherapy offers survival extension for brain tumour patients and The evolution of assays for… Read More

#News

Woman tests blood glucose level
#Diabetes #Eli Lilly #GLP-1 #Obesity #Phase III trial #Weight loss

Weight loss drug reduced type 2 diabetes risk by 94%

Topline results from the SURMOUNT-1 three-year study have shown that tirzepatide (Zepbound and Mounjaro) significantly reduced the risk of progression to type 2 diabetes by 94% among adults with pre-diabetes and obesity or overweight. Additionally, treatment with tirzepatide resulted in sustained weight loss through the treatment… Read More

#News

Endometrial biopsy
#AstraZeneca #European Commission #Immunotherapy #Oncology #PARP inhibitors #Phase III trial

Lynparza and Imfinzi combination approved in the EU for endometrial cancer

AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy as first-line treatment followed by Lynparza and Imfinzi has been approved for patients with mismatch repair proficient… Read More

#News #Regulatory #Trending News

Amgen HQ
#Amgen #Autoimmune disease #Immune system #Phase III trial

Amgen reports positive results for treatment of IgG4-RD

Amgen has reported positive topline results from its randomised, double-blind, multicentre, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of its treatment for Immunoglobulin G4-related disease (IgG4-RD). The company’s MITIGATE study was designed to evaluate the safety and efficacy of UPLINZA compared to placebo… Read More

#News

Monoclonal antibody
#Autoimmune disease #Janssen #Monoclonal antibodies #Neurology #Phase III trial

Janssen reports positive data for myasthenia gravis treatment

Janssen-Cilag has reported positive results from its Phase III Vivacity-MG3 study assessing its nipocalimab therapy for the treatment of patients with generalised myasthenia gravis (gMG). The Johnson & Johnson company showcased the data in a presentation at the European Academy of Neurology (EAN) 2024 Congress and… Read More

#News

Neurons in a brain with Alzheimer's disease
#Alzheimer's #Eli Lilly #FDA #Neurodegenerative disorders #Phase III trial

FDA approves second anti-amyloid beta antibody for Alzheimer’s

Eli Lilly’s anti-amyloid beta monoclonal antibody (mAb) Kisunla (donanemab) has become the second disease-modifying therapy for Alzheimer’s disease (AD) to reach the US market, following approval by the US Food and Drug Administration (FDA). It has been approved by the regulator for the treatment of patients… Read More

#News #Regulatory #Trending News

HIV cell
#Gilead Sciences #HIV #Phase III trial #Virology

Twice-yearly HIV injection demonstrates 100% efficacy

Interim analysis of the Phase III PURPOSE 1 trial indicates that Gilead Sciences twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrates 100% efficacy for the investigational use of HIV prevention in cisgender women. PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily… Read More

#News #Trending News

Woman with a nose bleed
#Bispecific Antibodies #Events #Haemophilia #Novo Nordisk #Phase III trial

Bispecific antibody successfully reduced bleeds in haemophilia A

Novo Nordisk has announced results from the Phase III FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors. The trial assessed both once-weekly and once-monthly prophylactic treatment with the investigational treatment Mim8. The data… Read More

#News

Man wearing a cap mask while sleeping
#American Diabetes Association #Diabetes #Eli Lilly #GLP-1 #Phase III trial #Sleep apnoea #Weight loss

Weight loss drug reduces sleep apnoea severity by 62%

Tirzepatide demonstrated a mean reduction of up to 62.8% on the apnoea-hypopnea index (AHI) compared to placebo in the SURMOUNT-OSA Phase III clinical trials. The drug was tested for the treatment of moderate-to-severe obstructive sleep apnoea (OSA) in adults with obesity, with and without positive airway… Read More

#News #Trending News

Brain scan
#France #Minoryx Therapeutics #Neurodegenerative disorders #Phase III trial

Leriglitazone halts progression of fatal neurodegenerative disorder

Leriglitazone has been shown to halt disease progression in adult patients with early cerebral adrenoleukodystrophy (cALD) in a compassionate-use study. cALD is a fatal neurodegenerative disorder that is characterised by growing, demyelinating brain lesions, with death occurring typically within three to four years of onset. Read More

#News

CAR-T therapy
#CAR-T #European Commission #Janssen #Myeloma #Oncology #Phase III trial

EC expands use of BCMA-targeted CAR-T therapy

The European Commission (EC) has approved a Type II variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). It is approved in patients who have received at least one prior therapy, including an immunomodulatory agent (IMiD)… Read More

#News #Regulatory

Bacteria in Petri dishes
#Antibiotic resistance #Antibiotics #Antimicrobial resistance (AMR) #GSK #Phase III trial

GSK announces positive data for gonorrhoea antibiotic

Positive results have been announced by GSK for its antibiotic targeting uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. First results from the EAGLE-1 Phase III trial for gepotidacin show that two oral doses of the antibiotic displayed superior success rates (92.6%) when compared to the… Read More

#Editor's Choice #News

#Antibodies #Cancer research #Oncology #Phase III trial #Therapeutic Antibodies

Improving the standard of care: Inside the DUO-E trial

Professor Shannon Westin is principal investigator of the DUO-E trial, here she speaks to DDW’s Megan Thomas about why the standard of care needs improving and the impact of therapeutic antibodies such as durvalumab. The DUO-E trial is a three-arm, randomised, double-blind, placebo-controlled, multicentre Phase III… Read More

#Cancer Research #Exclusive Content

Dementia
#Alzheimer's #Eli Lilly #FDA #Neurodegenerative disorders #Phase III trial

FDA advisory committee meeting delays approval of donanemab

The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial. The trial evaluated the efficacy and safety of Eli Lilly’s donanemab in early… Read More

#News #Regulatory

Peanut butter
#Allergy #FDA #Monoclonal antibodies #National Institute of Allergy and Infectious Diseases #Phase III trial

FDA approves first medication to reduce allergic reactions

The US Food and Drug Administration (FDA) has approved monoclonal antibody Xolair (omalizumab) for immunoglobulin E-mediated food allergy in some adults and children one year or older for the reduction of allergic reactions (Type I). The FDA said that Xolair is intended for repeated use to… Read More

#News #Regulatory