Worldwide Clinical Trials
NOVEMBER 12, 2024
By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. CGTs address rare and complex diseases at the root cause with increasing use in cancer, genetic disorders, and autoimmune diseases.
Pharmaceutical Technology
NOVEMBER 12, 2024
The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.
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AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 12, 2024
(Rasi Bhadramani/Getty Images) Forever chemicals are falling in the rain, running through our waterways, and swimming in our bloodstreams, and now, initial research suggests these potentially harmful pollutants are ‘clogging up’ a crucial drainage system in our bodies.
Bio Pharma Dive
NOVEMBER 12, 2024
Trace Neuroscience aims to advance an RNA-binding therapy designed to preserve — and potentially improve — muscle function in people living with the nerve-destroying disorder.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 12, 2024
The Indian Council of Medical Research (ICMR) has issued a call for proposals for its Centre for Advanced Research (CAR) initiative under the Extramural Research Programme, inviting experienced research teams to apply for funding aimed at advancing healthcare research in critical areas.
Bio Pharma Dive
NOVEMBER 12, 2024
Following mixed study results, the partners have backed away from seeking broad clearance of dato-dxd in lung cancer and instead are aiming for a narrower approval.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 12, 2024
The company, which secured $200 million from investors in a private funding deal last week, learned Tuesday of a serious side effect experienced by one participant on a high dose of its Rett therapy.
XTalks
NOVEMBER 12, 2024
On World Pneumonia Day 2024, observed on November 12, the focus shifts to one of the world’s most preventable and treatable diseases that remain a leading cause of death for children under five and a significant risk to vulnerable populations globally. Pneumonia is a lung infection that can be caused by viruses, bacteria or fungi and can result in millions of hospitalizations and deaths annually.
Bio Pharma Dive
NOVEMBER 12, 2024
Under deal terms, GSK will give Vesalius Therapeutics $80 million in upfront and equity payments to identify treatments for Parkinson’s and another neurodegenerative condition.
Pharmaceutical Technology
NOVEMBER 12, 2024
Varenicline, taken once-a-day, reduces cravings for nicotine and helps with withdrawal symptoms in smokers.
Fierce Pharma
NOVEMBER 12, 2024
Despite generic headwinds to Xarelto and challenges across different sectors of the conglomerate suggesting “twists and turns” in the road ahead, Bayer is confident that the course it’s laid out th | As Xarelto generics continue to eat away at sales, Bayer's Nubeqa and Kerendia are picking up the slack while Regeneron-partnered Eylea makes for a solid base.
Pharmaceutical Technology
NOVEMBER 12, 2024
A team of researchers from Uppsala University and KTH Royal Institute of Technology in Sweden has developed a new antibody, which could potentially treat various types of cancer.
Fierce Pharma
NOVEMBER 12, 2024
After a series of acquisitions and an activist investor’s accusation of overspending, Pfizer is exploring an opportunity to slim down by divesting its hospital drugs unit,
Pharmaceutical Technology
NOVEMBER 12, 2024
GlobalData analysis suggests that the research and development of DMTs and non-motor therapies will diversify Parkinson's disease treatments.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharma Times
NOVEMBER 12, 2024
Insight into double-blind, phase i/ii clinical trial for oesophageal cancer
Pharmaceutical Technology
NOVEMBER 12, 2024
Though prescribing climate-friendly dry powder inhalers is environmentally sound, some experts warn certain patients may be overlooked.
Pharma Times
NOVEMBER 12, 2024
Eco-friendly inhalers aim to reduce environmental impact
Pharmaceutical Technology
NOVEMBER 12, 2024
Zai Lab and argenx have announced receipt of approval from the National Medical Products Administration (NMPA) of China for the supplemental biologics license application (sBLA) for VYVGART Hytrulo 1,000mg vial for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
pharmaphorum
NOVEMBER 12, 2024
Daiichi Sankyo and AstraZeneca give up on their NSCLC application for Dato-DXd, and refile seeking a narrower label
Pharmaceutical Technology
NOVEMBER 12, 2024
At IDWeek 2024 in Los Angeles, California, recent updates on mpox (formerly known as monkeypox) were discussed.
XTalks
NOVEMBER 12, 2024
The US Food and Drug Administration (FDA) granted approval to Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel), a CD19-directed autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). ALL is a fast-growing cancer of the white blood cells (lymphocytes) that usually starts in the bone marrow and can quickly spread to other parts of the body, such as the blood, lymph nodes, liver, spleen and central nervous system.
Pharmaceutical Technology
NOVEMBER 12, 2024
The US Food and Drug Administration (FDA) has awarded the second breakthrough therapy designation (BTD) to Johnson & Johnson's (J&J) nipocalimab for treating individuals with moderate-to-severe Sjögren’s disease (SjD).
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
pharmaphorum
NOVEMBER 12, 2024
'Game-changer' daily pill to quit smoking returns to NHS after three-year absence after a deal between Teva and NHS England
BioPharma Reporter
NOVEMBER 12, 2024
The FDA had put a clinical hold on Novavax’s COVID-19-influenza combo vaccine after an adverse event in a patient.
pharmaphorum
NOVEMBER 12, 2024
Neurogene says Rett syndrome gene therapy improves clinical symptoms, but a serious adverse event causes shares to fall
BioPharma Reporter
NOVEMBER 12, 2024
The FDA had put a clinical hold on Novavaxâs COVID-19-influenza combo vaccine after an adverse event in a patient.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
pharmaphorum
NOVEMBER 12, 2024
The United Nations is calling for urgent global action to address the growing threat of antimicrobial resistance (AMR). Learn more about this pressing issue and what steps can be taken to combat it effectively.
Outsourcing Pharma
NOVEMBER 12, 2024
Abbiskoâs small molecule drug pimicotinib has smashed the primary goal of a phase 3 trial for the treatment of tenosynovial giant cell tumor (TGCT), taking the asset a step further to the market in China and elsewhere.
pharmaphorum
NOVEMBER 12, 2024
Merck KGaA is shaping up to take on Daiichi Sankyo and Ono Pharma in the market for tenosynovial giant cell tumour (TGCT) therapies after its drug candidate pimicotinib cleared a phase 3 trial.The German group said the CSF-1R inhibitor given as a once-daily, oral dose hit its primary endpoint in the MANEUVER study, achieving an objective response rate (ORR) at week 25 of 54% compared to 3.2% for a matched placebo in patients with TGCT, a rare disease affecting the joints and tendons.
Outsourcing Pharma
NOVEMBER 12, 2024
Abbisko’s small molecule drug pimicotinib has smashed the primary goal of a phase 3 trial for the treatment of tenosynovial giant cell tumor (TGCT), taking the asset a step further to the market in China and elsewhere.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
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