Bio Pharma Dive
JUNE 17, 2024
One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.
Pharmaceutical Technology
JUNE 17, 2024
Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 19, 2024
(Peter Dazeley/The Image Bank/Getty Images) Our body’s circadian clock affects everything from sleepiness to metabolism – and it might also influence how effective certain cancer treatments are, according to recent research.
Rethinking Clinical Trials
JUNE 17, 2024
Dr. Reto Auer In this Friday’s PCT Grand Rounds, Reto Auer of the University of Bern will present “Efficacy and Safety of Electronic Cigarettes for Smoking Cessation: Keeping a Trial on a Polarizing Topic Running Under Regulatory and Epidemic Changes.” The Grand Rounds session will be held on Friday, June 21, 2024, at 1:00 pm eastern.
Fierce Pharma
JUNE 20, 2024
For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.
Bio Pharma Dive
JUNE 21, 2024
Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 18, 2024
(Bloomberg Creative/Getty Images) Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s. [link] How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know.
Worldwide Clinical Trials
JUNE 21, 2024
The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments.
Bio Pharma Dive
JUNE 20, 2024
The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.
Pharmaceutical Technology
JUNE 21, 2024
Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2024
(VioletaStoimenova/Getty Images) To better treat and prevent depression, we need to understand more about the brains and bodies in which it occurs. Curiously, a handful of studies have identified links between depressive symptoms and body temperature, yet their small sample sizes have left too much room for doubt.
BioSpace
JUNE 19, 2024
Vaxxinity published data from an early-stage clinical trial showing that its investigative immunotherapy, UB-312, could improve movement in Parkinson’s disease and protect against pathological alpha-synuclein.
Bio Pharma Dive
JUNE 20, 2024
Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.
Pharmaceutical Technology
JUNE 17, 2024
TC-110 is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 17, 2024
(hiroyuki nakai/Getty Images) Imagine you turn up to the hospital looking for help because you feel dizzy and can’t stop slurring your speech – only to be told that you’re simply drunk. Yet, you haven’t had a drop of alcohol.
Fierce Pharma
JUNE 17, 2024
The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.
Bio Pharma Dive
JUNE 20, 2024
Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.
Pharmaceutical Technology
JUNE 18, 2024
As Asda sets up a nationwide retail pharmacy in the UK and US grocer pharmacies expand, scaling up this model will be the next frontier.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 16, 2024
Part algae, part red blood cell, these microrobots can travel to hard-to-reach tumors deep in the lungs. (Zhang et al., Sci. Adv., 2024/CC BY-NC) Tumors that travel to the lungs, or lung metastases, pose a formidable challenge in the realm of cancer treatment. Conventional chemotherapy often falls short because it’s inefficient.
BioSpace
JUNE 20, 2024
While Thursday’s label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
Bio Pharma Dive
JUNE 17, 2024
One biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.
Pharmaceutical Technology
JUNE 17, 2024
Equecabtagene autoleucel is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase II for Refractory Multiple Myeloma.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 19, 2024
The Directorate General of Foreign Trade (DGFT), under the Union ministry of commerce & industry, has issued a directive addressing the issuance of Registration-Cum-Membership Certificate (RCMC) for medical devices.
BioSpace
JUNE 19, 2024
PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study.
Bio Pharma Dive
JUNE 17, 2024
The new company, Spur Therapeutics, is getting another $50 million from Syncona to support its broadened pipeline, which targets Parkinson’s disease as well as heart conditions.
Pharmaceutical Technology
JUNE 17, 2024
Equecabtagene autoleucel is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase II for Relapsed Multiple Myeloma.
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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.
Fierce Pharma
JUNE 20, 2024
There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. | The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.
BioSpace
JUNE 19, 2024
Gilead Sciences reported zero cases of HIV infection occurred in the lenacapavir candidate group, compared to 16 cases in the Truvada arm and 39 incidents for those treated with Descovy, Gilead’s approved daily PrEP pills.
Bio Pharma Dive
JUNE 20, 2024
The decision makes Elevidys available to Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness.
Pharmaceutical Technology
JUNE 18, 2024
SPH-4336 is under clinical development by Shanghai Pharmaceutical Group and currently in Phase II for Well Differentiated Liposarcoma.
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