Bio Pharma Dive
APRIL 15, 2024
Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.
Rethinking Clinical Trials
APRIL 17, 2024
Dr. Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The Grand Rounds session will be held on Friday, April 19, 2024, at 1:00 pm eastern. The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.
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Pharmaceutical Technology
APRIL 12, 2024
Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 11, 2024
The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.
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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
BioSpace
APRIL 14, 2024
Metabolic dysfunction-associated steatohepatitis experts welcomed Madrigal’s Rezdiffra as an “important first," but there are more mid- to late-stage therapies showing promising results.
Bio Pharma Dive
APRIL 15, 2024
Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.
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
APRIL 10, 2024
Scientists looking to tackle our ongoing obesity crisis have made an important discovery: Intermittent calorie restriction leads to significant changes both in the gut and the brain, which may open up new options for maintaining a healthy weight.
Rethinking Clinical Trials
APRIL 10, 2024
Dr. Corita Grudzen, principal investigator of PRIM-ER In this Friday’s PCT Grand Rounds, Corita Grudzen of the Memorial Sloan Kettering Cancer Center will present “Primary Palliative Care for Emergency Medicine, a Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments,” including the results of the PRIM-ER trial. The Grand Rounds session will be held on Friday, April 12, 2024, at 1:00 pm eastern.
BioSpace
APRIL 14, 2024
GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.
Bio Pharma Dive
APRIL 15, 2024
Learn about why access to robust biomarkers such as cfHPV-DNA is pivotal in determining eligibility, assessing treatment response and detecting recurrence early to improve patient outcomes.
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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
Pharmaceutical Technology
APRIL 16, 2024
The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 11, 2024
Using viruses that infect bacteria to detect proteins sprouted by a notorious parasite, scientists have honed in on possible vaccine targets for schistosomiasis, a neglected tropical disease that currently affects an estimated 600 million people worldwide, causing 280,000 deaths per year.
pharmaphorum
APRIL 16, 2024
A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.
BioSpace
APRIL 12, 2024
This week’s American Association for Cancer Research annual meeting drove home the importance of antibody-drug conjugates as an emerging class of potential anti-cancer therapeutics.
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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.
Bio Pharma Dive
APRIL 10, 2024
The deal, which company CEO Reshma Kewalramani described as “just the right fit,” is the largest acquistion in Vertex’s 35-year history.
Pharmaceutical Technology
APRIL 15, 2024
Discover ImmunityBio Inc's groundbreaking patent for a cross-reactive SARS-CoV2 vaccine targeting multiple variants. Learn how this innovative method boosts immune response and memory cells for enhanced protection.
Fierce Pharma
APRIL 11, 2024
As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.
pharmaphorum
APRIL 15, 2024
Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.
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.
BioSpace
APRIL 14, 2024
AbbVie’s small molecule drug Qulipta has durable benefits and can reduce migraine frequency through 48 weeks of follow-up, according to interim Phase III data released on Friday.
Bio Pharma Dive
APRIL 10, 2024
The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.
Pharmaceutical Technology
APRIL 17, 2024
Discover the innovative patent by WuXi AppTec Co Ltd for preparing a dichloroacetic acid composition with minimal glyoxylic acid. Learn about the process and benefits of accurate glyoxylic acid measurement.
BioPharma Reporter
APRIL 11, 2024
Specific doses of Eli Lillyâs GLP-1 blockbuster drugs Mounjaro and Zepbound are currently facing a supply shortage, and frustrated patients are urging the pharma giant to act â fast.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
pharmaphorum
APRIL 15, 2024
Roche’s CD20xCD3 bispecific antibody Columvi has improved survival when used as a second-line therapy for diffuse large B-cell lymphoma (DLBCL) in a phase 3 trial, setting up regulatory filings for earlier use of the drug in the treatment pathway.
BioSpace
APRIL 15, 2024
A federal court in Massachusetts has granted Pfizer and BioNTech’s motion to put on hold Moderna’s lawsuit over alleged patent infringement related to their COVID-19 vaccine Comirnaty.
Bio Pharma Dive
APRIL 10, 2024
The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.
Pharmaceutical Technology
APRIL 17, 2024
Discover the groundbreaking patent by TCR2 Therapeutics Inc for T-cell receptor fusion proteins targeting tumor cell antigens. Revolutionizing disease treatment, including cancer, with engineered T cells expressing TFPs.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Fierce Pharma
APRIL 15, 2024
A Novartis drug with "pipeline in a pill" potential, according to one analyst group, has delivered on that promise once again. | In a phase 3 trial, treatment with Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said on Monday.
pharmaphorum
APRIL 16, 2024
FDA starts review of GSK’s 5-in-1 meningitis vaccine, cueing up a decision early next year, as it tries to chase down Pfizer's recently-approved Penbraya
BioSpace
APRIL 15, 2024
In a Phase I/II study, Ultragenyx’s antisense oligonucleotide GTX-102 led to significant cognitive, behavioral, sleep and gross motor improvements in patients with the rare genetic disorder Angelman syndrome.
Bio Pharma Dive
APRIL 16, 2024
Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.
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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.
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