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.
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.
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AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 9, 2024
In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Yet researchers have suspected there could be more to the story.
Pharmaceutical Technology
APRIL 12, 2024
Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.
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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
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.
Worldwide Clinical Trials
APRIL 15, 2024
As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. In fact, recent industry dynamics indicate a considerable shift in preference towards midsize CROs, driven by the need for more personalized, agile, and cost-effective partnerships.
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 9, 2024
Exports of Ayush (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) drugs and herbal products from the country have reported 1.65 per cent growth during the first ten months of the current fiscal year. The growth in the month of January stood at 14.
Pharmaceutical Technology
APRIL 11, 2024
The oral drug, which gained UK approval in September 2023, is used for the prevention of both chronic and episodic migraines.
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
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.
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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
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.
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.
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
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.
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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.
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.
Pharmaceutical Technology
APRIL 15, 2024
Discover Genzyme Corp's innovative method for detecting anti-drug antibodies in human body fluids. Learn how their patented process reduces interference in drug assays effectively.
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.
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.
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.
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.
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.
Pharmaceutical Technology
APRIL 15, 2024
Discover the groundbreaking gene therapy patent by Ginkgo BioWorks Inc for treating NPC1 using AAV vectors. Learn how this innovative approach offers hope for rare genetic disorders like Neimann-Pick Disease Type C.
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.
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.
pharmaphorum
APRIL 15, 2024
Shah Capital has fired a broadside at the management team of Novavax, seeking a change in leadership at the vaccine company and the appointment of two handpicked directors to the board. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs.
Bio Pharma Dive
APRIL 9, 2024
The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 10, 2024
The Drugs Technical Advisory Board (DTAB) has recommended various amendments to the Medical Devices Rules (MDR), 2017, for inclusion of disinfectants under the definition and applicability clauses and to bring in changes for quality management rules in line with the updated ISO standards for the devices.
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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.
Pharmaceutical Technology
APRIL 15, 2024
Discover the innovative patent by Zydus Lifesciences Ltd for a pharmaceutical composition in oral suspension form, enhancing stability and palatability for immunosuppressive agents.
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.
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.
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.
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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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