Pharmaceutical Technology
APRIL 24, 2024
Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.
Bio Pharma Dive
APRIL 25, 2024
“With each passing year, we're more committed to becoming a serious player in the genetic medicine space,” a Regeneron executive said.
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AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 25, 2024
Researchers have identified dysfunctions in two specific brain systems in people who have psychosis – systems that help us filter attention to important internal and external information and predict or anticipate rewards.
Rethinking Clinical Trials
APRIL 23, 2024
In an analysis of data from the TSOS study, younger patients and patients who were publicly insured or uninsured were among several subgroups of patients who were at significant risk of missing follow-up outcome assessments. The report was published this week in Injury. Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up.
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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
Worldwide Clinical Trials
APRIL 25, 2024
Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%. These data highlight both the prevalence of post-surgical pain and the critical need for comprehensive, non-opioid treatments aimed at alleviating it.
Pharmaceutical Technology
APRIL 22, 2024
Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.
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 24, 2024
The constant ebb and flow of hormones that guide the menstrual cycle don’t just affect reproductive anatomy. They also reshape the brain, and a study has given us insight into how this happens.
BioPharma Reporter
APRIL 23, 2024
Celularity, a biotech company specializing in placental-derived allogeneic cell therapies, will be showcasing data at the upcoming ASGCT Annual Meeting, showcasing the potential of their off-the-shelf natural killer (NK) cells to combat age-related diseases.
Fierce Pharma
APRIL 23, 2024
Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.
Pharmaceutical Technology
APRIL 22, 2024
Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.
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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 25, 2024
The cuts of four pipeline prospects come as BioMarin resets its priorities following the slow launch of its hemophilia gene therapy Roctavian.
pharmaphorum
APRIL 26, 2024
Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.
BioSpace
APRIL 21, 2024
A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.
XTalks
APRIL 25, 2024
Heart failure, affecting over 64 million people worldwide , remains a formidable challenge in the medical community despite advancements in pharmacotherapy over the past decade. The prognosis for heart failure patients is disheartening, with a mere half surviving beyond five years post-diagnosis. This stark reality highlights the urgent need for novel heart failure management options, particularly for advanced stages of the disease.
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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.
Pharmaceutical Technology
APRIL 22, 2024
GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).
Bio Pharma Dive
APRIL 22, 2024
A collaboration with BioArctic will focus on a technology designed to more effectively deliver drugs in the brain, following similar efforts by Roche.
pharmaphorum
APRIL 26, 2024
In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.
BioSpace
APRIL 22, 2024
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
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.
Fierce Pharma
APRIL 25, 2024
Just a few months after laying into CEOs from Bristol Myers Squibb, Merck & Co., and Johnson & Johnson about the high costs of their drugs, Sen. | Just a few months after laying into CEOs from Bristol Myers Squibb, Merck & Co. and Johnson & Johnson about the high costs of their drugs, Sen. Bernie Sanders, I-Vermont, is taking Novo Nordisk to task for allegedly turning its blockbuster GLP-1s Ozempic and Wegovy into “luxury goods.
Pharmaceutical Technology
APRIL 25, 2024
Marking another chapter in the long-running saga, J&J has deprioritised the CD388 influenza programme allowing Cidara to buy it back.
Bio Pharma Dive
APRIL 22, 2024
A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.
pharmaphorum
APRIL 24, 2024
A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system
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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.
BioSpace
APRIL 23, 2024
While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth.
Drug Patent Watch
APRIL 23, 2024
Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs.
Pharmaceutical Technology
APRIL 22, 2024
AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Non-Small Cell Lung Cancer.
Bio Pharma Dive
APRIL 22, 2024
The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.
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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
APRIL 23, 2024
Unlock the power of digital health through AI and clinical advancements. Learn how these technologies are shaping the future of healthcare and how to harness their potential.
BioSpace
APRIL 23, 2024
This is the first round in a series of cuts that will cost 75 people their jobs this year, according to a WARN notice. Employees in other states are affected as well.
Pharma Times
APRIL 25, 2024
The tool will help people find out about clinical trials for myeloma, MGUS, SMM and AL amyloidosis
Pharmaceutical Technology
APRIL 22, 2024
AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Renal Cell Carcinoma.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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