Bio Pharma Dive
AUGUST 10, 2023
The deal will help fund a cell-based treatment that completed Phase 1 testing last year and is designed to provide a “functional cure” for patients with HIV infections.
Worldwide Clinical Trials
AUGUST 10, 2023
As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research.
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Bio Pharma Dive
AUGUST 10, 2023
The drug, which will be sold under the brand name Talvey, is now cleared by the FDA to treat multiple myeloma, a blood cancer that J&J has identified as a research priority.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 10, 2023
The global COVID-19 pandemic has shown us just how devastating these outbreaks can be – and it could have been much worse. Now, scientists have developed an AI application that promises to warn us about dangerous variants in future pandemics.
Bio Pharma Dive
AUGUST 10, 2023
The planned facility in the biotech hotspot of Cambridge will include incubator space for startups and adds to Astellas’ R&D footprint in the Boston area.
Pharmaceutical Technology
AUGUST 10, 2023
AI is essential in drug discovery and development and a growing number of start-ups now operate in this area
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
AUGUST 10, 2023
Ten collective stakeholders of Indian healthcare industry, including the industry associations of medical devices manufacturers, patient interest group, and healthcare providers, have jointly demanded to the Union health minister Dr Mansukh Mandaviya to recall the New Drugs, Medical Devices & Cosmetics Bill, 2023 that is listed to be tabled in Parliament during the ongoing session.
Bio Pharma Dive
AUGUST 10, 2023
The success of Wegovy in a landmark heart disease study has fueled higher sales projections, even though the Danish drugmaker is still struggling to maintain a big enough supply.
Pharmaceutical Technology
AUGUST 10, 2023
Sensorion has received a private placement financing of $38.37m by its existing shareholders Invus and Sonnova Partners, and Redmile Group.
Rethinking Clinical Trials
AUGUST 10, 2023
Speaker Eric Perakslis, PhD Chief Science & Digital Officer Duke Clinical Research Institute Professor, Department of Population Health Sciences Chief Research Technology Strategist Duke University School of Medicine Slides Keywords Artificial intelligence; Machine learning; Gamification; Healthcare Key Points Once people start learning about what technology can do right and wrong, the immediate response is often to start minimizing the risks of technology.
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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
AUGUST 10, 2023
The FDA requested additional trial data for Galera’s avasopasem manganese for treating radiotherapy-induced severe oral mucositis.
Fierce Pharma
AUGUST 10, 2023
After Pfizer allegedly fired a compliance manager for raising the flag on potential fraud activity in China, the former employee is hitting back. | Frank Han, Pfizer's former director of global compliance analytics, has filed a civil complaint against the drugmaker. Han claims he was terminated for identifying potential issues relating to the Foreign Corrupt Practices Act.
Pharmaceutical Technology
AUGUST 10, 2023
ADARx Pharmaceuticals has concluded an oversubscribed Series C financing, securing $200m for advancing its clinical programmes
Intouch Solutions
AUGUST 10, 2023
The industry challenges faced in marketing in the rare disease space are not new. Small populations. Limited understanding of the patient or disease. Diagnostic odysseys that last, on average, seven years and are riddled with misdiagnosis. What is new, however, is the opportunity. At EVERSANA INTOUCH, our rare expertise and advanced technologies are helping solve some of the most difficult challenges in rare disease marketing.
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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
Pharmaceutical Technology
AUGUST 10, 2023
Regeneron has entered an agreement to acquire Decibel Therapeutics to accelerate key gene therapy programmes for hearing loss.
BioPharma Reporter
AUGUST 10, 2023
AGC Biologics, a global contract development and manufacturing organization (CDMO), has completed the expansion of its manufacturing space at its Milan Cell and Gene Center of Excellence production site.
Pharmaceutical Technology
AUGUST 10, 2023
The Phase II trial for tranexamic acid did not meet its primary endpoint of adhesion reduction post-bowel resection surgery.
Drug Patent Watch
AUGUST 10, 2023
A recent paper published in the journal “Intelligent Medicine” article discusses various aspects of using AI and machine learning in the pharmaceutical industry for drug discovery and development. Results The… The post Artificial Intelligence and Machine Learning in Drug Discovery and Development appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharmaceutical Technology
AUGUST 10, 2023
GenScript Biotech has formed a strategic collaboration agreement with T-MAXIMUM Biotech to develop CAR-T cell therapy.
Pharma Times
AUGUST 10, 2023
The therapy reaches and activates areas of the brain that are central to cognitive enhancement - News - PharmaTimes
Pharmaceutical Technology
AUGUST 10, 2023
Janssen’s bispecific antibody received accelerated approval as a subcutaneous therapy based on Phase II trial data.
XTalks
AUGUST 10, 2023
Plant-based meat pioneer Beyond Meat faced another financial setback on Wall Street this week. Beyond Meat revenue challenges are now in the spotlight, reflecting shifting consumer preferences and economic uncertainties that have plagued the once-favored investment. Beyond Meat’s revenue encountered a significant blow, plummeting by more than 30 percent during the second quarter of this year, as unveiled in its recent financial report on August 7.
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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
AUGUST 10, 2023
KKM-191-D is under clinical development by Genuone Science and is currently in the Phase I in clinical pathway.
Outsourcing Pharma
AUGUST 10, 2023
Chronic hives could be treated effectively, conveniently, and rapidly after positive results from a clinical trial by Novartis produced positive top line results.
Pharmaceutical Technology
AUGUST 10, 2023
JY-302 is under clinical development by Jin Yang Pharmaceutical and is currently in the Phase I in clinical pathway.
Fierce Pharma
AUGUST 10, 2023
Johnson & Johnson is digging its multiple myeloma moat deeper thanks to FDA approval for another novel drug. | Johnson & Johnson is digging its multiple myeloma moat deeper. The FDA has signed off on the company's Talvey, a first-in-class bispecific antibody targeting GPRC5D.
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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
AUGUST 10, 2023
CD70 CAR-T is under clinical development by UTC Therapeutics and is currently in the Phase II in clinical pathway.
Fierce Pharma
AUGUST 10, 2023
As Regeneron anxiously awaits an FDA decision on a high-dose version of Eylea (aflibercept), the company has continually referred to its durability compared to that of Roche’s upstart Vabysmos—whic | As Regeneron anxiously awaits an FDA decision on a high-dose version of Eylea (aflibercept), the company has continually referred to its staying power compared to that of Roche’s upstart Vabysmos—which has taken the macular degeneration (AMD) market by storm since receiving approval 19 months ago.
Pharmaceutical Technology
AUGUST 10, 2023
CD70 CAR-T is under clinical development by UTC Therapeutics and is currently in the Phase II in clinical pathway.
BioSpace
AUGUST 10, 2023
Amid record sales of its obesity treatment Wegovy, as well as diabetes drugs Ozempic and Rybelsus, Novo is buying Canadian biotech Inversago Pharma to further boost its weight-loss pipeline.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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