Fierce Pharma
DECEMBER 18, 2023
Following a string of approvals in the United States and beyond, Vertex Pharmaceuticals continues to build out its manufacturing network for the world’s first CRISPR-based gene therapy, Casgevy.
MedCity News
DECEMBER 18, 2023
Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024.
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Fierce Pharma
DECEMBER 18, 2023
On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. | GSK has more positive data to report in endometrial cancer as the company's PD-1/PARP combination turned in a trial win. The combination could represent a threat to a rival therapy at AstraZeneca.
PharmExec
DECEMBER 18, 2023
In the coming year, efficiency and automation will take center stage to maximize constrained resources but balancing sensible financial management with strategic investments will be vital.
Fierce Pharma
DECEMBER 18, 2023
Bristol Myers Squibb’s PD-1/LAG3 combo Opdualag has more than proved its worth in melanoma since its first-in-class approval in 2022. | The company opted to cut the phase 3 Relativity-123 study after an analysis found that the trial was unlikely to achieve its primary endpoints in microsatellite-stable patients with metastatic colorectal cancer.
MedCity News
DECEMBER 18, 2023
Last week, the ONC announced that TEFCA had finally gone live. This followed years of the ONC heralding the project’s potential to boost interoperability and increase patients’ access to their healthcare data. However, former ONC Chief Don Rucker believes that TEFCA is built on an archaic data exchange protocol that will prevent the initiative from being useful.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
DECEMBER 18, 2023
Applications for registered nurse and advanced practice registered nurse licensure too often contribute to this stigma and prevent nurses struggling with mental health issues from getting needed help.
Fierce Pharma
DECEMBER 18, 2023
The FDA has signed off on Astellas and Pfizer’s Padcev in combination with Merck’s Keytruda as a first-line treatment for bladder cancer.
MedCity News
DECEMBER 18, 2023
Value-based care depends on keeping a total population of patients healthier and less in need of higher-cost services. To do so, organizations must be able to predict costs in advance, better understand patient risks, and manage the cost of services. Corporate healthcare is set up to do just that.
PharmaVoice
DECEMBER 18, 2023
Advancements in cloud and AI technology will transform clinical trial efficiency and engagement.
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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.
MedCity News
DECEMBER 18, 2023
Nearly half of physicians are equally excited and concerned about the use of AI in their field, according to a new AMA survey. Those who felt optimistic about AI cited reduced administrative burden as the number one benefit they’re seeking. Patient privacy and the impact to the patient-physician relationship were the most common reasons physicians cited for having reservations about AI.
pharmaphorum
DECEMBER 18, 2023
Biogen’s Skyclarys is on course to becoming the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU after it was recommended by the EMA’s human medicines committee.
MedCity News
DECEMBER 18, 2023
Despite achieving its Phase 3 study’s main goal, the results for Point Biopharma’s therapy are short of what Novartis radiopharmaceutical Pluvicto achieved in a similarly designed clinical trial. Nevertheless, the data readout should clear the way for Eli Lilly to complete its $1.4 billion acquisition of Point.
European Pharmaceutical Review
DECEMBER 18, 2023
The Novo Nordisk Foundation has committed up to DKK 1.8 billion ($260 million) to establish a state-of-the-art research and vaccine development initiative in Denmark. Developed in partnership with the University of Copenhagen and Denmark’s Statens Serum Institut , the Foundation says this the first vaccines initiative globally to focus solely on understanding how to generate immunity in the airway itself.
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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
MedCity News
DECEMBER 18, 2023
Informed decision-making is crucial to operational efficiency, which fundamentally impacts the patient experience, but how do you facilitate it?
PharmExec
DECEMBER 18, 2023
Drug companies face new hurdles in a rapidly changing marketplace. How do they finance new drug development amid the uncertainty?
MedCity News
DECEMBER 18, 2023
HHS announced a new care model that aims to provide mothers with Medicaid coverage with more personalized maternal health care. This includes access to doulas and midwives and screening for health-related social needs.
Pharmaceutical Technology
DECEMBER 18, 2023
Following US and UK approvals, the EMA’s CHMP has recommended conditional approval for Casgevy, with a decision expected in Q1 2024.
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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.
MedCity News
DECEMBER 18, 2023
Season Health has secured a $7 million investment from Inception Health and Ziegler Link-age Fund. The financing will be used to develop and scale its food-as-medicine programs, including for diabetes and high-risk pregnancies.
PharmaTimes
DECEMBER 18, 2023
MCI patients had 25% lower levels of serotonin compared to healthy patients Researchers from Johns Hopkins Medicine have suggested that serotonin loss in parts of the brain may play a role in cognitive decline in the early stages of Alzheimer’s disease (AD). Published in the Journal of Alzheimer’s Disease , the study was supported by other contributing scientists from the Johns Hopkins University School of Medicine and the Johns Hopkins Bloomberg School of Public Health.
Pharmaceutical Technology
DECEMBER 18, 2023
The Novo Nordisk Foundation has invested Dkr1.8bn in the initiative to develop vaccines for various airborne infection diseases.
PharmaTimes
DECEMBER 18, 2023
MCI patients had 25% lower levels of serotonin compared to healthy patients - News - PharmaTimes
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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.
pharmaphorum
DECEMBER 18, 2023
Eisai files for approval in Japan for FGFR inhibitor tasurgratinib as a treatment for biliary tract cancers with FGFR2 gene fusions
PharmaTimes
DECEMBER 18, 2023
Earlier diagnosis could increase patient survival rates by five years or more - News - PharmaTimes
Pharmaceutical Commerce
DECEMBER 18, 2023
Cloud-based service to address verification of saleable returns under the latest DSCSA regulations.
pharmaphorum
DECEMBER 18, 2023
RUBY Part 2 trial of GSK's PD-1 inhibitor Jemperli and PARP inhibitor Zejula could open up wider use in first-line endometrial cancer
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Salesforce
DECEMBER 18, 2023
Think about what could happen if you don’t have a good handle on your field service assets. Without a proper process in place, you risk operational inefficiencies, increased costs, and a decline in overall performance. You might even jeopardize the safety of your employees, contractors , and customers. Enter asset service management, the process of effectively managing and maintaining physical assets in field service.
pharmaphorum
DECEMBER 18, 2023
Illumina will divest cancer detection company Grail after losing an appeal in an antitrust court case in the US
Clarivate
DECEMBER 18, 2023
As 2023 comes to a close , make sure you don’t miss out on the timely insights from Clarivate , created to help IP legal teams plan for the rapidly changing industry. The past year has been one of uncertainty for the global economy. From the possibility of a recession, to the swift acceleration of artificial intelligence (AI) and the race to understand impacts unknown.
PharmaTimes
DECEMBER 18, 2023
Earlier diagnosis could increase patient survival rates by five years or more The University of Glasgow has announced that an artificial intelligence (AI)-enhanced chest X-ray reporting solution has begun trials in NHS Greater Glasgow and Clyde (NHSGGC) for early detection of lung cancer. The Radiograph Accelerated Detection and Identification of Cancer of the Lung (RADICAL) trial is taking place at the Inverclyde Royal Hospital, the Vale of Leven Hospital and Paisley’s Royal Alexandria Hospital
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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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