Fierce Pharma
JUNE 29, 2023
After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.
MedCity News
JUNE 29, 2023
UNC Health recently launched a pilot for its in-house generative AI app called Ava, which stands for “AI virtual assistant.” The app allows staff members to ask questions about the different digital health tools available to them across the health system, and it gives them concise answers about how to use the tools effectively. The goal is to prevent staff from searching through vast training libraries.
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Fierce Pharma
JUNE 29, 2023
Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. | Much attention has been paid to Vertex’s efforts to develop a stem-cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans. Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes.
MedCity News
JUNE 29, 2023
To fully reap the benefits of telemedicine, it is crucial to provide comprehensive education to both staff and patients. Clinicians, doctors, and other medical care providers should all be trained on telehealth software — its functionality, integration into their workflow, effective communication during consultations, and where to seek technical assistance.
Fierce Pharma
JUNE 29, 2023
A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. | After a December FDA inspection revealed a principal trial investigator skirted several study protocols, BioXCel found forged emails making it out that the site had properly adhered to reporting requirements for adverse events.
Clarivate
JUNE 29, 2023
OpenAI’s launch of ChatGPT on March 14 heralds a new era of artificial intelligence that will have profound implications for society, including the life science and healthcare industries. As when any new technology appears on the horizon, a tremendous amount of overheated hyperbole has dominated coverage of the topic in the months since. There are, however, some truly alluring potential use cases for generative AI applications such as ChatGPT for the life sciences and healthcare industries – as
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Copyright Clearance Center
JUNE 29, 2023
This is the first in a series of blog posts in which CCC shares this analysis with the scholarly community to spark dialogue and drive action with respect to metadata management during each stage of the research lifecycle.
Fierce Pharma
JUNE 29, 2023
While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. | By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five phase 3 vaccine programs by 2025.
Copyright Clearance Center
JUNE 29, 2023
The post CCC Named a Stevie® Award Winner for Customer Service Department of the Year in the 2023 American Business Awards® appeared first on Copyright Clearance Center.
Fierce Pharma
JUNE 29, 2023
Half a decade after Abcam quit its 270 million pound sterling pursuit of Horizon Discovery, the British antibody research expert has potentially found itself on the opposite end of the dealmaking t | Half a decade after Abcam quit its £270 million pursuit of Horizon Discovery, the British antibody research expert has potentially found itself on the opposite end of the dealmaking table.
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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
JUNE 29, 2023
The FDA approved Roctavian for treating hemophilia A. The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder.
Fierce Pharma
JUNE 29, 2023
After years of back-and-forth with several generics makers, Sanofi came out on top in its latest Jevtana litigation, successfully blocking generic competition to the prostate cancer drug from Novar | Sanofi has vigorously defended its Jevtana patents for years and has now fought off the last outstanding competitor to the aging prostate cancer med.
European Pharmaceutical Review
JUNE 29, 2023
The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. The allogeneic pancreatic islet therapy is made from deceased donor pancreatic cells and is indicated for Type 1 diabetes patients who are unable to approach target glycated haemoglobin due to current repeated severe hypoglycaemia episodes even with intensive diabetes management and education.
PharmaVoice
JUNE 29, 2023
Transgender and nonbinary patients suffer more adverse health outcomes than the general population, yet are often underrepresented in clinical research. Now, there’s momentum to change the status quo.
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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
JUNE 29, 2023
Israeli health tech fund Shoni Health Ventures recently launched to invest in digital health and medical device startups that are in the pre-seed and seed stages of fundraising. The fund is affiliated with Sheba Medical Center, the largest hospital in Israel. Startups will have access to the hospital’s innovation center so that they can develop, pilot and commercialize their products.
European Pharmaceutical Review
JUNE 29, 2023
New drug mirikizumab doubled remission rates up to 50 percent in certain patient groups in two ulcerative colitis (UC) Phase III trials. Results from the studies were recently published in the New England Journal of Medicine. Researchers identified Interleukin-23 as an important protein in triggering and maintaining gut inflammation. This is relevant in Crohn’s disease, ulcerative colitis and chronic skin disease psoriasis.
Pharmaceutical Technology
JUNE 29, 2023
Genprex has announced that the FDA has granted fast-track designation for Reqorsa, its small cell lung cancer (SCLC) therapy.
European Pharmaceutical Review
JUNE 29, 2023
Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. However, it is difficult to predict exactly how processes could behave and how materials could react under each process conditions.
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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.
Pharmaceutical Technology
JUNE 29, 2023
The FDA has announced that Lantidra, a cellular therapy for type 1 diabetes, has become the first treatment of its kind to be approved.
MedCity News
JUNE 29, 2023
Eli Lilly is expanding its diabetes prospects by acquiring cell therapy developer Sigilon Therapeutics. The two companies are already partners in the development of a type 1 diabetes cell therapy currently in preclinical development.
Pharmaceutical Technology
JUNE 29, 2023
Carrie Harney, the vice president of government and regulatory Affairs at US Pharmacopeia (USP) explains US drug shortages.
MedCity News
JUNE 29, 2023
Experts suggest that the healthcare benefits landscape is evolving rapidly. Tell us whether you agree or disagree and what you think may be driving these changes. Your participation in this research will ensure the report results will be a valuable resource for you and the healthcare industry as a whole.
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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
JUNE 29, 2023
Experts warn caution around CRISPR gene editing technology on human embryos as it may have dangerous consequences.
MedCity News
JUNE 29, 2023
Starting July 1, Highmark Blue Cross Blue Shield Delaware members will be able to access Wellinks’ virtual services for Chronic Obstructive Pulmonary Disease (COPD). These services include pulmonary rehabilitation, coaching and tracking through connected devices and an app.
PharmaVoice
JUNE 29, 2023
From AI to diversity and decentralized trials, here’s how clinical trial operations are evolving.
PharmaTimes
JUNE 29, 2023
Partnership establishes several influenza therapy targets using artificial intelligence - News - PharmaTimes
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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
Spotio
JUNE 29, 2023
The State of Field Sales Report | 4th Edition Key highlights from the State of Field Sales Report include: Comprehensive analysis of the evolving field sales landscape, encompassing both B2B and B2C sectors. Insights into the challenges faced by field sales professionals and recommended strategies for overcoming them. In-depth examination of market dynamics and trends, providing strategic guidance for organizations to gain a competitive edge.
PharmaTimes
JUNE 29, 2023
PrecisionLife to analyse OXEGENE data to improve mechanistic understanding of endometriosis - News - PharmaTimes
Modus
JUNE 29, 2023
The modern buyer has created quite a conundrum for marketing and sales teams. They do so much themselves: research products, find answers to their problems, make up their minds. and that’s all before they even think about reaching out to your company.
Impetus Digital
JUNE 29, 2023
Register for one of Impetus’ upcoming webinars between July 17 – August 24: The Ins-and-Outs of Digital Patient Engagement About the webinar In this intimate learning session tailored exclusively to Pharma leaders, our expert speakers will share best practices and tips on how to best engage patients and patient advocates during all stages of the product life cycle.
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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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