Bio Pharma Dive
NOVEMBER 29, 2023
Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.
Pharmaceutical Technology
NOVEMBER 29, 2023
Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.
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Bio Pharma Dive
NOVEMBER 29, 2023
Drawn-out negotiations led to a lower price than initially expected, but analysts called the agreement a step forward for the biotech company.
Pharmaceutical Technology
NOVEMBER 29, 2023
After months of negotiations, the UK's DHSC and the Association of the British Pharmaceutical Industry emerged with a plan on to replace VPAS.
Bio Pharma Dive
NOVEMBER 29, 2023
The cuts will impact 7% of the cancer drug division’s employees, although about 90 new roles will be created around “areas of growth.
Pharmaceutical Technology
NOVEMBER 29, 2023
The agency has received reports of T-cell malignancies in patients who have previously received CAR-T cell immunotherapies.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 29, 2023
Aro Biotherapeutics has raised $41.5m in a Series B financing round to advance the development of ABX1100 for Pompe disease.
Bio Pharma Dive
NOVEMBER 29, 2023
The merger would have major effects for the makeup of the U.S. health insurance industry, and would almost certainly face a regulatory challenge.
Pharmaceutical Technology
NOVEMBER 29, 2023
Due to the increasing impact of climate change, drug packaging and shipping sectors have had to adapt by necessity.
Rethinking Clinical Trials
NOVEMBER 29, 2023
The NIH Office of Disease Prevention will continue its Methods: Mind the Gap webinar series on Friday, December 8, with "Supercharging Implementation Science With Insights From Behavioral Economics." Rinad Beidas, chair and Ralph Seal Paffenbarger Professor of Medical Social Sciences at the Feinberg School of Medicine at Northwestern University, will lead the webinar.
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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
NOVEMBER 29, 2023
With a target of net zero for 2050, pharmaceutical companies need to tackle Scope 3 emissions, that make up the majority of their carbon footprint.
Fierce Pharma
NOVEMBER 29, 2023
Seeking to identify ways to improve the discovery and production of medicines, Amgen is expanding its partnership with tech giant Amazon. | Amgen is growing its decade-old collaboration with Amazon Web Services—a widely used cloud platform—to create generative artificial intelligence that the companies aim to use to increase the manufacturing throughput of pharmaceuticals.
Pharmaceutical Technology
NOVEMBER 29, 2023
GlobalData’s report assesses the drugs in the Cyclin Dependent Kinase 4 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
FDA Law Blog
NOVEMBER 29, 2023
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — In October 2021, FDA and MHRA (United Kingdom’s Medicines and Healthcare products Regulatory Agency) jointly developed 10 guiding principles for the development of Good Machine Learning Practice (GMLP) with the goal of promoting “safe, effective, and high-quality medical devices” that are based on Artificial Intelligence/Machine Learning (AI/ML) technologies.
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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
NOVEMBER 29, 2023
GlobalData’s report assesses the drugs in the Bromodomain Containing Protein 4 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Pharma Times
NOVEMBER 29, 2023
The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 29, 2023
GlobalData’s report assesses the drugs in the Placenta Growth Factor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
BioSpace
NOVEMBER 29, 2023
The regulator accepted Karuna Therapeutics' NDA for KarXT and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
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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
NOVEMBER 29, 2023
BrainStorm Cell Therapeutics’s NurOwn is approaching the conclusion of a three-year regulatory journey that commenced in February 2021 when the US Food and Drug Administration (FDA) advised against filing a Biologics License Application (BLA).
BioSpace
NOVEMBER 29, 2023
Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.
Pharmaceutical Technology
NOVEMBER 29, 2023
At CPHI Barcelona 2023 and Phacilitate 2023, experts called for closer integration between manufacturing, storage, and logistics for cell and gene therapies.
ACRP blog
NOVEMBER 29, 2023
In the best of all possible worlds, clinical trial teams at study sites get along professionally and productively with each and every clinical research associate (CRA) who visits in person or remotely to monitor the progress and compliance of studies on behalf of their sponsors. In the real world, however, the relationship may be more of a “can’t live with them, can’t live without them” scenario as far as the site team members’ feelings about certain CRAs are concerned.
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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
NOVEMBER 29, 2023
Closing the first day of the CTO Europe conference, a global CRO shares insights on the drug development lifecycle in oncology.
Intouch Solutions
NOVEMBER 29, 2023
For the past year, EVERSANA INTOUCH has been “pharmatizing” AI, reshaping the way healthcare content is created, approved and disseminated. The latest AI-charged approach involves an enterprise-level partnership with Adobe and the integration of Adobe Firefly, a revolutionary new generative AI technology, into the creative process. This unprecedented collaboration is elevating content creation capabilities and further advancing an omnichannel approach to deliver effective, engaging and perfectly
Pharmaceutical Technology
NOVEMBER 29, 2023
Claire Skentelbery, the director general of EuropaBio, discusses potential challenges with the latest changes to the EU’s pharmaceutical legislation.
XTalks
NOVEMBER 29, 2023
In a significant move towards revolutionizing the alternative dairy protein market, cell programming and biosecurity platform Ginkgo Bioworks has joined forces with Vivici BV , an innovative business-to-business (B2B) ingredients startup. This collaboration is set to usher in a new era of sustainable and nutritious protein production, leveraging Ginkgo Bioworks’ expertise in cell programming and biosecurity.
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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
NOVEMBER 29, 2023
AmacaThera has secured CAD$4m in a Series A extension funding round to develop AMT-143 for post-surgery pain management.
XTalks
NOVEMBER 29, 2023
Masimo, headquartered in Irvine, CA, recently announced the market release of its Masimo W1 health watch, following the receipt of US Food and Drug Administration (FDA) 510(k) clearance for both over-the-counter (OTC) and prescription use (Rx). This FDA clearance broadens the approved indications for the Masimo W1 as a medical device in the US, permitting its use by adults in hospitals, clinics, long-term care facilities and at home.
Pharmaceutical Technology
NOVEMBER 29, 2023
Candel has fired 50% of its workforce and directed its resources to advance the development of CAN-2409 and CAN-3110.
XTalks
NOVEMBER 29, 2023
The US Food and Drug Administration (FDA) is warning about rare but serious side effects for the antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). The agency said the serious drug reaction, called drug reaction with eosinophilia and systemic symptoms (DRESS), can be life-threatening if not diagnosed and treated rapidly.
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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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