Japan grants approval for CSL and Arcturus’ Covid-19 vaccine
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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FDA names chief scientist Bumpus as Woodcock’s successor
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.
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FDA opens investigation into secondary cancer risk with CAR-T therapies
Pharmaceutical Technology
NOVEMBER 29, 2023
The agency has received reports of T-cell malignancies in patients who have previously received CAR-T cell immunotherapies.
BioMarin secures hemophilia gene therapy coverage in Germany
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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Aro Biotherapeutics raises funds for Pompe disease treatment
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.
Gilead to lay off staff at cell therapy unit Kite
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.
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Cigna, Humana in talks to merge: WSJ
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.
How to manage temperature-controlled shipments in unpredictable climate zones
Pharmaceutical Technology
NOVEMBER 29, 2023
Due to the increasing impact of climate change, drug packaging and shipping sectors have had to adapt by necessity.
November 29, 2023: Special Biostatistics Series Continues With Guidelines for Stepped-Wedge Trials
Rethinking Clinical Trials
NOVEMBER 29, 2023
In this Friday’s PCT Grand Rounds, Jim Hughes of the University of Washington will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Guidelines for Design and Analysis of Stepped-Wedge Trials.” The session will be held on Friday, December 1, at 1:00 pm eastern. Hughes is a professor emeritus of biostatistics at the University of Washington.
Milner Therapeutics to establish new genomics laboratory for drug discovery
Pharma Times
NOVEMBER 29, 2023
The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes
Candel downsizes to focus on oncolytic virus-based cancer therapies
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.
Amgen expands pact with Amazon to usher drug manufacturing into the AI era
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.
CTO Europe 2023: Reflections on drug development through the phases
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.
bit.bio and KCL to collaborate for neurodevelopmental disorders
Pharma Times
NOVEMBER 29, 2023
The partners will utilise bit.
The New Age of Decentralized Clinical Trials
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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
Pharma’s path to Net Zero: Targeting Scope 3 emissions
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.
November 29, 2023: NIH Offers Methods Webinar on Implementation Science With Insights From Behavioral Economics
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.
AmacaThera secures capital for non-opioid therapy development
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.
As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost
Fierce Pharma
NOVEMBER 29, 2023
The revelation of an FDA investigation< | As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators.
Cyclin Dependent Kinase 4 drugs in development, 2023
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.
CSL, Arcturus get first approval for self-assembling RNA jab
pharmaphorum
NOVEMBER 29, 2023
Japan’s medicines regulator has approved the first vaccine based on self-assembling RNA, a spin on the mRNA technology used in current shots, which is designed to deliver greater efficacy with a lower dose.
Bromodomain Containing Protein 4 drugs in development, 2023
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.
Why the Novo Nordisk Foundation is betting big on stem cells
pharmaphorum
NOVEMBER 29, 2023
Why the Novo Nordisk Foundation is betting big on stem cells Mike.
The New Age of Decentralized Clinical Trials
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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.
Placenta Growth Factor drugs in development, 2023
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.
What the FDA’s groundbreaking guidance really means for psychedelic therapy clinical trials
pharmaphorum
NOVEMBER 29, 2023
What the FDA’s groundbreaking guidance really means for psychedelic therapy clinical trials Mike.
FDA meets with BrainStorm Cell Therapeutics to discuss NurOwn for ALS
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).
AbbVie cues up filing for c-Met ADC in lung cancer
pharmaphorum
NOVEMBER 29, 2023
AbbVie is preparing to file for accelerated approval of telisotuzumab vedotin (Teliso-V) as a treatment for some patients with lung cancer after the drug hit the mark in a pivotal phase 2 trial.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Eli Lilly advances small molecule drug portfolio with Prism Biolab partnership
Pharmaceutical Technology
NOVEMBER 29, 2023
Prism Biolab is entitled to get development and commercial milestone payments of up to $660m from Lilly.
Who Monitors the Monitors? CRA Evaluations Essential to Better Trials and Relationships
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.
CPHI Barcelona: A tough funding environment necessitates integration and flexibility for ATMP manufacturing
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.
EVERSANA INTOUCH is Making Content Velocity Fly
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
How Machine Learning Drives Clinical Trial Efficiency
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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.
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