Wed.Nov 29, 2023

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FDA names chief scientist Bumpus as Woodcock’s successor

Bio Pharma Dive

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.

Scientist 286
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Japan grants approval for CSL and Arcturus’ Covid-19 vaccine 

Pharmaceutical Technology

Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

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BioMarin secures hemophilia gene therapy coverage in Germany

Bio Pharma Dive

Drawn-out negotiations led to a lower price than initially expected, but analysts called the agreement a step forward for the biotech company.

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VPAS is dead, long live VPAG—could the UK’s new clawback revision save the day?    

Pharmaceutical Technology

After months of negotiations, the UK's DHSC and the Association of the British Pharmaceutical Industry emerged with a plan on to replace VPAS.

Marketing 246
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Gilead to lay off staff at cell therapy unit Kite

Bio Pharma Dive

The cuts will impact 7% of the cancer drug division’s employees, although about 90 new roles will be created around “areas of growth.

Drugs 277
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FDA opens investigation into secondary cancer risk with CAR-T therapies

Pharmaceutical Technology

The agency has received reports of T-cell malignancies in patients who have previously received CAR-T cell immunotherapies.

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More Trending

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Aro Biotherapeutics raises funds for Pompe disease treatment

Pharmaceutical Technology

Aro Biotherapeutics has raised $41.5m in a Series B financing round to advance the development of ABX1100 for Pompe disease.

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Cigna, Humana in talks to merge: WSJ

Bio Pharma Dive

The merger would have major effects for the makeup of the U.S. health insurance industry, and would almost certainly face a regulatory challenge.

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How to manage temperature-controlled shipments in unpredictable climate zones

Pharmaceutical Technology

Due to the increasing impact of climate change, drug packaging and shipping sectors have had to adapt by necessity.

Packaging 243
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November 29, 2023: NIH Offers Methods Webinar on Implementation Science With Insights From Behavioral Economics

Rethinking Clinical Trials

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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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Pharma’s path to Net Zero: Targeting Scope 3 emissions 

Pharmaceutical Technology

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.

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Amgen expands pact with Amazon to usher drug manufacturing into the AI era

Fierce Pharma

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.

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Cyclin Dependent Kinase 4 drugs in development, 2023

Pharmaceutical Technology

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.

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Are Predetermined Change Control Plans on the road to Global Harmonization?

FDA Law Blog

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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The New Age of Decentralized Clinical Trials

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.

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Bromodomain Containing Protein 4 drugs in development, 2023

Pharmaceutical Technology

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.

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Milner Therapeutics to establish new genomics laboratory for drug discovery

Pharma Times

The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes

Genome 150
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Placenta Growth Factor drugs in development, 2023

Pharmaceutical Technology

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.

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Who Monitors the Monitors? CRA Evaluations Essential to Better Trials and Relationships

ACRP blog

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.

Trials 105
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Accelerating Clinical Supply Through Integrated Drug Development

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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FDA meets with BrainStorm Cell Therapeutics to discuss NurOwn for ALS

Pharmaceutical Technology

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).

Licensing 130
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Ginkgo Bioworks and Vivici Partner to Revolutionize Alternative Dairy Protein Production

XTalks

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.

Protein 105
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CPHI Barcelona: A tough funding environment necessitates integration and flexibility for ATMP manufacturing

Pharmaceutical Technology

At CPHI Barcelona 2023 and Phacilitate 2023, experts called for closer integration between manufacturing, storage, and logistics for cell and gene therapies.

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Masimo W1 Health Watch Now FDA-Cleared for Wider Use

XTalks

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.

Engineer 104
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How Machine Learning Drives Clinical Trial Efficiency

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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CTO Europe 2023: Reflections on drug development through the phases

Pharmaceutical Technology

Closing the first day of the CTO Europe conference, a global CRO shares insights on the drug development lifecycle in oncology.

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FDA Warns of Rare but Serious Reactions to Antiseizure Drugs Levetiracetam and Clobazam

XTalks

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.

Drugs 102
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European Pharmaceutical legislation Q&A: hindrance or help?

Pharmaceutical Technology

Claire Skentelbery, the director general of EuropaBio, discusses potential challenges with the latest changes to the EU’s pharmaceutical legislation.

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CSL, Arcturus get first approval for self-assembling RNA jab

pharmaphorum

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.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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AmacaThera secures capital for non-opioid therapy development

Pharmaceutical Technology

AmacaThera has secured CAD$4m in a Series A extension funding round to develop AMT-143 for post-surgery pain management.

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Karuna Secures FDA Decision Date for Schizophrenia Candidate KarXT

BioSpace

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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Candel downsizes to focus on oncolytic virus-based cancer therapies

Pharmaceutical Technology

Candel has fired 50% of its workforce and directed its resources to advance the development of CAN-2409 and CAN-3110.

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AbbVie Buys ImmunoGen in $10B Deal, Gains Access to ADC for Ovarian Cancer

BioSpace

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.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.