Wed.Dec 27, 2023

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AstraZeneca buys Chinese CAR-T biotech Gracell in a $1.2bn deal

Pharmaceutical Technology

The deal is worth approximately $1.2bn in combined upfront and potential contingent value payments and is expected to close in Q1 2024.

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Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Fierce Pharma

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. | Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

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Bristol Myers Squibb agrees to acquire RPT company RayzeBio for $4.1bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of RayzeBio in a total equity value of nearly $4.1bn.

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Lab space in London helps meet UK’s ‘severe shortage’

Drug Discovery World

Kadans Science Partner has acquired space within the Knowledge Quarter, London to deliver laboratory accommodation to the UK life sciences market. The Knowledge Quarter Kings Cross boasts a range of academic, research, and scientific organisations from The Francis Crick Institute and University College London (UCL) to the Wellcome Trust, Google, GSK, Merck (MSD) and AstraZeneca.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ARTBIO divulges plans for proprietary isotope manufacturing technology

Pharmaceutical Technology

ARTBIO is developing a proprietary radiotherapy manufacturing technology to overcome distribution and supply chain challenges.

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Pfizer's Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

Fierce Pharma

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. | After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. Shortly before the holiday, Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain hospital meds.

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BMS strikes again, with $4.1bn RayzeBio takeover bid

pharmaphorum

Bristol-Myers Squibb makes a foray into the radiopharmaceutical category with a $4.

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The DDW Podcast: 2023 in review

Drug Discovery World

As 2023 draws to a close, DDW’s Multimedia Editor and podcast host Megan Thomas rounds up all the free episodes of the DDW podcast that were released. You can also find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts. DDW Highlights Innovative. Evolving. Developing. Busy. These are just some of the words that come to mind when talking about not just the drug discovery sector, but the lives of those working in and around it.

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Hospital Price Transparency Gets a Boost by PatientRightsAdvocate.org

XTalks

PatientRightsAdvocate.org (PRA), a leading non-profit organization championing the cause of healthcare price transparency in America, launched Hospital Price Files Finder , a freely available dashboard tool containing pricing files for 6,000 hospitals nationwide. It is a searchable tool containing all available hospital pricing files in spreadsheets that are human and machine-readable, converted from the original format as necessary.

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Looking to the future of UK medical device exports

pharmaphorum

In this second of our festive podcast series, the pharmaphorum podcast welcomed Brandon Medical CEO Keith Jackson and the Association of British HealthTech Industries (or ABHI) director of communications, Jonathan Evans, to discuss UK medical device exports, including a particular recent strategic APAC partnership and the general and ongoing representation of industry innovation to stakeholders including government, NHS, and regulators.

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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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6 Top Picks: Clinical Trial Blogs Not to Miss

Imperical Blog

The Imperial blog team took a look at our 2023 clinical trial blogs, and we’re shining the spotlight on our top six picks. So here they are, in no particular order: six clinical trial blogs worth reading (and re-reading). 1. Supply Chain: Master these key… The post 6 Top Picks: Clinical Trial Blogs Not to Miss appeared first on Imperial Clinical Research Services Blog.

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The rapidly evolving role of patient organisations

pharmaphorum

Patient organisations play a crucial role in the rapidly evolving landscape of healthcare, life sciences, and research. Learn about their role in advocacy, research, and navigating regulatory processes in this informative article.

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New patent for IMPAX drug TWINJECT 0.15

Drug Patent Watch

Annual Drug Patent Expirations for TWINJECT+0.15 Twinject 0.15 is a drug marketed by Impax and is included in one NDA. It is available from four suppliers. There are two patents… The post New patent for IMPAX drug TWINJECT 0.15 appeared first on DrugPatentWatch - Make Better Decisions.

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Update: Apple Watches back on sale after appeal

pharmaphorum

Apple will appeal a decision by the USTR not to veto a ban on US imports of some of its smartwatches, found to violate patents held by wearables company Masimo

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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New patent for IMPAX drug TWINJECT 0.3

Drug Patent Watch

Annual Drug Patent Expirations for TWINJECT+0.3 Twinject 0.3 is a drug marketed by Impax and is included in one NDA. It is available from four suppliers. There are two patents… The post New patent for IMPAX drug TWINJECT 0.3 appeared first on DrugPatentWatch - Make Better Decisions.

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Velocity Supported Clinical Trials That Led to 12 Product Approvals in 2023

Velocity Clinical Research

Velocity has made an incredible impact over the past year! Our sites conducted clinical trials that supported 12 U.S. product approvals in 2023, contributing to the betterment of global health. To date, Velocity has contributed to research programs for over 50 product approvals. From pioneering vaccines to cutting-edge drugs, Velocity’s team worldwide has worked diligently to support these significant achievements.

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New patent for IMPAX drug ADRENACLICK

Drug Patent Watch

Annual Drug Patent Expirations for ADRENACLICK Adrenaclick is a drug marketed by Impax and is included in one NDA. It is available from four suppliers. There are two patents protecting… The post New patent for IMPAX drug ADRENACLICK appeared first on DrugPatentWatch - Make Better Decisions.

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DDW Highlights: 27 December 2023

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. There have been some ground-breaking advances in women’s health this week, with new treatments for hot flushes and pregnancy sickness, and a discovery that could aid in development of treatments for secondary breast cancer.

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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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Top 3 Most-Read Supply Chain Logistics Pieces of the Year

Pharmaceutical Commerce

The most popular pieces pertaining to the supply chain featured ADMs, vaccine supply chains, and wholesalers.

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New DDW Highlights podcast for 27 December 2023

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. There have been some ground-breaking advances in women’s health this week, with new treatments for hot flushes and pregnancy sickness, and a discovery that could aid in development of treatments for secondary breast cancer.

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Site Readiness in Vaccine Trials: Lessons Learned from the COVID-19 Pandemic

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post Site Readiness in Vaccine Trials: Lessons Learned from the COVID-19 Pandemic appeared first on WCG.

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Which pharmaceutical companies have the most drug patents in Czech Republic?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Czech Republic. Patents must be filed in each country (or, in some cases regional patent office) where patent protection… The post Which pharmaceutical companies have the most drug patents in Czech Republic? appeared first on DrugPatentWatch - Make Better Decisions.

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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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2024: Recapturing the Progress Made with CTA Negotiations During the Pandemic

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post 2024: Recapturing the Progress Made with CTA Negotiations During the Pandemic appeared first on WCG.

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Apple to appeal after US backs ban on watch imports

pharmaphorum

Apple has launched an appeal against a decision by the Biden administration not to veto a ban on imports into the US of some of its smartwatches, after a complaint that the devices violate patents held by Masimo on the use of wearables to measure blood oxygen levels.

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2024: Past Promises, the Future Hope of Neuroscience Clinical Research

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post 2024: Past Promises, the Future Hope of Neuroscience Clinical Research appeared first on WCG.

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Psychedelics: From Powerful Potential to the Psychiatrist’s Practice

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post Psychedelics: From Powerful Potential to the Psychiatrist’s Practice appeared first on WCG.

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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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The Impact of Artificial Intelligence (AI) on Ethical Review by IRBs 

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post The Impact of Artificial Intelligence (AI) on Ethical Review by IRBs appeared first on WCG.

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Diversity, Equity, and Inclusion in Rare Disease Clinical Trials: Current Opportunities and Outcomes 

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post Diversity, Equity, and Inclusion in Rare Disease Clinical Trials: Current Opportunities and Outcomes appeared first on WCG.

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The Decentralization of Vaccines in 2024 and Beyond

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post The Decentralization of Vaccines in 2024 and Beyond appeared first on WCG.

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Deploying AI Across the Clinical Trial Life Cycle?

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post Deploying AI Across the Clinical Trial Life Cycle  appeared first on WCG.

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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.