Wed.Nov 29, 2023

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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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GE HealthCare Launches New AI Suite to Catch Breast Cancer Sooner

MedCity News

At RSNA 2023, GE HealthCare announced the launch of a new AI suite designed to simplify radiologists’ workflows when reading mammograms and help them detect breast cancer in patients sooner. The new offering includes three AI tools made by iCAD.

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As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

Fierce Pharma

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.

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Report: Global Healthcare Benefit Costs Expected to Rise 9.9% in 2024

MedCity News

Globally, health benefit costs are expected to increase 9.9% in 2024, according to a new report from Willis Towers Watson. This is a slightly slower pace than in 2023, which saw a record-high increase of 10.7%.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy

PharmExec

The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.

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Beyond QA: The Next Wave of Medical Chatbots

MedCity News

Medical chatbots have the potential to shape the future of healthcare data retrieval and decision-making support. But this can’t become a reality unless precautions are taken to make sure the answers are both grounded in reality and extracted from reliable sources.

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Long Term Impact: How the Healthcare Industry Can Survive Staffing Shortages

MedCity News

By streamlining front-end processes, reducing errors, and ensuring prompt service delivery, AI and automation not only boost the patient experience but also optimize revenue streams.

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Ferring reveals long-term data for cancer gene therapy

European Pharmaceutical Review

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. Adstiladrin is the first FDA-approved intravesical gene therapy to be authorised for adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

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MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Jeff Good, Chief Sustainability Executive at Northwestern Medicine

MedCity News

For the November episode, we discuss some recent executive hires and departures occurring in the healthcare sector, as well as layoffs affecting the industry. We also hear from Jeff Good, who just became Northwestern Medicine’s first chief sustainability executive.

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'High Severity' Flu Season Among Children Spotlights Importance of Vaccination

PharmExec

The CDC’s Morbidity and Mortality Weekly Report show pediatric influenza hospitalization rates returned to levels that preceded the COVID-19 pandemic.

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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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CMS: 4.6M Choose ACA Marketplace Coverage

MedCity News

Of those who have chosen ACA Marketplace coverage so far in the 2024 Open Enrollment Period, 20% are new consumers and 80% are returning consumers, according to CMS.

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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.

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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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Milner Therapeutics to establish new genomics laboratory for drug discovery

PharmaTimes

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

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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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What’s on the Horizon in Pharma Marketing & Innovation: Q&A With Faruk Capan, Chief Innovation Officer at EVERSANA

PharmExec

Capan discusses the industry is embracing new technologies and how these use cases may evolve in the coming year.

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Pharma unite to secure renewable energy in key manufacturing markets

European Pharmaceutical Review

For the first time, companies across the global healthcare sector, including AstraZeneca , GSK, Novo Nordisk and Roche, have united to discuss with energy providers in China and India, about scaling renewable power across their supply chains. This step is important as these countries are key markets for pharmaceuticals manufacturing. Based on data on sales/value-based shares from various companies for APIs and Chemicals, India and China are estimated to account for up to half of materials for me

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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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FDA kicks off review of Karuna’s schizophrenia drug KarXT

pharmaphorum

Karuna Therapeutics said this morning that the FDA has formally started its review of KarXT, aiming to become the first drug to reach the market for schizophrenia with a new mechanism of action in decades.

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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.

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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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AbbVie cues up filing for c-Met ADC in lung cancer

pharmaphorum

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.

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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.

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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

PharmaVoice

U.S. tax law changes six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

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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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FDA to Evaluate Novel Treatment for Schizophrenia

Pharmaceutical Commerce

In clinical trials, KarXT (xanomeline-trospium) demonstrated a combination of strong tolerability and clinically meaningful symptom reduction in adult patients with schizophrenia.

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Vivos Therapeutics' Obstructive Sleep Apnea Oral Appliance Gains FDA 510(k) Clearance

PharmExec

Vivos becomes the first company to bring to market an alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA.

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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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How Data Management Companies Can Explore Digital Health Records in Canadian Hospitals

Scott’s Directories

The digital transformation in healthcare is not just a trend; it’s a necessary evolution. As we move further into the 21st century, the importance of data management in enhancing healthcare services cannot be overstated. This blog delves into how data management companies are revolutionizing healthcare through digital health records, focusing on the list of hospitals in Canada.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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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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Patient Advocate Engagement: A Customer Story

Impetus Digital

Learn how our client executed a series of 3 virtual touchpoints with 5 rare disease patient advocates to: Develop a b etter understanding of the current treatment landscape and lived patient experiences, including key gaps and unmet treatment needs. Design content for a virtual patient advisory board or needs assessment survey and leverage the results to educate research teams and healthcare providers on patients’ experiences and priorities.

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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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What Percentage of Sales Reps Hit Quota?

Sales Talent

This question doesn’t get asked often enough and has major implications. It impacts realistic earnings projections for salespeople, what companies should expect from their new hires’ sales performance, and ultimately, salesforce turnover rates. This topic recently came up in a conversation with Shane Jamison , a tech sales coach who works with earlier stage tech companies looking to scale.

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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.