Tue.Sep 26, 2023

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WuXi debuts first vaccine CDMO site in China, where it plans to employ more than 500

Fierce Pharma

Amid a global expansion spree at WuXi Biologics, the company's immunization-focused subsidiary has christened its inaugural CDMO site in China. | WuXi Vaccines launched its first standalone vaccine contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development.

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Digital Therapeutics: A Panacea for Care or Overvalued Health Tech?

MedCity News

Digital therapeutics will be one of the topics discussed at INVEST Digital Health scheduled for October 26 at Health Wildcatters headquarters in Pegasus Park in Dallas. Register today!

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J&J, IBM face class-action lawsuit over patient data breach

Fierce Pharma

As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach. | As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach.

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Costco Takes On Healthcare, Though Differently From Other Retailers, Experts Say

MedCity News

Costco is partnering with Sesame to offer Costco Members discounted pricing on virtual health services, including primary care and mental health. But the move is a little different from other retailers like CVS Health and Walgreens.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Merck KGaA's MilliporeSigma pumps €28M into 2 new mRNA production plants

Fierce Pharma

On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercializ | On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.

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Virtual Reality Headset Takes EEG Measurements

Medgadget

Researchers at the University of Texas at Austin have developed an electroencephalogram (EEG) sensor that is incorporated into a virtual reality headset. The technology can measure brain activity while someone is undergoing an immersive virtual reality experience. The device may assist in enhancing medical virtual reality interventions, such as those used to treat post-traumatic stress disorder or phobias, by revealing brain activity during different tasks or experiences that help clinicians to

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After NASH Hopes Are Dashed, Intercept Pharma Agrees to $794M Buyout

MedCity News

Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.

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After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy's Alfasigma

Fierce Pharma

It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver | The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent attempt at cutting costs.

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Intermountain CEO: You Don’t Have To Be a Payvider to Reach Scale in VBC

MedCity News

The advancement of value-based care cannot and should not exist solely in a payvider model, Intermountain Health CEO Rob Allen argued in an interview last week. Having its own health plan made things “a little easier” when Intermountain began getting serious about at-risk contracts, but achieving success in value-based care “is more about your commitment to the approach” and forging strong relationships with payers of all types.

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Gilead Sciences, after trial win, moves ahead with $247M settlement in HIV antitrust case

Fierce Pharma

Even after Gilead Sciences and Teva Pharmaceutical Industries prevailed in a high- | The preliminary settlement deal comes after Gilead and Teva, a generics giant, prevailed in a high-stakes jury trial this summer.

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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: MA Premiums To Remain the Same for Most Beneficiaries in 2024

MedCity News

The average monthly plan premium for Medicare Advantage is expected to increase only slightly in 2024 from 2023, CMS said. About 73% of beneficiaries will see no increase at all.

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Implantable Bioreactor for Kidney Cells

Medgadget

Researchers at the University of California San Francisco have developed an implantable bioreactor that may pave the way for artificial kidneys. Dialysis and kidney transplants both have significant disadvantages for patients with kidney failure, and so scientists are trying to develop a lab created kidney that would not require harsh immunosuppression or a donor kidney.

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Cartwheel Snags $20M For School-based Mental Health Services

MedCity News

Cartwheel, a startup that partners with school districts to provide virtual mental health services, raised $20 million in Series A funds. The company is working with about 50 school districts and charter school networks across Massachusetts, Illinois, New York, Rhode Island and Connecticut.

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Do humans have a place in pharma’s AI future?

PharmaVoice

From COTA’s large datasets and AI model assistants to a company guiding patients through cancer care, AI can help — but it’s a long way from human-free.

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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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MedCity Pivot Podcast: Tackling Rare Disease With Someone Who Was Touched By It

MedCity News

Rich Horgan believes that there’s an alternative path to drug development that can lower costs and the time it takes to bring drugs to market. He is trying to apply it to the field of rare and ultra-rare diseases.

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Considerations for safety data migration methods

European Pharmaceutical Review

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. These database transfer activities must follow industry standards and pharmacovigilance regulation, which has become increasingly stringent over the last decade. The concept of good pharmacovigilance practice (GVP) has been implemented in multiple regions across the globe to ensure these migrations are validated and data integrity i

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Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own

MedCity News

Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner.

Medicine 101
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Lymphoma maintenance therapy delivers promise in CTCL

European Pharmaceutical Review

Resminostat (Kinselby) has been clinically proven to postpone disease progression, new data from one of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to date has revealed. The treatment is an oral small molecule class I, IIb and IV histone deacetylase (HDAC) inhibitor. Data from the RESMAIN resminostat study Findings from the RESMAIN study of the maintenance therapy could significantly change clinical practice in advanced CTCL, according to the company.

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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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Embracing AI: Q&A with Shalu Chadha

PharmExec

Accenture’s global life sciences technology lead discusses how the life sciences industry has embraced artificial intelligence.

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UKHSA reaches vaccine deal with CSL Seqirus

PharmaTimes

Agreement will provide timely boost to pandemic preparedness against influenza - News - PharmaTimes

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IP cost forecasting: adding accuracy, removing guesswork [New Report]

Clarivate

Intellectual Property (IP) portfolios are expanding dramatically—and so are the costs of securing and maintaining patent and trademark rights. The fees for applications, local agents and renewals have become a major cost center and a management challenge. These pressures place extra strain on corporate IP leaders’ budgets. Overshooting the annual IP budget puts pressure on the company’s bottom line.

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Oxford Biodynamics launches prostate screening test

PharmaTimes

EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate - News - PharmaTimes

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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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Join Clarify Health at the AAPL Regional Network Meeting

Clarify Health

Join Clarify Health on September 29 th , 2023, at the American Association of Physician Liaisons (AAPL) regional networking meeting in Columbus, OH. The fall networking meeting is an opportunity for physician liaisons to network and gain valuable education from industry peers. AAPL Regional Meetings Designed with affordability in mind, these regional meetings are especially beneficial for physician liaison teams operating on tighter budgets.

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Real world data’s role in strategic site selection

Clarivate

One of the critical factors determining the success of a clinical trial is the selection of appropriate clinical sites that have evidenced access to specific patient populations. Siting can significantly impact a trial’s efficiency, cost-effectiveness, and ability to generate robust, reliable data. Patient recruitment accounts for 32% of all trial costs and patient drop out averages 18%, according to Deloitte figures.

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Clinical Trial Supplies Planning Checklist

PharmaTech

A convenient checklist from the experts at Experic to jump-start your planning so supply challenges won’t hinder your progress! Download the checklist today and take advantage of Experic's expert tips to optimize your clinical trial supply planning.

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From Surgical Technologist To Territory Manager In Spine Med Device With Samantha Patterson

Evolve Your Success

In this industry, there probably is nothing sweeter than hearing the profound impact we make on people’s lives. Just like in today’s episode. Samuel Adeyinka sits down with Samantha Patterson , who shares her journey from being a surgical technologist to becoming a territory manager in spine medical devices. A recent graduate of the Medical Sales Career Builder program, she discusses the challenges she faced before finding the program, her experience during the program, and the moment she receiv

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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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Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Legacy MEDSearch

Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology.

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BenevolentAI Signs Collaboration with Merck

PharmaTech

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

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The competitive edge: Unlocking the full potential of autoinjectors through comprehensive in-house manufacturing

Pharmaceutical Technology

To optimise autoinjector combination product development, it is crucial for pharma and biotech to partner with device companies that have in-house control over the whole device manufacturing process.

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Independent Rx Forum - Charting the Course of Community Pharmacies

Pharmacy Times

Tune in to this episode of the Independent Rx Forum to gain a comprehensive understanding of the enduring significance of independent and community pharmacies.

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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.