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FDA appears receptive to surrogate endpoint supporting accelerated approval of multiple myeloma drugs

Fierce Pharma

The FDA appears receptive to the idea of using the measurement to support accelerated approvals of new drugs, even though the agency has a few questions. . | New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma.

FDA 310
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Rising Investment in Patient Support Drives a Greater Biopharma Focus on Measurement

Fierce Pharma

Delivering on these heightened expectations has fueled the urgency to invest in patient engagement and support. A seismic shift has occurred in the healthcare landscape.

Biopharma 244
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Embracing Personalization in Biopharma Patient Support Programs

Fierce Pharma

Embracing Personalization in Biopharma Patient Support Programs mteefey Tue, 04/18/2023 - 14:48

Biopharma 246
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EConsent Workflows Must Evolve to Support Interoperability and Health Equity

MedCity News

CTO Aneesh Chopra will moderate a webinar on April 16 at 1pm ET on eConsent, The post EConsent Workflows Must Evolve to Support Interoperability and Health Equity appeared first on MedCity News. Former U.S.

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

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 studies throughout (..)

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After monumental MASH nod, Madrigal plots $600M stock sale to support Rezdiffra launch

Fierce Pharma

Now, the company looks to support the upcoming launch by selling shares. Just a few days ago, Madrigal Pharmaceuticals made history by winning FDA approval for its metabolic dysfunction-associated steatohepatitis (MASH) med Rezdiffra.

Sales 130
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'The Top Line': How to support patients during a drug shortage, plus this week's headlines

Fierce Pharma

In this episode of "The Top Line," Zoey Becker talks with Dr. | This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines.

Patients 241
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Making the Case for Case Management for Cell and Gene Therapies

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. It is crucial to ensure supply chain risks are mitigated and have proactive strategies in place to address unforeseen challenges before they become an issue.

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How Machine Learning Drives Clinical Trial Efficiency

We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows. In this paper, we explore real-time data access and analysis for proactive study management.

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Buyer’s Checklist: How to Evaluate a B2B Contact Data Provider

Leveraging a data provider to help identify and connect with qualified prospects supports company revenue goals by alleviating common headaches associated with prospecting research and empowers sales productivity. So what’s the problem? Many organizations fail to properly evaluate vendors during the selection process.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Revvity Signals provides a centralized analytics platform built to support today’s clinical study requirements and increase trial efficiency, glean actionable analytic insights, automate data collection and harmonization, support safety and efficacy decision-making, and enable a singular view across a company’s entire candidate portfolio.

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How to Stay Competitive in the Evolving State of Martech

The growing demand among buyers for open marketing platforms that can support “BYOD” (bring your own data). How AI-powered analytics are leading to more intriguing and satisfying customer interactions.