Fierce Pharma

SEPTEMBER 10, 2024

After much anticipation and concern, the BIOSECURE Act—which would prevent U.S. companies from working with certain Chinese biotech service providers—has passed a key threshold. | Late Monday, the U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with five named Chinese life-sci companies: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.

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MedCity News

SEPTEMBER 10, 2024

Some of the most difficult processes for digital health startups to navigate are those related to reimbursement and coding. Startups will often need to create entirely new codes for their products, so they should start thinking about this sooner rather than later, experts said at a recent conference. The post Why Digital Health Startups Should Start Thinking About Their Reimbursement Pathway Earlier appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 10, 2024

Eleven months after sustaining a rejection from the FDA for Dupixent to treat c | Eleven months after sustaining a rejection from the FDA for Dupixent to treat chronic spontaneous urticaria, Sanofi and Regeneron have presented data from a phase 3 trial that could help push the megablockbuster across the finish line in the indication.

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FDA 147

MedCity News

SEPTEMBER 10, 2024

A CEO and father of two reflects on the Surgeon General’s recent advisory, evolving pressures on today’s parents and the impact on mental health. The post Parenting: The New Mental Health Threat? appeared first on MedCity News.

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Management Patients 109

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Fierce Pharma

SEPTEMBER 10, 2024

In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special | In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special report.

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Specialization 130

Pharmaceutical Commerce

SEPTEMBER 10, 2024

A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab.

Patients 105

Patients 105

PharmaVoice

SEPTEMBER 10, 2024

Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

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Medicine Pharmaceutical 98

MedCity News

SEPTEMBER 10, 2024

Adding generative AI and other AI tools to coding and chart review practices streamlines a complex process and better positions plans for risk adjustment audits. The post Medicare Advantage Audit Ready with AI appeared first on MedCity News.

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Pharmaceutical Technology

SEPTEMBER 10, 2024

Baltimore opted out of a national settlement last year, instead pursuing its own claim against the opioid manufacturer.

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Manufacturing 105

Clarivate

SEPTEMBER 10, 2024

New Clarivate report assesses current and expected trends and investigates the impact of technologies, including AI, on librarians and their communities through a global survey of academic, national and public libraries. Advanced technologies, in particular Artificial Intelligence (AI), are reshaping the world of education and research, offering new possibilities for enhancing learning outcomes, accelerating discovery and improving content accessibility.

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Education Leads Government 64

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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.

Safety

pharmaphorum

SEPTEMBER 10, 2024

Bayer and Boehringer present data on competing oral HER2 drugs at WCLC, as they run phase 3 trials in NSCLC with HER2 activations.

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Clarivate

SEPTEMBER 10, 2024

Reliable insights require quality monitoring and a high level of accuracy. New generative artificial intelligence (AI) and large language model (LLM) technologies offer new possibilities for patent researchers. They can create workflow efficiencies for those who want to capture quick insights from the ever-expanding volume of global patent publications.

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Management 59

European Pharmaceutical Review

SEPTEMBER 10, 2024

Results from GSK’s two Phase III clinical trials evaluating the biologic depemokimab has shown promise in extending dosing intervals in severe asthma, with individuals just requiring two doses annually. The injectable treatment was assessed against placebo in the SWIFT-1 and SWIFT-2 trials and open label extension study (AGILE). It is the first ultra-long-acting biologic to be evaluated in Phase III trials.

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Medicine Pharmaceutical Patients 59

Pharmaceutical Commerce

SEPTEMBER 10, 2024

The latest news for pharma industry insiders.

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Pharma 105

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Distribution

PharmaTimes

SEPTEMBER 10, 2024

Molecular imaging agent 99mTc-maraciclatide to aid in disease prognostication

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Pharmaceutical Technology

SEPTEMBER 10, 2024

Datopotamab deruxtecan, developed under a collaboration between AstraZeneca and Daiichi Sankyo, elicited higher overall survival than chemotherapy.

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Patients 59

PharmExec

SEPTEMBER 10, 2024

In this interview, Melissa Krebs, CEO and founder of GelSana, shares her journey in developing cutting-edge biomaterials that could transform the $78 billion wound care market.

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Marketing 52

PharmaTech

SEPTEMBER 10, 2024

Susan J. Schniepp, member of the editorial advisory boards for Pharmaceutical Technology, Pharmaceutical Technology EuropeT, and BioPharm International, provides an update on her experience working in the pharmaceutical industry and what she sees for the industry’s future.

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Pharmaceutical 52

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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.

Safety

PharmExec

SEPTEMBER 10, 2024

Results from the Phase Ib Beamion LUNG-1 trial found that zongertinib achieved an objective response rate of 66.7% in previously treated patients with advanced non-small cell lung cancer with HER2 mutations.

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Patients 52

PharmaTech

SEPTEMBER 10, 2024

The 2024 CPHI Pharma Awards comprise finalists spanning 14 categories and includes awards for future leaders, women of the year, and an “at the heart of pharma” category.

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Pharma 52

PharmExec

SEPTEMBER 10, 2024

In this part of their Pharmaceutical Executive video interview, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, comment on how Eli Lilly's recent announcement to sell Zepbound DTC will impact the counterfeit weight loss drug issue.

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Pharmaceutical 52

pharmaphorum

SEPTEMBER 10, 2024

Terns Pharma files $125m+ public offering to support trials of its oral GLP-1 agonist candidate TERN-601 for obesity.

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Pharma 63

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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

Distribution

PharmaTimes

SEPTEMBER 10, 2024

Critically ill individuals will benefit from futuristic tech

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Medicine Patients 83

pharmaphorum

SEPTEMBER 10, 2024

GSK's long-acting drug antibody for severe asthma, depemokimab, cut the rate of attacks by 54% in phase 3 trials presented at ERS.

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PharmaVoice

SEPTEMBER 10, 2024

Quality-adjusted life years are an important tool to frame a drug’s cost effectiveness, but they leave out other determinants of health.

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pharmaphorum

SEPTEMBER 10, 2024

Researchers have shown that COPD exacerbations can be predicted by looking for vocal biomarkers in recorded speech

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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

Leads

PharmExec

SEPTEMBER 10, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Medicine 52

Pharmaceutical Technology

SEPTEMBER 10, 2024

The study involved over 3,600 participants, including FDRs of newly diagnosed type 1 diabetes patients in Denmark and children in Sweden.

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Patients 52

PharmExec

SEPTEMBER 10, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

Marketing 52

Marketing Pharma 52

Pharmaceutical Technology

SEPTEMBER 10, 2024

The US House of Representatives has passed a bill to restrict business with certain Chinese biotech companies.

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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.

Specialization