Fierce Pharma

JUNE 21, 2024

Amid an influx of efforts to help the African continent claim vaccine sovereignty, a new financing mechanism devised by Gavi, the Vaccine Alliance, the African Union and the Africa Centres for Dise | Amid an influx of efforts to help the African continent claim vaccine sovereignty, a new financing mechanism devised by Gavi, the Vaccine Alliance, the African Union and the Africa Centres for Disease Control and Prevention (Africa CDC) has taken flight.

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Manufacturing 287

MedCity News

JUNE 21, 2024

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. Peter Marks, the agency’s top biologics official, reviewed the same data and reached a different conclusion. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.

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Fierce Pharma

JUNE 21, 2024

Cystic fibrosis (CF) patients and their families in England can rest a little easier this week, thanks to an extended long-term reimbursement deal inked by Vertex Pharmaceuticals and the country’s | Cystic fibrosis (CF) patients and their families in England can rest a little easier this week, thanks to an extended long-term reimbursement deal inked by Vertex Pharmaceuticals and the country’s National Health Service (NHS).

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MedCity News

JUNE 21, 2024

This not only enhances the quality of care and patient satisfaction but also optimizes operational efficiency. The post AI-Driven Breakthroughs: Transforming Patient Care through Research Consulting appeared first on MedCity News.

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Consulting Patients 117

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Fierce Pharma

JUNE 21, 2024

In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.< | In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.

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Manufacturing Pharmaceutical 267

MedCity News

JUNE 21, 2024

Underrepresentation of racial and ethnic groups and other historically disenfranchised populations in clinical trials continues to be a major challenge. Medical Affairs can help identify solutions. The post The Role of Medical Affairs in Bridging Clinical Trial Access for All Patients appeared first on MedCity News.

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MedCity News

JUNE 21, 2024

MedCity’s annual INVEST Digital Health conference in Dallas September 18 will delve into innovation at the intersection of AI and drug development, investment trends, consumer-focused diagnostics and validating digital health tools. The post What’s on the Agenda for MedCity INVEST Digital Health in Dallas? appeared first on MedCity News.

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European Pharmaceutical Review

JUNE 21, 2024

Gilead Sciences ’ twice-yearly injectable HIV-1 capsid inhibitor enabled 100 percent efficacy for investigational use of HIV prevention in cisgender women. This is according to interim analysis topline results of the Phase III PURPOSE 1 trial. Lenacapavir showed superiority to once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).

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Safety Medical Pharmaceutical 98

MedCity News

JUNE 21, 2024

Knownwell acquired one of its competitors, just six months after announcing its $20 million Series A funding round. The startup, which provides hybrid primary care and metabolic health treatment, bought Alfie Health, an online obesity management clinic with an AI platform that generates personalized recommendations for weight management. The post Knownwell Acquires Competitor to Expand Access to Comprehensive Obesity Care appeared first on MedCity News.

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Management 102

Pharmaceutical Technology

JUNE 21, 2024

Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.

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FDA 98

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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.

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Pharmaceutical Commerce

JUNE 21, 2024

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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Distribution Biopharma Pharma Marketing 102

pharmaphorum

JUNE 21, 2024

Twice-yearly lenacapavir injection provides 100% protection from HIV when used as PrEP in cisgender women, says Gilead.

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Pharmaceutical Technology

JUNE 21, 2024

Both Novo Nordisk and Eli Lilly have filed lawsuits against unapproved sellers of their diabetes and weight loss drugs.

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pharmaphorum

JUNE 21, 2024

NWEH launches software that takes legwork out of serious adverse event reporting in clinical trials and could reduce costs.

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Side effects 97

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Clarivate

JUNE 21, 2024

AI and systematic literature reviews: potential benefits and use cases Good quality evidence is the hallmark of any successful roadmap to access. Systematic literature reviews (SLRs) and meta-analysis are generally considered to be among the most robust forms of evidence; their adherence to strict methodological guidelines helps negate the inherent bias of researchers.

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Training Government Ethics Medical science 81

PharmaTimes

JUNE 21, 2024

The method provides a more accurate and ethical approach to drug testing for medicines

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Ethics Medicine 104

pharmaphorum

JUNE 21, 2024

Chimps’ self-medication with plants could aid drug discovery Phil.

Medical 105

Medical 105

MedCity News

JUNE 21, 2024

In a recent interview, Don Antonucci, president and CEO of Providence Health Plan, spoke about how the industry needs to improve value-based care. The post What’s Missing from Value-Based Care Convos, According to Providence Health Plan’s CEO appeared first on MedCity News.

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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

PharmaTimes

JUNE 21, 2024

According to WHO, cardiovascular diseases are responsible for 17.

Medical 100

Medical 100

Scott Burrows

JUNE 21, 2024

In a world filled with stories of resilience and triumph, my journey stands as a testament to the power of determination and unwavering optimism. From the heights of athletic glory to the depths of life-altering challenges, I have navigated a path guided by three fundamental principles: vision, mindset, and grit. Embracing Vision: Seeing Beyond Circumstances My story began on the football field, where I excelled as a star wide receiver for Florida State University.

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Manufacturing Management 52

PharmaTech

JUNE 21, 2024

President and CEO of Pharmaceutics International, Inc. (Pii), John Fowler, reacts to the agility and flexibility needed to support the development and manufacture of today's complex biotherapeutics.

Manufacturing 52

Manufacturing Pharmaceutical 52

pharmaphorum

JUNE 21, 2024

Sustainability is all important for the planet and its people, and in today’s podcast web editor Nicole Raleigh speaks with Harriet Lewis, director of public affairs and communications at Chiesi UK & Ireland, about how partnerships between the NHS and pharma industry can support the journey to more sustainable practices, from R&D and drug reimbursement to medicines and recycling.

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Patients Medicine Pharma 52

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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

Pharmaceutical Technology

JUNE 21, 2024

South Korea is moving forward with reforming its national health insurance system to improve patients' access to healthcare support under the Second Stage Comprehensive Insurance Plan, for the period 2024-28.

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Insurance Healthcare Healthcare Patients 52

PharmExec

JUNE 21, 2024

Results of the PURPOSE 1 trial indicated that a twice-yearly injection of lenacapavir outperformed the once-daily oral Truvada preventing HIV in cisgender women.

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Pharmaceutical Technology

JUNE 21, 2024

The company has also raised $130.7m in a private placement, which along with Tectonics' previous cash reserves.

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PharmExec

JUNE 21, 2024

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

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FDA 52

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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

Pharmaceutical Technology

JUNE 21, 2024

AstraZeneca has received approval for Truqap in combination with Faslodex in the EU to treat certain advanced breast cancer cases in adults.

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PharmExec

JUNE 21, 2024

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

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Pharmaceutical Commerce

JUNE 21, 2024

Mark Bouck discusses PharmAlliance’s latest acquisitions, while reiterating its goals surrounding health economics and outcomes research.

Marketing 52

Marketing 52

PharmExec

JUNE 21, 2024

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

Pharma 52

Pharma 52

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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.

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