Tue.Apr 25, 2023

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FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time

Fierce Pharma

FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time aliu Tue, 04/25/2023 - 14:16

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Report: Firearm-related Injuries Cost US Healthcare $1B Annually

MedCity News

In just 2020, deaths from gun violence cost the U.S. healthcare system $290 million, or about $6,400 per patient, according to a report from the Commonwealth Fund. These costs are mostly covered by Medicaid and other government insurance programs.

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Talc plaintiffs urge court to reject Johnson & Johnson's latest bankruptcy attempt

Fierce Pharma

Talc plaintiffs urge court to reject Johnson & Johnson's latest bankruptcy attempt kdunleavy Tue, 04/25/2023 - 09:35

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Achieve Precision Medicine Through AI and Analytics Solutions [Sponsored]

MedCity News

MedCity News connected with Integra Connect’s COO, Cory Wiegert at ViVE 2023 to discuss how their new platform will go beyond the “one size fits all” approach to data curation.

Medicine 122
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Amid Novartis' pipeline culls, investors focus on key Kisqali and Pluvicto expansions

Fierce Pharma

Amid Novartis' pipeline culls, investors focus on key Kisqali and Pluvicto expansions aliu Tue, 04/25/2023 - 10:40

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Medtronic Gains FDA Approval for Newest Insulin Pump

MedCity News

Medtronic recently received FDA approval for its MiniMed 780G system, which is an insulin pump that automatically adjusts and corrects type 1 diabetes patients’ glucose levels every five minutes. The news comes two years after Medtronic submitted the system for FDA approval and three years after the company began selling the product in Europe.

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More Trending

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Pioneering malaria vaccine gains regulatory clearance

European Pharmaceutical Review

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. [Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

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Amgen faces patent infringement claims on big-selling osteoporosis drug Evenity

Fierce Pharma

Amgen faces patent infringement claims on big-selling osteoporosis drug Evenity kdunleavy Tue, 04/25/2023 - 13:31

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How Rehab Therapists Can Use RTM to Optimize Patient Care

MedCity News

CMS has shown that they understand the value and efficacy of remote care as a billable service for rehab therapists—let’s not miss this opportunity to take the best care of our patients while getting paid.

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Biogen's Alzheimer's disease sales are negative as Aduhelm fallout lingers

Fierce Pharma

Biogen's Alzheimer's disease sales are negative as Aduhelm fallout lingers fkansteiner Tue, 04/25/2023 - 11:09

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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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Smart Medicine: Artificial Intelligence is Shaping Drug Discovery and Development in Ways Never Once Imagined

MedCity News

Traditionally, pharmaceutical companies have been slow to adopt these newer technologies, instead relying on well-established and proven – but usually complex – manufacturing processes. However, the time to begin investing in – and exploring – AI, machine learning, and big data is now.

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Assertio picks up Spectrum and its approved drug Rolvedon in $248M-plus deal

Fierce Pharma

Assertio picks up Spectrum and its approved drug Rolvedon in $248M-plus deal zbecker Tue, 04/25/2023 - 11:04

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From “Fake News” to “News You Can Use”

PM360

No one disputes how much the media landscape has evolved over the last two decades. What has been discussed, at times very passionately, is the role and reputation of media in today’s environment. As marketing and communications professionals, we wanted to take a deeper look into how media is perceived, how social media has changed the game, and how we can best adapt to this ever-evolving dynamic.

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Biogen Drug Wins Accelerated FDA Nod for Treating Rare Genetic Form of ALS

MedCity News

The Biogen amyotrophic lateral sclerosis drug, Qalsody, treats patients whose disease is driven by mutations to a gene called SOD1. It’s the first drug approved to target a genetic cause of ALS.

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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 Will it Take for the U.S. to Modernize its Public Health Systems?

PM360

How can countries be better prepared for the next pandemic? How do they need to change their public health infrastructure to ensure they don’t face similar challenges as posed by COVID-19? What can countries learn from each other to get these more modernized systems in place to improve their ability to exchange public health data across the globe? These questions were at the heart of many discussions during the 2023 Healthcare Information Management System Society (HIMSS) Global Health Conferen

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What Type of Medical Sales Company Should You Pursue?

MedReps

When it comes to medical sales jobs, there are plenty of options. Going beyond which specialty you prefer, you also need to pick a type of medical sales company. All of these options, ranging from the big-name Fortune 500 members to the smaller startups, have their own sets of pros and cons. Understanding them can help you make an informed decision that will lead you in the right direction.

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Innovative Contracting in Europe—A Double Hurdle to Value?

PM360

In many markets around the world, but particularly in Europe, there have always been post-regulatory hurdles for pharmaceutical companies to achieve their price and access ambitions. In most of the developed markets, there are rigorous health technology assessment (HTA) processes that ascribe a particular benefit to a drug in the context of current therapeutic options.

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Survey: Mental Health Access Is Lacking, Employers Say

MedCity News

Only 31% of employers are satisfied with their behavioral health networks, a new survey found. When it comes to behavioral health directories, just 34% of employers agreed that directories had accurate information.

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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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Medspoke Launches as a New Audio Platform Geared Toward Physicians

PM360

In January 2021, Watzan saw the rise of podcasts and wanted to develop an audio platform that mixed social media and talk and allowed users to listen to short, 15-second audio clips about any of their favorite subjects posted by other users. Now, they are taking the tech behind that platform, which was called ililli , and spinning it off into a similar, but entirely medically focused platform called Medspoke.

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Roy Vagelos is retiring and leaving a legacy of leadership lessons

PharmaVoice

The longtime pharma leader is stepping down from his role as chair of Regeneron’s board in June after decades in drug development.

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Biosimilars Market Set for Biggest Year Yet in 2023

PM360

In perhaps the most significant moment for the U.S. biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. As the world’s top-selling biologic drug, with annual sales topping $21 billion, Humira is used to treat a wide range of chronic conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, juvenile idiopathic arthriti

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How Can Health Systems Reduce Their Carbon Emissions? Experts Weigh In

MedCity News

The healthcare sector accounts for 8.5% of the country’s greenhouse gas emissions. Health systems have a moral obligation to reduce these emissions, experts argued during HIMSS23. The panelists shared tips about climate change mitigation strategies, such as to ask all tech vendors for their carbon reduction plan and to look for savings in the energy budget.

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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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5 Digital Media Tactics to Amplify Public Health Marketing Campaigns

PM360

Mass media public service announcement (PSA) campaigns on print, billboard, and linear TV have been the status quo for years. But we can do better. Digital media is transforming what’s possible for public health marketing, allowing brands to raise awareness in a much more efficient, measurable way. Here are five actionable digital tactics you can use to engage audiences and elicit the behavioral changes needed to support important public health initiatives. #1 – Tell a Story Through Video

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Stimulating Wounds with Electricity for Rapid Healing

Medgadget

Researchers at Chalmers University of Technology in Sweden have developed a microfluidic system to test the effects of electrical stimulation in wound healing. The researchers hope that their experiments might lead to new medical devices that can assist with chronic wounds. Their microfluidic chip contains artificial skin that contains a layer of cells which the researchers can ‘wound’ and then apply an electrical charge to.

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Monoclonal antibody combination treatment given NICE approval

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) has approved monoclonal antibody (mAb) drug daratumumab (Darzalex ® ) in combination with bortezomib (Velcade ® ) and dexamethasone (DVD) for myeloma at first relapse in England.  The new treatment can increase remission times by more than two years, research has shown. Approximately 3,000 myeloma patients will be able to benefit from the combination treatment each year on the NHS.

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Rapid Test for Mpox Virus Developed

Medgadget

Researchers at Penn State have engineered a rapid testing technology for mpox, previously known as monkeypox. The mpox virus, which is transmitted through close contact with an infected person and that spread around the world last year, left healthcare staff grappling with a new problem. As the disease can be transmitted before symptoms arise, diagnosis is important in helping to stop the spread.

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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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5 Human-Generated Guidelines for Using Generative AI

PM360

Generative AI’s potential for tsunami-like disruption has sounded the alarm for knowledge workers worldwide. Marketing and communication agencies everywhere must quickly get comfortable, competent, and creative with generative AI such as ChatGPT or DALL-E. It’s Smart to Use and Dumb to Trust Many healthcare marketing agencies are eager to integrate AI as a core offering.

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Pharma 2023: Marketing to the Masses

PharmExec

Digital and innovation leader takes issue with the current state of pharma marketing and suggests new approaches are needed.

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Addressing Common Reuse Questions in Medical Communications

Copyright Clearance Center

The post Addressing Common Reuse Questions in Medical Communications appeared first on Copyright Clearance Center.

Medical 98
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Sanofi releases AVAXIM Junior in the UK

PharmaTimes

Therapy provides immunisation against infection caused by hepatitis A in children aged 12 months to 15 years

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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.