Sat.Aug 10, 2024 - Fri.Aug 16, 2024

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Keeping Counterfeit Goods Out of the Supply Chain

Pharmaceutical Commerce

In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, comments on other ways to limit ‘bad actors’ attempts to sneak counterfeit drugs into the supply chain, aside from the DSCSA.

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With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time

Fierce Pharma

With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

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Trending Sources

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How Often Do LLMs Hallucinate When Producing Medical Summaries?

MedCity News

Researchers at the University of Massachusetts Amherst released a paper this week showing that large language models tend to hallucinate quite a bit when producing medical summaries. The post How Often Do LLMs Hallucinate When Producing Medical Summaries? appeared first on MedCity News.

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People need to know how to use AI now

pharmaphorum

With the implementation of advancing technologies in industry comes the parallel need for suitable upskilling of the workforce – but this doesn’t as yet always pan out, and in today’s pharmaphorum podcast COO of Enthought Mike Connell discusses the growing skills gap in R&D in life sciences and the 80/20 rule with web editor Nicole Raleigh, as well as the need for correct education of people and machines, both.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Complying with the DSCSA

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, describes the outcome of the joint public meeting held by the Partnership for DSCSA Governance and the FDA.

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To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

Fierce Pharma

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.

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More Trending

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With FDA okay, AZ takes on MSD in early-stage lung cancer

pharmaphorum

AstraZeneca has claimed FDA approval for its immunotherapy Imfinzi before and after surgery for non-small cell lung cancer, setting up a contest with MSD's rival Keytruda.PD-L1 inhibitor Imfinzi (durvalumab) has been cleared for use in adult patients who need surgery for early-stage (IIA-IIIB) NSCLC and have no ALK or EGFR mutations that would make them suitable for targeted therapies.

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Maintaining a Specialty Medication Regimen

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.

Medical 104
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J&J and Roche are the strongest companies in the biopharma industry, says S&P Global

Fierce Pharma

Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. | Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.

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What Will the Future of Retail Health Look Like?

MedCity News

Retailers aren’t giving up on healthcare — but they are trying to be more strategic in their efforts to disrupt the space. As these companies re-strategize, experts think they need to center their efforts on building trust and fostering long-term patient engagement. The post What Will the Future of Retail Health Look Like? appeared first on MedCity News.

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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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Baxter slims down again, selling kidney division to Carlyle

pharmaphorum

Baxter International has agreed to sell its kidney treatment division to private equity firm Carlyle Group in a $3.8 billion cash deal, continuing its efforts to streamline its operations and reduce debt.

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Medicare Unveils Results of First-Round Drug Price Negotiations

Pharmaceutical Commerce

By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.

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Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath

Fierce Pharma

Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

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First Walgreens Store Files to Unionize with the Pharmacy Guild

MedCity News

Pharmacists and pharmacy technicians at a Walgreens store in Vancouver, Washington, have filed a petition to join the Pharmacy Guild. The workers argued that they are facing heavy workloads and inadequate staffing. The post First Walgreens Store Files to Unionize with the Pharmacy Guild appeared first on MedCity News.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Remembering Paul Bannister, dear friend and finance manager

pharmaphorum

Our longtime Finance Director Paul Bannister was a part of the fabric of pharmaphorum almost from the beginning and an integral part of keeping the publication running. And, most importantly, he was the soul of the place and a friend to all.

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Lessons from COVID: Tuskegee impacts still erode trust in healthcare, but hope shines through

PharmaVoice

A long-time leader in public health and outreach to people of color, Dr. Reed Tuckson offers the lessons he learned from the COVID pandemic and how pharma can better serve those communities.

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Novo Nordisk plans new $220M raw ingredients plant in Denmark

Fierce Pharma

Even as supplies of Novo Nordisk’s immensely popular GLP-1 drugs Ozempic and Wegovy start to stabilize, the Danish drugmaker continues to announce manufacturing and capacity upgrades at a rapid cli | Novo Nordisk Pharmatech, a unit that specializes in producing drug ingredients, is spending 1.5 billion Danish kroner ($220 million) to build a plant in Køge, Denmark, that will make raw materials, the company said Friday.

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Study: LLMs Identify Mental Health Crises with Accuracy Comparable to Clinicians

MedCity News

OpenAI’s GPT-4 was able to identify suicidal ideation with similar accuracy to clinicians, but in a much shorter amount of time, a new study from Brightside Health found. The post Study: LLMs Identify Mental Health Crises with Accuracy Comparable to Clinicians appeared first on MedCity News.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Africa on high alert as mpox cases rise quickly

pharmaphorum

The rapid spread of a new variant of mpox – previously known as monkeypox – has prompted the Africa Centers for Disease Control and Prevention (Africa CDC) to declare a public health emergency.

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

Marketing 105
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Fiercest Women in Life Sciences 2024: Nominations open now

Fierce Pharma

It’s time once again to nominate the fiercest women you know in the life science industry for our annual list. | It’s time once again to nominate the fiercest women you know in the life science industry for our annual list.

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Adapting to a Patient-Centric Care Model with Tech-Enabled Urgent Care

MedCity News

As patient expectations evolve, the healthcare industry must evolve with them. This means the tools, processes, and technology involved in care delivery must adapt, too. The post Adapting to a Patient-Centric Care Model with Tech-Enabled Urgent Care appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Incyte builds GvHD presence with Niktimvo approval

pharmaphorum

FDA clears Incyte's potential blockbuster Niktimvo as a treatment for chronic GvHD, making it a companion to the company's Jakafi for the disorder.

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Digital Health Networks Announces Finalists of 2nd Annual CineHealth International Health & Wellness Film and Video Festival

PM360

Winners Across Five Categories to Be Awarded During Ceremony at Digital Pharma East in Philadelphia, PA on September 10th August 12, 2023 – LOS ANGELES, CA – Digital Health Networks, today announced the finalists in the first annual CineHealth International Health and Wellness Film and Video Festival. At the awards ceremony in Philadelphia, PA, winners will be honored on the evening of Tuesday, September 10 th during Digital Pharma East for their work in film, video and podcasting.

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As mpox outbreak spreads across Africa, Siga's antiviral Tpoxx misses the bar in Congo study

Fierce Pharma

Just as a new strain of mpox spreads across Africa, results from a preliminary analysis of a study that began during the 2022 viral outbreak stands to provide more clarity on the clinical benefit o | Despite missing the trial's primary endpoint of time to lesion resolution, the study suggested that the treatment may be most beneficial for those treated early and those with severe disease.

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Report: A “Multifaceted Approach” Is Needed To Tackle the Obesity Epidemic

MedCity News

The obesity epidemic is due to factors like inadequate access to care, stigma and a lack of insurance coverage for effective treatments, according to a new report published in the American Journal of Managed Care. The post Report: A “Multifaceted Approach” Is Needed To Tackle the Obesity Epidemic appeared first on MedCity News.

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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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AstraZeneca said to be wavering on £450m UK vaccine plant

pharmaphorum

AstraZeneca's plan to invest £450m in a vaccines plant in the UK has been thrown into doubt by a bid to slash state aid, reports FT

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AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

Pharmaceutical Technology

The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.

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GSK notches another Zantac win as Florida court tosses expert testimony linking heartburn drug to cancer

Fierce Pharma

After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation. | After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation, thanks to a decision in Florida that put the kibosh on suspect expert testimony.

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Bend the Curve: Schools’ Crucial Role in Early Intervention for Youth Mental Health

MedCity News

To change the trajectory of the youth mental health pandemic, we must commit to “bending the curve” by building strong, prevention-oriented partnerships. Collaboration between caretakers, schools, and mental health professionals is vital. The post Bend the Curve: Schools’ Crucial Role in Early Intervention for Youth Mental Health appeared first on MedCity News.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.