Sat.Sep 16, 2023 - Fri.Sep 22, 2023

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Breaking Through Gridlock in the Mental Health Care System

MedCity News

For the gridlock in mental healthcare to be resolved, 100% of mental healthcare providers must practice measurement-based care, utilizing validated rating scales to monitor and measure longitudinal outcomes for every patient. And payers then must offer reimbursement that appropriately rewards providers for delivering high-quality, effective care, and incentivize proactive mental health management.

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Novo Nordisk Foundation pumps $136M into new clinical cell therapy manufacturing 'hub' in Denmark

Fierce Pharma

Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.

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The Right Profile & Path

David Bagga

The Medical device sales industry is a well-known career destination that hundreds of thousands of candidates are trying to break into everyday. Medical Device Sales Career Home Blog The Right Profile & Path to take to Breaking into MDS The Right Profile & Path to take to Breaking into Medical Device Sales The Medical device […] The post The Right Profile & Path appeared first on.

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Three years after an FDA rejection, DBV sees a path for its peanut patch

PharmaVoice

Despite lower-than-expected demand for a competing treatment, DBV’s chief medical officer says the company’s topical skin patch could be a game-changing option for patients.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Can AI Compose Clinical Documentation? Absolutely, but with Limits.

MedCity News

A recent academic study of the leading LLM AI models’ ability to read and interpret clinical information demonstrates the incredible power of these tools to support healthcare, but concludes that LLMs should be used as “a supplement to existing workflows rather than as a replacement for human expertise.

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Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. | Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer.

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21Grams, Area 23, and IPG Health Dominate The Creative Floor Awards 2023

PM360

The Creative Floor Healthcare Awards , celebrated the world’s best health and wellness creative work, agency talent, and clients yesterday at its 10 th -year anniversary party. Area 23 won the Most Awarded Agency and IPG Health won the Most Awarded Network. 21Grams took home Best Communications Agency. Bravest Client Awards went to Uyum Evcin from CSL Vifor and Peter Zenobi from Sanofi.

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7 AI Pitfalls That Hospitals Should Avoid

MedCity News

As hospitals across the nation adopt more and more AI technology, there are some common hazards of which they should be wary. During a conference presentation on Tuesday, healthcare AI expert Suchi Saria laid out seven AI pitfalls hospitals should look out for — some of these include being duped by Big Tech companies’ marketing strategies and focusing too much on administrative use cases.

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Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant

Fierce Pharma

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.

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The 2023 PharmaVoice 100

PharmaVoice

This year’s honorees are influential and devoted leaders lifting the pillars of the industry to new heights.

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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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Consequences of the First 10 Drugs Selected for Medicare’s Negotiation Program

PM360

As many in the industry now know, the Inflation Reduction Act (IRA) is the most significant reform of Medicare prescription drug coverage since the creation of Part D and has wide-ranging implications for the healthcare industry. The recent announcement of the first 10 drugs selected for price negotiations is a significant first step in Medicare’s effort to directly set drug prices for seniors.

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How the FTC Is Tackling ‘Below the Radar’ Healthcare Deals

MedCity News

The Federal Trade Commission doesn’t get notified about every deal, which can lead to a slow consolidation of the market, said Lina Khan, chair of the FTC. She made these comments on Monday during the Oliver Wyman Health Innovation Summit 2023 held in Chicago.

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With trial win, AbbVie cues up Botox for another cosmetic indication

Fierce Pharma

With the loss of elasticity in the skin that accompanies aging, platysma bands can become more apparent, protruding from the neck. | Already approved as an injection to reduce wrinkles in the forehead and around the eyes, AbbVie's Botox is in position to expand its cosmetic uses to the moderate to severe form of platysma prominence, a condition which causes muscle bands to protrude from the neck.

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Researchers of Nobel class: Citation Laureates 2023

Clarivate

The Citation Laureates 2023 list has been announced, recognizing a select group of influential, highly cited researchers whose contributions are on par with Nobel Prize recipients. We explore their profound impact on our world and their enduring commitment to the pursuit of knowledge, inspiring the next generation of researchers. We at the Institute for Scientific Information (ISI) at Clarivate have announced 23 new Citation Laureates , a designation that recognizes researchers of Nobel class b

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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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How Pharma Brands Grow: An Evidence-based Approach to Pharma Brand Marketing

PM360

Pity the poor pharma brand marketer. Over the past many years, they’ve seen their colleagues on the performance marketing side grow in influence and sophistication as their datasets and digital channels have expanded their value to the business. In contrast, brand marketing can feel like a vestige from another era of marketing, poorly understood, with poor metrics, and little consensus of how brand marketing contributes to the overall business.

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FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine

MedCity News

ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.

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In new lawsuits, Lilly accuses 8 companies of making and selling compounded versions of Mounjaro

Fierce Pharma

With the surge in demand for GLP-1 diabetes and weight loss drugs—and companies struggling to supply them—it was only a matter of time before knockoffs reached the market. | Early this summer, Novo Nordisk filed multiple lawsuits accusing companies of producing and selling compounded versions of Ozempic and Wegovy. Now, Eli Lilly has done the same, filing eight separate complaints in five states.

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New manufacturing facility could drive gold standard in cell therapy

European Pharmaceutical Review

A new Denmark-based manufacturing facility is set to establish the final development steps and upscaling of cell therapies. To establish it, the Novo Nordisk Foundation is committing up to £127 million. CEO of the Novo Nordisk Foundation Cellerator, Thomas HR Carlsen, told EPR that for cell therapy manufacturing, “The biggest challenge is producing high-quality, consistent cell therapies at the scale required for use in clinical trials… biological complexity [of living cells] means that the man

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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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Battery Charged by Tears for Smart Contact Lenses

Medgadget

Researchers at Nanyang Technological University in Singapore have developed a tiny, flexible battery that is intended for use in smart contact lenses. The device is as thin as the human cornea and can be charged by a saline solution, which is particularly useful in the eye, as it is full of salty tears. When the battery-equipped smart lens is not in use, such as at night, then it can be stored in a saline solution, helping to further recharge the battery.

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How HCA Is Integrating Google’s Generative AI Into Its Emergency Departments

MedCity News

This year, HCA Healthcare and Google Cloud have expanded their partnership by exploring ways to integrate Google’s generative AI into HCA’s workflows. The most developed project under this initiative is a pilot that began in February in which HCA’s emergency department physicians are testing a voice-enabled medical dictation tool to save them time on clinical documentation.

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Look out, AZ. Lilly and Boehringer's Jardiance is ready to roll in chronic kidney disease after FDA nod

Fierce Pharma

Fast on the heels of winning a European approval to treat chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim's versatile SGLT2 inhibitor Jardiance is expanding its reach in the U.S., | After AstraZeneca's Farxiga won a class-first chronic kidney disease approval back in 2021, Eli Lilly and Boehringer are entering the fray with their SGLT2 drug Jardiance.

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The Global Vaccine R&D Pipeline and Delivery Implications

PharmExec

The current vaccine pipeline brings promise of significant global health advancements—yet development gaps remain, and the future delivery challenges must be considered.

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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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Cells Release Insulin in Response to Music

Medgadget

Researchers at ETH Zurich have developed an insulin delivery system that relies on music as a trigger. The unusual technology is based on calcium ion channels that typically reside in the cell membrane. Such channels are sensitive to mechanical deformation and these researchers discovered that sound waves will activate the channels. When insulin-producing cells are genetically modified to express this channel, they will experience an influx in calcium ions when music is played close by, promptin

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Remote Patient Monitoring: Gaining Insight into Patient Health from Afar [Sponsored]

MedCity News

The era of remote patient monitoring is ushering in a new era of healthcare, characterized by data-driven insights, personalized care, and efficient resource utilization.

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UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

Fierce Pharma

After a manufacturing-related complete response letter held up the U.S. | UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.

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Study Highlights PBMs’ Role in Drug Prices

Pharmaceutical Commerce

An analysis by 3 Axis Advisors has found that there is a large variability in pharmacy reimbursement of prescription drugs depending on PBM contracts with insurers. This creates a system with huge inconsistencies on the prices of both generics and branded products.

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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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Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

Medgadget

Researchers at the Terasaki Institute in Los Angeles have developed a new method to create 3D printed muscle constructs with enhanced muscle cell alignment and maturation. The technique involves creating microparticles loaded with insulin-like growth factor (IGF) using a microfluidic platform. Then, these particles are included in a bioink that also incorporates myoblast cells and a gelatin-based hydrogel.

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HHS: Medicaid/CHIP Coverage To Be Reinstated for 500K People

MedCity News

Thirty states have been conducting Medicaid and CHIP automatic renewals incorrectly, leading to many individuals being wrongly removed from coverage. Because of this, nearly 500,000 children and other individuals will have their coverage reinstated.

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After TIGIT divorce, Novartis returns tislelizumab to BeiGene as PD-1 gains first European nod

Fierce Pharma

Novartis has ended its major cancer immunotherapy collaboration with BeiGene more than two years after touting the benefits of having a PD-1 inhibitor. | Novartis has ended its major cancer immunotherapy collaboration with BeiGene more than two years after touting the benefits of having a PD-1 inhibitor.

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6 Things to Consider to Build Creative that Makes an Impact

PM360

Last we spoke, executing omnichannel digital media using programmatic as the foundation was the topic. But we cannot talk about the media channels and how to connect them without talking about the creative. It has an outsized impact on your media plans’ performance and we need it to drive success. According to Ipsos, 75% of campaign success is driven by the creative.

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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.