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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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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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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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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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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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.

Patients 131
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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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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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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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FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

PharmaTimes

The updated vaccines more closely target current circulating variants - News - PharmaTimes

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Endangered horseshoe crabs could lead the charge in pharma’s animal-free future

PharmaVoice

An effort to spare the species from blood collection is one of many ways the industry is turning away from animals for R&D.

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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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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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Pfizer’s Vydura recommended by NICE for acute migraines

PharmaTimes

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use - News - PharmaTimes

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

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Clarivate announces the inaugural Eugene Garfield Memorial Lecture

Clarivate

Dr. Henry Small will deliver the lecture to commemorate the 50th anniversary of his groundbreaking paper on co-citation in scientific literature. To commemorate the legacy of Eugene Garfield, founder of the Institute for Scientific Information (ISI) , Clarivate is proud to announce the inaugural Eugene Garfield Memorial Lecture. It will be delivered by Dr.

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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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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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Advanced therapy collaboration network launched in Scotland

European Pharmaceutical Review

The Cell and Gene Therapy Catapult (CGT Catapult) , supported by Scotland’s national economic development agency, Scottish Enterprise, has launched a new cooperative network to foster collaboration and increase knowledge sharing across the Advanced Therapy Medicinal Products (ATMP) industry in Scotland. Events, as well as talks from industry leaders and networking opportunities, will be coordinated by a new ‘Scottish Advanced Therapy Medicinal Products (ATMP) and Vaccines Network’ to aid individ

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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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FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy

Pharmaceutical Technology

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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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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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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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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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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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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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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ARS Pharmaceuticals hit with surprise FDA rejection of Neffy, its nasal spray epinephrine alternative

Fierce Pharma

Positive FDA advisory committee votes aren’t always a blueprint for approval. | Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.

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Evaxion and Afrigen Biologics to develop mRNA vaccine for gonorrhoea

PharmaTimes

The collaboration will utilise Evaxion’s EDEN-discovered antigen targets - News - PharmaTimes

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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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Signal: Illumina leads $15m investment in Broken String Biosciences

Pharmaceutical Technology

Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.

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3 Tech Investment Lessons From Houston Methodist’s Chief Innovation Officer

MedCity News

Roberta Schwartz, Houston Methodist’s chief innovation officer, has had years of experience overseeing technology adoption at her organization. At a conference, she shared some pieces of wisdom that give us a window into her technology investment strategy. For example, she highlighted how important it is for digital health tools to have strong EHR integrations, and she encouraged hospital leaders to not be afraid of starting various technology initiatives in unrelated areas.

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Bristol Myers joins AstraZeneca, Merck in touting positive lung cancer drug use around surgery

Fierce Pharma

It’s not a proper market showdown without all the players. | It’s not a proper market showdown without all the players. In the perioperative treatment of early-stage non-small cell lung cancer with a PD-1/L1 inhibitor, Bristol Myers Squibb is touting a new trial win. The results follow positive readouts from AstraZeneca and Merck.

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Evaxion validates its infectious disease AI vaccine platform

PharmaTimes

The platform identifies antigens to fight against bacterial infectious disease - News - PharmaTimes

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time