February, 2023

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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

Pharma 363
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The Preprint Citation Index: linking preprints to the trusted Web of Science ecosystem

Clarivate

After many months of planning, we are launching the Preprint Citation Index , a multidisciplinary collection of preprints from leading repositories that helps researchers stay current with the newest research while maintaining confidence in the resources they rely on. With the launch of the Preprint Citation Index , we are making it even easier for researchers to include preprints in their existing research workflows.

Leads 145
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Virtual reality training in pharma: just a headset away?

European Pharmaceutical Review

The COVID-19 pandemic led to an unparalleled paradigm shift in the use of and the incorporation of new technologies into our workflows. This was particularly apparent in academia and the pharmaceutical industry, where we have seen words such as Teams and Zoom becoming part of our new lexicon of language for meetings. Now we reach for these types of online meetings without a second thought, due to the clear productivity benefits they provide over real in-person meetings. 1 However, notwithstandin

Training 144
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GoodRx Illegally Sold Users’ Data to Google & Facebook, FTC Says

MedCity News

GoodRx failed to notify users that it sold their personal health information to Google, Facebook and other tech companies, the FTC claimed. The agency filed an order that prohibits GoodRx from sharing its users’ data with third parties for advertising purposes and requires the company to pay a $1.5 million penalty. GoodRx agreed to pay the settlement but did not admit to wrongdoing.

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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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Tiny Patch for Cardiac Ultrasound Imaging

Medgadget

Engineers at the University of California San Diego have developed a wearable ultrasound system for cardiac imaging. The postage stamp-sized patch can be worn on the skin of the chest and uses AI and ultrasound waves to perform advanced imaging of the heart. The technology can even be worn to perform cardiac ultrasound imaging during exercise. Each patch can be worn for up to 24 hours, and provides information on how much blood the heart is pumping, a key metric in detecting and appraising a var

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

Medicine 117

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ChatGPT AI-Generated Content Dangerous for Healthcare?

Healthcare Success

ChatGPT is an artificial intelligence chatbot that can have human-like conversations, translate, and provide users with information. It can also write good content. Like, really good. And now that Google has openly stated, “Appropriate use of AI or automation is not against our guidelines,” it begs the question: Should we use it to produce healthcare content?

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabin

Medicine 132
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Healthcare is Moving to the Home. Are Health Plans Ready?

MedCity News

The future of healthcare means more home-based care. By taking steps now to embrace this shift, health plans will set the pace for supporting patients in the place where they most want to receive care.

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3D Bioengineered Skin Grafts Fit Complex Anatomy

Medgadget

Researchers at Columbia University’s Irving Medical Center have developed a method to create three-dimensional bioengineered skin grafts. To date, bioengineered skin is typically created in flat sheets. However, these are difficult to fit to complex anatomy, such as the hand, and so these researchers have designed a more sophisticated technique that combines laser scanning, 3D printing, and cell culture to create seamless three dimensional skin grafts.

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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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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

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GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg

Fierce Pharma

GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02

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What the latest DEA Proposed Rule Means for Telemedicine Prescribing of Controlled Substances

Nixon Gwilt Law

Late Friday (February 24, 2023), the US Drug Enforcement Agency (DEA) released a proposed rule to make permanent some of the flexibilities allowed during the Public Health Emergency (PHE) for telemedicine companies whose providers prescribe controlled substances. Keep reading this timely post to find out: What these proposed changes are; How they will impact your telemedicine business; and Where (and how) stakeholders can weigh in on the DEA’s proposal in the 30-day comment period.

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First successful CAR-T treatment for muscle inflammation

European Pharmaceutical Review

University Hospital Erlangen in Germany is the first in the world to use chimeric antigen receptor (CAR) T-cells to successfully treat a patient suffering from a severe case of muscle inflammation (myositis). The researchers noted that risk of developing a very severe form of the autoimmune inflammatory disease is high. The patient who received the CAR T treatment was diagnosed with anti-synthetase syndrome.

Medicine 128
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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All Generations Find Telehealth Beneficial, New CVS Health Data Shows

MedCity News

A new CVS Health survey found that 76% of adults agree that telehealth is more convenient than other healthcare options. Additionally, 75% agree that it is more flexible, 75% believe that it is easier to schedule appointments and 77% said that it is quicker to provide care. The percentages varied slightly by generation, although a vast majority of each age group still said they agreed with these characteristics for telehealth.

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Ingestible Sensor Reveals Gastric Motility

Medgadget

Researchers at MIT have developed an ingestible sensor that can reveal gastrointestinal motility issues, such as gastroparesis and gastroesophageal reflux disease. The technology is intended for use as an easy at-home method to diagnose such issues, which typically require more invasive and inconvenient procedures, such as endoscopy or X-ray imaging.

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Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.

Safety 111
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Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit

Fierce Pharma

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

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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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Brian Fox is bringing ‘fresh eyes’ to ad agency Klick

PharmaVoice

Why the recently appointed president of commercial solutions sees near limitless potential to expand Klick’s footprint across the life sciences — and how generative AI is playing a role.

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Shining a light on Raman for microbiological analysis

European Pharmaceutical Review

Advances with microbiological methods are providing more accurate and sensitive datasets at a faster rate, relating to bacterial identity, numbers, responses to environments and so on. Recent years have seen progress with applying a long-established spectrophotometric phenomenon – Raman spectra – to advance our understanding of bacterial populations, including differentiating between living and dead cells and interpreting phenotypic variations to different environmental stressors.

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Healthcare and Gen X: 4 Things Marketers Need to Get Right

MedCity News

Gen X is at the height of its spending potential. Its U.S. population of 65 million has saved a collective $13 trillion and owns 29% of the nation’s household wealth (versus just 6.4% owned by millennials).

Marketing 142
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Wearable Device Senses When Vocal Fatigue Sets in

Medgadget

Researchers at Northwestern University have developed a wearable that can detect when someone is talking or singing, and tallies this information up to provide a warning when the wearer might be at risk of vocal fatigue. Overusing your voice in a short space of time can lead to vocal fatigue and even injury. This technology is useful for patients with vocal disorders, but also for people who rely on their voices a lot, such as singers, politicians, and teachers.

Leads 108
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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 epilepsy researchers are moving the needle past anti-seizure treatments

Pharmaceutical Technology

While several therapeutics are available for treating symptoms associated with epilepsy, researchers and patients have strongly called out the need for more holistic treatments that would address the condition as a whole. Although recently approved drugs can treat seizures more safely, they do not treat the comorbidities that patients experience. Several biotech companies and researchers are now exploring medical devices and gene therapies to address not just common forms of epilepsy, but also r

Patients 105
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FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

FDA 346
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12 Ways To Boost Sales Efficiency In 2023

Spotio

Every sales manager wants a full pipeline. But generating more sales is only part of the equation. While sales effectiveness does well to improve conversions, there’s another component that should be a priority: sales efficiency. Sales efficiency is the key to not only generating more sales for your business but also streamlining your sales processes so that you get more sales, faster.

Sales 103
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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. Changes have been spurred by the COVID-19 pandemic, which emphasised the need to urgently modernise outdated EU pharmaceutical law and revise regulatory ambitions in the MedTech sector.

Medical 117
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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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HHS Aims To Reduce Prescription Drug Costs Through 3 New Models

MedCity News

The U.S. Department of Health & Human Services announced three models Tuesday that will be tested by the CMS Innovation Center and aim to lower prescription drug costs. The models, which include access to $2 generic drugs, build on the Inflation Reduction Act of 2022.

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Automated Feeding Platform to Study Mosquito Disease Transmission

Medgadget

A team at Rice University has developed an automated feeding platform for mosquitoes that allows researchers to test different types of repellent and investigate mosquito-borne disease transmission. Traditionally, such mosquito research would require human volunteers or animal subjects for the mosquitos to feed on, but this is obviously inconvenient and a little distasteful.

Medicine 107
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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

FDA 105
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Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics

Fierce Pharma

Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics fkansteiner Tue, 02/07/2023 - 10:08

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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