Sat.Feb 04, 2023 - Fri.Feb 10, 2023

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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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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.

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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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Blue Shield of California Adds Virta Health to Network for Diabetes Care

MedCity News

Virta is available this month to all Blue Shield of California members enrolled in preferred provider organization plans for individual and family, fully insured, self funded and Medicare Advantage. The payer has been working with Virta since 2019 when the digital health company joined Blue Shield of California’s Wellvolution, a platform of digital lifestyle apps.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novartis, Bayer marshal relief for Turkey and Syria following devastating earthquake

Fierce Pharma

Novartis, Bayer marshal relief for Turkey and Syria following devastating earthquake fkansteiner Wed, 02/08/2023 - 09:56

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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

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Why One VC Thinks Women’s Health Is Poised to Take Off Soon

MedCity News

Francesca de Quesada Covey, chief investment officer at investment firm TheVentureCity, believes the women’s health sector will come into its own in the next few years. She said startups focused on improving care delivery will probably have the easiest time raising funds of all the companies in the femtech space.

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BREAKING: Bayer taps Roche vet Anderson as its next CEO, pushing out Baumann

Fierce Pharma

BREAKING: Bayer taps Roche vet Anderson as its next CEO, pushing out Baumann esagonowsky Wed, 02/08/2023 - 11:28

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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

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Disruptive Factors Shape RA Landscape

Pharmaceutical Commerce

As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.

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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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Report: 88% Of Employers Are Planning Changes to Health Vendor Partnerships

MedCity News

Employers are most interested in switching up their vendor partners for wellbeing programs, the Willis Towers Watson survey found. About 55% of respondents said they will make changes to their wellbeing vendor partners in 2023 or 2024, while 12% already did in 2022.

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Docs likely to be 'cautious' when prescribing GSK's first-in-class anemia drug Jesduvroq, survey finds

Fierce Pharma

Docs likely to be 'cautious' when prescribing GSK's first-in-class anemia drug Jesduvroq, survey finds fkansteiner Thu, 02/09/2023 - 14:18

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Risk-sharing agreements are growing at a rate of 24%

Pharmaceutical Technology

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world. This is not the first treatment to come with a high price tag.

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CCC Receives 2023 Top Workplaces USA National Award

Copyright Clearance Center

February 7, 20 23 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, has earned a 2023 Top Workplaces USA national award from Energage , a purpose-driven organization that develops solutions to build and brand Top Workplaces. This employer recognition program recognizes companies with 150 or more employees across the country that have built great workplace cultures.

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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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Evernorth: Suicide-related Behavior Is on the Rise for American Youth

MedCity News

Suicide-related diagnoses in children and adolescents increased 14% since before the pandemic, a new Evernorth analysis shows. Female and Asian/Pacific Islander youth are especially struggling.

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Biden takes aim at pharma in SOTU speech, vowing to defend IRA from repeal efforts

Fierce Pharma

Biden takes aim at pharma in SOTU speech, vowing to defend IRA from repeal efforts kdunleavy Wed, 02/08/2023 - 10:38

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Feinstein Institutes researchers discover new protein for sepsis treatment

Pharmaceutical Technology

Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis. Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy.

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Globus Medical and NuVasive to Combine in All-Stock Transaction to Create Innovative Global Musculoskeletal Company Focused on Patient Care

Legacy MEDSearch

Globus Medical (NYSE: GMED), a leading musculoskeletal solutions company, and NUVASIVE (NASDAQ: NUVA), the leader in spine technology innovation, today announced they have entered into a definitive agreement to combine in an all-stock transaction. The transaction brings together two well-regarded technology companies in the musculoskeletal industry, which have a shared vision focused on innovation in a relentless pursuit of unmet clinical needs to improve patient care.

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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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Behavior Hacking, Prevention, and Wellness: Why the Future of Healthcare Still Depends on People

MedCity News

No matter how much data the AI has on you, missing is the personal relationship. Emerging tech, wearables—all that is great. But at the end of the day, so much of it still depends on interpersonal relationship building and leveraging, adding an intelligence layer to the loop.

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Eli Lilly's employment decisions under fire once again as sales rep lodges age discrimination claim

Fierce Pharma

Eli Lilly's employment decisions under fire once again as sales rep lodges age discrimination claim zbecker Thu, 02/09/2023 - 14:45

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AbbVie reports rise in full-year 2022 net revenues

Pharmaceutical Technology

AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on an operational basis. The company reported an increase of 1.6% on a reported basis in global net revenues to $15.121bn for the fourth quarter (Q4) of 2022. For the full-year, worldwide net revenues from the Immunology portfolio stood at $28.924bn, increasing 14.4% on a reported basis.

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62 High-Impact Sales Enablement Tools for 2023 (By Category)

Spotio

On average, 50% of a sales rep ’s time daily is wasted on the wrong prospects. Even if you only have five full-time reps, that’s 100 paid hours every week that produce zero ROI. This stat might be less surprising when you learn that companies spend 5x more on hiring a sales rep than they do training them. Poor sales training is a problem that persists in any industry.

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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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3 Ways Digital Health Can Curb Opioid Use

MedCity News

The power of digital health in helping people manage pain is clear, yet it remains untapped potential. All the players, from digital health vendors to payers and providers, need to work together to make it a scalable reality.

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Galapagos' Jyseleca flops phase 3 Crohn's study, dealing another blow to troubled JAK inhibitor

Fierce Pharma

Galapagos' Jyseleca flops phase 3 Crohn's study, dealing another blow to troubled JAK inhibitor zbecker Thu, 02/09/2023 - 09:56

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Taking Steps to Right the Wrongs: The Impact of Racial Bias in Healthcare and Medicine

PharmExec

Health disparities brought on by racial bias remain quite prevalent in areas such as drug access, use of diagnostics, and representation in clinical trials, but society-jarring events in recent years have sparked renewed efforts by industry to tackle these issues with tangible and hopeful gains.

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CoolHealth Enters U.S. Market With TargetCool™, A Breakthrough FDA-Class II Medical Device Offering Unprecedented Precise, Rapid Cooling For Pain Management And Bruise Minimization

Legacy MEDSearch

Recens, Inc. dba CoolHealth (“CoolHealth”), a venture-backed medical device company developing innovative cooling technologies, is entering the U.S. market with a breakthrough FDA-Class II medical device, TargetCool. Leveraging groundbreaking, tuneable cooling technology, TargetCool rapidly cools the skin allowing providers to specifically set a “target” skin temperature down to the exact degree and second– a first in medical cooling.

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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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Weight Loss in a Pill Device Firm Allurion Heads to NYSE via SPAC Merger

MedCity News

Allurion Technologies has developed a gastric balloon that does not require surgery. The merger deal taking Allurion public comes as the company continues global commercialization of its technology.

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Eisai starts clock ticking on approval filing for subcutaneous sibling to Alzheimer's drug Leqembi

Fierce Pharma

Eisai starts clock ticking on approval filing for subcutaneous sibling to Alzheimer's drug Leqembi ntaylor Tue, 02/07/2023 - 08:59

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Launch Readiness 2023: Key trends impacting pharma product launches

Tribeca Knowledge

I n our latest report, Launch Readiness 2023, we look at the prospects and challenges for new medicines entering the market in the shadow of COVID-19. We consider the state of the launch pipeline, where opportunities are ripe for launch excellence, and how companies can best negotiate the many market-access challenges further complicated by COVID-19 and its legacy effects on healthcare systems.

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Candela Introduces the New FDA-Cleared Profound Matrix™ System

Legacy MEDSearch

Candela, the leading provider of energy-based solutions worldwide, and the pioneer of the first and only long-pulse radiofrequency (RF) microneedling device, announces the launch of the all-new Profound Matrix system. Designed to correct, maintain, and restore skin at various stages of the aging journey, this multi-application system features the Sublime , Sublative RF, and all-new Matrix Pro applicators.

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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.