Fri.Nov 01, 2024

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Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Fierce Pharma

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

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ReferralMD Named to AVIA Marketplaceā€™s 2024 Top Conversational AI Companies

Referral MD

MT. PLEASANT, S.C. , Nov. 1, 2024 /PRNewswire-PRWeb/ — ReferralMD, a leader in healthcare technology solutions, announced today that it was recognized as a 2024 Top Company in Conversational AI upon the conclusion of extensive research and company outreach by AVIA Marketplace, the leading digital health marketplace. ReferralMD offers a comprehensive platform that seamlessly integrates with Electronic Health Records (EHR), Practice Management, and Scheduling systems, automating time-consu

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'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

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Verastem Oncology submits NDA for ovarian cancer treatment

Pharmaceutical Technology

Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).

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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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In FDA adcomm, Lexicon gets another thumbs down for type 1 diabetes hopeful Zynquista

Fierce Pharma

Despite its unique ability to block sodium-glucose linked transporter 2 (SGLT2) in the kidneys and SGLT1 in the intestines, Lexiconā€™s Zynquista (sotagliflozin) has had difficulty negotiating r | Despite its unique ability to block sodium-glucose linked transporter 2 (SGLT2) in the kidneys and SGLT1 in the intestines, Lexiconā€™s Zynquista (sotagliflozin) has had difficulty negotiating regulatory hurdles.

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Heard at HLTH 2024 Part 2: Insights from Innovative Healthcare ExecutivesĀ 

MedCity News

Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare. The post Heard at HLTH 2024 Part 2: Insights from Innovative Healthcare Executives appeared first on MedCity News.

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A sickle cell cure exists. But patients need more than just gene therapy.

PharmaVoice

Almost a year after two historic approvals, Pfizer is pulling a sickle cell disease treatment from the market, and the outlook for patients feels shakier. But there’s still hope in the pipeline.

Patients 101
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After prior settlements, Apotex and Heritage hand over a combined $49M to resolve longstanding price-fixing claims

Fierce Pharma

After prior settlements, Apotex and Heritage hand over a combined $49M to resolve longstanding price-fixing claims fkansteiner Fri, 11/01/2024 - 10:19

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The Sewing Machine Changed American Industry Forever ā€” Ambient Listening Tools Could Have a Similar Effect in Healthcare

MedCity News

The ability to reduce physician burnout is one of the most exciting things about AI, said CHAI CEO Brian Anderson. In his view, ambient listening AI could end up changing the healthcare delivery world in a similar way that the advent of the sewing machine changed the textile and fashion industry in the 1840s. The post The Sewing Machine Changed American Industry Forever ā€” Ambient Listening Tools Could Have a Similar Effect in Healthcare appeared first on MedCity News.

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Lexicon's type 1 diabetes drug voted down by FDA adcomm

pharmaphorum

FDA advisors vote against Lexicon Pharma's type 1 diabetes and chronic kidney disease therapy sotagliflozin ahead of December verdict

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Innovations Shaping the Future of Kidney Care

MedCity News

To improve outcomes further, healthcare providers will need to take bold action to diagnose and manage this kidney disease before it becomes chronic or fatal. The post Innovations Shaping the Future of Kidney Care appeared first on MedCity News.

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NICE trumpets new standard for health AI evaluations

pharmaphorum

With artificial intelligence technologies for healthcare on the rise, UK health technology assessment (HTA) agency NICE has published an economic evaluation standard that it says will help inform coverage and reimbursement decisions.

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GoodRx Expands Womenā€™s Health Options with New Birth Control and Menopause Offerings

MedCity News

GoodRx announced a new e-commerce solution starting with over-the-counter birth control pill Opill. It also is offering new affordability programs for menopause medications with Pfizer. The post GoodRx Expands Women’s Health Options with New Birth Control and Menopause Offerings appeared first on MedCity News.

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Report: Medicare Part D Premiums Rise an Average of 11% Nationwide

Pharmaceutical Commerce

Analysis finds that while basic Part D coverage costs have decreased by 4%, mid- and high-tier plans have seen hikes of 4% and 21%, respectively.

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

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Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings

MedCity News

Novo Nordiskā€™s Wegovy achieved statistically significant improvement in a Phase 3 study in the fatty liver disease MASH. Based on these preliminary results, the company plans to seek U.S. and European Union approvals in this indication in 2025. The post Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings appeared first on MedCity News.

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The Top 100 Women-Led Businesses in Massachusetts in 2024

Copyright Clearance Center

The Womenā€™s Edge and Globe Magazine celebrate the stateā€™s leading companies and nonprofit organizations led by women.

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Create a Winning Playbook for Employee Caregivers

MedCity News

Tomorrowā€™s goal scoring companies will go on offense today by giving an assist to their caregiving team members. The post Create a Winning Playbook for Employee Caregivers appeared first on MedCity News.

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US court upholds Avadelā€™s narcolepsy drug approval amid exclusivity battleĀ 

Pharmaceutical Technology

The US District Court upholds the FDAā€™s approval of Avadelā€™s Lumryz, dismissing Jazzā€™s challenge over market exclusivity for its own drug.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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Heard at HLTH 2024: Insights from Innovative Healthcare Executives

MedCity News

Executives from Imagine360, Verily, BrightInsight, Lantern, and Rhapsody shared their approaches to reducing healthcare costs and facilitating digital transformation. The post Heard at HLTH 2024: Insights from Innovative Healthcare Executives appeared first on MedCity News.

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Eisai, Biogen eye 2025 approval for Leqembi autoinjector

pharmaphorum

Eisai and Biogen complete their rolling application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi

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Hapman to Showcase New Conveyor at Pack Expo 2024

PharmaTech

The system is Hapmanā€™s first major product launch since 2008, following a year of intensive R&D that builds upon the companyā€™s eight decades of tubular drag conveyor expertise.

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Top Challenges for Pharma Marketing in 2025

Pharma Marketing Network

The world of pharma marketing is changing rapidly, and 2025 will be no exception. For pharma marketing executives, adapting to these shifts isnā€™t just about keeping upā€”itā€™s about staying ahead. From digital transformation and personalized marketing to compliance and competition, the upcoming years will demand flexibility and innovative thinking. So, what will be the top challenges in 2025, and how can pharma marketers tackle them?

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sustainability continues to steer pharmaceutical packaging market

European Pharmaceutical Review

The worldwide pharmaceutical container packaging market is expected to rise in revenue from $104.12 billion in 2025 to approximately $174.45 billion by 2033, according to a study published by Towards Packaging. The research expects that the market will expand at a CAGR of 6.49 percent between 2024 and 2033. Sustainability Key factors contributing to growth of the market include sustainability trends ā€œlike waste reduction and resource conservationā€.

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Staying on Top of Pharmaceutical Marketing News

Pharma Marketing Network

Pharmaceutical marketing moves fast. In an industry where new technologies, regulations, and consumer expectations are constantly shifting, staying informed is critical for marketing success. For pharma marketing executives, tracking news isnā€™t just about staying updatedā€”itā€™s about staying competitive. This guide will outline effective ways to stay on top of pharmaceutical marketing news, so youā€™re always ready to make informed, timely decisions.

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Eisai Completes Rolling Biologics License Application to FDA for Subcutaneous Maintenance Dosing Option of Leqembi for Alzheimer Disease

PharmExec

The subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat mild cognitive impairment or mild dementia associated with Alzheimer disease based on data from the Clarity AD study.

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The Mental Healthcare Consumer Journey

Healthcare Success

Our Senior Marketing Strategist, Kathy Gaughran, recently shared invaluable insights at the 2024 Mental Health Marketing (MHM) conference about how to reach consumers during their healthcare journey. Since her session wasnā€™t recorded at the venue, I interviewed Kathy on our podcast so we could share her insights with our wider audience. Whether your healthcare business is mental health focused or not, I invite you to listen and discover: Key Takeaways The Consumer Journey Todayā€™s healthcare cons

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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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Wegovy Demonstrates Superiority Over Placebo in Patients with Metabolic Dysfunction-Associated Steatohepatitis

PharmExec

Results from Part I of the Phase III ESSENCE trial found that Wegovy 2.4 mg achieved a 37% improvement in liver fibrosis without worsening steatohepatitis in patients with metabolic dysfunction-associated steatohepatitis compared to 22.5% in the placebo group.

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Drug Digest: From Theory to Reality: Automating Process Development

PharmaTech

In this episode of Drug Digest, industry experts discuss the ongoing development of automating biomanufacturing processes, including its challenges and practical applications.

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The Evolution of Pharma Industry Demands

Pharmaceutical Commerce

In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Delphine Perridy, chief commercial officer, Envirotainer, describes the progression of expectations when it comes to the sector, specifically as it relates to new drug development.

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Key Benefits of RWD in Privacy and Targeting Effectiveness

PharmExec

Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discussed how the use of Real-World Data has evolved in the healthcare industry in terms of privacy and targeting effectiveness.

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Unlocking Excellence: How Catalent Is Transforming Japanā€™s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalentā€™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