Fri.Nov 01, 2024

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

MedCity News

Novo Nordisk’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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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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Argenx' Vyvgart launch in CIDP picks up as the company barrels toward 10 indications by 2030

Fierce Pharma

Just a few months into a new launch in chronic inflammatory demyelinating polyneuropathy (CIDP), agrenx’ Vyvgart is already making headway in the rare disease space, just one of the long-term growt | So far, argenx's Vyvgart has reached 300 patients with chronic inflammatory demyelinating polyneuropathy (CIDP) after securing an FDA approval in the disease in late June.

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

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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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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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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Create a Winning Playbook for Employee Caregivers

MedCity News

Tomorrow’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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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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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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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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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.

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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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ReferralMD Named to AVIA Marketplace’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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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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The Top 100 Women-Led Businesses in Massachusetts in 2024

Copyright Clearance Center

The Women’s Edge and Globe Magazine celebrate the state’s leading companies and nonprofit organizations led by women.

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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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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 wasn’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 Today’s healthcare cons

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

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US court upholds Avadel’s narcolepsy drug approval amid exclusivity battle 

Pharmaceutical Technology

The US District Court upholds the FDA’s approval of Avadel’s Lumryz, dismissing Jazz’s challenge over market exclusivity for its own drug.

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Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years

Pharmacy Times

ASHP investigators determined the severity and impact of ongoing drug shortages, with approximately 99% of respondents reporting that they experienced a shortage.

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Pharma Pulse 11/1/24: Targeting Patients Without Cookies, Personalized Diabetes Care Approaches & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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 “like waste reduction and resource conservation”.

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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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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 isn’t just about keeping up—it’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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FDA Rare Disease Innovation Moves Forward

PharmaTech

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

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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 isn’t just about staying updated—it’s about staying competitive. This guide will outline effective ways to stay on top of pharmaceutical marketing news, so you’re always ready to make informed, timely decisions.

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Hapman to Showcase New Conveyor at Pack Expo 2024

PharmaTech

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

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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NCCN visits Vietnam in continued cancer care collaboration

Pharmaceutical Technology

Through a partnership, the NCCN is adapting its Harmonized Guidelines for cancer treatment for use in Vietnam.

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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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How hybrid models and tech are shaping the future of clinical research 

Pharmaceutical Technology

Decentralized clinical trials are transforming medical research with more flexibility, improved patient engagement and faster recruitment.

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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