Wed.Aug 07, 2024

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Novartis' IgAN ambition takes shape with expanded FDA nod for Fabhalta

Fierce Pharma

The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line. | The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line.

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Cigna Distributes Grants to 22 Nonprofits Focused on Youth Mental Health

MedCity News

Cigna is distributing about $3 million to 22 nonprofits addressing youth mental health. Over the next three years, the company is allocating $9 million total. The post Cigna Distributes Grants to 22 Nonprofits Focused on Youth Mental Health appeared first on MedCity News.

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Novo Nordisk pulls its FDA heart failure submission for Wegovy, will reapply early next year

Fierce Pharma

Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold. | Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold. In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025.

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WebMD’s New Tech Targets Referral Leakage as Providers Continue to Battle Rising Costs

MedCity News

WebMD Ignite recently released new products aimed at helping providers close financial gaps by targeting a specific problem: revenue leakage. The post WebMD’s New Tech Targets Referral Leakage as Providers Continue to Battle Rising Costs appeared first on MedCity News.

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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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Amgen's marketing efforts help boost Tepezza sales

Fierce Pharma

Amgen’s roller coaster ride known as Tepezza is ascending again. Is the thyroid eye disease (TED) treatment finally gaining momentum that is sustainable? | Amgen’s roller coaster ride known as Tepezza is ascending again. Is the thyroid eye disease (TED) treatment finally gaining momentum that is sustainable? In the second quarter, Tepezza generated $479 million in sales for an increase of 8% year over year and 13% sequentially.

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The Critical Imperative for Health Plans to Tackle Late Payment Interest

MedCity News

Health plans can reduce late payment interest by up to 25% year over year by focusing on three critical areas. The post The Critical Imperative for Health Plans to Tackle Late Payment Interest appeared first on MedCity News.

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Path Forward for Cancer Biotech G1 Therapeutics Is $405M Acquisition by Pharmacosmos

MedCity News

G1 Therapeutics turned research from the University of North Carolina at Chapel Hill into novel cancer drug Cosela, which is approved in the U.S. and China. Pharmacosmos says its G1 acquisition will enable Cosela to reach more lung cancer patients around the world. The post Path Forward for Cancer Biotech G1 Therapeutics Is $405M Acquisition by Pharmacosmos appeared first on MedCity News.

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England's NICE clears Vertex, CRISPR's Casgevy in beta thalassemia after passing on sickle cell use

Fierce Pharma

On the rocky road to ensuring access to gene therapy Casgevy in the U.K., Vertex and CRISPR Therapeutics are making inroads by securing a thumbs up from England’s National Institute for Health and | The cost-effectiveness regulator recommended government funding for the groundbreaking gene-editing therapy in one of its two approved indications.

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BioMarin keeps but scales down Roctavian gene therapy ops

pharmaphorum

BioMarin Pharma has decided not to divest its haemophilia A gene therapy Roctavian but is reining back its ambitions for the business, for now

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After 2023 snub, Amneal clinches approval for extended-release Parkinson's disease med Crexont

Fierce Pharma

As multiple drugmakers race to bring novel, levodopa-based Parkinson’s disease treatments to the market, New Jersey’s Amneal has taken home the gold in the U.S. | Late Wednesday, the FDA granted approval to Amneal’s Crexont—formerly known as IPX203—which is an oral, extended-release formulation of the common Parkinson’s disease (PD) drugs carbidopa/levodopa (CD/LD).

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

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Pandemic Lesson: How to Move Healthcare From the Emergency Room to the Living Room

MedCity News

As many as 25 percent of all ER visits by older adults come from people with dementia. A better alternative is urgent medical response at home – working with seniors in their own familiar place without the pressures, distractions, or costs of a bustling ER. Or the endless wait times. The post Pandemic Lesson: How to Move Healthcare From the Emergency Room to the Living Room appeared first on MedCity News.

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Madrigal's Rezdiffra off to strong start, but 'bumpiness' is coming: analyst

Fierce Pharma

In its first full quarter on the market, Madrigal Pharmaceuticals’ Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), achieved sales of $14.6 million. | In its first full quarter on the market, Madrigal Pharmaceuticals’ Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), achieved sales of $14.6 million.

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Wegovy slowdown rattles Novo Nordisk investors

pharmaphorum

Weaker sales of obesity drug Wegovy cause a dip in Novo Nordisk's share price, but CEO says volume growth is strong and will accelerate in second half

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With Wegovy supplies back on tap, Novo Nordisk's obesity med doubles US prescriptions from start of year

Fierce Pharma

With supplies of its star obesity med Wegovy now largely unfettered, Novo Nordisk is dialing up its sales expectations for the remainder of the year—and teasing the potential for net price declines | With supplies of its star obesity med Wegovy now largely unfettered, Novo Nordisk is dialing up its sales expectations for the remainder of the year—and teasing the potential for net price declines on the immensely popular GLP-1.

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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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Levicept says non-opioid drug cuts arthritis pain in phase 2

pharmaphorum

A non-opioid drug for pain developed by UK biotech Levicept, with a new mechanism of action, has shown it can reduce pain associated with osteoarthritis in a phase 2 trial.Neurotrophin-3 (NT-3) inhibitor LEVI-04 hit all its primary and secondary objectives in the trial, which enrolled 510 patients with moderate-to-severe osteoarthritis of the knee, raising the hope it could become a non-addictive option for patients needing chronic pain relief.

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After sharp declines, Merck KGaA and analysts share optimism about potential CDMO rebound

Fierce Pharma

Despite a rocky start to the year for Merck KGaA’s contract development and manufacturing group, the German company is finding some reason to be optimistic about its recent performance. | After a rocky start to the year, Merck KGaA’s CDMO and process solutions units appear to be nearing a comeback.

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The Value in Committing to Conscientious Corporate Stewardship

Pharmaceutical Commerce

Why it is important for organizations to set long-term goals when planning for a sustainable future?

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NICE backs osteoporosis drug, but diagnosis is an obstacle

pharmaphorum

Around 14,000 women in England may soon be able to access osteoporosis drug Eladynos from Theramex after NICE backed NHS use

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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What Is the DSCSA?

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Michael Rowe, Two Labs’ Sr. Director, DSCSA/Serialization Compliance Services, Two Labs, offers a brief overview of the Drug Supply Chain Security Act.

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There’s No Such Thing as Too Much Data

PM360

In June 2024, the FDA extended a Cooperative Research and Development Agreement (CRADA) to assess data quality in multicenter clinical trials using statistical modeling and ML. François Torche, Chief Product & Technology Officer & Co-Founder at CluePoints dispels the myth that, at least in RBQM, there is such a thing as too much data, and discusses how advanced data analytics platforms are the key to ensuring every data point has a chance to share its story.

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Pharma Pulse 8/7/24: Struggling AI Startups Look for a Bailout from Big Tech, Strategic Market Access Ensures the Right Treatments at the Right Time & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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AI UPDATE: Generative AI to Have Massive Impact on Search

PM360

Pharma Brands Can Take Steps Now to Prepare Intelligence is changing how we access information and the industry behind it. Since Google’s launch, when people needed to ask a question or find information they jumped to a search engine. While we have come a long way from the original 10 blue links, the search industry has not seen such a watershed moment in its lifespan until now.

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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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Servier bags FDA okay for glioma drug from $2bn Agios buy

pharmaphorum

FDA approves Servier's IDH 1/2 inhibitor vorasidenib as the first targeted therapy for incurable brain cancer glioma

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MRC and MND Association award £3.9m to KCL and UCL for ALS/FTD research

PharmaTimes

Researchers aim to explore and investigate axonal dysfunction in neurodegeneration

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Data Visualization: A Useful Tool

PM360

How to fully exploit data visualization in clinical trials to ensure all valuable insights are unlocked. Data visualization is a hot topic in clinical trials with its potential to increase efficiency, protect participant safety, and guide informed decision-making to deliver the best chances for trial success. However, data visualization is evolving rapidly and is about far more than just moving from lists and spreadsheets to graphs and charts.

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Navigating Innovation and Regulation in Cell and Gene Therapy

PharmaTech

Join this insightful dialogue where we’ll explore advancements in the evolving world of cell and gene therapy analysis with Daniel Galbraith, Chief Scientific Officer of Solvias. Daniel shares insights from the forefront of drug development, including the complexities of development and commercialization, the financial dynamics of new therapies and changing regulatory landscapes.

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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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Pharma’s Big Challenge: Privacy

PM360

Tackling the Tough Questions and Hidden Opportunities for Healthcare Advertisers As the landscape of consumer privacy legislation rapidly evolves, healthcare marketing teams are reassessing their advertising strategies. New laws aimed at safeguarding personal information are transforming how companies interact with consumers and HCPs. For insights into the implications of these legislative changes, we turned to Karin Hayes, SVP Analytics and Insights, OptimizeRx.

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Patient engagement throughout the product life cycle

pharmaphorum

One of the things that makes patient engagement for pharma companies so challenging is that it's not something that can be added to one step of a process and then checked off the list. Real patient engagement needs to be integrated into processes every step of the way. In today's podcast, brought to you by Reverba, Reverba CEO Cheryl Lubbert joins host Jonah Comstock to walk through the steps of the product lifestyle and explore the role of the patient at each of those stages: from preclinical t

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The Power of Prediction To Drive Success

PM360

How predictive models of data and analytics are changing the industry We live in an age where predictive data and analytics—the use of data to forecast future outcomes—permeate nearly every industry and are changing most of our lives. From getting ahead of serious illness, such as a predictive analytics tool1 that can successfully identify which stage 0 breast cancers are likely to spread and recur with greater than 90% accuracy, to the sports world, such as my hometown Boston Red Sox who can de

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Baptist Memorial Achieves Significant Efficiency Gains with ReferralMD

Referral MD

Mt. Pleasant, South Carolina, August 8, 2024 /PRNewswire-PRWeb ReferralMD, a leader in healthcare technology solutions, is excited to announce that Baptist Memorial Health Care, one of the nation’s largest not-for-profit health care systems and the largest Medicaid provider in the region, has significantly improved their referral management process with ReferralMD.

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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.