Tue.Aug 20, 2024

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New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

Safety 351
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Maternal Health Crisis: Lack of Access to Care “Doesn’t Paint the Whole Picture,” Expert Says

MedCity News

The lack of access to quality healthcare is often cited as the reason for maternal health disparities. But these issues go beyond access, according to Bayo Curry-Winchell, MD, founder of Beyond Clinical Walls and urgent care medical director at St. Mary’s Health Network. The post Maternal Health Crisis: Lack of Access to Care “Doesn’t Paint the Whole Picture,” Expert Says appeared first on MedCity News.

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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. | As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

Biopharma 335
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Eli Lilly Drug Reduces Risk of Diabetes Onset, Building Case for Broader Use of the Therapy

MedCity News

In a Phase 3 study, Eli Lilly’s tirzepatide led to a 94% reduction in the risk that obese or overweight prediabetes patients progress to type 2 diabetes. Lilly was already planning to expand use of the blockbuster metabolic disorders drug to sleep apnea and heart failure. The post Eli Lilly Drug Reduces Risk of Diabetes Onset, Building Case for Broader Use of the Therapy appeared first on MedCity News.

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

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Lilly adds to tirzepatide's impressive pedigree with new data showing the med helps stave off diabetes

Fierce Pharma

Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show. | Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show.

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Proposed Medicare Codes a Game-Changer for Digital Health

MedCity News

If enacted, the codes will represent the first major step toward broad-based reimbursement for digital therapeutics, and acknowledgement that CMS recognizes the substantial role new digital solutions can provide. The post Proposed Medicare Codes a Game-Changer for Digital Health appeared first on MedCity News.

Patients 112

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Leveraging Experienced Revenue Integrity Professionals to Enhance CDM Technology

MedCity News

Three ways healthcare organizations can benefit from leveraging qualified revenue integrity professionals to enhance CDM technology and drive additional ROI The post Leveraging Experienced Revenue Integrity Professionals to Enhance CDM Technology appeared first on MedCity News.

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Teva faces fresh Copaxone kickbacks case from Medicare providers as it defends against DOJ claims

Fierce Pharma

For years, Teva has been defending itself against allegations that it used illegal Medicare co-pay schemes to fuel sales of its multiple sclerosis drug Copaxone. | The new lawsuit, filed in a Kansas court, comes as Teva defends against similar allegations made by the U.S. government.

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Lilly says tirzepatide staves off diabetes in phase 3 trial

pharmaphorum

Eli Lilly's latest clinical readout for dual GIP/GLP-1 agonist tirzepatide is a big one, with data suggesting the drug can reduce the risk of developing type 2 diabetes in overweight and obese adults with pre-diabetes.There's plenty of evidence to show that prediabetes – a higher-than-normal blood sugar level resulting from a level of insulin resistance that isn't high enough to be considered full-blown diabetes – can be reversed if patients commit to an intensive regimen of dietary restriction

Patients 108
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Accelerating Claim Processing: Strategies to Shorten the Life of a Claim 

MedCity News

These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. The post Accelerating Claim Processing: Strategies to Shorten the Life of a Claim appeared first on MedCity News.

Leads 109
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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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Expert says supplies of mpox vaccine unlikely to suffice

pharmaphorum

Emergent BioSolutions has agreed to donate 50,000 doses of its mpox vaccine for use in the current outbreak, but an expert has warned supplies are unlikely to meet demand

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Top 20 biopharmas’ market cap up 4.3% in Q2 2024 as GLP-1 drug innovators hold top spots

Pharmaceutical Technology

The top 20 biopharmaceutical companies demonstrated resilience during the second quarter (Q2) of 2024 as global markets and investor optimism improved with anticipation of a potential interest rate cut from the US Federal Reserve.

Marketing 105
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Adcendo licenses Multitude anti-TF ADC in $1bn+ deal

pharmaphorum

Danish biotech Adcendo has accelerated its progression to a clinical-stage biotech by licensing an antibody-drug conjugate (ADC) from China's Multitude Therapeutics with potential in various forms of cancer.Copenhagen-based Adcendo is paying what is rumours to be tens of millions of dollars in upfront fees for rights to Multitude's anti-tissue factor (TF) ADC AMT-754 – now renamed ADCE-T02 – outside mainland China, Hong Kong, Macau, and Taiwan.

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Public Exits Are Getting More Feasible In The Medtech Space

MedCity News

After several quarters with little to no exit activity in the medtech space, several startups made exits in the second quarter of 2024, according to a new report. The post Public Exits Are Getting More Feasible In The Medtech Space appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Leadership Behaviors that Drive High-Performance in a Hybrid Workplace

ALULA

Hybrid work continues to impact employees’ preferences, but how does it impact their leaders? In 2021, the World Trend Index reported that 73% of employees wanted flexible remote work options. The latest insights from Gallup show the number dipping only slightly to 60% today. Remote-capable employees are getting what they want , as most are working in a hybrid or exclusively remote arrangement.

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GSK bags breakthrough status for B7-H3 ADC for lung cancer

pharmaphorum

GSK gets FDA breakthrough status for its B7-H3 directed ADC, licensed from Hansah Pharma in a $1.

FDA 128
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23andMe inches closes to cancer immunotherapy, guided by its genetic database

PharmaVoice

Dr. Jennifer Low, head of 23andMe’s therapeutics division, is taking the company into new territory with a potential cancer treatment that targets a unique pathway.

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Buoyed by muscular dystrophy data, Avidity raises $345m

pharmaphorum

Avidity Bio raises $345m from its second big public offering of 2024, after reporting encouraging Duchenne muscular dystrophy data.

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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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Emergent joins mpox fight with 50,000 vaccine dose donation to Africa

Pharmaceutical Technology

Supplies of Emergent’s smallpox vaccine ACAM2000 will accompany Bavarian Nordic’s vaccine to African countries.

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Structuring the unstructured: Deterministic AI and white box data cleanliness

pharmaphorum

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Jane Reed, director of life sciences at Linguamatics, an IQVIA company, to discuss some of the major barriers preventing researchers from accessing the data they need to advance drug discovery and development and address safety concerns – and just how AI technologies can assist.

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eXmoor pharma’s manufacturing facility receives licence from MHRA

PharmaTimes

The company’s Cell & Gene Therapy Centre can now offer a full range of GMP services

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Pharma Pulse 8/20/24: Moderna Announces Free mRNA Course, OpenAI Disrupts Iranian Misinformation Campaign & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 105
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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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Colombia’s president signs law to strengthen pharmaceutical sector

Pharmaceutical Technology

On July 2024, Colombia's President Gustavo Petro signed Law 2386 of 2024, which declared the pharmaceutical sector as strategic, at least in writing.

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How expanded data coverage drives success for healthcare providers

Clarify Health

Within healthcare, harnessing data effectively is crucial for any organization striving to deliver exceptional patient care, drive operational efficiency, and remain competitive. Safe to say, the last several years have been extraordinarily difficult for health systems – in 2023 alone, 40% of health systems were not profitable. More than ever, these circumstances underpin the necessity for organizations to leverage the best and most reliable data in order to continue delivering the best care pos

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Johnson & Johnson Set to Acquire V-Wave Ltd

PharmExec

The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.

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How expanded data coverage drives healthcare success 

Clarify Health

Within healthcare, harnessing data effectively is crucial for any organization striving to deliver exceptional patient care, drive operational efficiency, and remain competitive. Safe to say, the last several years have been extraordinarily difficult for health systems – in 2023 alone, 40% of health systems were not profitable. More than ever, these circumstances underpin the necessity for organizations to leverage the best and most reliable data in order to continue delivering the best care pos

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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FDA Approves Johnson & Johnson’s Rybrevant and Lazcluze for Advanced Non-Small Cell Lung Cancer

PharmExec

Approval marks the first multitargeted regimen to surpass Tagrisso in efficacy in the first-line treatment of advanced non-small cell lung cancer, according to Johnson & Johnson.

FDA 52
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AbelsonTaylor Group Launches AT Activate, a Full-Service Healthcare Media Agency

PM360

CHICAGO, Aug. 12, 2024 – Leading healthcare marketer AbelsonTaylor Group has launched a full-service media agency, AT Activate , to provide one-stop, data-driven media strategy, planning, buying and analytics services to ensure that healthcare media campaigns hit their targets and deliver measurable business success for clients. AT Activate will leverage the full capabilities, advanced analytics expertise, and established media network of AbelsonTaylor Group.

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IMF Chief Medical Officer Discusses Global Initiatives to Improve Myeloma Treatment

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, chief medical officer, IMF, offers a glimpse at multiple initiatives that the IMF is working towards to improve myeloma treatment globally.

Medical 52
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Genentech Enters an Approximately $2 Billion Deal to License Sangamo Therapeutics Technologies for Developing Neurodegenerative Disease Therapeutics

PharmaTech

Genentech will have access to Sangamo’s capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines for certain neurodegenerative diseases.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.