Sat.Nov 23, 2024 - Fri.Nov 29, 2024

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These 3 Mindset Shifts Will Help Providers Deliver Consumer-Driven Care, Investor Says

MedCity News

One of the most important things providers can do on the journey toward consumer-driven care is to check their paternalism at the door, said Nworah Ayogu, head of healthcare impact at Thrive Capital. The post These 3 Mindset Shifts Will Help Providers Deliver Consumer-Driven Care, Investor Says appeared first on MedCity News.

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ASH: Incyte's Monjuvi triumphs in follicular lymphoma phase 3, teeing up FDA filing

Fierce Pharma

Incyte’s previously disclosed phase 3 win in relapsed or refract | In the phase 3 inMIND study, Monjuvi—added to Bristol Myers Squibb's Revlimid and Roche's Rituxan—triggered a 57% reduction in the risk of disease progression, relapse or death in R/R FL patients compared with those who were treated with placebo, Revlimid and Rituxan.

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DSCSA Compliance Strategies: How Business Networks Are Transforming Pharma Logis.

Pharma IQ

Explore strategies for DSCSA compliance with insights from Aladdin Mandishah, Director of Product Marketing at SAP.

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The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

When the General Data Protection Regulation (GDPR) 1 came into effect in 2018, this appeared to accelerate the migration out of Europe for pharmaceutical clinical trials. This was not so much due to non-compliance but stemmed from regulatory ambiguity. As the EU now sets its sights on the regulation of artificial intelligence (AI) through the EU Artificial Intelligence Act (EU AI Act), 2 similar questions arise regarding the implementation and enforcement of the regulation.

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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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This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths

MedCity News

Endoscopy, the standard for detecting esophageal precancer, is quite an invasive procedure — so a lot of people who should be screened end up never being tested. Lucid Diagnostics is trying to solve this problem by selling a quick, office-based diagnostic. The post This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths appeared first on MedCity News.

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Novartis plots more than 100 layoffs in New Jersey as part of rework to Xolair, cancer combo field sales teams

Fierce Pharma

While Novartis has largely wrapped up its transformation into a leaner innovative medicines company—which included multiple rounds of staff cuts over the years—employment changes are still afoot at | Novartis is laying off a total of 139 staffers in East Hanover, New Jersey, where the company’s U.S. headquarters is located. The move will primarily affect commercial field sales associates working on the brands Xolair for asthma and allergies and the oncology combo made up of kinase inhibitors Taf

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GLP-1 receptor agonists aid broader outcomes in kidney disease, major analysis finds

European Pharmaceutical Review

Glucagon-like peptide-1 (GLP-1) receptor agonists have shown to provide meaningful benefits in chronic kidney disease (CKD) and individuals with and without diabetes. This based on the largest, most comprehensive analysis of GLP-1 antagonists on kidney and cardiovascular outcomes. While GLP-1 receptor agonists have shown benefit for type 2 diabetes, obesity and cardiovascular disease, its impact as a treatment in chronic kidney disease is not as clear, the researchers explained.

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How 3 Health Systems Are Scaling Hybrid & Home-Based Models

MedCity News

Leaders from three health systems — Providence, OSF HealthCare and UMass Memorial Health — detailed how their organizations are maximizing hybrid and home-based care models during a recent panel. The post How 3 Health Systems Are Scaling Hybrid & Home-Based Models appeared first on MedCity News.

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Bristol Myers Squibb hands pink slips to 195 workers in NJ as cost-cutting effort rolls on

Fierce Pharma

Bristol Myers Squibb has executed another round of layoffs in its ongoing cost-savings push. | Bristol Myers Squibb has executed another round of layoffs in its ongoing cost-savings push. The company has handed pink slips to 195 more employees, according to a New Jersey Worker Adjustment and Retraining Notification (WARN) update.

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Airways unbound: The biologic revolution in asthma treatment  

Pharmaceutical Technology

In recent years, the evolution of biologic therapies for severe asthma has paralleled advancements in other chronic conditions such as rheumatoid arthritis and psoriasis, where biologics have also transformed treatment paradigms.

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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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FDA probing cancer cases with Bluebird's CALD gene therapy

pharmaphorum

The FDA is scrutinising reports of haematological cancers in patients treated with bluebird bio's Skysona gene therapy for neurological disease CALD.

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Synapticure Secures $25M To Scale Virtual Care for Neurodegenerative Diseases

MedCity News

Synapticure’s Series A round was led by B Capital and included participation from CommonSpirit Health, CVS Health Ventures and RA Capital. The post Synapticure Secures $25M To Scale Virtual Care for Neurodegenerative Diseases appeared first on MedCity News.

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Merck preps filings after blockbuster-in-waiting Winrevair succeeds in severe PAH study

Fierce Pharma

Eight months after snaring an inaugural FDA green light, Merck & Co. is bolstering the case for the chief asset in its $11.5 billion Acceleron acquisition. | In the phase 3 ZENITH study, Merck’s activin signaling inhibitor Winrevair met its primary endpoint of time to first morbidity or mortality event, which included all-cause death, lung transplantation, or hospitalization for at least 24 hours linked to disease worsening in patients with PAH.

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UK Government to launch first ever men’s health strategy

Pharmaceutical Technology

The government said that men are less likely than women to seek medical help, particularly for mental health issues.

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

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Biden ramps up Medicare coverage of obesity drugs

pharmaphorum

Outgoing US President Joe Biden has proposed a dramatic expansion of Medicare coverage of obesity drugs, but will the plan see the light of day?

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The Promise and Challenge of GLP-1 Medications: Ensuring ROI in Obesity Care

MedCity News

Pricy GLP-1 medications are here to stay — let’s focus on turning their potential into lasting, meaningful impact. The post The Promise and Challenge of GLP-1 Medications: Ensuring ROI in Obesity Care appeared first on MedCity News.

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Kelun's Merck-partnered ADC snags first nod in China to kick off TROP2 fight with Gilead

Fierce Pharma

The competition among three TROP2 antibody-drug conjugates is ent | The competition among three TROP2 antibody-drug conjugates is entering a new stage as Kelun-Biotech’s Merck & Co.-partnered sacituzumab tirumotecan has become the second therapy in the class to win a marketing approval.

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Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat

Pharmaceutical Technology

The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.

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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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Halozyme abandons its €2bn pursuit of Evotec

pharmaphorum

Halozyme Therapeutics has withdrawn its offer to acquire Evotec, saying that the German company had been unwilling to engage with negotiations.

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Roche Expands Its Scope in Allogeneic Cell Therapy With $1B Poseida Therapeutics Acquisition

MedCity News

Roche is acquiring Poseida Therapeutics, a biotech developing allogeneic cell therapies for cancers and immunological indications. The two companies have been partners in hematological malignancies since 2022. The post Roche Expands Its Scope in Allogeneic Cell Therapy With $1B Poseida Therapeutics Acquisition appeared first on MedCity News.

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Look out, Pfizer: BridgeBio scores 'best-case' FDA nod for Attruby in cardiomyopathy

Fierce Pharma

On a Zoom call last month from California, BridgeBio CEO Neil Kumar needled a colleague about the remote possibility of the New York Yankees rallying to win the World Series as they trailed the Los | The FDA has signed off on BridgeBio's Attruby (acoramidis), a potential blockbuster to treat patients with the rare heart disease transthyretin amyloid cardiomyopathy.

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EMA launches ESMP for better management of drug shortages in EU

Pharmaceutical Technology

The ESMP platform enables marketing authorisation holders to report shortages and will be mandatory from 2025.

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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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Relief for AZ as Truqap hits the spot in prostate cancer

pharmaphorum

After a disappointing result with Truqap in triple-negative breast cancer, AstraZeneca chalks up a win in prostate cancer.

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Weight Loss With Amgen Drug in Line With Eli Lilly Med, But Dosing Could Be Differentiator

MedCity News

Amgen’s experimental obesity drug, MariTide, led to an average 20% reduction in weight in a Phase 2 clinical trial. While investors hoped for greater weight loss, some analysts say less burdensome monthly dosing of MariTide could make it competitive against weekly injectable weight drugs Zepbound and Wegovy. The post Weight Loss With Amgen Drug in Line With Eli Lilly Med, But Dosing Could Be Differentiator appeared first on MedCity News.

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Sanofi opens $590M modular vaccine, biologics plant in Singapore

Fierce Pharma

Two months after Sanofi completed construction in France of its innovative Modulus vaccine and biologics plant—which can be reconfigured within days during a pandemic—the drugmaker said it has

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CervoMed’s stock rises as FDA grants orphan drug status to dementia drug

Pharmaceutical Technology

There are currently no FDA- or EMA-approved treatment options available for any form of frontotemporal dementia.

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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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UK digital health funding should be ringfenced, says report

pharmaphorum

IT industry group techUK has called on the government to guarantee funding for digital transformation and cyber resilience in health and social care.

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FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

MedCity News

BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis. But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March. The post FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug appeared first on MedCity News.

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FDA oncology advisory committee to weigh Exelixis' Cabometyx in neuroendocrine tumors

Fierce Pharma

Before Exelexis’ Cabometyx can pass muster with the FDA in its hopeful neuroendocrine tumors indication next April, it will have to first face the agency’s Oncologic Drugs Advisory Committee ( | The agency's Oncologic Drugs Advisory Committee is set to discuss the treatment and its phase 3 CABINET study in March ahead of the FDA's planned decision date of April 2025.

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Gilead adds investigational HIV vaccine to its portfolio from Spanish biotech   

Pharmaceutical Technology

Gilead and Aelix first teamed up in 2018 for a clinical research collaboration agreement to investigate the vaccine.

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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