Sat.Oct 19, 2024 - Fri.Oct 25, 2024

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Embedding into the provider’s workflow is key to a specialty drug’s success

PharmaVoice

Providers struggle with time-consuming processes. Patients are waiting for therapy. Embedded EMR system solutions can streamline therapy initiation and improve outcomes.

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Starboard wants to hold Pfizer leadership 'accountable' for overpaid M&A deals, poor return on R&D investment

Fierce Pharma

Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job. | Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job in a new presentation.

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The Convergence of Digital Health and Life Sciences

MedCity News

Despite the challenges of interoperability, regulatory compliance, technology adoption, and data privacy, the benefits of digital health are undeniable. Collaboration between policymakers, clinicians, IT developers, and patients, can help overcome these obstacles. The post The Convergence of Digital Health and Life Sciences appeared first on MedCity News.

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Novo joins Lilly in asking FDA for ban on GLP-1 compounding

pharmaphorum

Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.

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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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Prior Authorization: Why It’s Essential in Healthcare

Referral MD

Prior authorization is a crucial healthcare topic related to the relationship between a patient, their healthcare provider, and the insurance company. This blog will outline everything you need to know about prior authorization , its definition, and its importance to healthcare. What is prior authorization? A patient’s physician or healthcare provider can decide what treatment the patient needs.

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In boon for Pfizer and Merck, CDC panel backs expanded use of pneumococcal vaccines

Fierce Pharma

With an expanded recommendation from the Center for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP), pneumococcal conjugate vaccines (PCV) from Pfizer and | The CDC's immunization committee voted to expand the recommendation for pneumococcal conjugate vaccines, including both Pfizer’s Prevnar 20 and Merck’s newer Capvaxive.

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Otsuka eyes early filing of IgAN drug after phase 3 readout

pharmaphorum

Otsuka is hoping to file for approval of its anti-APRIL antibody sibeprenlimab as a treatment for kidney disorder IgA nephropathy (IgAN) after the drug hit the target in a phase 3 trial.The Japanese drugmaker said that interim results from the 530-patient VISIONARY study showed that sibeprenlimab achieved a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatine ratio (uPCR) – a measure of how well the kidneys are working – after nine months of treatmen

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Trial highlights potential next-gen biologic for lung cancer

European Pharmaceutical Review

New clinical data has shown a potential best-in-class next-generation antibody-drug conjugate (ADC) can offer promising response rates in extensive-stage small cell lung cancer. The biologic ZL-1310 is being investigated in an ongoing Phase Ia/Ib study in these patients who have had at least one platinum-based chemotherapy regimen. Overall response rate was 74 percent in individuals with at least one post-treatment evaluation.

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DOJ challenges Johnson & Johnson's talc bankruptcy attempt in Texas

Fierce Pharma

With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had

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4 Things That Worry FDA Commissioner Robert Califf

MedCity News

This week at HLTH, FDA Commissioner Robert Califf discussed the current state of healthcare AI. He talked about some of the qualms he has, such as his worry that AI is worsening health inequities and his concern that providers aren’t capable of validating AI tools’ effectiveness. The post 4 Things That Worry FDA Commissioner Robert Califf appeared first on MedCity News.

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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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Gilead, MSD say HIV combo could be weekly, oral HIV drug

pharmaphorum

An antiretroviral combination developed by Gilead and MSD suppressed HIV with a single weekly oral dose in a phase 2 trial reported at IDWeek 2024

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CHMP Gives Positive Opinion to Novo Nordisk Hemophilia Treatment

PharmaTech

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.

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Novo plots US, EU approval filings after oral semaglutide shows cardio benefits in certain diabetes patients

Fierce Pharma

As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too. | As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too.

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CGMs Aren’t Just for People with Diabetes Anymore, Dexcom COO Says

MedCity News

This week at HLTH, Dexcom COO Jake Leach discussed Stelo, his company’s new product. Stelo is an over-the-counter continuous glucose monitor meant for all adults who don’t take insulin. The post CGMs Aren’t Just for People with Diabetes Anymore, Dexcom COO Says appeared first on MedCity News.

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

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Lundbeck planning for four novel drugs in phase 3 in 2026

pharmaphorum

Denmark's Lundbeck has said that efforts to build its R&D portfolio are on track to deliver four new molecular entities (NMEs) in phase 3 trials in 2026, including an epilepsy drug from its recently announced $2.6 billion takeover of Longboard Pharma.

Pharma 101
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Sales Territory Design: Simple 10-Step Process for Field Sales Teams

Spotio

Designing sales territories has never been more important for door to door and field sales teams. Unfortunately, designing sales territories is a process that the majority of sales managers rush through. Aligning territory design with business priorities is crucial, as poor planning is a major issue impacting sales reps’ ability to meet quotas.

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Pfizer lays off 75 more workers in North Carolina in wake of late-stage DMD trial fail

Fierce Pharma

Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. | Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. The layoffs come three months after the company axed 150 positions in Sanford following a high-profile phase 3 trial failure for its Duchenne muscular dystrophy gene therapy candidate.

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Targeting the Blast Radius: Why Spatial AI Diagnostics Are Crucial for Maximizing the Impact of Antibody-Drug Conjugates

MedCity News

As the field of oncology evolves, we need to shift away from traditional binary “yes-no” biomarkers to a more nuanced, spatial understanding of tumor biology. This approach will allow for more personalized treatment plans that are tailored to the unique characteristics of each patient’s tumor. The post Targeting the Blast Radius: Why Spatial AI Diagnostics Are Crucial for Maximizing the Impact of Antibody-Drug Conjugates appeared first on MedCity News.

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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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France warns of penalties if Opella production goes offshore

pharmaphorum

Sanofi is now in exclusive talks with private equity company Clayton Dubilier & Rice over the sale of a controlling stake in its consumer health business Opella, as the French government seeks guarantees it will keep production and jobs in France.

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Pharma companies must adapt to keep pace with AI developments, say experts

Pharmaceutical Technology

At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.

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Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide

Fierce Pharma

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and Wegovy, claiming the drugs are too complex to safely replicate.

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How To Spot Deepfakes and Other Cybersecurity Panel Takeaways from HLTH

MedCity News

Two chief information security officers offer some advice at a cybersecurity panel at HLTH. The post How To Spot Deepfakes and Other Cybersecurity Panel Takeaways from HLTH appeared first on MedCity News.

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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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UK launches scheme to boost dementia trial participation

pharmaphorum

UK scheme to tackle "historically low" numbers of people taking part in dementia trials launches with £20m in government funding

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What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?

PharmaTech

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

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CDMO Samsung Biologics bags $1.2B production contract, bringing total 2024 deal value to $3.3B+

Fierce Pharma

With multiple high-profile production pacts already in the books for 2024, CDMO Samsung Biologics has hooked another big one. | Following a string of high-profile deals, Samsung Biologics has locked down a $1.2 billion contract with an unnamed Asia-based pharmaceutical company that’s expected to run through December 2037. Samsung did not elaborate on the identity of its new partner or the types of drugs it will help produce under the accord.

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Avandra Imaging Emerges from Stealth to Solve a Last-Mile Problem in Medical Research

MedCity News

Avandra Imaging, a federated network for de-identified imaging data, emerged from stealth at HLTH — as well as announced a partnership with Datavant. The post Avandra Imaging Emerges from Stealth to Solve a Last-Mile Problem in Medical Research appeared first on MedCity News.

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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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GSK plans $800m US manufacturing investment

pharmaphorum

GSK has made another investment in its manufacturing network, setting aside $800 million to build two plants at its Marietta site in the US.The programme represents the largest capital spend by the UK drugmaker on production capacity to date and will double the size and capacity of GSK's existing medicines and vaccines facility in Marietta, Pennsylvania, creating around 200 new jobs.

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EU CHMP recommends AstraZeneca and Ionis’ Wainzua for ATTRv-PN

Pharmaceutical Technology

The European Union's CHMP has recommended the approval of AstraZeneca and Ionis Pharmaceuticals’ Wainzua to treat ATTRv-PN.

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Sanofi shrugs off potential RSV competition from Merck as Beyfortus grows sales 382%

Fierce Pharma

Despite Merck & Co. | Despite Merck & Co. homing in on approval for its infant respiratory syncytial virus antibody clesrovimab, Sanofi thinks Beyfortus can hold its own. On a Friday call with analysts, Sanofi execs pointed to an efficacy edge for its preventive and stressed that more competition in the space is a net positive.

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Can Primary Care Thrive Outside of Traditional Healthcare Players?

MedCity News

Recent failures in the retail health space beg the question: Is primary care only suited to remain within traditional players? Four healthcare executives shared their responses to this question during a panel at HLTH in Las Vegas. The post Can Primary Care Thrive Outside of Traditional Healthcare Players? appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time