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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How Generative AI Will Find a Place in the Pharma Industry Now and in the Years to Come

MedCity News

Pharmaceutical and biotech companies are using generative AI to predict drug-target interactions, optimize lead compounds, and generate novel molecular structures. During the recent MedCity News INVEST Digital Health conference, a panel discussed these applications and more. The post How Generative AI Will Find a Place in the Pharma Industry Now and in the Years to Come appeared first on MedCity News.

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NICE recommendation for new Alexion PNH treatment

PharmaTimes

danicopan shown to improve haemoglobin levels and reduce anaemia

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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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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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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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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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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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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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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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A slow start for self-amplifying mRNA vaccines

Pharmaceutical Technology

A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.

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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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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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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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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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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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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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AZ, Ionis get CHMP backing for ATTR polyneuropathy drug

pharmaphorum

AstraZeneca and Ionis are on track for EU approval of ATTR polyneuropathy therapy Wainzua after the CHMP backs the drug

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AstraZeneca’s Polyneuropathy Treatment Recommended for EU Approval

PharmaTech

Wainzua had been previously approved for use by patients with ATTRv-PN in the United States, under the brand name Wainua.

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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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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 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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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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After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah

Fierce Pharma

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. | Iterum's Orlynvah was approved by the FDA Friday to treat certain uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative antibacterial treatment options.

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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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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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PursueCare brings Pear addiction DTx apps back to life

pharmaphorum

Two digital therapeutics for addiction are available again through PursueCare, which acquired them from now-defunct Pear Tx last year

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GSK pumps up to $800m for US manufacturing site upgrade

Pharmaceutical Technology

A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.

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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time