Thu.Oct 24, 2024

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Marinus to trim workforce, weigh 'strategic alternatives' after another Ztalmy trial miss sends shares tumbling

Fierce Pharma

It’s déjà vu for Marnius Pharmaceuticals. | The recent trial flop for Ztalmy, this time in tuberous sclerosis complex (TSC)-associated seizures, leaves the company in a cost-cutting scramble as it moves to explore "strategic alternatives.

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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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GSK answers Pfizer's RSV approval with data targeting matching nod in younger adults

Fierce Pharma

Results from two phase 3 trials show that GSK’s RSV vaccine Arexvy excelled in a broad age range of immunocompromised and other at-risk patients.

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Video: Was Carrum’s CEO the Voice of Reason at HLTH?

MedCity News

Sach Jain, the CEO of Carrum Health, which helps self-insured employers manage their surgical care costs, had a sobering perspective at HLTH, a conference that celebrates innovation in healthcare. The post Video: Was Carrum’s CEO the Voice of Reason at HLTH? 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 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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WhatsApp lands Moderna in hot water with PMCPA

pharmaphorum

WhatsApp message earns Moderna a reprimand under the ABPI Code, with Novo Nordisk, Otsuka, AstraZeneca and Daiichi Sankyo also breaching the rules

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Gates Foundation Joins Radiant Bio’s $35M Round for Antibody Drugs With ‘Better Grip’

MedCity News

Radiant Biotherapeutics’ Multabodies are antibodies engineered to offer better binding strength to their targets. The preclinical startup’s lead program goes after a cancer immunotherapy target being pursued by several biotech companies already in early clinical development. The post Gates Foundation Joins Radiant Bio’s $35M Round for Antibody Drugs With ‘Better Grip’ appeared first on MedCity News.

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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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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 72
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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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The Dangers Surrounding Bits and Bytes

Pharmaceutical Commerce

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jeffrey Bernstein, director of cybersecurity and data privacy for Kaufman Rossin’s risk advisory services, forecasts how cyber threats could potentially evolve over the next decade.

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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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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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Behind the Headlines: GLP-1 Shortage, Nobel Prize, RNA Editing, and More

PharmaTech

Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.

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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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Retrofitting Facilities for Cell and Gene Therapy Production

PharmaTech

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses how facilities used for solid dosage manufacturing may be retrofitted into sustainable cell and gene therapy production facilities.

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

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How supervised machine learning optimizes AI use in clinical trials

Pharmaceutical Technology

In pharma, smaller-scale AI and supervised machine learning models could provide more effective solutions than large language models (LLM).

Pharma 64
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How to Enhance DEI in Clinical Trials

PharmExec

Integrating DEI strategies into clinical trials is both crucial for advancing biomedical knowledge and for bolstering trust and equitability within underrepresented communities.

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Pharma Trends: Shaping the Future of Healthcare Marketing

Pharma Marketing Network

The pharmaceutical industry is changing at lightning speed. New drugs, evolving technologies, and emerging marketing channels are creating fresh opportunities for pharma marketing executives. How do you keep up? As more patients turn to digital platforms for information and brands compete in an increasingly crowded market, pharma marketers need to be agile, creative, and tech-savvy to succeed.

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Can a Celebrity Influencer Work for Your Brand?

Eversana Intouch

In a recent article for PM360, Susan Perlbachs, Chief Creative Officer at EVERSANA INTOUCH, delves into the growing trend of celebrity influencers in pharmaceutical advertising, exploring both the opportunities and challenges they present. She highlights how celebrities can provide brands with instant recognition and broad reach, sharing examples like Travis Kelce’s involvement in Pfizer’s “Got Booster?

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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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The Impact of Artificial Intelligence on the Creation of Medicines

PharmExec

Najat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can help reduce healthcare costs at the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.

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Developing donanemab – balancing cost versus benefit

European Pharmaceutical Review

A new regulatory authorisation has opened opportunity for eligible Alzheimer’s patients in Great Britain to access a new treatment that could provide them with “more time in the early symptomatic stage of the disease to do what matters most to them,” shared Ilya Yuffa, Executive Vice President And President of Lilly International, Eli Lilly and Company, following the Medicines and Healthcare products Regulatory Agency (MHRA)’s decision this week.

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Merck Agrees to Terms to Acquire Modifi Biosciences

PharmExec

Under terms of the deal, Merck will provide an upfront payment of $30 million, with potential milestone payments of up to $1.3 billion for the Yale University spinout that develops targeted therapies for cancer.

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Operating Without a Commercial Blueprint: Empowering the Field for Niche Therapy Launches

Pharmaceutical Commerce

How emerging biotech companies can create fruitful partnerships between home office commercial teams and the field force to enable this intelligence gathering, while driving commercial success.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Optimising drug release of personalised 3D printed tablets

European Pharmaceutical Review

To modulate drug release, researchers have developed 3D-printed tablets using surface geometries controlled by mathematical functions. They highlighted that for drug delivery using 3D printing, a common issue is attaining precise control of drug release profiles. “The ability to predict dissolution curves based on tablet structure, and vice versa, holds promising prospects for tablet design and the application of 3D printing in pharmaceuticals”, the authors explained.

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Advantages & Disadvantages of Using Compounded Medications

PharmExec

Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss how compounded medications differ from commercially available drugs in terms of their manufacturing process, quality standards, and more.

Medical 52
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Bayer partners medtech firm Impli on fertility R&D

pharmaphorum

Bayer partners medtech firm Impli on an implantable hormone biosensor with applications in fertility treatment and beyond.

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FDA Approves AbbVie Therapy for Adults with Advanced Parkinson’s Disease

PharmaTech

Vyalev, also known as Produodopa, has been approved in 35 countries, with more than 4200 patients having started treatment.

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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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Why pharma megamergers may become a relic of the past

PharmaVoice

Despite pent up M&A demand, FTC scrutiny has had a chilling effect on pharma’s appetite for striking major deals.

Pharma 59
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Pharmacists “desperation” by Novo Nordisk over semaglutide copycat block

Pharmaceutical Technology

Novo Nordisk has asked the FDA to add semaglutide to a list that would effectively block manufacturing of copycat versions of Wegovy and Ozempic.

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Pharma Pulse 10/24/24: Safeguarding Customer Data, Price Transparency Reveals Inequities Beyond Patients & more

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

Pharma 52
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Shaping the Future of Pharmacogenomics: STRIPE Drives Stakeholder Consensus at Inaugural Meeting

Pharmacy Times

Benjamin Brown of Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) discusses his own experience as a patient with cancer and how consensus around pharmacogenomic practices can improve the lives of patients.

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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