Mon.Dec 02, 2024

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Sanofi charts biggest China investment to date with plans for €1B insulin 'manufacturing base' in Beijing

Fierce Pharma

Shortly after a similarly sized venture from Pfizer, French pharma juggernaut Sanofi has unveiled a major manufacturing outlay in China, marking its biggest investment in the country to date. | Sanofi is laying out roughly 1 billion euros ($1.04 billion) to establish a new production base in the Beijing Economic and Technological Development Zone. The new manufacturing site, which will become Sanofi’s fourth in China, is being designed to beef up local end-to-end insulin production.

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A New Perspective on Suicide: It’s More Than Just Depression

MedCity News

It’s about interpreting the full range of factors, from biology to life circumstances, that can push someone to the edge. The post A New Perspective on Suicide: It’s More Than Just Depression appeared first on MedCity News.

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FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports

Fierce Pharma

The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week. The FDA notification came seven weeks after the New England Journal of Medicine (NEJM) published a report that seven of 67 children who received Skysona during clinical trials had developed blood cancer.

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Tackling Burnout: How AI Lifts the Coding Burden on Physicians

MedCity News

Besides the impact to physician satisfaction, the cost of this administrative burden is staggering: Organizations spend $82.7 billion annually on documentation, coding, and other administrative tasks, straining both budgets and staff. The post Tackling Burnout: How AI Lifts the Coding Burden on Physicians appeared first on MedCity News.

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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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After temporary reprieve, Advanz Pharma's liver med Ocaliva loses marketing nod in Europe

Fierce Pharma

After a rough few months for Intercept and Advanz Pharma's Ocaliva on both sides of the Atlantic, the other shoe has dropped for the rare liver disease drug in Europe. | The General Court of the European Union decided not to extend a suspension of the European Commission’s decision to revoke Ocaliva’s marketing authorization. In turn, Intercept's liver disease drug, which is marketed by Advanz Pharma overseas, has lost its EU approval.

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Applied Therapeutics Drug Is Denied FDA Approval in Rare Inherited Metabolic Disease

MedCity News

The FDA cited deficiencies in its govorestat’s application in galactosemia, a rare metabolic disease, Applied Therapeutics said. The biotech is still on track to submit a separate application for the drug in sorbitol dehydrogenase (SORD) deficiency, another rare disease that has no FDA-approved therapies. The post Applied Therapeutics Drug Is Denied FDA Approval in Rare Inherited Metabolic Disease appeared first on MedCity News.

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4 Key Insights into Payer and Provider Leaders’ Vision for AI

MedCity News

In a recent report, Define Ventures revealed key insights from payers and providers on how they’re shaping their AI strategies. The post 4 Key Insights into Payer and Provider Leaders’ Vision for AI appeared first on MedCity News.

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How Your Value Proposition Helps Increase Patient Volume and Revenue

Healthcare Success

Your value proposition is more than just a catchy phrase —it’s a vital tool that piques interest, communicates your brand identity, and compels consumers to book an appointment. And, it can increase patient volume and revenue. Here’s why: Your value proposition is, at its foundation, an essential component of your brand messaging. A quick primer: Your Tagline A concise, memorable statement that explains what your organization stands for.

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3 Innovations Philips Is Showcasing at RSNA 2024

MedCity News

Philips is showcasing its partnerships and new products at RSNA 2024, including an expanded collaboration with AWS and a CT scanner that the company said uses up to 80% less radiation than traditional systems. The post 3 Innovations Philips Is Showcasing at RSNA 2024 appeared first on MedCity News.

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Orexo exits depression DTx alliance with GAIA

pharmaphorum

Four years after buying US rights to GAIA's digital therapeutic to help people with depression, Swedish drugmaker Orexo has terminated the deal.

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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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Novartis Tries Again in Huntington’s, Putting Up $1B to Partner on a PTC Therapeutics Drug

MedCity News

Novartis is securing global rights to a PTC Therapeutics Huntington’s disease drug candidate that has encouraging Phase 2 data that will be discussed with the FDA to plan a pivotal study. Last year, Novartis discontinued its Huntington’s program after safety issues emerged in Phase 2 testing. The post Novartis Tries Again in Huntington’s, Putting Up $1B to Partner on a PTC Therapeutics Drug appeared first on MedCity News.

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Novartis pays $1bn upfront for Huntington's drug from PTC

pharmaphorum

Novartis has made a return to the Huntington's disease stage by licensing an oral mRNA splicer from PTC Therapeutics for $1 billion upfront

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Complying with CGMPs for Sterile Manufacturing

PharmaTech

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

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BMS files legal challenge to HHS' 340B rebate decision

pharmaphorum

Bristol-Myers Squibb has become the latest pharma in the US to file a legal challenge to a block on a 340B drug rebate model opposed by HRSA.

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

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Wrapping Up 2024 – How Malaysian Salespeople Can Prepare for 2025

Contrarian Sales Techniques

December always feels like a mix of emotions, doesn’t it? For salespeople like us, it’s part reflection, part hustle, and maybe a little exhaustion mixed in too. But this final stretch is crucial—not just for wrapping up the year but for setting yourself up for success in the next one. So, how can you make the most of this month without completely burning out?

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Driving Innovation: How Quantified’s Product Momentum is Transforming Sales Training

Quantified

As the sales tech stack continues to be transformed, staying ahead requires more than effort—it demands precision, insight, and adaptability. At Quantified, we’re empowering sales teams to rise to this challenge with our latest innovations in AI sales training and AI role play. We were the first to create simulation-based role play, so our momentum isn’t just about keeping up with the market.

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FDA Accepts GSK’s Biologics License Application of Blenrep for Relapsed or Refractory Multiple Myeloma

PharmExec

Acceptance of the Biologics License Application of Blenrep was based on promising results from the DREAMM-7 and DREAMM-8 Phase III trials in patients with relapsed or refractory multiple myeloma.

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How to Use Sales Techniques to Land Your Dream Job

Contrarian Sales Techniques

Job hunting feels like a chore, right? But here's the thing - it's really just selling yourself. Let me show you what I mean. Disclaimer : This post is just me sharing my own thoughts and experiences from working in the pharmaceutical sales industry. It’s not official advice or a statement from any organization. Just a bit of my own perspective on what goes on behind the scenes.

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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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New mass spectrometry Chapter could “revolutionise” biopharma quality assurance

European Pharmaceutical Review

New guidelines from the The US Pharmacopeia (USP) on mass spectrometry-based quantification of host cell protein (HCP) impurities in biologic drugs are available, as of 1 December. This follows an announcement by USP about its intent to revise General Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Liquid Chromatography-Mass Spectrometry.

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Roche Inks Deal to Acquire Poseida Therapeutics

PharmExec

Under terms of the deal, Roche will gain access to Poseida’s pipeline, including P-BCMA-ALLO1, an allogeneic CAR T-cell therapy for multiple myeloma, and P-CD19CD20-ALLO1, a dual CAR T-cell therapy in early trials for B-cell malignancies and autoimmune diseases.

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Machine Health in Pharmaceutical Production

Pharmaceutical Commerce

Predictive maintenance in pharmaceutical production can help reduce downtime and increase efficiency. Grundfos Machine Health (GMH) uses artificial intelligence (AI)-driven wireless sensors to monitor motor health in real-time, identifying potential issues. This approach not only reduces maintenance costs but also ensures compliance with industry standards.

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Leaders: The Key to Employee Experience Success in 2025

ALULA

Want to know the single biggest factor in creating an exceptional employee experience (EX)? Look no further than your leaders. As we wrap up 2024, the data is crystal clear: managers account for 70% of the variance in employee engagement scores across all business units. That's not just a number – it's a wake-up call for organizations wanting to boost retention and performance in 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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Shaping the Future of Commercialization

Pharmaceutical Commerce

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chase Feiger, MD, co-founder, Ostro, outlines the trends he expects to see over the next 10-15 years when it comes to the intersection of AI and life sciences.

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Pharma Horizons: Sustainability

European Pharmaceutical Review

This report delves into the latest developments in sustainability impacting the pharmaceutical sector today. Inside, articles explore current key topics including regulation, manufacturing, green chemistry, digitalisation and clinical trials. Stay up to date with the latest developments in sustainability including articles on: The key regulatory frameworks impacting the pharmaceutical industry and the challenges and opportunities around their implementation How digitalisation can transform and

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Milk-based therapies could be coming. This biotech CEO is aiming to lead the way.

PharmaVoice

Intrinsic Medicines is entering phase 2 trials in Parkinson’s disease and IBS for its human milk oligosaccharide drug candidates next year.

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Leadership Insights 2024: What Worked, What Matters, What's Next

ALULA

Discover key leadership insights from 2024 to elevate your leadership in 2025. Learn practical strategies for connection, observation, and communication that drive results.

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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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United States Protests China’s Semiconductor Chip Industry, Announces Export Restrictions

Pharmaceutical Commerce

A total of 140 companies are being placed on the Entity List, in an effort to limit China’s effectiveness in the sector.

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Pharma Pulse 12/2/24: Retooling the ‘Gene’ Value Machine & more

PharmExec

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

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Fate Therapeutics makes Bob Valamehr president and CEO

Pharmaceutical Technology

Fate has announced the retirement of president and CEO Scott Wolchko with Bob Valamehr set to assume the role from 1 January 2025.

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Pharma giants vie for oral GLP-1R approval

PharmaTimes

Race to create first oral drug for obesity intensifies

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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.