Fri.Oct 04, 2024

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In sustained rare disease push, Recordati lays out $825M upfront to acquire Sanofi's CAD drug Enjaymo

Fierce Pharma

As Sanofi continues to clean out its medicine chest, Italy’s Recordati is getting in on the action. | Recordati is floating $825 million upfront—plus another $250 million in potential commercial milestones—to get its hands on the global rights to Sanofi’s rare disease biologic Enjaymo. In 2022, Enjaymo became the first and only therapy specifically approved by the FDA for treating patients with the uncommon blood disorder cold agglutinin disease.

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Sanofi Drug for Rare Blood Disease Is Heading to Recordati for $825M

MedCity News

Recordati is acquiring Sanofi’s Enjaymo, the only approved drug for the rare blood disorder cold agglutinin disease. Achieving sales milestones could bring the deal’s value to more than $1 billion. The post Sanofi Drug for Rare Blood Disease Is Heading to Recordati for $825M appeared first on MedCity News.

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US' top IV fluid maker Baxter voices uncertainty about recovery timeline at NC facility hit by Helene

Fierce Pharma

After announcing the closure of its biggest manufacturing site Sunday due to flooding caused by Hurricane Helene, Baxter International—the U.S.’ top supplier of hospital IV fluids—is laying out det | While progress is already being made after Hurricane Helene, which resulted in water “permeating” Baxter’s large IV fluid production plant in North Carolina, the company cautioned that it does not yet have a timeline for when operations will be back online.

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Most Healthcare Organizations Have Paid $500K or More in Ransom Post-Cyberattack, Report Says

MedCity News

More than three-quarters of healthcare organizations reported paying more than $500,000 in ransom as a result of cyberattacks, according to a new report. The post Most Healthcare Organizations Have Paid $500K or More in Ransom Post-Cyberattack, Report Says appeared first on MedCity News.

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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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FDA approval give BMS an edge in NSCLC treatment

pharmaphorum

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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User Activity Monitoring: Real-Time Visibility Within the EHR to Stay Ahead of Insider Threats

MedCity News

It has become standard practice for healthcare organizations to focus on identifying and stopping external threats to the privacy and security of data, but one often overlooked risk may be right inside your offices — snooping employees and malicious insider threats. The post User Activity Monitoring: Real-Time Visibility Within the EHR to Stay Ahead of Insider Threats appeared first on MedCity News.

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Data-Driven Transformation: The Role of Data Quality in Accelerating Healthcare Performance

MedCity News

As organizations dive further into their datasets and explore how artificial intelligence (AI) and machine learning (ML) can help reveal new insights, one thing must remain at the forefront: data quality. The post Data-Driven Transformation: The Role of Data Quality in Accelerating Healthcare Performance appeared first on MedCity News.

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Teva and mAbxience partner to develop biosimilar candidate for oncology

Pharmaceutical Technology

Teva Pharmaceuticals International and mAbxience have entered into a worldwide licencing agreement to develop an anti programmed cell death protein 1 oncology biosimilar candidate.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from Alpha Sophia, Rezilient Health, Rippl, Nym, and Mithradote Bio. The post StartUPDATES: New Developments from Healthcare Startups appeared first on MedCity News.

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An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped?

PharmaVoice

Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.

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

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Walmart Expands Centers of Excellence Benefit To Include All Cancers

MedCity News

Walmart’s Cancer Centers of Excellence program historically focused on some of the most prevalent cancers, such as breast, lung, colon, prostate, pancreatic and blood cancer. Now, employees can access the same benefit for a whole host of other cancers, including bone, pituitary, liver, thyroid, central nervous system and gynecological. The post Walmart Expands Centers of Excellence Benefit To Include All Cancers appeared first on MedCity News.

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KOL Collaboration Series: Pharmacy Desert Prevalence

Pharmaceutical Commerce

In this video interview with Pharma Commerce Editor Nicholas Saraceno, John Stefankiewicz, VP of Analytics, Cencora, details why these pharmacy deserts have become so widespread.

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CPHI Milan 2024: Compliance and Automation in Aseptic Processing

PharmaTech

Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.

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Your Patients Want Personalization — Here’s How to Deliver It With Cloud Computing

Salesforce

The healthcare sector is undergoing rapid evolution , driven by shifting patient expectations and cutting-edge technologies. Innovations like genomics, personalized medicine, and digital health tools are transforming the landscape. As organizations embrace more digitized operations, including cloud computing in healthcare, they must also navigate a complex web of regulatory requirements such as the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. and the General Data Prote

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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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Strengthening the Chain

Pharmaceutical Commerce

Headlining our October issue of Pharmaceutical Commerce is a look inside an emerging key component of cold chain transport and management—ensuring the safety and control of novel injectable drugs through to their "last mile.

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Enhancing intestinal drug delivery with Quality by Design

European Pharmaceutical Review

A study has reported an approach for optimising metronidazole colonic delivery systems, to increase their potential efficacy when treating diverticulitis. Researchers developed intestinal colon-coated sustained-release matrix metronidazole tablets, using a Quality by Design (QbD) approach. Arévalo-Pérez et al. noted that metronidazole is a synthetic nitroimidazole and has activity against anaerobic bacteria.

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FDA Approves Bristol Myers Squibb’s Opdivo in Combination with Chemotherapy for Resectable Non-Small Cell Lung Cancer

PharmExec

Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.

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Drug Digest: Securing the Supply Chain for Small-Molecule APIs and Excipients

PharmaTech

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, Pharmaceutical Technology Group, interviews experts about key trends impacting small-molecule APIs and excipients, the importance of supply chain resilience, ways in which advanced manufacturing approaches can prove beneficial, and potential hurdles facing companies seeking to secure their small-molecule API and excipient supply chains.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Animating for Your Audience: The Right Visual for Your Dev Stage

PharmExec

From early-stage funding to commercialization, startups must adapt their strategies and messaging to effectively attract investors, build partnerships, and ultimately succeed.

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Recordati to acquire worldwide rights to Sanofi’s antibody Enjaymo

Pharmaceutical Technology

Recordati has reached an agreement with Sanofi for acquiring the worldwide rights to Enjaymo, the only approved treatment specifically targeting cold agglutinin disease (CAD), a rare B-cell lymphoproliferative disorder.

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Piramal to Invest $80 Million in Sterile Injectables Facility Expansion in Kentucky

PharmaTech

When the expansion is completed, Piramal expects manufacturing capacity to be increased by the first quarter of 2027 from 104 product batches per year to more than 240.

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BMS receives FDA approval for Opdivo to treat NSCLC

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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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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Advancing Development and Manufacturing of Microbiome-Derived Therapeutics (BIO 2024)

PharmaTech

Aaron Cowley, PhD, chief technical officer and co-founder, Captozyme, discussed the advancement in development of microbiome-derived therapeutics at BIO 20204.

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Resilience secures funds to enhance production of essential medicine components

Pharmaceutical Technology

National Resilience’s subsidiary Resilience Government Services has received around $17.5m in funding for expanding critical medicine components manufacturing.

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FDA Approves Exact Sciences' Cologuard Plus Non-Invasive Colorectal Cancer Screening Test

PharmExec

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

FDA 52
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FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy trial

Pharmaceutical Technology

Two years after the FDA placed partial clinical hold, Avidity can resume research of del-desiran as a treatment for myotonic dystrophy type 1.

FDA 52
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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

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Pharma Pulse 10/4/24: Regulatory Challenges With Data Collection, Poor Sleep Quality Linked to Dementia & 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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The benefits of using a nimble platform from phase to phase

Pharmaceutical Technology

It is common for sponsors to switch digital platforms between clinical trial phases, but sponsors can achieve much by using the same one.

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Hologic Launches Breast Cancer Myth Busting Campaign

PharmExec

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

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NHS proposes phased launch for Eli Lilly’s Mounjaro

Pharmaceutical Technology

The roadmap suggests those with the greatest clinical need will get priority access, according to the NHS national medical director.

Medical 52
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.