Fierce Pharma

APRIL 10, 2024

New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. | New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. The FDA appears receptive to the idea of using the measurement to support accelerated approvals of new drugs, even though the agency has a few questions.

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FDA 260

MedCity News

APRIL 10, 2024

Nurse managers being too busy to train and support their team members is one of the biggest reasons nurses are exiting the healthcare industry, according to a new report. The post Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem appeared first on MedCity News.

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Healthcare Healthcare Training Management 128

Fierce Pharma

APRIL 10, 2024

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S. FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses.

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FDA Manufacturing Pharmaceutical products Healthcare 248

MedCity News

APRIL 10, 2024

About 32% of health insurance sites and apps “don’t meet the foundational level of functionality and intuitive organization of information,” according to a new J.D. Power report. The post Report: Payers Aren’t Providing an Adequate Digital Experience appeared first on MedCity News.

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Insurance 124

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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

Distribution

Fierce Pharma

APRIL 10, 2024

In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kisqali (ribociclib) as it makes adjustments to its manufacturing processes for the drug.

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Recruitment FDA Manufacturing Patients 236

MedCity News

APRIL 10, 2024

Vertex Pharmaceuticals gains a Phase 3-ready Alpine Immune Sciences drug with potential applications in a wide range of immunological disorders. The lead indication for the Alpine drug, povetacicept, is the chronic kidney disease IgA nephropathy. The post Vertex Pharma Bolsters Immunology Profile With $4.9B Alpine Immune Sciences Acquisition appeared first on MedCity News.

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MedCity News

APRIL 10, 2024

In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability. The post Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance appeared first on MedCity News.

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Fierce Pharma

APRIL 10, 2024

Leading AstraZeneca investor defends CEO pay ahead of shareholder vote: FT zbecker Wed, 04/10/2024 - 10:49

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Leads 148

MedCity News

APRIL 10, 2024

There are several steps that CISOs and cybersecurity professionals can take to get ahead of looming digital threats in the healthcare space. The post Three Key Challenges for Healthcare CISOs appeared first on MedCity News.

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Healthcare Healthcare 111

pharmaphorum

APRIL 10, 2024

The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.

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Manufacturing 129

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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.

Safety

Pharmaceutical Commerce

APRIL 10, 2024

If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.

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Patients Manufacturing 105

Copyright Clearance Center

APRIL 10, 2024

A spate of recent lawsuits is shining light on how some generative AI (GenAI) companies are using copyrighted materials, without permission, as a core part of their products. Among the most recent examples is the New York Times Company’s’ lawsuit against OpenAI, which alleges a variety of copyright-related claims.

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PharmaVoice

APRIL 10, 2024

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

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Medicine 96

pharmaphorum

APRIL 10, 2024

Essential Pharma has bought Renaissance Pharma, adding its first developmental drug candidate, a therapy for rare cancer neuroblastoma.

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Pharma 104

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

PharmaVoice

APRIL 10, 2024

TAE Life Sciences is bringing radiation-based cancer therapy to clinical trials globally in the coming years.

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pharmaphorum

APRIL 10, 2024

In another departure from its focus on genetic medicines, Vertex Pharma has agreed a $4.9 billion purchase of Alpine Immune Sciences, adding a mid-stage drug candidate for kidney disease IgA nephropathy (IgAN). The $65-per-share deal is due to close within the next three months, said Vertex, which plans to fund the acquisition with cash in hand. It is the largest acquisition in the biopharma sector so far in 2024.

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Biopharma Medicine Pharma 88

European Pharmaceutical Review

APRIL 10, 2024

A novel routine nuclease testing regimen developed to ensure resilience against nuclease contamination can be utilised as part a laboratory’s quality management system (QMS), a paper reports. The regimen may be applied as a quality indicator fulfilling certain ISO quality control criteria, and offers “documented, systematic feedback”. Cleavable, fluorescent DNA and RNA substrates were used to detect, monitor and control for nuclease contamination in the laboratory, according to the authors.

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Management Pharmaceutical 82

pharmaphorum

APRIL 10, 2024

e-therapeutics is the latest UK biotech to say it plans to delist from the AIM, citing a lack of interest from institutional investors.

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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.

Safety

MedCity News

APRIL 10, 2024

These health tech companies focused on the consumer and self-insured employer market will take part in the MedCity INVEST Pitch Perfect contest May 21-22 in Chicago. Register today! The post 6 Women’s Health Startups You Should Get to Know appeared first on MedCity News.

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Insurance Marketing Food 75

PharmaTimes

APRIL 10, 2024

Solid tumour cancers account for 90% of adult human cancers and 50% of childhood malignancies

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Networking Patients 103

pharmaphorum

APRIL 10, 2024

Roche gets EU approval for its HER2-low companion diagnostic, used to identify breast cancer patients eligible for treatment with Enhertu.

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Patients 82

Pharmaceutical Technology

APRIL 10, 2024

Bayer has partnered with Google Cloud to develop AI-powered solutions for radiologists, creating scalable and compliant imaging software.

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Management

PharmaTimes

APRIL 10, 2024

The most common form of cancer in men is responsible for 12,000 deaths every year in the UK

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Pharmaceutical Commerce

APRIL 10, 2024

The latest news for pharma industry insiders.

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Pharma Patients 103

Quantified

APRIL 10, 2024

Modern video is a powerful medium in today’s work environments. It’s a technology that’s transforming the way companies generate leads, connect with prospective clients, and build enthusiasm for their products and services. But whether your sales reps are participating in virtual meetings, uploading pre-recorded content to social media, connecting through video voicemail, or posting personalized invitations to conferences, webinars, or product launches, they have less than 10 seconds to make a g

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Training Sales Sales Management Prospecting 52

PharmaTech

APRIL 10, 2024

Catalent’s approach to containment mitigates cross-contamination risk and regulatory issues, ultimately safeguarding patients. Download this article written by Karolina Narczykiewicz, an EHS expert at Catalent Pharma.

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Pharma Patients 52

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

Clarify Health

APRIL 10, 2024

Physician engagement is a crucial factor in the success and growth of healthcare organizations. Engaged physicians are not only more likely to deliver high-quality care to patients, but also play a pivotal role in driving operational efficiency and innovation. Using data analytics to support and educate physicians can streamline processes, provide meaningful feedback, and show the impact of engagement on patient health and satisfaction.

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Physicians Doctors Education Healthcare 52

PharmaTech

APRIL 10, 2024

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The level of containment necessary for a potent drug product is not just limited to potent or non-potent classification. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility.

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Manufacturing Specialization Safety 52

Pharmaceutical Technology

APRIL 10, 2024

Discover how Aerie Pharmaceuticals' patented compounds target kinases and proteins to treat eye diseases, inflammation, and more. Explore the groundbreaking method for treating ocular disorders with Formula (I) compound.

Pharmaceutical 52

Pharmaceutical 52

PharmaTech

APRIL 10, 2024

Oral drug products that contain highly potent active pharmaceutical ingredients (HPAPIs) continue to be a driving force in the global pharmaceutical market. In this Q&A article, industry experts discuss some of the challenges in HPAPI drug product manufacturing and the key issues sponsors should consider when partnering with a contract development and manufacturing organization (CDMO).

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Manufacturing Pharmaceutical Marketing 52

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients