Wed.Apr 10, 2024

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FDA appears receptive to surrogate endpoint supporting accelerated approval of multiple myeloma drugs

Fierce Pharma

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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Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem

MedCity News

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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FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Fierce Pharma

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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UK calls time-out on post-Brexit rules opposed by industry

pharmaphorum

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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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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Novartis halts recruitment of Kisqali trials as it adjusts production methods

Fierce Pharma

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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Report: Payers Aren’t Providing an Adequate Digital Experience

MedCity News

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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How Efficient Logistics Can Change the Lives of Rare Disease Patients

Pharmaceutical Commerce

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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Leading AstraZeneca investor defends CEO pay ahead of shareholder vote: FT

Fierce Pharma

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

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The Licensing Vector: A Fair Approach to Content Use in LLMs

Copyright Clearance Center

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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AACR: BTK degrader could treat CNS B-cell malignancies

European Pharmaceutical Review

First evidence of clinical activity in the brain for a targeted protein degrader has been demonstrated with NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The small molecule anti-cancer treatment from Nurix Therapeutics is currently being investigated in a Phase I clinical trial in patients with relapsed or refractory B cell malignancies.

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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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Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance

MedCity News

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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Unique testing regimen could prevent nuclease contamination

European Pharmaceutical Review

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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Three Key Challenges for Healthcare CISOs

MedCity News

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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Psychiatry drugs finally have pharma’s attention. Can they keep it?

PharmaVoice

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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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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Vertex Pharma Bolsters Immunology Profile With $4.9B Alpine Immune Sciences Acquisition

MedCity News

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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What’s old is new: The revival of a one-time radiotherapy cancer treatment

PharmaVoice

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

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Advancing microbiome innovation

European Pharmaceutical Review

Over the past decade, there has been an increase in discussions involving industry stakeholders, regulatory agencies, and physicians about developments in the emerging microbiome therapeutics industry. The field initially triggered inquiries and these conversations have since evolved, indicating a noticeable positive shift in attitudes over time. The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the i

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Essential adds neuroblastoma drug with Renaissance buy

pharmaphorum

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

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

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Bio-Rad and Alleghany Health Network partner for patients with solid tumour cancer

PharmaTimes

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

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Vertex wagers $4.9bn on Alpine kidney disease therapy

pharmaphorum

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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6 Women’s Health Startups You Should Get to Know

MedCity News

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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e-therapeutics is latest UK biotech to seek AIM de-listing

pharmaphorum

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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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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Study reveals shorter scans for prostate cancer could improve diagnosis

PharmaTimes

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

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Roche gets EU okay for first HER2-low test kit

pharmaphorum

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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Bayer and Google Cloud to develop AI solutions for radiologists

Pharmaceutical Technology

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

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Pharma Pulse 4/10/24: 7% of Patients with Cancer Participate in Research, Technologies Being Used to Enhance Trial Enrollment and Diversity & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Elevating Video Introductions With AI Sales Training 

Quantified

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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Catalent's Holistic Approach To High Potency API Operations

PharmaTech

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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How provider organizations can use data analytics to increase physician engagement

Clarify Health

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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Developing & Manufacturing Drugs with HPAPIs

PharmaTech

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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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