Thu.Dec 07, 2023

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As Biden administration eyes 'march-in' rights to lower drug prices, pharma gears up for battle

Fierce Pharma

While so-called “march-in” rights have yet to materialize in the United States, the controversial measure to cut drug prices appears to be gaining traction with the government. | While so-called “march-in” rights have yet to materialize in the United States, the controversial measure to cut drug prices appears to be gaining traction with the government.

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AI’s Role in Transforming Healthcare

MedCity News

Embracing the possibilities that AI unlocks, our commitment to seamlessly integrating AI into healthcare workflows reflects our belief that technology should melt into the background, empowering human caregivers to focus on delivering compassionate patient care.

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Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls

Fierce Pharma

When it comes to manufacturing cell therapies, it's often said that the "process is the product." But churning out these complex, individualized drugs has routinely tripped up even the industry's l | In recent months, Novartis has faced scrutiny from the FDA over Kymriah production shortfalls, a newly posted letter shows. The company says it's working to address the situation.

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ChatGPT Does a Bad Job of Answering People’s Medication Questions, Study Finds

MedCity News

Researchers recently tested ChatGPT’s ability to answer patient questions about medication, finding that the AI model gave wrong or incomplete answers about 75% of the time. Providers should be wary of the fact that the model does not always give sound medical advice, given many of their patients could be turning to ChatGPT to answer health-related questions.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Sanofi's quiet Sarclisa chalks up a first-in-class win with eyes on a first-line multiple myeloma nod

Fierce Pharma

In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little. | In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little with Johnson & Johnson.

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AbbVie swoops on Pfizer spin-out Cerevel with $8.7bn offer

pharmaphorum

AbbVie has announced its second major takeover deal in the space of a few days, offering $8.7 billion to buy central nervous system drug specialist Cerevel Therapeutics which spun out of Pfizer in 2018.

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How Can Health Systems Cut Through the AI Noise? 3 Leaders Answer

MedCity News

During a webinar, three health system leaders discussed strategies they use to ensure successful AI deployment. They agreed that one of the best ways health systems can prime themselves for fruitful AI deployments is beginning with a specific problem to solve — as opposed to having AI startups tell them which problems need to be addressed.

Medicine 109
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Bristol Myers' Opdivo-Yervoy combo shows success in first-line colorectal cancer

Fierce Pharma

It’s been more than three years since Bristol Myers Squibb’s powerhouse immuno-oncology combination treatment of Opdivo and Yervoy has scored a combined FDA approval. | It’s been more than three years since Bristol Myers Squibb’s powerhouse immuno-oncology combination treatment of Opdivo and Yervoy has scored a combined FDA approval. But the duo could be on its way to a new endorsement based on a phase 3 trial that shows it can keep certain first-line colorectal cancer patients alive longer than

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Why Nurses Crave Time to Teach Other Nurses

MedCity News

During a critical nursing shortage, practicing nurses want to be allowed more time for teaching and mentoring fellow nurse learners, as there are multiple benefits for both sides that could result in improved satisfaction.

Education 106
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Fierce Pharma Asia—WuXi Bio's plunge; Daiichi-Novartis $182M settlement; Merck KGaA's Abbisko deal

Fierce Pharma

WuXi Biologics' gloomy business update triggered a stock market avalanche. Daiichi Sankyo and Novartis reached a $182 million settlement on their BRAF drug patent dispute. | WuXi Biologics' gloomy business update triggered a stock market avalanche. Daiichi Sankyo and Novartis reached a $182 million settlement on their BRAF drug patent dispute.

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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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Common drug could facilitate “huge step-change” in managing type 1 diabetes

European Pharmaceutical Review

Results from a world-first human trial, published in the New England Journal of Medicine , has shown that a drug called baricitinib has promise as the first disease-modifying treatment of its kind for type 1 diabetes, that can be administered as a tablet.  baricitinib… [demonstrated an ability to] preserve the body’s own insulin production and suppress the progression of type 1 diabetes in people who initiated treatment within 100 days of diagnosis” The researchers noted that baricit

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'The Top Line': Turning down the toxicity of nature’s most powerful antifungal

Fierce Pharma

The antifungal agent Amphotericin B is highly effective against a wide range of deadly fungi and resistance is rare, even after decades of use. | Amphotericin B, an effective antifungal with rare resistance, is associated with significant kidney damage, prompting the search for a potential alternative. This week on "The Top Line," Fierce Biotech Research’s Helen Floersh spoke with Martin Burke, M.D., Ph.D., founder of antifungal startup Sfunga Therapeutics, to discuss the design and pa

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Biden may order compulsory licensing in drug pricing move

pharmaphorum

The White House said today that it may take enforced ownership of patents on medicines developed with public funding if their manufacturers set their prices too high. The proposed framework for so-called ‘march-in rights’ on taxpayer-funded drugs and other inventions is the latest entry in the US federal government’s playbook to limit price increases for drugs, and will no doubt throw it once again into open contention with the pharma industry.

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Vanda expands commercial presence with $100M deal for US rights to J&J multiple sclerosis drug

Fierce Pharma

Vanda Pharmaceuticals has a new commercial asset under its belt after striking a deal to buy certain rights to Johnson & Johnson’s multiple sclerosis med Ponvory for $100 million. | The multiple sclerosis drug has "potentially broad applications," Vanda's CEO said. J&J launched the med in 2021 and has yet to reveal its sales figures.

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Trial finds Lilly’s Olumiant could treat type 1 diabetes

pharmaphorum

Treatment with Eli Lilly’s JAK inhibitor Olumiant has been shown to preserve the function of insulin-producing pancreatic beta cells in patients with type 1 diabetes, potentially opening up a whole new avenue of therapy.

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Prevalence of Eight Chronic Health Conditions Reach Unprecedented Levels in US

PharmExec

Arthritis, asthma, cancer, cardiovascular diseases, chronic kidney disease, COPD, depression, and diabetes reach the highest recorded levels since the America’s Health Rankings Annual Report began tracking them in 1990.

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Medtronic drops $738m takeover of wearable insulin pump firm

pharmaphorum

Medtech giant Medtronic has decided not to go ahead with a planned acquisition of EOFlow, a developer of patch-based insulin pumps, saying that there have been “multiple breaches” of their takeover agreement.

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How to Choose the Right Distribution Partner

MedCity News

By understanding the interconnectedness of the healthcare industry, aligning goals and maintaining an open line of communication, distributors and healthcare organizations can cultivate lasting, dependable partnerships, while working together to develop innovative ideas and solutions.

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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.

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Japan approves BMS’ Abecma for multiple myeloma treatment

Pharmaceutical Technology

Japan has granted approval for the sBLA of Bristol-Myers Squibb (BMS) for Abecma to treat relapsed or refractory multiple myeloma (RRMM).

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Sanofi says new drugs can add €10bn to sales by 2030

pharmaphorum

Sanofi said this morning that its pipeline includes 12 potential blockbuster drugs that could generate more than €10 billion ($11 billion) in annual sales by the end of the decade, a sharp increase on earlier predictions.

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‘Innovation-first’ mindset vital for advanced therapies sector future

European Pharmaceutical Review

A report from the Advanced Therapies Treatment Centre (ATTC) Network has highlighted urgent need for rapid change and improvement in the field to maximise patient access to advanced therapies. It was compiled based on expertise gathered at the ATTC Network’s UK Advanced Therapies Adoption Challenge event in October. At the event, attendees discussed barriers and develop solutions to the advanced therapies adoption challenge.

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FDA fast tracks Solid Biosciences’s Duchenne gene therapy

Pharmaceutical Technology

The FDA has granted fast track designation to Solid Biosciences’s gene therapy SGT-003 for the treatment of DMD.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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Lung cancer screening recommended in Scotland, Wales and Northern Ireland

PharmaTimes

The disease is one of the leading causes of cancer deaths in the UK - News - PharmaTimes

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MedKitDoc Founder Develops Advanced Telemedicine Platform Integrating Medtech for Effective Remote Healthcare

MedCity News

MedKitDoc Founder Dorian Koch shared the journey of the startup, which wants to transform the way patients receive healthcare.

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Clarivate named as a Representative Vendor in the 2023 Gartner® Market Guide for Intellectual Property Management Software With R&D-Specific Use Cases report

Clarivate

Research and development (R&D) plays a fundamental role in generating the innovation that is essential for maintaining competitive advantage. We are pleased that Clarivate is included in the recently released Gartner report, Market Guide for Intellectual Property Management Software With R&D-specific Use Cases. “This guide offers R&D leaders a sampling of available IP management products that deliver on R&D-related use cases.

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Ipsen/Genfit eye June FDA verdict for liver drug elafibranor

pharmaphorum

The FDA has kicked off a priority review of Genfit and Ipsen’s elafibranor as a treatment for rare cholestatic liver disease primary biliary cholangitis (PBC), setting a date of 10th June to deliver a decision.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Real Chemistry’s CEO on biopharma’s outlook in 2024

PharmaVoice

Shankar Narayanan, CEO of marketing consulting firm Real Chemistry, weighs in on where the industry is headed in the New Year.

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How to Get into Pharmaceutical Sales

Rep-Lite

Getting into pharmaceutical sales and selling pharmaceutical products may require patience and persistence, but for individuals with the right qualifications and a passion for the field, it can be a rewarding and financially lucrative career. In this article, we’ll delve into the intricacies of how to get into pharmaceutical sales and the pivotal role of training.

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Calcitonin Gene Related Peptide Type 1 Receptor drugs in development, 2023

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Calcitonin Gene Related Peptide Type 1 Receptor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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What is Sales in Banking? A Friendly Guide from a Customer's Perspective

Contrarian Sales Techniques

Wondering about, "What is sales in banking?" Well, you're not alone. As someone who's navigated the banking world from a customer's viewpoint, I've got some insights to share. Imagine we're just a couple of friends talking over coffee, and I'm about to unravel the mystery of sales in the banking sector. What is Sales in Banking? Sales in banking, simply put, is the process where banks and financial institutions persuade us, the customers, to use their products and services.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.