Tue.Nov 15, 2022

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Pfizer musters J&J, PhRMA's support in closely watched Vyndaqel copay assistance case at Supreme Court

Fierce Pharma

Pfizer musters J&J, PhRMA's support in closely watched Vyndaqel copay assistance case at Supreme Court. fkansteiner. Tue, 11/15/2022 - 08:48.

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Data privacy concerns don’t hinder digital health app usage

pharmaphorum

A new survey conducted by juli, an AI-powered chronic condition platform, has revealed that the value placed on digital privacy differs widely among US users. With the HLTH 2022 event now well underway, digital health industry leaders all gathered together to attend in Las Vegas this week, the juli survey results reveal consumer responses to be more varied than one would have expected when it comes to data privacy.

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Ardelyx FDA docs portend another showdown at this week's expert hearing on kidney disease prospect

Fierce Pharma

Ardelyx FDA docs portend another showdown at this week's expert hearing on kidney disease prospect. fkansteiner. Tue, 11/15/2022 - 10:30.

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HLTH 2022 – Day 2

pharmaphorum

Early on Day 2, Matthew Holt (who we recently featured in our Health Innovators video series ) will interview Walmart EVP Dr. Cheryl Pegus & SCAN Health Plan’s Dr. Sachin Jain. Then we’ll hear from Aptar Digital Health’s Sai Shankar and Pierre Laurent in a session all about patients as partners in healthcare. The day will continue with other hot topics for pharma, including health equity, cell and gene therapy, oncology, and pharmacy model disruption.

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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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GSK, J&J and AZ top global drug access index, but foundation says plenty more work needs to be done

Fierce Pharma

GSK, J&J and AZ top global drug access index, but foundation says plenty more work needs to be done. zbecker. Tue, 11/15/2022 - 18:46.

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Highly Cited Researchers 2022: Using deeper qualitative analysis to help spot research misconduct

Clarivate

Today we reveal our annual list of Highly Cited Researchers. This year we recognize 6,938 scientists and social scientists who demonstrate significant and broad influence among their peers in their chosen field or fields of research. The exceptional individuals designated Highly Cited Researchers 2022 have published multiple highly cited papers, ranking in the top 1% by citations for field and year over the last decade.

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Dementia: Lifestyle Habits Are Way More Important Than We Think

MedCity News

Ideally, novel therapeutics will be introduced in combination with lifestyle interventions that are going to need to be personalized to each individual, and anchored in reliable, longitudinal metrics to enable modifications as needed.

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AbbVie inks $54M settlement to resolve Namenda 'pay-for-delay' lawsuit

Fierce Pharma

AbbVie inks $54M settlement to resolve Namenda 'pay-for-delay' lawsuit. zbecker. Tue, 11/15/2022 - 11:15.

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Judge Declares Georgia’s 6-week Abortion Ban Unconstitutional

MedCity News

Judge Robert McBurney of Fulton County said sections of the Living Infants Fairness and Equality Act passed in 2019 were unconstitutional when drafted and enacted, therefore there is “no legal basis” for the ban which has banned abortion after six weeks. .

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FDA moves to boost access to overdose reversal med with preliminary over-the-counter endorsement

Fierce Pharma

FDA moves to boost access to overdose reversal med with preliminary over-the-counter endorsement. fkansteiner. Tue, 11/15/2022 - 16:25.

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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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Roche deepens ties with Jnana with a second licensing deal

pharmaphorum

Swiss pharma group Roche has doubled down on a partnership with Jnana Therapeutics, paying $50 million upfront to tap into the Boston-based biotech drug discovery platform for a wide-ranging push across cancer, immune-mediated, and neurological diseases. The new agreement – announced on the same day that Jnana finalised a $107 million series C financing – has a potential deal value of around $2 billion and comes two years after Roche paid $40 million upfront with $1 billion at the back-end for a

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Lumos' oral growth hormone drug falls short of Novo's injectable incumbent at interim analysis

Fierce Pharma

Lumos' oral growth hormone drug falls short of Novo's injectable incumbent at interim analysis. ntaylor. Tue, 11/15/2022 - 08:42.

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Making Tumors Tastier for the Immune System

Medgadget

Researchers at The University of Texas MD Anderson Cancer Center have developed a nanotechnology platform that can make cancer cells more vulnerable to immune attack in the body. The researchers call their system the bispecific tumor-transforming nanoconjugate (BiTN) platform. The idea is to make solid tumors more appealing for the immune system by attaching a molecule that acts as an “eat me” signal to white blood cells.

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PharmaJet inks deal to use needle-free delivery tech in polio vaccination campaign

Fierce Pharma

PharmaJet inks deal to use needle-free delivery tech in polio vaccination campaign. ntaylor. Tue, 11/15/2022 - 08:36.

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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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A ‘bold vision’ to prevent diabetes

PharmaVoice

Despite hearing that there’s “no money in prevention,” the CEO of Sigrid Therapeutics is forging ahead with the company’s goal of stopping Type 2 diabetes before it starts.

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Indivior inks $145M Opiant buyout to add nasal opioid overdose drug to portfolio

Fierce Pharma

Indivior inks $145M Opiant buyout to add nasal opioid overdose drug to portfolio. ntaylor. Tue, 11/15/2022 - 09:15.

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New Quantum Health Solution Aims To Provide Employers More Flexibility

MedCity News

The new solution is called Quantum Health Access, which offers healthcare benefits navigation, provider search, claims assistance, point solution referral and member engagement communications.

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TriSalus inks SPAC merger to fund cancer trials of pressure-enabled drug delivery technology

Fierce Pharma

TriSalus inks SPAC merger to fund cancer trials of pressure-enabled drug delivery technology. ntaylor. Tue, 11/15/2022 - 10:03.

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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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Realized Hope: Leveraging Our Modern Understanding of Human Biology To Fulfill the Decades-old Promise of a Miracle Drug

MedCity News

Seventy-four years ago, patients received hope for a medical miracle. Despite the disappointments which have accompanied that hope, steroids continue to play an important role in the treatment of debilitating symptoms of many autoimmune and other conditions. Now, equipped with decades of advances in our understanding of human biology, the time has come to innovate and execute on that promise.

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Propelling clinical research into the 21st century

pharmaphorum

Two and a half years ago, Covid-19 began to infect hundreds, then thousands, then millions of people, and was eventually declared a global pandemic. Lockdowns and 25-second handwashing, face masks, home-schooling, and working from home became the new normal. The term “social distancing” entered into common parlance and we transitioned to a life largely spent at home.

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VC Viewpoint: Cash-pay Care Delivery Has a Serious Social Stratification Problem

MedCity News

When it comes to her feelings about investing in care delivery startups, it’s a real “mixed bag” for Ulili Onovakpuri, managing partner at Kapor Capital. This is because a lot of them operate on a cash-pay model. She summarized the issue quite succinctly: there’s an incredible amount of innovation happening, but the people who could benefit the most from this type of care will be the last ones to receive it.

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Non-Invasive Spinal Modulation for Cerebral Palsy

Medgadget

SpineX , a medtech company based in California, has developed the Spinal Cord Innovation in Pediatrics (SCiP) device, a non-invasive spinal cord neuromodulation technology that is intended to treat children with cerebral palsy. The technology is designed to be used in conjunction with activity-based neurorehabilitation therapy with the goal of improving functional movements in such children.

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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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Making the Most of Structured Data

MedCity News

As the industry strives for data use that is standardized, consistent, and fluid, payers that automate data flow, in the long run, will be able to discern the risk of each member and prioritize their needs to drive member services for outcomes-based care delivery.

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2022 WHO Biosimilar Guideline improves access, IGBA says

European Pharmaceutical Review

The International Generic and Biosimilar Medicines Association (IGBA)’s new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline suggests how the guideline provides great opportunity to revaluate how regulatory requirements can better advance biosimilar access. According to IGBA, the World Health Organization ( WHO) Biosimilars Guideline has been a useful tool for health authorities to boost international regulatory convergence and consistency of term

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Can We Break the Link Between Pain and Addiction?

MedCity News

Opioids are our most effective tool for treating pain, but what if there were a better way to stop pain without relying on addictive substances? To develop a non-addictive painkiller, scientists have been searching for proteins that appear on pain neurons but not in the reward pathway, and this has been no small task.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Since 1991, GAMP ® – a community of practice within the International Society for Pharmaceutical Engineering (ISPE) – has set the tone for the validation practices necessary for regulated pharmaceutical companies to meet the computerized system expectations of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), the Medicines and Healthcare Regulatory Agency (MHRA) in the UK, the Chinese National Medicinal Products Ad

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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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5 Topics Every Medical Sales Training Program Should Include

MedReps

If you want to break into medical sales, there are a certain number of things you need to know. First, you must have some basic medical knowledge, whether it’s from a biology class or an anatomy and physiology course. This will be enough to help you understand exactly what you’re selling and utilize the terminology your customers use on a daily basis.

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LSX Inv€$tival Showcase round-up

pharmaphorum

On 14th November, investors and life science & healthcare executives descended on London’s famed Old Billingsgate building to attend LSX’s Inv€$tival Showcase, part of Europe’s biggest dedicated healthcare investment week. Now in its seventh year, the Showcase gives life science and healthcare corporates the opportunity to pitch, profile, and connect with investors and partners, alongside masterclasses and dedicated 1:1 partnering.

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#HLTH: ‘Unicorns are real’ — and here’s how they can navigate a challenging biotech market

PharmaVoice

Venture capitalists tackle ways companies can stay afloat while the market’s turbulent waters rise.

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Lilly said to be pulling Twitter ads after verification debacle

pharmaphorum

Eli Lilly is reported to be axing millions of dollars worth of advertising spend on Twitter, in the wake of a fake post by an account claiming to be the drugmaker’s ‘verified’ account last week, that wreaked havoc with its share price. It seems Lilly might have cut Twitter some slack if it had responded promptly to its frantic attempts to get the post – put up by someone who paid $8 to verify the imposter @EliLillyandCo account – which claimed that “insulin is free now.&#

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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.