Sat.Nov 12, 2022 - Fri.Nov 18, 2022

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Nothing to sneeze at: AstraZeneca donates thousands of nasal spray flu vaccines after Swiss pricing row

Fierce Pharma

Nothing to sneeze at: AstraZeneca donates thousands of nasal spray flu vaccines after Swiss pricing row. fkansteiner. Thu, 11/17/2022 - 13:27.

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.

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Two Pharmacy Owners Plead Guilty in $18M Foreign Medicare Fraud Scheme

MedCity News

The scheme started in New York but became a complex international endeavor as the two men attempted to launder money received from fraudulent Medicare claims for cancer drugs during the pandemic.

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MHRA approves first gene therapy for infusion into the brain

European Pharmaceutical Review

Upstaza (eladocagene exuparvovec) is the first and only approved treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and is the first marketed gene therapy for direct infusion into the brain. The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain.

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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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NICE gives thumbs-down to 5 COVID-19 drugs including AZ's Evusheld and Merck's Lagevrio

Fierce Pharma

NICE gives thumbs-down to 5 COVID-19 drugs including AZ's Evusheld and Merck's Lagevrio. kdunleavy. Wed, 11/16/2022 - 09:44.

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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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Implantable Device Adheres to Muscle, Treats Atrophy

Medgadget

Scientists at the Wyss Institute for Biologically Inspired Engineering at Harvard have developed a mechanically active gel-elastomer-nitinol tissue adhesive, otherwise known as MAGENTA. The implantable device functions as a soft robot, and it can be adhered to the outside of a muscle. When an electrical charge is applied to the device, a spring inside made from nitinol (a shape memory alloy) heats up and begins to actuate, creating a contraction and stretching effect on the attached muscle.

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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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Novartis said to be eyeing sale of ophthalmology, respiratory units

pharmaphorum

Novartis has already spun out its eyecare business Alcon, and is now considering the sale of its ophthalmology and respiratory medicines businesses as it continues a narrowing of its focus, according to media reports. A Bloomberg article citing people close to the matter claims that Novartis is engaged in early discussions about the sale of the two units, which could raise billions of dollars in capital that could be reinvested into the pharma group’s pipeline.

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Telehealth: A Boon for Treating Substance Use Disorder? Or a Risk?

MedCity News

While telehealth has provided many benefits throughout the pandemic, it can be a lonely and sterile way of receiving treatment. Individuals experiencing substance use disorder who only receive treatment through telehealth may miss opportunities to connect with others in support of the recovery process.

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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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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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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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Machine learning: An essential tool in the shift to risk-based quality management

MedCity News

Risk-based quality management is a data monitoring approach that accelerates the drug development pathway without compromising on safety – and one that is enhanced by the use of technologies such as artificial intelligence.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working.

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Novartis targets eye, respiratory units for potential sell-offs after Sandoz: Bloomberg

Fierce Pharma

Novartis targets eye, respiratory units for potential sell-offs after Sandoz: Bloomberg. aliu. Wed, 11/16/2022 - 10:15.

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Extra Hot Nanoparticles for Cancer Therapy

Medgadget

Researchers at Oregon State University created a new type of hyperthermic magnetic nanoparticle that is intended to assist in destroying tumors through localized heating under an alternating magnetic field. Previous iterations of such technologies could heat up to about 44 degrees Celsius (111 F), which was only effective in easy-to-access tumors that can be reached with a hypodermic needle, allowing a clinician to inject a large number of the nanoparticles directly into the tumor.

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Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression

MedCity News

Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzeild has received FDA approval for delaying the onset of the most severe stage of this chronic disease.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Ultimate Door to Door Sales Guide (With Tips & Scripts)

Spotio

Looking to level-up your door to door sales process in 2022? This guide is for you. Let’s be honest. There is a stigma around door to door sales and that it’s an antiquated way of selling. As the next generation of outside sales reps join the workforce, the majority are unaware just how powerful door to door selling can be. We know the reason D2D prospecting is still relevant: It works.

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With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug

Fierce Pharma

With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug. kdunleavy. Fri, 11/18/2022 - 10:21.

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Meeting MSL training needs in an evolving landscape

pharmaphorum

As medical treatments become more complex, the role of the Medical Science Liaison (MSL) has never been more important. Healthcare professionals trust MSLs to keep them informed and up-to-date about the latest treatments, especially in fast-moving areas like oncology. But who keeps the MSLs up-to-date, and who makes sure they have the hard and soft skills necessary to be an effective partner for healthcare professionals?

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With Its New, Outsourced Virtual Care Model, Will the Third Time Be the Charm for Amazon?

MedCity News

Instead of building its own network of providers and bringing hybrid care services to employers like it did with Amazon Care, the new Amazon Clinic model is direct-to-consumer and outsources to third-party providers. It will likely be the more successful route for the retailer, after failing with Haven and Amazon Care, experts said.

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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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4 pioneering social media campaigns in pharma this year

PharmaVoice

The key to a great social media campaign is often simplicity, and these pharma companies hit the nail on the head with unique strategies that aim to educate.

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Lilly wades deeper into copycat insulin market, scoring interchangeability tag for Lantus biosim

Fierce Pharma

Lilly wades deeper into copycat insulin market, scoring interchangeability tag for Lantus biosim. fkansteiner. Fri, 11/18/2022 - 11:01.

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GSK, J&J, and AZ head this year’s access to medicines ranking

pharmaphorum

The 2022 edition of the Access to Medicine Index (ATMI) – which places the top 20 pharma companies for their efforts to improve delivery of medicines to lower income countries – sees GSK retain the number one position, newly joined by Johnson & Johnson in second and AstraZeneca in third. GSK scored highly as its R&D programmes encompass a sizeable chunk of the 83 high burden priority diseases covered in the assessment, an integrated access to medicine strategy in its governance, and robu

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LG, Amwell Launch New Healthcare TV Kit to Fight Burnout and Workforce Shortages

MedCity News

LG launched the first solution to come from its collaboration with Amwell. The product, called the Carepoint TV Kit 200L, is in beta testing but will soon be sold to hospitals to help clinicians virtually connect to patients’ rooms. Powered by Amwell’s Converge platform, the product is aimed at helping clinicians more easily engage with patients amid healthcare’s workforce shortage crisis.

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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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NICE to update endometriosis guidelines to improve diagnosis and surgical management

Pharmaceutical Technology

The National Institute of Health and Care Excellence (NICE) has agreed to update its guidelines on endometriosis diagnosis, surgical management, and surgical management when fertility is a priority. The decision came following a surveillance review led by NICE, which identified sufficient new evidence to support this update. This marks the first update to NICE’s endometriosis guidelines since 2017, representing a huge milestone for patients and practitioners alike.

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With Arcutis' steroid-free cream off to the races in plaque psoriasis, company pads case for eczema expansion

Fierce Pharma

With Arcutis' steroid-free cream off to the races in plaque psoriasis, company pads case for eczema expansion. fkansteiner. Wed, 11/16/2022 - 09:31.

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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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Evernorth Exec: Healthcare Access Will Be the Greatest Problem for Consumers and Employers

MedCity News

To combat this issue, Joan Harvey of Evernorth stressed the importance of an omnichannel care model that leverages both in-person and virtual care. She made these comments at the HLTH conference in Las Vegas.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.