Wed.Aug 31, 2022

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Life expectancy declines again

World of DTC Marketing

According to STAT News, “Americans born in 2021 can expect to live for just 76.1 years — the lowest life expectancy has been since 1996, according to a new government analysis published Wednesday. This is the biggest two-year decline — 2.7 years in total — in almost 100 years.” It’s only going to get worse too. The Covid-19 pandemic is the primary cause of the decline, but we are ignoring another statistic.

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Novartis extends Kaiku digital patient monitoring partnership

pharmaphorum

Kaiku Health’s year-old alliance with Novartis to develop a digital patient monitoring and management (DPPM) system for patients with melanoma is being extended, according to the two partners. The original agreement last year focused on melanoma patients who are receiving BRAF/MEK combination therapies – specifically Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) drugs – and has resulted in the development of a digital module tailored to their needs.

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Report: Providers are overconfident in their cloud security

MedCity News

The threats of ransomware and phishing are more prevalent than ever, but not all healthcare providers have appropriately adjusted their strategies to mitigate increasing risk. In fact, a new report shows that many healthcare organizations could be overestimating their level of cloud security.

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Woman of the Week: Thread’s Kim Boericke

PharmaVoice

Fresh off an eight-year tour of duty at ICON, the CRO industry veteran is stepping into a new role and a new title as chief delivery officer at Thread.

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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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Why automation, AI and ML are the future of the post-pandemic healthcare world in fraud and waste prevention

MedCity News

While basic medical coding errors and Covid care upcoding are much more common, the grim reality that in 2021 alone, the Department of Justice (DOJ) recovered more than $5 billion from civil fraud and false claims.

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8 Key Features to Consider When Replacing QUOSA as Your Literature Management Tool

Copyright Clearance Center

The post 8 Key Features to Consider When Replacing QUOSA as Your Literature Management Tool appeared first on Copyright Clearance Center.

More Trending

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Phase 3 trial confirms Lumakras role in lung cancer

pharmaphorum

Amgen’s pathfinder KRAS inhibitor Lumakras has been shown to be effective in KRAS-mutated non-small cell lung cancer (NSCLC) in a phase 3 trial that should serve as a confirmation study for its earlier accelerated approval in this setting. The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with

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Medicare Shared Savings Program saved more than $1.6B in 2021, CMS says

MedCity News

This is the fifth consecutive year the program has achieved savings by working with Accountable Care Organizations. Participating ACOs also had better quality measures for physical and mental health conditions than those not in the program.

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FDA clears bivalent Omicron shots from Pfizer, Moderna

pharmaphorum

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron subvariants BA.5 and BA.5. The US regulator has cleared a 30 µg booster dose of a new version of Pfizer’s Comirnaty shot – 15 µg encoding the spike protein of the original wild-type SARS-CoV-2 strain and 15-µg of mRNA coding for Omicron BA.4/BA.5 – for people aged 12 and over.

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Economic instability, loneliness, food insecurity block seniors from accessing care, survey finds

MedCity News

The survey is from Medicare Advantage company Alignment Healthcare. It focused on social determinants of health, which are proven to have more of an effect on overall health than clinical care.

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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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Psyomics links up with Hertfordshire Partnership University NHS Foundation Trust

PharmaTimes

Hertfordshire Trust to invest in mental health care with wide-ranging digital assessment platform

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A Covid-19 reflection: Incorporating what we’ve learned for improved preparedness

MedCity News

Beyond preparedness policies, we need to think forward to policies that rapidly identify the spread of zoonotic disease to prevent or minimize the impact.

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Kaiku Health enters wider partnership with Novartis

PharmaTimes

Following a successful collaboration, the companies will now partner to focus on precision medicine

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Forecyte Bio and Cytiva to Collaborate on Cell and Gene Therapy Manufacturing and Development

PharmaTech

Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.

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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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The People Behind the Data: Improving Employee Engagement and Retention at Penrod

Penrod

Here’s the thing about data , though: it doesn’t always feel very human. So how do we use data when it comes to the most inherently human aspect of our business — our people? One of our most critical “people” data points is employee engagement. Once a quarter, we send out a confidential engagement survey using Culture Amp. To understand overall engagement, we ask questions through the lens of pride, level of recommendation (Net Promoter), commitment, and motivation.

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Costa Rica’s commitment to developing talent in industry 4.0

Pharmaceutical Technology

Availability of labour is an important factor for foreign investors, with the education and skill sets found within that labour force being a decisive driver when it comes to FDI site selection. Data from the UN Conference on Trade and Development’s World Investment Report 2020 and the World Economic Forum’s Global Competitiveness Report 2019 indicates that countries with a higher-skilled and better-educated workforce attract more greenfield FDI projects, but how does a country ensure its workfo

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4 Benefits of Video for the Pharma Industry

Pharma Marketing Network

Video is, without a doubt, revolutionizing the pharmaceutical industry. It presents a tremendous opportunity for pharma and healthcare brands as it is one of the most effective mediums for delivering your message and results in high conversion rates. Why Video Works. We live in a fast-paced, short-lived world that is full of endless information. For digital users especially, this combination means drastically decreasing attention spans.

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Episode 008: Driving Success with Marie-Claude Jacques, Vice President of Sales, US at Baylis Medical

Med Device Careers

In this episode, we sit down with Marie-Claude Jacques, Vice President of Sales, US for Baylis Medical. In our conversation, we discuss her experience as an individual contributor, her perspective on hiring and managing teams, driving customer adoption, and the acquisition of Baylis Medical by Boston Scientific. Marie-Claude has spent over 14 years launching products, opening new markets, and developing teams across North America with Baylis Medical.

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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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Wearables: managing complexities in data privacy and consent in healthcare tech

Pharmaceutical Technology

Over the last few years, the trend for wearables has shown the potential benefits of transforming healthcare through digital technologies. Alongside fitness trackers and smartwatches, there are also medical devices used to monitor a patient’s vitals and some even contain SIM cards to enable two-way communication. Devices such as insulin pumps, heart pacemakers, and inhalers can track patient data in real-time and transmit to the user’s phone, an app, or their doctor, making the data immediately

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Futura eyes FDA filing as topical ED drug passes phase 3 test

pharmaphorum

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. The results of the FM71 trial of MED3000 showed that the topical gel formulation achieved a significant improvement in erectile function compared to baseline at 24 weeks, across the range of mild, moderate and severe ED.

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Negotiation: Splitting the Pie

Pharmaceutical Commerce

Professor Barry Nalebuff of the Yale School of Management explains what is really at stake in any negotiation and ensures you get your half.

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Jounce setback casts deeper pall over ICOS as cancer target

pharmaphorum

A phase 2 trial of Jounce Therapeutics’ ICOS agonist vopratelimab has ended in failure, casting further doubt about the validity of ICOS as a target for cancer therapies. The SELECT study showed that a combination of vopratelimab with Jounce’s PD-1 inhibitor pimivalimab was no more effective than pimivalimab alone when used as a second-line treatment for patients with non-small cell lung cancer (NSCLC) who had not previously been treated with immunotherapy.

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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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Pharmacists Can Fill Unmet Patient Care Needs for Mental Health, Substance Use Disorders

Pharmacy Times

Data have shown there is a rising need for mental health and substance use disorder services, yet there is a shortage of psychiatrists in the country that is estimated to worsen by 2024.

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Priority review sets up Feb verdict on Sanofi, Sobi haemophilia drug

pharmaphorum

The FDA will carry out a speedy review of Sanofi and Sobi’s once-weekly haemophilia A treatment efanesoctocog alfa (BIVV001), with a decision now expected by 28 February next year. BIVV001 is a Factor VIII replacement therapy that is being developed as a successor to Eloctate (efmoroctocog alfa), Sanofi and Sobi’s current Factor VIII drug that is dosed every four days and has seen its sales decline in an increasingly competitive market.

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Overview of New USP Chapters, Upcoming USP Chapters on Temperature Excursion Management for Drug Storage, Distribution

Pharmacy Times

Desmond Hunt, PhD, senior principal scientist at US Pharmacopeia (USP), discusses the standards and resources that USP has recently published or is looking at now on the subject of pharmacy in transit.

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US-based development, testing and fill/finish capacity is now available

PharmaTech

Since 2020, the CDMO landscape has undergone significant changes. Dearth of fill/finish capacity in the US, exacerbated by Covid and vaccine production, caused market dislocation but also opportunity. Here what over 300 decision makers had to say about post-Covid trends - and also the discovery of the industry's best kept secret.a fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing and fill/finish cGMP manufacturing for sterile injectable and topical

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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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FDA Authorizes Updated COVID-19 Boosters From Moderna, Pfizer-BioNTech

Pharmacy Times

With these bivalent vaccine authorizations, the monovalent mRNA COVID-19 vaccines are still not authorized as booster doses for individuals 12 years of age and older.

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Accelerating Biopharmaceutical Virtual FATs in a Pandemic

PharmaTech

Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches.

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Inflammatory Bowel Disease and C. difficile Infection (CDI)

Pharmacy Times

A gastroenterologist, Dr. Bincy Abraham, provides an overview of C. difficile infection (CDI) in patients with inflammatory bowel disease (IBD).

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Industry Perspectives on Quality–A Conversation with Pfizer CentreOne

PharmaTech

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.

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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.