Fri.Dec 23, 2022

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Financial Management: The Next Area for Innovation in Serving Seniors

MedCity News

Some financial management service companies have earned the patronage of local governments and prestigious funders, including the National Institutes of Health and AARP. It is time for health plans, particularly MA plans, to pay attention as well.

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Lilly and ProQR to expand genetic medicine development agreement

Pharmaceutical Technology

Eli Lilly and Company has expanded a licencing and partnership agreement with ProQR Therapeutics to discover, develop and market new genetic medicines. The companies entered the initial agreement in September last year. This alliance is utilising the Axiomer ribonucleic acid (RNA) editing platform of ProQR to address ailments affecting the liver and nervous system.

Medicine 131
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The Battle Between Primary Care and Time: The Doctors are Losing

MedCity News

With most doctors spending less than 15 to 20 minutes with their patients per visit, there is not much time for fact-finding, let alone education for the doctor to learn what preventive screening resources are available for their patients, even if that care is reimbursable by Medicare/Medicaid, such as a lung cancer screening.

Doctors 119
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Collaboration promotes sustainable pharmaceutical packaging

European Pharmaceutical Review

Astellas Pharma, Eisai, Daiichi Sankyo and Takeda have agreed to collaborate to reduce the environmental burden in the field of pharmaceutical packaging. As part of the collaboration, the four pharma companies plan to share knowledge on packaging technologies to reduce environmental burden. . Areas covered will include blister packs made of biomass-based plastic instead of petroleum-derived plastic, compact packaging, recycled packaging materials, and recyclable packaging materials.

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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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How UnitedHealthcare Is Supporting Americans’ Travel

MedCity News

UnitedHealthcare has recently introduced a set of three travel protection plans called SafeTrip, which offer healthcare insurance and trip cancellation coverage for Americans.

Insurance 112
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7 commercial, sales, and marketing predictions for 2023

pharmaphorum

In 2022, life sciences companies have been hard at work breaking down silos to better serve patients and healthcare professionals (HCPs). They’ve laid the necessary groundwork for cross-functional visibility, collaboration, and connectivity. And in 2023, these investments will hopefully pay off. Here are seven commercial predictions from Veeva’s industry experts for the year ahead.

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Simplify, standardise, digitalise to transform manufacturing

European Pharmaceutical Review

With over 90,000 employees across the globe, Sanofi supplies over 5 billion doses of medicines and vaccines every year, supporting the health needs of millions of patients in more than 170 countries. This responsibility has increased significantly in recent years, due to the COVID-19 pandemic ; the war in Ukraine; rising energy costs and inflation and the increase in geopolitical tensions globally – all of which are creating unprecedented upheaval and disruptions to global supply chains.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from Equiva, First In Venture Studio, and Parallel Bio.

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FDA approves first capsid inhibitor for HIV

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Gilead’s Sunlenca (lenacapavir), a capsid inhibitor for adults living with human immunodeficiency virus type 1 (HIV-1), who cannot be successfully treated with other available treatments. Sunlenca is the first of a new class of drugs called capsid inhibitors to be approved by the FDA for treating HIV-1.

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FDA grants approval for Gilead’s multi-drug resistant HIV-1 treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. The treatment is indicated for adult patients who are heavily treatment-experienced (HTE) with multi-drug resistant (MDR) HIV-1 infection. This approval is backed by findings from the multicentre, double-blinded, placebo-controlled, international Phase II/III CAPELLA clinical trial of lenacap

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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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After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

pharmaphorum

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Here, Richard Staines reports on phase I/II data unveiled at the American Society of Hematology conference that supports further clinical development of inobrodib in multiple myeloma and other blood cancers.

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Merck and Kelun-Biotech enter ADC development deal

Pharmaceutical Technology

Merck (MSD outside North America) has signed an exclusive licence and partnership agreement with Kelun-Biotech for developing seven investigational preclinical antibody-drug conjugates (ADC) to treat cancer. As per the deal, Merck will receive exclusive international licences from Kelun-Biotech for carrying out the research, development, production and marketing of these ADC therapies.

Sales 52
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Exploring the importance we play in our own health maintenance – a pharmaphorum podcast extra

pharmaphorum

While at Anthropy 2022, pharmaphorum’s web editor Nicole Raleigh briefly spoke with Karyn Johnston, chief executive of East Cheshire Hospice, who had taken part in the Adelphi Group’s panel, ‘Later life care and dementia’. Discussing provocative statements, the new Fourth Age, the hundreds of different forms of dementia, and the complexity of patients at end of life – longevity, it was clear, is a gift, but one that comes with its own challenges.

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Study: Travel Times Are Still a Major Obstacle for Women Seeking Breast Cancer Screening

Pharmacy Times

In 10 states, the data showed more than 26% of women had limited accessibility to mammography, primarily in the Rocky Mountains and the South.

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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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Merck puts big bucks behind ADC alliance with China’s Kelun

pharmaphorum

Merck & Co’s efforts to diversify its cancer pipeline beyond immunotherapy blockbuster Keytruda have taken a big step forward with a wide-ranging alliance with China’s Kelun-Biotech that spans seven antibody-drug conjugates (ADCs) in early development. Merck is paying a relatively modest $175 million upfront to secure rights to the programmes, along with an undisclosed equity investment, but the combined value of the deal could reach an eye-watering $9.3 billion if all seven make

Media 52
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NIH Awards $7.8 Million for Antibiotic Study of Patients With Emphysema, HIV

Pharmacy Times

The National Institute of Health’s grant funds a phase 2 clinical trial of doxycycline in a large group of individuals with the 2 conditions who are smokers or used to smoke.

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Roche claims US approval for lymphoma bispecific Lunsumio

pharmaphorum

The FDA has given a green light to Roche’s CD20xCD3 bispecific antibody Lunsumio as a treatment for relapsed or refractory follicular lymphoma, following the lead of the European Commission which cleared the drug in June. The US regulator has approved Lunsumio (mosunetuzumab) for the same indication – patients who have previously been treated with two or more lines of systemic therapy – making it the first CD20xCD3 bispecific to be authorised for this form of non-Hodgkin lymphoma (NHL).

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Top 5 Most Read Zoster Articles in 2022

Pharmacy Times

From newsworthy moments to groundbreaking research, these are the most popular articles in the zoster space, published on Pharmacy Times® during 2022.

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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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EC approves Zynlonta® for large B-cell lymphoma

European Pharmaceutical Review

The European Commission (EC) has granted conditional marketing authorisation for Zynlonta ® (loncastuximab tesirine), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Zynlonta is being developed by Sobi and ADC Therapeutics. The approval follows a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use in September.

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FDA Approves Bispecific Antibody Mosunetuzumab-axgb to Treat Relapsed/Refractory Follicular Lymphoma

Pharmacy Times

The phase 2 GO29781 study showed that 80% of patients who had received at least 2 prior therapies achieved durable response rates with mosunetuzumab-axgb treatment.

FDA 49
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How to Win More Quality Sales Opportunities with the Right Sales Performance Platform

Quantified

Efficiency is tightening up most revenue engines: CRMs are eliminating manual admin work; automated marketing tools allow for better timing and personalization; team-wide communication tools are more practical and intuitive than ever. But training remains trapped in conventional systems and processes. This is bad news when your organization already knows the value of shifting to fast, remote, technology-enabled protocols.

Sales 52
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Innovator Liability Theory Applies to Pharmaceuticals

Pharmacy Times

Can a brand name manufacturer be held liable for damages caused by a drug product manufactured by another firm?

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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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Bottlenecks in buffer preparation – solving downstream issues for upstream gains

European Pharmaceutical Review

Scrutiny of the lifecycle management of buffer solutions has increased recently. However, it has been one of the most overlooked yet fundamental parts of the manufacturing process for biomolecules for many years. The potential for bottlenecks within the scheduling process has a direct effect on facility productivity and a significant impact on the overall cost of manufacturing.

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Study: Survivors of Hodgkin Lymphoma Show Signs of Dementia in Early Adulthood

Pharmacy Times

Participants who survived Hodgkin lymphoma as children showed signs of being biologically older than their peers, with a heightened risk of cognitive problems.

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FDA approves twice-yearly resistant HIV therapy from Gilead

pharmaphorum

Gilead Sciences has claimed FDA approval for Sunlenca, a therapy from Gilead Sciences for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, at the second time of asking. Sunlenca – based on HIV capsid inhibitor lenacapavir – is intended as an add-on to current treatment for the infection. In trials, 81% of participants taking the regimen achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable after six months, w

FDA 52
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Expert Discusses How Pharmacists Can Treat PONV With Medication, Other Therapies

Pharmacy Times

Jawad Saleh, PharmD, BSPharm, BCCCP, BCPS, clinical manager of Pharmacy Services at the Hospital for Special Surgery, discusses how pharmacists can treat postoperative nausea and vomiting.

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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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Expert: Immune System Acts as a Perfect Analogy of Appropriate, Inappropriate Discrimination, Showing Disorder Discrimination Can Cause When It Runs Awry

Pharmacy Times

Steve Simske, PhD, discusses his research investigating how the occurrence of discrimination in biology can act as an agnostic analogy for discrimination in humans’ social environments.

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Study: Imbruvica for CLL Is Less Likely to Lead to Next-Line Treatment Than Acalabrutinib

Pharmacy Times

Results show possible impact of using Janssen Pharmaceuticals’ ibrutinib in the front-line setting, providing additional data on chronic lymphocytic leukemia therapies.

Leads 26