August, 2022

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Woman of the Week: COTA’s Miruna Sasu

PharmaVoice

Miruna Sasu is on a mission to use real world data to help wipe out cancer. She believes this audacious goal is within reach, and as president and CEO of COTA, she is inspiring her team to create a “path to care” for oncology patients.

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FDA authorizes Pfizer and Moderna Covid boosters targeted against Omicron strains

STAT

The Food and Drug Administration on Wednesday authorized new Covid booster shots from Moderna and Pfizer that more closely match the strains of the coronavirus that are currently circulating in the U.S. Pfizer’s booster, made with partner BioNTech, is being authorized for people as young as 12 years old. The Moderna booster is being authorized for people ages 18 and up.

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Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld

pharmaphorum

Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, because the government has shelved plans to offer treatment with AstraZeneca’s antibody therapy Evusheld. That’s the position of multiple patient organisations, clinicians and medical groups, who have criticised the Department of Health’s decision to defer procurement of Evusheld supplies until cost-effectiveness agency

Vaccines 145
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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

Following numerous recalls, the industry is striving to investigate the causes, sources and ways to mitigate carcinogenic nitrosamine impurities. In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

Packaging 143
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.

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New study use musical tests for early detection of cognitive decline

Pharma Times

Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people

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More Trending

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The 5 Stages of Hashimoto’s Thyroiditis

The Thyroid Pharmacist

Did you know that most cases of thyroid disease are autoimmune in nature? (1). Hashimoto’s thyroiditis is an autoimmune condition that happens to affect the thyroid gland. This means that our immune system recognizes the thyroid gland as a foreign invader and begins to attack it, eventually leading to the destruction of our thyroid tissue. When this destruction goes on long enough, the person will lose their ability to produce thyroid hormone.

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Digital health app linked to better outcomes in heart failure

pharmaphorum

A study of a mobile health app used to support patients hospitalised with heart failure has concluded that it provided a modest improvement in quality-of-life scores, as well as better clinical outcomes. The finding comes from the large-scale CONNECT-HF cluster study, which looked at various patient engagement and education interventions to see if they could help patients with heart failure do better after discharge from hospital.

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Non-viral CRISPR could overcome cell and gene therapy bottlenecks

European Pharmaceutical Review

Scientists from the Gladstone Institutes and University of California San Francisco (UCSF) say a new variation of the CRISPR-Cas9 gene editing system enables especially long DNA sequences to be introduced to precise locations in the genomes of cells with remarkably high efficiency without the need for viral vectors. “One of our goals for many years has been to put lengthy DNA instructions into a targeted site in the genome in a way that doesn’t depend on viral vectors,” commented Alex Marson, MD

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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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The Price of Innovation: ‘Paying for a Cure’ Remains Costly Proposition

PharmExec

Curative-type therapies offer great hope in further transforming treatments for cancer and other diseases, but addressing the economics of these products—and ultimately the cost-benefit equation—is daunting. What is being done to smooth the path for pricing and reimbursement?

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3 ways pharma can prep for Biden’s sweeping drug pricing policies

PharmaVoice

Now that Medicare will be able to negotiate drug prices under the Inflation Reduction Act, the industry can expect to see some changes. Here are some tips on how to navigate the changing tide.

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Pharma Distribution: Carving New Ground

Pharmaceutical Commerce

Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own.

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Long COVID but short on treatment options

pharmaphorum

With COVID-19 vaccines and therapeutics developed in rapid time, Ben Hargreaves investigates why this has not been the case with the creation of a treatment for Long COVID. The condition is more common than might be thought and presents a significant burden to patients, and yet the pipeline of potential therapies remains relatively sparse. When the pandemic first struck, the gravity of the situation did not take long to set in.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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MHRA approves Pluvicto® and Locametz® for prostate cancer

European Pharmaceutical Review

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Pluvicto ® (lutetium [ 177 Lu] vipivotide tetraxetan), for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

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Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. VLA15 is the only vaccine for Lyme disease in clinical development, according to GlobalData, the parent company of Pharmaceutical Technology.

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A World of Opportunity

PharmExec

Marie-France Tschudin, president, innovative medicines international, and chief commercial officer at Novartis, taps into life lessons to help bring therapies to people in novel ways­.

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Overcoming mental health’s drug development challenges with AI

PharmaVoice

PsychoGenics is leveraging AI-driven drug discovery platforms to advance mental health treatments for schizophrenia, bipolar disorder and treatment-resistant depression.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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MIT’s AI model can detect Parkinson’s by tracking breathing patterns

Pharma Times

The tool uses a series of connected algorithms that can assess if someone has PD from their nocturnal breathing

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Sword’s digital musculoskeletal care approach improves mental health; study

pharmaphorum

A clinical trial has found that a digital care programme for people with musculoskeletal pain developed by Sword Health can improve their productivity at work, even if they also have mental health issues. Sword Health’s virtual musculoskeletal programme care programme pairs patients with a physical therapist they can talk with via telehealth, guiding them through exercises to address pain and other symptoms and also provides cognitive behavioural therapy (CBT) modules to help them develop

Diabetes 119
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Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

Dubbed Disability Diversity in Clinical Trials (DDiCT), the initiative aims to provide recommendations on how to improve access, engagement, speed of enrolment and participation of people with disabilities in clinical trials. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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No drugs for prions: could new approaches alleviate therapeutic scarcity?

Pharmaceutical Technology

The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. Also referred to as prion diseases, TSEs are rare and fatal neurodegenerative conditions. As per the prevailing prion theory, a misfolded version of a normal cell-surface protein acts as the chief infectious agent.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Leading by Example

The Honest Apothecary

It is my conviction that managers really do make all the difference in the world. Great managers get great results and build great teams. Bad managers don’t. But it is also my conviction that managers generally mirror the leadership culture created by those they report to. There is, if you will, a “trickle down” effect in the style and priorities of your management.

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Right under our noses: Could COVID-19 vaccines be better as nasal spray?

PharmaVoice

Nasal vaccines under development by Codagenix, Xanadu Bio and others have the potential to finally help reduce virus transmission and breakthrough infections.

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Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial

Pharma Times

Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy

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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Managing the next pandemic: the role of nasal vaccine administration

European Pharmaceutical Review

The COVID-19 pandemic has reminded the pharmaceutical industry of several key lessons. It has highlighted the value of cutting-edge technologies, such as messenger RNA (mRNA) vaccines, and reinforced the industry’s understanding of the power of collaboration, including with contract partners such as contract development and manufacturing organisations (CDMOs).

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FDA grants Fast-Track status for Relmada’s major depressive disorder therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). A new chemical entity and NMDA receptor (NMDAR) channel blocker, REL-1017 acts on hyperactive channels while preserving physiological glutamatergic neurotransmission. Presently, the therapy is being analysed in late-stage studies.

Labelling 119
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Auransa, Polaris harness AI, quantum computing to discover cancer drugs

Outsourcing Pharma

The AI and QC specialists have joined to use AI and QC in order to discover biological pathways relevant to the treatment of triple-negative breast cancer.

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The ‘long COVID’ nightmare: Data-driven alliance offers understanding of the lasting viral impact

PharmaVoice

A collaboration between Stanford University researchers and Komodo Health aims to advance knowledge of lingering COVID symptoms, health disparities and intervention strategies.

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What is a 340B covered entity?

PhRMA

We are committed to engaging a wide range of audiences and having a dialogue on opportunities to create a better health care system. We believe health literacy can not only help patients make appropriate decisions about their own health but also help enable constructive conversations on how we can support a regulatory and policy environment that helps patients access life-saving medications.

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