September, 2022

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Fungi find their way into cancer tumors, but what they’re doing there is a mystery

STAT

For a while, scientists thought the trillions of microbes on our bodies lived in landscapes connected to the outside world — our skin, hair, and gut — but research in the last few years has shown that’s not so. When Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, looked deeper, he and several other research groups around the world found bacteria in the milieu of tumors.

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The 2022 PharmaVoice 100

PharmaVoice

From standout executives to R&D pioneers — this year’s class of honorees is defining the next era of leadership.

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Trending Sources

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Genetically modified herpes combats advanced cancers

Pharma Times

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

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First patient dosed with HIV gene therapy

European Pharmaceutical Review

A breakthrough gene-editing therapy for human immunodeficiency virus type 1 (HIV) infection has entered first-in-human testing in what is being called “a major milestone in the search for a cure for HIV/AIDS”. EBT-101, a CRISPR-Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) has been administered to the first individual in a Phase I/II trial designed to establish its safety and efficacy.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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EMCrit 333 – The State of the Fluids Show with the EMCrit Core Team

EMCrit Project

Where are we on Fluids on 2022? EMCrit Project by Scott Weingart, MD FCCM.

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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

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Entrepreneurs: Vincent Keunen

PharmaVoice

With his unique platform, the has built a bridge between patients, physicians and researchers around the world.

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HeartBeat.bio and Molecular Devices link up to automate cardiac organoids

Pharma Times

Collaboration will involve sophisticated screening for cardiac-based drug discovery

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The discovery of a new and compounding cybersecurity threat to pharmacies

pharmaphorum

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc

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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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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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New data: The 340B program is driving up costs for patients and our health care system

PhRMA

Guess what? The 340B program grew, yet again, hitting a whopping $43.9 billion in sales at the discounted 340B price in 2021. But there has not been evidence of corresponding growth in care provided to vulnerable patients at 340B covered entities. And making matters worse, fresh data show that 340B may actually be driving up costs for some patients and our health care system as whole.

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Pfizer isn’t sharing Covid vaccines with researchers for next-gen studies

STAT

WASHINGTON — Researchers studying next-generation vaccines to fight an evolving Covid-19 threat are running into problems getting existing vaccines to use in their research. Because Pfizer and Moderna hold the patents for the current vaccines, researchers would likely have to get the companies’ permission to use them for research into products like nasal or pan-coronavirus vaccines.

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Why precision medicine could be the next frontier in treating autism

PharmaVoice

Swiss-based Stalicla is banking on an AI-driven precision medicine discovery platform to deliver needed therapies in the autism space.

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Eisai's Lecanemab phase 3 study meets primary endpoint

Pharma Times

Results show reduction of clinical decline in global study of people with Alzheimer's Disease

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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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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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Tetra and Cellvera partner to develop oral Covid-19 treatment

Pharmaceutical Technology

Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez. Onternabez is a selective full agonist of the type 2 cannabinoid receptor (CB2R).

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The Manufacturing Edge on Path to Market

PharmExec

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

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STAT+: In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

STAT

At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.

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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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Red Jacket: Fabio Gratton

PharmaVoice

The serial entrepreneur has relied on his gift for storytelling, creativity and a bit of “magic” as he’s launched one successful niche tech company after another.

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Modus completes recruitment for sevuparin study

Pharma Times

Phase 1b study evaluates effects of sevuparin on the symptoms of volunteer participants

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Succeeding in Pharmacy School: Tips, Tricks, and Advice

Pharmacy Is Right For Me

School is starting again, and pharmacy students across the country are hitting the books. Pharmacy school is an exciting time for many, but it can also be scary and intimidating. Check out some tips, tricks, and advice to set yourself up for success in your journey to becoming a pharmacist! Time Management Balancing your classes with studying, extra-curricular activities, working, family, friends, and not to mention sleep can be a tricky balancing act as a pharmacy student.

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Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

PhRMA

As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline.

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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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Bridge Bio will use Brainomix AI in lung fibrosis trial

pharmaphorum

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

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On the Texas-Mexico border, a bold plan to diversify Alzheimer’s research takes shape

STAT

BROWNSVILLE, Texas — Gladys Maestre is on a scouting mission. The Alzheimer’s disease researcher is driving through Southmost, a Mexican American neighborhood just north of looming sections of the border wall and a checkpoint that leads to Mexico. She passes barking dogs and “no trespassing” signs, but doesn’t see a single person outside, despite the comfortable stuffed recliners, refrigerators, and shade canopies that furnish many yards.

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Red Jacket: Udit Batra

PharmaVoice

A combination of logic and love — that’s how the CEO of Waters Corp. leads and how he inspires those around him to “solve the problems that matter.

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Tilt collaborates with MSD on immunotherapy clinical trial

Pharma Times

The study will focus on checkpoint inhibitor refractory non-small cell lung cancer

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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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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Small populations, paediatric patients, and the desire from patients and their caregivers to receive active therapy can make the conduct of randomised trials with placebo control untenable. As an alternative, regulatory agencies have allowed the use of RWE to estimate a historical control (HC) compared to patients enrolled in an uncontrolled study.

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Recognizing National Sickle Cell Awareness Month

PhRMA

September is National Sickle Cell Awareness Month and a time for us to underscore the biopharmaceutical industry’s ongoing commitment to improve the lives of patients, families and communities affected by sickle cell disease.

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Novartis probed by Swiss authorities over ‘unlawful’ patent use

pharmaphorum

The competition authorities in Switzerland said this morning they have carried out a raid on a pharma company – now confirmed to be Novartis – as part of an investigation into a “possible unlawful use of a patent to reduce competitive pressure.” The Swiss Competition Commission (COMCO) arrived unexpectedly at Novartis at dawn on Tuesday morning, to gather information on an unidentified dermatology drug, as part of a wider investigation into the drugmaker by the European Commission.

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Where caregiving is a family affair, Alzheimer’s places a heavy burden on children and spouses

STAT

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

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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.