July, 2021

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EU backs approval of Moderna’s COVID-19 vaccine in 12-17 year-olds

Pharma Times

Study in adolescents met it primary endpoint, successfully bridging immune responses to those observed in an efficacy study in adults

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Virtual reality therapy: The future of chronic pain management?

pharmaphorum

Could virtual reality tools be effective in helping patients ‘unlearn’ their chronic pain? p harmaphorum speaks to Professor Christopher Eccleston from the University of Bath’s Centre of Pain Research to find out how digital therapeutics are shaping the future of pain management. A digital software developed by Finnish drugmaker Orion is aiming to address chronic pain conditions using virtual reality (VR) devices that provide an immersive gamified therapeutic treatment program.

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Johnson & Johnson Recalls Sunscreen Because of Benzene Traces

NY Times

The company said it had determined that daily exposure to five Neutrogena and Aveeno sprays would not cause adverse health effects, but recalled the products out of an abundance of caution.

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ACD/Labs, Science Data Experts establish AI partnership

Outsourcing Pharma

The two companies will work together to come up with solutions that use machine learning and artificial intelligence to help accelerate innovation in R&D.

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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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Crisis Communications and FDA

Eye on FDA

In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage. Perhaps no other decision by the Food and Drug Administration has garnered as much controversy, as the recent one to authorize the accelerated approval a new treatment for Alzheimer’s.

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Which pharmaceutical companies have the most ointment dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most ointment dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most ointment dosed drugs…. The post Which pharmaceutical companies have the most ointment dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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Moderna plans triple vaccine targeting flu, COVID and RSV

pharmaphorum

Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains. . The first patents have now been enrolled into the study of the shot – codenamed mRNA-1010 – which is designed to generate antibodies against influenza A H1N1, H3N2 and influenza B Yamagata and Victoria – all of which are recommended by the World Health Organization (WHO).

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As Lebanon’s Crisis Deepens, Lines for Fuel Grow, and Food and Medicine Are Scarce

NY Times

The World Bank said the financial crisis could rank among the world’s three worst since the mid-1800s. The currency has lost more than 90 percent of its value and unemployment has skyrocketed.

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Medicenna takes on deadly brain cancer in clinical trial

Outsourcing Pharma

The immunotherapy firm is conducting a Phase III trial centered on an innovative approach to treating recurrent glioblastoma, an aggressive brain cancer.

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What They Said – FDA Press Releases Mid-2021

Eye on FDA

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’

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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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New patent for Eisai Inc drug LENVIMA

Drug Patent Watch

Annual Drug Patent Expirations for LENVIMA Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph…. The post New patent for Eisai Inc drug LENVIMA appeared first on DrugPatentWatch - Make Better Decisions.

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New hope for long COVID blood tests after antibody discovery

Pharma Times

Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms

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AI-driven ‘clock’ predicts aging-related illness and mortality

pharmaphorum

Scientists in the US have developed an artificial intelligence-powered ‘clock’ that can estimate a person’s chance of developing an illness or dying based on the pattern of cytokines in their blood. The “inflammatory age” or iAge clock – described in the journal Nature Aging – uses a snapshot of the level of chronic inflammation in the body to predict the chances of developing cardiovascular or neurodegenerative diseases and to give an estimate of lifespan.

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F.D.A. Attaches Warning of Guillain-Barré Syndrome to Johnson & Johnson Covid Vaccine

NY Times

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

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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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ReiThera’s COVID-19 vaccine looks to Phase 3 trial after preliminary Phase 2 data

Outsourcing Pharma

Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiTheraâs COVID-19 vaccine candidate, according to Phase 2 preliminary data.

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OPDP Sends Untitled Letter

Eye on FDA

Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a subscription prior to 2019, would need to sign up again. Apologies for the inconvenience and thanks for your patience. Years ago, a single regulatory action letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) would not have merited a blog posting in and o

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Which pharmaceutical companies have the most drug patents in Poland?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Poland. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Poland? appeared first on DrugPatentWatch - Make Better Decisions.

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Jardiance becomes first SGLT2 inhibitor to show benefit in HFpEF

Pharma Times

Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of Jardiance in HFpEF patients

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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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UK biotech ‘booming’ as sector rakes in £1.6bn in Q2 financing

pharmaphorum

The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for UK biotech and life sciences companies, headlined by DNA sequencing company Oxford Nanopore’s £195 million raise in May that was just shy of the £205 million re

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The FDA Should Fully Approve Pfizer and Moderna's Vaccines

NY Times

The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.

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Statins may reduce risk of COVID-19 death: researchers

Outsourcing Pharma

A recent study indicates patients taking the cholesterol-lowering drugs prior to COVID hospitalization are far less likely to die as a result of the virus.

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CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

Pharma in Brief

CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel ). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the Panel’s non-binding recommendations in April 2022.

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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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New patent for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are thirteen patents protecting this drug. XHANCE drug…. The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

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PHE study finds COVID-19 vaccines ‘highly effective’ in at-risk groups

Pharma Times

Vaccine effectiveness against symptomatic disease in at-risk groups is approximately 60% after one dose of either the AZ or Pfizer/BioNTech vaccines

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Rapid COVID immune status test launched in UK, Ireland

pharmaphorum

You’ve had your two COVID-19 jabs, but are you actually protected against infection? That’s a question that a fingerprick test launched today in the UK and Ireland could help to answer. The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

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One Dose of J.&J. Vaccine Is Ineffective Against Delta, Study Suggests

NY Times

Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.

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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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Pharma industry, CROs adapting to COVID-19 impacts: survey

Outsourcing Pharma

A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges.

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Google’s DeepMind puts human proteome online for free

pharmaphorum

The most complete database of protein structures ever assembled, developed with the help of Google’s artificial intelligence unit DeepMind, has been made freely available to researchers around the world. DeepMind partnered with the European Molecular Biology Laboratory (EMBL) to come up with the AlphaFold database, which predicts the three-dimensional structures of the human proteome – nearly all (98.5%) of the 20,000 or so proteins expressed by the human genome.

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Oxford researchers launch HIV vaccine trial

Pharma Times

Vaccine will be evaluated in 13 HIV-negative adults aged 18-65 years old

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NICE ‘no’ for Orchard Therapeutics’ gene therapy Libmeldy

Pharma Times

NICE concluded the cost-effectiveness estimates for Libmeldy are unlikely to be within the range that it would consider an effective use of NHS resources

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Digitisation key to improving mental health services in England; report

pharmaphorum

Faced with a looming mental health crisis, the UK government has been urged to invest in the digitisation of service provision across the NHS in England in a new report from think tank Future Care Capital. The study’s author – FCC’s head of policy and research Dr Peter Bloomfield, argues that there has been a lack of support for mental health services for many years in the UK, and the pathways for accessing them are “convoluted, waiting lists are extensive, and outcomes are po