2021

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FDA clears GE Healthcare AI algorithm for patient intubation

pharmaphorum

An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. The new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation – for example prior to ventilation in patients with critical COVID-19 – and make sure their ETTs are positioned correctly.

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New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials

Outsourcing Pharma

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

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Nearly 32,000 Kaiser Permanente workers set to strike Nov. 15. Tens of thousands more mulling their own demonstrations

Fierce Healthcare

Nearly 32,000 Kaiser Permanente workers set to strike Nov. 15. Tens of thousands more mulling their own demonstrations. dmuoio. Fri, 11/05/2021 - 10:58.

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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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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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Around 250 digital health apps are launching every day, says IQVIA

pharmaphorum

There was a dramatic increase in the launch of health-related mobile applications last year, taking the total number on offer in app stories to 350,000 – and while average quality is currently “middling” it is on the rise, according to a report from IQVIA. The pandemic contributed to another 90,000 apps being introduced in 2020 – an average of 250 per day – and this coupled with rising number and functionality of wearable devices “provides evidence of digital health’s acc

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SMA Awareness Month: How pharma and digital solutions can improve patient care

pharmaphorum

Spinal Muscular Atrophy (SMA) is a rare disease affecting the motor nerve cells in the spinal cord. It’s a debilitating condition that affects 1 per 8,000 to 10,000 people worldwide , impacting their ability to walk, eat, and breathe. SMA Type 1 represents an estimated 50% of all cases, for which life expectancy is less than 18 months without treatment. .

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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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BioNTech takes its first cancer vaccine into phase 2

pharmaphorum

It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot. Now, the German company has issued a reminder of its original R&D mission with the start of the first phase 2 trial of BNT111 – the first of several cancer vaccine candidates – in patients with skin cancer.

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AI could be used to guide drug therapy for heart failure

pharmaphorum

UK researchers have used artificial intelligence (AI) to develop a way to identify patients with heart failure who would benefit from treatment with beta blockers, by interrogating data from nine landmark clinical trials. The study applied machine learning to trial data involving 15,659 patients who were being treated for heart failure with reduced ejection fraction (HFrEF), a form of heart failure where the left side of the heart isn’t able to pump blood effectively around the body.

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Older people ‘more likely to engage with digital physiotherapy care’

pharmaphorum

Researchers in the US have found that older people are far more likely to engage with digital physiotherapy programmes digitally than those in younger age groups. Gen Xers, working-age baby boomers and retirees – collectively the over-41 age bracket – were more likely to start a musculoskeletal (MSK) programme delivered via digital channels than Gen Zers and millennials, according to Hinge Health, whose back and joint pain programme was used in the study.

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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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DeepVerge’s nanochip-based COVID breath test could be ready this year

pharmaphorum

DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. The company has already completed of the system that resembles a breathalyser in phase 1 and phase 2 studies with the SARS-CoV-2 virus in the safety of laboratories.

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EU probes low platelet safety issue with COVID-19 shots

pharmaphorum

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be a concerning week for vaccine safety.

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A new approach to COVID-19 treatment

pharmaphorum

While pharma has raced to develop COVID-19 vaccines, US-based company NeuroRx is taking a different approach to treating the virus. CEO Dr. Jonathan Javitt tells pharmaphorum about the science behind the company’s Zyesami, which targets the alveolar type II cells in the lung that are critical for transmission of oxygen. Zyesami was developed in conjunction with partner Relief Therapeutics, and NeuroRx is currently awaiting results from a Phase 2b/3 trial ( COVID-AIV ) evaluating the therapeutic

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Digital health: the new normal?

pharmaphorum

Personalised and tailored healthcare that utilises patient’s data is rapidly becoming a reality. Ben Hargreaves looks at the concrete steps already being taken by companies in the area. Amongst the many ways in which the pandemic has changed the way in which we live, one of the most common experiences for most people was to revise what it means to have a face-to-face meeting.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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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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IBM-led group wins German contract for digital vaccine passport

pharmaphorum

Germany has awarded a tender to a consortium led by IBM to develop a secure app that will provide a digital version of the country’s paper vaccine certificates. The €2.7 million ($3.2 million) contract covers the app and a backend system to allow for integration with IT systems operating in medical practices and vaccination centres, according to details published in the Official Journal of the EU.

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Privacy issues widespread with digital health apps, says BMJ

pharmaphorum

Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. The team from Macquarie University compared 15,000 free mobile health (mHealth) apps available on the Google Play store and compared their privacy practices to those found in 8,000 non-health apps, finding “serious problems with privacy and inconsistent privacy practices.” The range of apps put under scrutiny included tools for managing hea

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Gene editing: beyond the hype

pharmaphorum

Genome editing is an exciting but still nascent field, and companies in the area face as many obstacles as they do opportunities. Sangamo CEO Sandy Macrae told us how his company is being cautious about the hype and finding ways to be financially viable in an emerging space. ‘Cutting edge’ is, for once, a truly apt description when it comes to gene editing – both because the field is pushing medicine into areas we might never have dreamed possible, and because these technologies involve literall

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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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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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Digital fabric could be used to measure health data

pharmaphorum

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. The team from Massachusetts Institute of Technology (MIT) claim this is the first example of a fabric which can record data in a digital rather than in an analogue format, allowing it to be programmed like any other digital device.

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UK Vaccine Taskforce head lifts lid on Novavax deal

pharmaphorum

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in the country at a plant owned by FUJIFILM Diosynth Biotechnologies in Stockton-on-Tees.

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How blockchain can revolutionise medical records and save lives

pharmaphorum

Balancing medical privacy with ease of access for healthcare professionals is a challenge, but technology could provide the solution, says Aleph Zero Foundation’s Matthew Niemerg. Most people don’t think of healthcare when they hear blockchain, and that’s understandable; the technology so far hasn’t gone much beyond financial instruments – at least, not in the eyes of the public.

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The digital transformation of pharma’s physician engagement strategies

pharmaphorum

The exact shape of healthcare’s post-COVID ‘new normal’ is still being framed, but it is clear that some trends are already taking shape – and one of the key ones is digital transformation in pharma. The pandemic has ushered in a number of major changes to healthcare systems, notably in the ways in which pharmaceutical companies communicate, visit and engage with physicians.

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UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

pharmaphorum

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.

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Unlocking health data to improve oncology outcomes

pharmaphorum

As the largest single-payer healthcare system in Europe, the UK’s National Health Service (NHS) has a uniquely beneficial health data and real-world evidence (RWE) environment. It’s one that has global potential to improve patient outcomes but efforts to harness the true potential of these information flows are only just beginning. The foundation for this is the NHS’ longstanding commitment to collecting healthcare data.

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GDPR represents an “urgent threat” to the EU’s research leadership role

pharmaphorum

More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? . A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data.

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Study finds Germany trails Spain and the US in digital health

pharmaphorum

Germany is lagging behind other countries in the adoption of digital health, including Spain and the US, according to a new survey carried out on behalf of drugmaker Fresenius. . The three-country poll found that Spain is way out in front, with over half of people asked responding that digital is already playing a major role in the networking of healthcare facilities, diagnosing illnesses and telemedicine.

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Gilead says Veklury should work against COVID-19 variants

pharmaphorum

Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa. According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.

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Gamification for patient care, medical education, and virtual engagement

pharmaphorum

“Gamification” – adding game-like elements into non-game or real-world settings – has become a popular concept in the pharmaceutical, healthcare, and event industries, especially as virtual engagement becomes more common during COVID-19. However, it is proving more than a mere buzzword. With diverse applications and approaches, it is quickly becoming a promising tool for patient adherence, chronic disease management, preventive medicine, rehabilitation, and paediatric care, as well as for medica

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Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

pharmaphorum

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year.

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Apple, Google block NHS contact tracing app update on privacy grounds

pharmaphorum

A scheduled update to the NHS COVID-19 app has been blocked because it allows location tracking – something prohibited by Apple and Google, which developed some of the code it uses. . The new version of the app used in England and Wales was due to become available today to coincide with the relaxation of lockdown rules, with the public now able to attend venues such as non-essential shops, pub beer garden, gyms and hairdressers.

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White paper reveals pathway for digital therapeutics use in Italy

pharmaphorum

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month. The book features insights and recommendations from 40 leading experts in the field, who hope that Italy will begin to follow in the footsteps of early adopters of digital therapeutics such as Germany, France and

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Italian ‘chatbot’ predicted COVID-19 spikes, says study

pharmaphorum

An online tool used by people in Italy to manage their potential exposure to COVID-19 using a simple chat interface has shown that it can spot emerging trends days ahead of the national surveillance system. The decision support system (DSS) – developed by Italian digital health startup Paginemediche – provided a way for people to assess and interpret their symptoms and provide guidance on what to do next, such as self-isolate or seek out a test.

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