Sat.Jun 12, 2021 - Fri.Jun 18, 2021

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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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Partnership delivers research, care to diverse communities

Outsourcing Pharma

Elligo Health Research is joining forces with Laguna Clinical research Associates to expand access to clinical care to a broader range of patient populations.

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AZ, Pfizer/BioNTech vaccines ‘highly effective’ against Delta variant

Pharma Times

New real world data from PHE shows vaccines can protect against hospitalisation caused by variant

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Gender Pay Gap Worsens Within European Life Sciences Industry

Pharma Marketing Network

The Healthcare Businesswoman’s Association Europe region released an update to its 2018 industry gender pay gap report that shows there is a clear increase in the pay gap between men and women in the life sciences sector in Europe. The median pay gap increased from 11 percent to 13 percent however there is better news looking at individual countries and industry sectors.

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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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Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEO

pharmaphorum

NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of insulin delivered by an externally worn pump, at around 25 specialist centres across England.

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Australia, NZ appealing to clinical researchers: Greenphire

Outsourcing Pharma

Thanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.

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Shared decision making recommendations will ensure people are at the heart of healthcare

NICE

Six years ago, after major surgery, I was diagnosed with Leiomyosarcoma, a soft tissue cancer. In the months - years even - leading up to that diagnosis, I experienced the exact opposite of shared decision making. Decisions were taken for me, not with me. There was no full discussion of the various options available, nor explanation of their likely consequences.

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AZ’s COVID jab tackles delta variant, but antibody fails clinical trial

pharmaphorum

The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the AstraZeneca/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients infected with delta (B.1.617.2, formerly known as the Indian variant), with no deaths recorded, according to AZ.

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Mobile patient engagement solution lands industry award

Outsourcing Pharma

United BioSource received the 2021 Healthiverse Heroes Award for Life Sciences in recognition of its automated clinical trial patient outreach technology.

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Novartis’ Cosentyx wins NICE backing for non-radiographic axial spondyloarthritis

Pharma Times

Axial spondyloarthritis affects approximately one in 200 people in the UK

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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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Alfa Laval makes ‘full-single-use’ cell harvesting possible amid industry challenges

Pharma Mirror

As growing strain on pharmaceutical technology necessitates more efficient practice, Alfa Laval has launched the CultureOne™, the industry’s first premium separator system for single-use cell culture processing. According to Bioplan Associates, single-use bioprocessing technologies now dominate the pre-commercial manufacturing space. However, Alfa Laval states many companies have not been able to make the transition to ‘full-single-use’ when harvesting proteins due to the lack of a single-use di

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Daiichi Sankyo claims first okay for oncolytic virus in Japan

pharmaphorum

Daiichi Sankyo has made a little bit of pharma industry history, becoming the first drugmaker to win approval in Japan for a therapy for cancer based on a virus that selectively kills malignant cells. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted a conditional approval to the company’s Delytact (teserpaturev) for the treatment of patients with malignant glioma, an aggressive form of brain cancer that affects around 2,500 people in Japan.

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DIA 2021 set to shed some light on decentralized trials process, accelerated approval pathways

Outsourcing Pharma

Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.

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Researchers develop COVID-19 antibody test to detect new variants

Pharma Times

New antibody tests can detect if an individual has been exposed to COVID-19 variants, including Alpha and Delta variants

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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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Leadership Series V: Be the Man in the Arena

Colors Make me Happy

As I reflect on my career path, the constructive feedback received from my peers, learners, mentors and loved ones, and the personal and professional challenges I had to overcome, nothing summarizes my leadership style better than the famous quote by Theodore Roosevelt, known as the “Man in the Arena.” "It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better.

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Pandemic paves way for innovative hybrid healthcare

pharmaphorum

While the heroic abilities of the NHS have been on display throughout the COVID-19 pandemic, the last year has also exposed the longstanding limitations and frailties of our underfunded healthcare system, says Maya Ward. With an estimated 100,000 unfilled posts and staff turnover expected to increase due to emotional exhaustion, the health service’s workforce stands to be further stretched by an ageing population.

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Jazz Pharma collaborates wiith groups on digital cancer community

Outsourcing Pharma

The pharma firm is collaborating with oncology organizations on Nothing Small About it, a resource for small-cell lung cancer patients and their loved ones.

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Gov’t announces £36m AI research funding boost for NHS

Pharma Times

NHSX and Accelerated Access Collaborative (AAC) have backed 38 AI-driven research projects

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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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Oral Contraceptive Drug Interactions

Med Ed 101

Oral contraceptives are the most commonly used contraceptive method in the United States. We are often asked about efficacy, missed pills, and return to fertility; however, it’s important to keep drug interactions in mind, too. Below is a non-exhaustive list of common combined oral contraceptive drug interactions. Liver enzyme-inducing drugs Drugs that induce the cytochrome […].

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Transforming pharma R&D with a scientist-centric approach to AI & automation

pharmaphorum

As biopharmaceutical products have become increasingly complex, both in design and in regulatory requirements, we need a new way of working. Markus Gershater looks at how automation and artificial intelligence (AI) can transform pharma R&D. Due to increasing complexity in R&D, pharma teams are under pressure to drive down costs and speed up time to market whilst improving outcomes, and most recognise that incorporating automation and AI into their workflows will be game-changing.

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Hot-melt extrusion can improve bioavailability: Avomeen

Outsourcing Pharma

With bioavailability challenges a frequent frustration for drug developers, one research outfit suggests a technique that could reduce the headaches.

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Vertex, CRISPR Therapeutics’ blood disorder gene therapy shows more promise

Pharma Times

CTX001 is being evaluated as a one-time treatment for transfusion dependent beta thalassemia and sickle cell disease

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Taking Too Many Inhalers: Adherence Benefits of Once-Daily Options

Med Ed 101

In practice, many patients become overwhelmed by polypharmacy. A diagnosis of COPD or asthma can significantly increase the medication administration burden. I’ve heard many patients report that they are taking “too many inhalers.” The basic strategy to remedy medication adherence issues is to assess adherence status, identify the cause of nonadherence, and apply a focused […].

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What’s affordable anyway? The future of NHS drug spending

pharmaphorum

The single biggest monetary difference that can be made to the successor to the UK’s 2019 Voluntary Scheme for branded medicines pricing and access (VPAS) is to address the question of how the allowable growth rate for branded medicines is set. Now that VPAS has hit the mid-point and stakeholders are already thinking ahead to the next deal, Leela Barham delves further.

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Direct-to-patient services boost results, reduce burden: Thermo Fisher

Outsourcing Pharma

A representative from Thermo Fisher Scientific addresses how bringing research and resources directly to participants can address problems with studies.

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Pfizer’s JAK inhibitor Xeljanz shows benefit in COVID-19 pneumonia

Pharma Times

Xeljanz reduced the incidence of death or respiratory failure compared to placebo in hospitalised patients

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Accord launches app to help cancer patients manage symptoms

pharmaphorum

Accord Healthcare has introduced a new app in the UK designed to help people undergoing treatment for cancer maintain their physical and mental wellbeing. The Unify Health app helps patients understand their illness, track symptoms and treatment progress, receive tips on health habits and importantly can also be used to connect patients with local pharmacists who can provide additional advice and support.

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Biogen’s ambitions in gene therapy hit by another failed pivotal trial

pharmaphorum

When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category. . Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal.

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How the patient voice is becoming vital for drug approval

pharmaphorum

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read below for a preview!

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Biogen abandons tau antibody for Alzheimer’s after phase 2 miss

pharmaphorum

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit on cognition symptoms in patients with mild Alzheimer’s, despite being effective at clearing tau out of cerebrospinal fluid.

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MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for

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Regeneron drug saves lives in severe COVID-19, but it’s not for all

pharmaphorum

People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. The therapy significantly reduced the risk of death, the length of hospital stay and the need for a ventilator in the study , which involved around 1,000 subjects who were given a blood test to check whether they had made any antibodies of their own to fight the virus.

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Sage/Biogen’s zuranolone works in depression, but maybe not enough

pharmaphorum

Sage Therapeutics and Biogen’s antidepressant candidate zuranolone has hit its objectives in a phase 3 trial, but a falloff in efficacy over time has raised concerns about the commercial potential of the drug. The WATERFALL trial of zuranolone showed that a two-week course of the oral GABA A receptor modulator significantly reduced symptoms of depression compared to placebo, with a rapid onset of action that started to be seen within three days.