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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Cancer Moonshot partnership hones in on digital biomarkers

Outsourcing Pharma

Medable will collaborate with Aural Analytics in an initiative funded by the NIHâs seven-year Beau Biden Cancer Moonshot research and development program.

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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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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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BMS pays $650m upfront for Eisai’s first ADC candidate for cancer

pharmaphorum

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 billion. . BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor alpha (FR?

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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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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.

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Consumer group seeks resignation of top FDA staffers over Aduhelm okay

pharmaphorum

With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director of Public Citizen’s Health Research group – Michael Carome – calls the FDA’s approval “reckless” and “one of the most

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White House pledges $3 billion war chest for COVID antivirals

pharmaphorum

The Biden Administration has said it will allocate $3 billion of its pandemic rescue plan to the development of a new generation of antiviral therapies for COVID-19, as well as future viral threats. The plan was announced today by National Institute of Allergy and Infectious Diseases (NIAID) director and chief medical advisor Anthony Fauci, who said a key objective would be to find oral drugs that could be taken at home early on in the course of the disease.

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Supporting and empowering carers to make their voices heard

pharmaphorum

There are an estimated nine million carers in the UK, and their contributions to society, individually and as a group, are unparalleled. Nadine von Dongen and Antonella Porta remind us why carers are the unrecognised backbone of our society. Every day, carers look after some of the most vulnerable people around us, attending to their basic and complex needs and striving to enhance their quality of life.

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Novavax unveils phase 3 COVID jab data, but has it missed the boat in US?

pharmaphorum

The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme. Novavax’ price spiked 9% after the data were announced today, but fell back just as quickly, despite the company’s assertions that it should now be in a position to file for emergency use authorisation (EUA) of NVX-CoV2373 in the third quarter.

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Scottish dads set for mental health app, thanks to Movember funding

pharmaphorum

A Scottish charity has been awarded funding from the Movember men’s health campaign to develop an app to support fathers with mental health concerns. Father’s Network Scotland (FNS) has claimed a share of a £1.86 million ($2.6 million) funding pot earmarked for the development of digital and tech ideas that can help men tackle the mental health challenges that stem from social isolation, which have become increasingly acute during the pandemic.

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New hybrid healthcare agency Stirred launches

pharmaphorum

Healthcare communications specialists Jo Spadaccino and Stuart Hehir have launched a new agency named Stirred which will offer communications, marketing and creative consultancy to healthcare businesses. Spaduccino and Hehir previously worked together at health communications agency Pegasus (recently renamed Mind + Matter). “As the world repairs and responds to the needs of today, health has now truly become everyone’s business,” said Hehir. “Jo and I have always felt a huge

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EU and AZ both claim victory in COVID jab supply lawsuit

pharmaphorum

A court in Belgium has ordered AstraZeneca to deliver additional doses of its COVID-19 vaccine to EU member states by 27 September, although far fewer than the amount sought by the European Commission. The EU had requested 120 million doses by the end of this month and 300 million by end-September, but the judge in the Court of First Instance in Brussels set the total at 80 million doses by 27 September.

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Health Union Acquires WEGO Health

pharmaphorum

Health Union , the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world’s largest network of patient leaders – advocates, community leaders, creators and influencers. Combining Health Union’s targeted scale and depth in the condition experience with WEGO Health’s breadth of patient leaders in nearly all health conditions, Health Union aims to change the face of social health, connecting people in meaning

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Exscientia buys Allcyte to add patient sample testing to its AI platform

pharmaphorum

UK-based artificial intelligence pioneer Exscientia has made a play to stay at the forefront of the field, acquiring Austrian rival Allcyte with the help of its recent $525 million financing. The €50 million ($61 million) deal – in cash and stock – will give Exscientia ownership of a technology platform that takes patient samples and tests them against a library of approved or experimental drugs, using an AI-enabled imaging system to determine which compounds are having an effect.

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EHA21: Study raises BMS’ hopes for Reblozyl in less severe disease

pharmaphorum

Bristol-Myers Squibb has taken another step towards achieving its blockbuster hopes for beta thalassaemia-associated anaemia therapy Reblozyl, after hitting the target in a phase 2 trial in patients who don’t require regular blood transfusions. . Reblozyl (luspatercept) is already approved to treat thalassaemia patients who depend on transfusions, but getting approval in patients with milder disease is seen as the key to unlocking sales that analysts think could eventually reach between $2

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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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