Sat.Feb 27, 2021 - Fri.Mar 05, 2021

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Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’

Outsourcing Pharma

The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the learnings from the trial â and how could they be applied to vaccine development in the future?

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How accidental advocacy is amplifying the GM1 voice

pharmaphorum

Rare disease families need to stand up and be counted if they want things to change said mum and advocate Christine Waggoner. She spoke to pharmaphorum as part of our Patients Insights series. Like many “rare disease mums”, Christine is an accidental advocate. After her daughter, Iris, was diagnosed with a rare disease at five, friends, family, and strangers donated so much to a research fund-raising campaign that she had to set up a non-profit to deal with it all.

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Can you get melatonin over the counter in the UK?

Druggist

Melatonin is a hormone that is released at night by the pineal gland located in the brain. Melatonin controls the sleep-wake cycle (24-hour cycle). In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., 1998). This post answers the question: Can you get melatonin over the counter in the UK?

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DarshanTalks: Blockchain & Information Technology – March 1, 2021

Pharma Marketing Network

[link]. Blockchain technology has become an increasing tool for life science organizations. How is this technology being implemented, and what value does it offer? Join Darshan Kulkarni as he talks with guest Jim Nasr about the function of blockchain, and how distributed ledger technologies such as blockchain are making an impact on healthcare. The post DarshanTalks: Blockchain & Information Technology</br> – March 1, 2021 appeared first on Pharma Marketing Network.

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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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Prostate cancer drug demonstrates major survival benefit

Outsourcing Pharma

According to Noxopharm, a recent study shows combining its Veyonda drug and a radiopharmaceutical yields favorable results against prostate cancer.

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How advanced technology can streamline the COVID-19 vaccine rollout

pharmaphorum

Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over. More than 100 million people worldwide have been vaccinated thus far, but several new variants of the virus have emerged in South Africa, Brazil and the United Ki

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Understanding and Adapting to the New Patient Journey

Pharma Marketing Network

We’ve talked before about how COVID-19 has upended our personal and business lives, and how the pharma industry was able to – impressively – shift gears to meet the challenges the pandemic brought. But what about patients? And what about the disrupted patient journey? What can our industry do to ensure patients maintain continuity of care at a time when good health is imperative?

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Genetic services can overcome rare disease trial challenges: InformedDNA

Outsourcing Pharma

A leader from the genetic solutions firm explains how genetic testing and counseling can help trial teams form more beneficial connections with patients.

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How clinical trial software can be used to optimize clinical trials

pharmaphorum

Clinical trial software facilitates clinical trials from conception to finish. For example protocol management, CRF design , metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. The aim is to get quality clinical products to the market faster. Traditionally spreadsheets have been used to record and manage all the various aspects of clinical trials.

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New Drug Approval for in-House Developed Anti-Insomnia Drug Dayvigo (Lemborexant) in Hong Kong

Pharma Mirror

Eisai Co., Ltd. announced that its Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. has obtained approval for the in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. This approval is the first approval for DAYVIGO in Asia outside of Japan.

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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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Understanding and Adapting to the New Patient Journey

Pharma Marketing Network

We’ve talked before about how COVID-19 has upended our personal and business lives, and how the pharma industry was able to – impressively – shift gears to meet the challenges the pandemic brought. But what about patients? And what about the disrupted patient journey? What can our industry do to ensure patients maintain continuity of care at a time when good health is imperative?

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US Army taps PPD to conduct PTSD treatment research

Outsourcing Pharma

The CRO will receive funding to fuel a five-year Research Project Award, with the goal to design and conduct research of potential PTSD treatment options.

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Why AI equity is the next step for transformational pharma

pharmaphorum

AI can be transformative for all areas of healthcare, but often these systems are built off biased datasets that don’t reflect the true diversity of the general public – leading to approaches that only work for specific populations. Intouch Group’s Abid Rahman explains this concept of AI equity and gives some practical tips for how companies can work towards it.

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I Holland Announces a New Leadership Team

Pharma Mirror

I Holland, leaders in the manufacture of tablet tooling for the pharmaceutical and nutraceutical markets, has announced a series of appointments to form a new senior management team to lead the company moving forward. The new Board of Directors consists of six highly-experienced team members many of which remain from the previous management team. David Hinds has handed over the baton of Managing Director to Javier Raposo but will continue to serve on the Board as Non-Executive Director.

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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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How Much Melatonin is Safe to Take?

BuzzRx

Melatonin is a hormone naturally produced by the central nervous system in the pineal gland, which is located in the brain. Melatonin release is correlated with the time of day. For example, melatonin levels are lowest during the day and peak during the evening when it is dark. Melatonin secretion regulates the body’s circadian rhythms while synchronizing the sleep-wake cycle throughout the day.

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Shimmer launches upgraded wearable for remote patient monitoring

Outsourcing Pharma

The Verisense Pulse+ can measure heart rate, oxygen saturation, emotional responses, and activity and sleep levels of at-home clinical trial participants.

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GSK hits trouble with Trelegy as EU regulators block asthma indication

pharmaphorum

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. It’s a blow for GSK, which hopes that Trelegy (fluticasone furoate+umeclidinium+vilanterol) will help to revive the fortunes of its respiratory diseases franchise.

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Novartis Piqray(R) – First and only treatment specially for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer receives HSA approval

Pharma Mirror

Novartis announced the Health Sciences Authority (HSA) has approved* Piqray®, an ?-specific class I phosphatidylinositol-3-kinase (PIK3CA) inhibitor, for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2-) negative, advanced breast cancer with a PIK3CA mutation in combination with fulvestrant after disease progression following an endocrine-based regimen.

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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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NHS prescription charges set to rise in England

Pharma Times

Charge will increase to £9.

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People on the Move: March 2021

Outsourcing Pharma

The companies announcing acquisitions, new hires, promotions and other news this month include Syneos, Elligo, PCI Pharma Services, I Holland and more.

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UK chancellor Sunak urged to boost pharma and biotech in budget

pharmaphorum

UK chancellor Rishi Sunak has been urged to recognise the leading role that pharma companies are playing in the economy in this week’s budget. Sunak is due to make his closely-watched budget speech tomorrow (Wednesday) in the House of Commons, starting from about 12.30. The Conservative Party has strong ties with pharma and life sciences and has been backing the industry since David Cameron led it back to power in 2010 with a range of policies aimed at boosting research and investment.

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Accelerating Investigator Recruitment with NLP

Pharma Mirror

NLP and social graphs are effective instruments to speed up investigator recruitment and ensure timely pharmaceutical product releases. Read how NLP can leverage the power of unstructured data and help find doctors-influencers that can substantially provide assistance to a clinical trial. Igor Kruglyak is a Senior Advisor at the global IT service provider Avenga and a 35+ year veteran executive of global key development and deployment projects.

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Genomics plc scores $30m to expand patient-centric health platform

Pharma Times

Latest funding round includes investments from Foresite Capital and F-Prime Capital

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Vocal biomarkers enable unique diagnosis, monitoring capabilities

Outsourcing Pharma

A leader from Vocalis Health explains how health data can be culled from patient voice recordings to screen and monitor COVID-19 and other conditions.

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ISA plans trials of T-cell boosting COVID-19 therapy

pharmaphorum

ISA Pharmaceuticals is planning to take its COVID-19 immunotherapy into the clinic, aiming to harness the power of T-cells to prevent the disease from becoming serious in infected patients. Based in Leiden, the Netherlands, ISA said it has completed preclinical work on ISA106 and is planning clinical trials with a phase 1 dose-finding study in healthy volunteers due in the next few months.

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Medications For Weight Loss – Clinical Breakdown

Med Ed 101

Obesity is a major risk factor for many comorbidities (hypertension, dyslipidemia, osteoarthritis, sleep apnea, heart disease, type 2 diabetes) and increases all-cause and cardiovascular mortality. With over 40% of Americans qualifying as obese (body mass index ?30 kg/m2) in 2017-18 it is no surprise that weight loss remains a hot ticket item today.

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Modified COVID-19 vaccines can avoid ‘lengthy’ clinical studies, says MHRA

Pharma Times

UK’s regulatory authority will fast-track jabs modified to new variants

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Lonza expands solid-form services at Oregon facility

Outsourcing Pharma

The company has increased capabilities at its Bend, Oregon location, including its SimpliFiH Solutions first-in-human services for small-molecule drugs.

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Health Innovators: Owlstone Medical’s Billy Boyle on breath biopsy technology

pharmaphorum

In the latest episode of our Health Innovators series, Paul Tunnah speaks to Billy Boyle, co-founder and CEO of Owlstone Medical, one of the UK’s most promising diagnostic startups. The Cambridge, UK-based company is on a mission to save 100,000 lives and $1.5bn in healthcare costs with its breath biopsy platform for early detection of cancer. Owlstone is developing a breath-based analyser that captures Volatile Organic Compounds (VOCs) in breath non-invasively, and analyses them with high sensi

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Semaglutide For Weight Loss – STEP 1 Trial

Med Ed 101

A new treatment for chronic weight management is likely on the way. In a recent trial, investigators looked at semaglutide for weight loss. The final results of the STEP1 trial (Semaglutide Treatment Effect in People with obesity) were recently reported in the New England Journal of Medicine. Semaglutide, a GLP-1 receptor agonist approved for type […].

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ConserV Bio partners with eTheRNA on mRNA vaccine development

Pharma Times

Collaboration will focus on vaccines for infectious diseases

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Syneos, Protocol First to collaborate on trial data solutions

Outsourcing Pharma

The partnership reportedly will center on optimizing integration for EHR data and remote-source data review to help accelerate clinical research results.

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Could personalised medicine change treatment for migraine?

pharmaphorum

The concept of personalised medicine is becoming established in cancer, with an increasing number of drugs targeting specific mutations making it to market. Alec Mian, CEO at diagnostics firm Curelator, spoke to pharmaphorum’s news editor Richard Staines about the company’s plans to apply a similar paradigm to other diseases such as migraine. . There has been noticeable progress in migraine as a disease area in the last few years, with a new class of drugs coming to market that could help preven