Sat.Mar 13, 2021 - Fri.Mar 19, 2021

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The Apple Watch in clinical trials: Current uses and future possibilities

Bio Pharma Dive

Why the Apple Watch will likely be one of the top choices for use by sponsors, CROs and clinical trial teams wishing to use wearables in their trials.

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Pharma’s reputational high will be short-lived

World of DTC Marketing

SUMMARY: Via the Financial Times , “pharmaceutical companies have never had it so good. The rapid rollout of Covid-19 vaccines has made household names of Pfizer and AstraZeneca, and the whole industry is winning praise for co-operation” However, the bump in reputation will be short-lived because companies need to earn the public’s trust every day, and pharma is already damaging their perception with people.

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AZ’s vaccine safety review shows ‘no evidence’ of an increased risk of blood clots

Pharma Times

Review included available safety data from over 17 million people vaccinated in the EU and UK with COVID-19 jab

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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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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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Record funding flowed into cell, gene therapy companies last year

Bio Pharma Dive

Nearly $20 billion was invested in biotechs developing cell-, gene- and tissue-based treatments in 2020, according to a new report from industry group ARM.

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Dear FDA: WTF?

World of DTC Marketing

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. A brand name is only as effective, or ineffective, as the messaging and brand experience that goes with it.

Branding 180

More Trending

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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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A first-of-its-kind mRNA drug falls short in cystic fibrosis

Bio Pharma Dive

A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines.

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Do pharma marketers have a responsibility to the public?

World of DTC Marketing

IN BRIEF: As a marketer, most of us, like a Jungian archetype, are true Communicators. Yet are those skills only reserved for big budgets, bold pitches, and grand innovations? Or do we, as individuals, have a special responsibility to the public at this moment in time? After all, we are already the translators of science for our clients. . A March 12th, Marist/NPR pole on vaccines is disturbing, but from what I have seen in everyday life, it is worse: · 25% of Black respondents and 28% of white

Marketing 180
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GSK, Medicago launch late-stage trial of plant-derived COVID-19 vaccine

Pharma Times

Vaccine candidate has previously been granted FDA fast track designation

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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Gilead, Merck combine forces in HIV

Bio Pharma Dive

The rivals are now working together on oral and injectable treatments that combine their closely watched experimental drugs lenacapavir and islatravir.

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Value-Based healthcare won’t work

World of DTC Marketing

SUMMARY: Value-based healthcare is a healthcare delivery model in which providers, including hospitals and physicians, are paid based on patient health outcomes. Under value-based care agreements, providers are rewarded for helping patients improve their health, reduce the effects and incidence of chronic disease, and live healthier lives in an evidence-based way.

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New research adds to evidence that POTS may be an autoimmune disorder

Scienmag

Persistent work from scientists at The University of Toledo could aid in diagnosing and treating postural orthostatic tachycardia syndrome Credit: Daniel Miller / The University of Toledo The symptoms of postural orthostatic tachycardia syndrome, or POTS, can be as varied as they are confounding. There can be fatigue, pain, bleeding disorders and anxiety.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

pharmaphorum

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers. Following this, more than 40 megabytes of classified information from the agency’s review were published on the dark web and several journalists, including th

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Detailed Lilly data give mixed picture of Alzheimer's drug's benefit

Bio Pharma Dive

Highly anticipated results from a Phase 2 study of donanemab showed treatment slowed disease progression, but mixed data on other measures could temper optimism in its potential.

Drugs 321
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UK and EU regulators reaffirm the safety of AZ/Oxford Uni’s COVID-19 vaccine

Pharma Times

MHRA and EMA conclude the vaccine's benefits continue to outweigh risks

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Takeover of Spanish manufacturer STE Tecpharm, S. L. – Romaco expands processing business

Pharma Mirror

With the acquisition of the Spanish manufacturer STE Tecpharm, S. L., Romaco strengthens its position as a turnkey supplier of processing technologies. In particular, Tecpharm’s patented drum coaters will complement Romaco Innojet’s granulation and fluid bed technologies. On 18 March 2021, Romaco Holding GmbH announced the purchase of the Spanish manufacturer of processing technology STE Tecpharm, S.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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How to Position Your Program to Investors: Leveraging FDA Feedback to Communicate Risk and Boost Confidence

Camargo

When pitching to investors, a sponsor is not just selling them on the product; it is also selling them on its own ability to develop that product. Investors want to know the risks involved with the program, but they are also evaluating the sponsor as a risk factor of its own. Investing in emerging biopharma companies is a dangerous proposition, especially in Seed or Series A rounds, so savvy early-stage investors will seek their best risk-adjusted return on investment.

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Lilly lays out 2-year plan to gain approval for Alzheimer's drug

Bio Pharma Dive

Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.

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Cambridge Sleep Sciences and Parkinson’s Concierge to test sleep device in Parkinson’s disease

Pharma Times

SleepHub device to be assessed in people with Parkinson's associated sleep issues

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Cannabis Isn’t as Safe as You Think

Pharma Mirror

After over a half-century of lobbying, it seems that cannabis prohibition may finally come to an end at the federal level. For a lot of Americans, many of whom have seen their states legalize cannabis and marijuana products to varying degrees, this may seem like a natural course of events for the harmless but controversial plant. Except, cannabis isn’t entirely harmless.

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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 Everyday Contact Lenses Could Help Monitor Ocular Disease

XTalks

Researchers at Purdue University have developed contact lenses with a new integrated technology that can monitor, and may even be able to diagnose, ocular disease progression. The novel technology has been applied to commercial soft contact lenses so they can be used as a bioinstrumentation tool for unobstructed ocular monitoring. Eye health and ocular disease screening and monitoring typically involve the use of an electroretinogram (ERG), which measures the electrophysical activity of the reti

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AbbVie's approval delay raises further concerns about JAK drugs

Bio Pharma Dive

An FDA request for more data, which comes on the heels of troubling results from a safety study of Pfizer's Xeljanz, could push back by three months AbbVie's plans to get Rinvoq approved in psoriatic arthritis.

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Sanofi, Regeneron’s Libtayo improves survival in cervical cancer patients

Pharma Times

Phase III trial stopped early for positive result on overall survival

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DZNE and Eisai Enter Into Research Collaboration Agreement Aiming for Novel Drug Discovery for Neurodegenerative Disorders

Pharma Mirror

Deutsches Zentrum fur Neurodegenerative Erkrankungen and Eisai Co., Ltd. today announced that both parties have entered into a research collaboration agreement aiming to create potential novel treatments for neurodegenerative disorders including Alzheimer’s disease (AD) which modulate immune competence in neurons and glia cells. DZNE is a world-leading interdisciplinary public research organization constituted with ten research sites in Germany that investigates methods for prevention, dia

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Could a smartphone cough app stop future pandemics?

pharmaphorum

A host of companies are looking at cough apps to detect the presence of COVID-19. But one company called Hyfe wants to take the idea a step further and use them to detect future pandemics, reports Richard Staines. . The pandemic has seen a plethora of digital tools emerge to help manage patients remotely, with the ubiquitous use of smartphone technology allowing medics to monitor patients’ vital signs without risky face-to-face contact.

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Three drugmakers nab $639M as biotech's IPO pace eclipses a record year

Bio Pharma Dive

Nineteen biotechs have now gone public in the first quarter of 2021, raising a combined $3.6 billion and continuing a surge that began during the coronavirus pandemic.

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Finalists from last year’s CROY share their highlights

Pharma Times

Clinical Researcher of the Year – The Americas finalists reveal their positive experiences with the 2020 competition.

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PCR Buffer: Polymerase Chain Reaction Mediator

Pharma Mirror

PCR buffer is a vital component of the Polymerase Chain Reaction, also called molecular photocopying. The reaction has helped scientists worldwide study DNA by providing its ample amount from minimal samples. It is almost impossible to carry on a PCR reaction without a buffer. But what is the main function of a PCR Buffer? How does it help in creating DNA copies?

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.