Sat.May 08, 2021 - Fri.May 14, 2021

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Fate offers glimpse at 'natural killer' cell therapy for leukemia

Bio Pharma Dive

The biotech's treatment is part of a wave of new treatments meant to mimic the effects of natural killer cell transplants in leukemia, though analysts remain skeptical.

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Thoughts on working with and in the pharma industry

World of DTC Marketing

THOUGHT: I love working in the pharma industry. Yes, I have been critical of the industry because I believe there is too much focus on pleasing Wall Street, yet I believe that there are some really good people starting to climb the ladder and that soon we’ll see some really substantial changes. Believe in what we can do together. One change in the workplace is that employees want more of a say about their company when it comes to social and moral issues.

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In the News: April 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire. The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval.

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After Months of Prodding, CDC Updates Guidance on COVID-19 Airborne Transmission

BioSpace

The CDC says that COVID-19 is an airborne threat, stating that transmission and subsequent infection can occur via inhalation of very fine respiratory droplets and aerosolized particles.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Moderna founder launches new biotech, looking to cure diseases through 'endless RNA'

Bio Pharma Dive

Laronde comes equipped with $50 million in funding from Flagship Pioneering and a goal to upend how diseases are treated with long-lasting RNA medicines.

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The responsibility for chronic health issues

World of DTC Marketing

IN SUMMARY: Hypertension, diabetes, and obesity drive a lot of healthcare costs, and the obesity epidemic may be one of the root causes of the rise in rates of hypertension, diabetes and even certain types of cancer. As the oldest millennials start to hit 40, many are finding themselves coping with chronic health conditions — more so than previous generations, according to some recent research and it’s going to lead to higher healthcare costs for ALL of us.

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Cellino Develops Scalable, Closed-Loop System for Autologous Stem Cell Manufacturing

BioSpace

Cellino’s unique blend of lasers and machine learning is transforming the manufacture of autologous stem cell therapies from an inconsistent hand-crafted endeavor to a scalable, efficient, closed-loop, modern process.

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FDA authorizes Pfizer's coronavirus vaccine for younger teens

Bio Pharma Dive

The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states are beginning to report waning demand.

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Marketing to physicians

World of DTC Marketing

QUICK READ: Reaching physicians with key brand messages isn’t hard, but the online landscape has become crowded with many players. By far, Medscape is still number one in physician reach , and medical journal advertising has been proven to result in more branded Rx’s. Deloitte showed there is a significant trust gap between pharmaceutical companies and people working in healthcare.

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Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix

pharmaphorum

Coronavirus won’t be circulating in the UK by August, according to the outgoing chief of the country’s vaccine rollout scheme, Dr Clive Dix. Dix led the programme from December until he stepped down last week and told the Daily Telegraph that the UK’s vaccination campaign should be enough to protect from the virus and its known variants by the summer.

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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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Clearing Up a Misconception: COVID-19 Vaccines and Infertility/Pregnancy Loss

BioSpace

A study, published recently in the New England Journal of Medicine, demonstrated no obvious safety signals among pregnant persons who received the mRNA vaccines.

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Merck, with new breast cancer data, aims to rebound from FDA rejection

Bio Pharma Dive

Study results could address concerns raised by FDA advisers who recently voted against approval of Keytruda in patients with early-stage breast cancer.

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Strategies for Your Content Marketing to Have Greater Impact

World of DTC Marketing

It’s 2021. Trends are a whole lot different from what they were a decade ago. This doesn’t just relate to fashion or hobby choices, either. It’s also highly relevant in the marketing world. One of the most essential methods to generate organic traffic is content marketing when it comes to marketing. With the right content marketing strategy in place, a website has the ability to do that all-important climb to the first page of Google.

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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

pharmaphorum

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot. . The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the heart – with the vaccine.

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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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Flagship Pioneering Announces Launch of mRNA Cousin eRNA with Laronde

BioSpace

Over the past year, the world at large has become more familiar with mRNA technology thanks to vaccines developed against COVID-19. Now the world will be introduced to a new type of RNA-based medicine called Endless RNA, or eRNA for short.

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Heron, on third attempt, secures FDA approval for non-opioid painkiller

Bio Pharma Dive

The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020.

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Moderna lands COVID-19 variant vaccine contract, plans flu combo shot

BioPharma Reporter

Moderna has agreed to provide 15m doses of its updated variant COVID-19 vaccine to Australia, providing a boost to its efforts to generate ongoing revenues from its coronavirus work.

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AI in action: Report highlights the real-world benefits of AI in healthcare

pharmaphorum

Joined up thinking is the key to converting AI-driven advances into real benefits for healthcare systems, say NHSX. Healthcare systems the world over have been facing the same challenges for some time – and the pandemic has only served to compound them. Aging populations, a growing number of people living with long-term conditions, and dwindling resources meant the NHS was already being asked to do more with less before COVID-19 hit.

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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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Going to Work Could be Safer than Staying Home in a Pandemic, U of Chicago Study Finds

BioSpace

Staying at home during the COVID-19 pandemic actually increased the spread of infection, according to new study published by the University of Chicago and, soon, by the National Bureau of Economic Research.

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Amgen asks FDA for approval of key asthma drug

Bio Pharma Dive

Tezepelumab is one of Amgen's top experimental medicines and a U.S. OK would help its efforts to offset revenue declines from its aging blockbusters.

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Researchers find CD38-targeting drugs may show promise against prostate cancer

Pharma Times

Researchers are initiating clinical trials to evaluate whether targeting the CD38 pathway can provide benefit for people with prostate cancer

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Alvotech files lawsuit challenging AbbVie’s Humira patent thicket

pharmaphorum

Biosimilars firm Alvotech has filed a lawsuit that challenges AbbVie’s legal defences surrounding the inflammatory disease drug Humira in the US. Alvotech is challenging the patent thicket surrounding Humira, a common ploy in pharma that seems to be particularly effective in the US. Several biological drugs have remained unchallenged on the US market thanks to a legal force-field from supplementary patents, after the main patent has expired and after protection has lapsed in Europe and other cou

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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New Cell Therapy Shows Promise in Treating HIV

BioSpace

At the Seraph Research Institute, scientists presented new research at the 2021 ASGCT that shows promise in treating HIV.

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The use of AI in rare disease has hidden flaws

Bio Pharma Dive

A strategy needs to be put in place to profile patients and then form profile-specific strategies to accelerate diagnosis through HCP outreach, education, etc.

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Pharma TV Ad Spending Trends: Companies in the Top Ten this Week

XTalks

Given that people have spent most of the past year being locked down at home due to the COVID-19 pandemic, it comes as no surprise that much of that time has been spent binging content on TV and through digital streaming services. In light of this, pharma wasted no time throwing some added cash towards TV ads. Taking advantage of the opportunity, the top ten pharma brands spent 17 percent more on TV ads in April 2020 compared to just a month prior, raising their monthly ad expenditures from $156

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4 ways to embed data-driven best practice in pharma HCP communications

pharmaphorum

Virtual communications between sales reps and HCPs jumped significantly during 2020, making it more important than ever for pharma companies to maintain up-to-date customer data. Over the 12 months to December 2020 the number of global Veeva CRM Engage Meetings increased sixfold, while those held in Europe saw an eight-fold increase – with 200,000 remote meetings conducted in Europe in November alone.

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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.

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Rare Disease Companies Unite to Advocate for Life-Changing Therapies

BioSpace

The Rare Disease Company Coalition’s 10 founding members have brought 22 treatments to market and currently have more than 160 rare disease programs in the works.

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Gingko Bioworks to go public through $2.5B SPAC deal

Bio Pharma Dive

Bellco Capital, led by Kite Pharma and Allogene Therapeutics founder Arie Belldegrun, will co-sponsor the transaction alongside Eagle Equity Partners.

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AZ/Daiichi Sankyo’s datopotamab deruxtecan demonstrates ‘promising’ early results in TNBC

Pharma Times

New data presented at the 2021 European Society of Medical Oncology (ESMO) Breast Cancer virtual congress

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How a lack of mental health diagnosis is affecting young men

pharmaphorum

As lockdown gradually eases, things are starting to look up but the lasting impact COVID-19 has had on our wellbeing remains. During Mental Health Awareness Month we look at the mental health stigma amongst men. To say we’re in the midst of a mental health crisis is not an exaggeration. Mental health concerns have been increasing for years and have only been amplified by the COVID-19 crisis and national lockdowns.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.