August, 2021

Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms

Bio Pharma Dive

Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter

HCP’s use of social media: the good and the not so good

World of DTC Marketing

SUMMARY: A survey of more than 4,000 physicians showed that virtually every physician uses social media for personal reasons, while two-thirds use it for professional reasons.

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Developmental and Reproductive Toxicology (DART) Studies: What Are They, and How Do They Fit into Your Program?

Camargo

Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings.

SAVE THE DATE: PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 – Sep. 16th

Pharma Marketing Network

SAVE THE DATE – PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 | SEP. 16th, 12:00PM – 1:30PM EST. SAVE YOUR SEAT TODAY. Telehealth: Is It Here to Stay?

Lessons in Supply Chain Digitization from PepsiCo and Conagra

Speaker: Craig Weiss, ConAgra Brands; Mari Roberts PepsiCo; and Matt Elenjickal, FourKites

Supply chain digitalization is key to success as market volatility, widespread disruption & stiff competition for consumer dollars puts pressure on every aspect of the supply chain. Register to hear how 2 global brands are accelerating digital transformation and increasing efficiency & automation throughout their operations.

Superfoods, Super You!

Riverside Clinical Research

A healthy diet can reduce the risk of heart disease, high blood pressure, diabetes and cancer. It can also help you feel and look your best. In order to maintain a healthy diet, we need to consume (in moderation) foods with a wide array of necessary nutrients.

How to address patient privacy and data-security concerns in clinical trials

Clairnes

The post How to address patient privacy and data-security concerns in clinical trials appeared first on Clinical Trial Recruitment & Management Services.

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Change of leadership is needed badly at the FDA and CDC

World of DTC Marketing

SUMMARY: It’s almost impossible for the average person to get accurate and reliable information from the media. Even vaccine booster shots are being debated by HCPs and Pfizer. We need to follow the science. Physiican trust in the FDA is decling as well.

In the News: July 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. Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence.

Increase in extreme precipitation in the northeast caused by Atlantic variability and climate change

Scienmag

Results explain the increase in heavy rain and snow events across the northeast Credit: Figure by Huanping Huang. Recent record-breaking rainfall across the northeastern United States is part of a larger trend.

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Win for Consumers: Federal and State Responses to Surprise Bills 

Triage Cancer

Have you ever been sure you picked an in-network provider for a treatment or test, but later received a surprisingly high bill?

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3 Ways End-to-End Visibility Helps Minimize the Risks of Ocean Freight

Download this playbook to learn how end-to-end visibility helps to mitigate risk associated with the ocean freight market.

Ep. 014 – RJ Lewis and Diane Bartoli of ePocrates Discusses the State of eCME – August 9, 2021

Pharma Marketing Network

Tune in with the Pharma Marketing Network for an insightful conversation with R.J.

How Bayer lured a biotech away from an IPO and into a buyout

Bio Pharma Dive

Vividion Therapeutics was headed toward an IPO earlier this year, but a company executive said Bayer’s $1.5B offer ended up being a more attractive option

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DTC Study: Marketers misaligned with online health seeker needs

World of DTC Marketing

SUMMARY: People are going online more and more to sarch for health information after seeing a DTC pharma TV spot. Pharma websites are not consdiered a top resource for infromation on new products. Cost is not that big of an issue for people who have health insurance.

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 1

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.

4 Silver Linings of the Chaotic Ocean Freight Market

Speaker: Peter Tirschwell, Chris Stauber, Sarah Barnes Humphrey, and Audrey Ross

Join this webinar exploring the silver linings that have emerged from the chaotic ocean freight market. The discussion will highlight solutions that prioritize digitization and build a more efficient international supply chain. Jan 25 at 10am CT.

Oscillometry: An underutilized yet conclusive tool

ERT

As a leader in digital data solutions, ERT recognizes the importance of continuous learning and innovation within the industry to serve our customers best. As such, we regularly host webinar sessions led by experts in various therapeutic areas to educate stakeholders in the clinical trial industry.

Ivermectin Should Not Be Used to Treat Covid, F.D.A. Says

NY Times

“You are not a horse,” the Food and Drug Administration said. Stop it.”. Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Vaccination and Immunization Mississippi Food and Drug Administration ivermectin

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Older people ‘more likely to engage with digital physiotherapy care’

Pharma Phorum

Researchers in the US have found that older people are far more likely to engage with digital physiotherapy programmes digitally than those in younger age groups.

US to offer coronavirus boosters to all Americans in aggressive plan to counter delta's spread

Bio Pharma Dive

The Biden administration's call comes ahead of FDA authorization for additional doses in people who aren't immunocompromised, although agency head Janet Woodcock joined other officials in supporting the plan

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The Smart Data Revolution: How AB InBev Drives Efficiency with Visibility Data

Speaker: AB InBev and FourKites

Register for our upcoming webinar to learn how leveraging the right data to make quick, well-informed decisions is the key to success in supply chain & logistics. Join FourKites and AB InBev to learn what’s possible with a data-driven supply chain strategy & real-time transportation visibility.

Health literacy is a huge problem

World of DTC Marketing

SUMMARY: The states struggling the most with covid-19 infections also have the least healthy populations. About two out of five American adults are obese, according to the CDC. Mostly because they don’t understand how what they eat effects their health.

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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance.

New COVID-19 Variant C.1.2 Sparking International Concern

BioSpace

A new variant, C.1.2. is causing public health experts worldwide to keep an eye out for its presence as it seems to be more infectious and even more resistant to vaccines than other variants

F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday

NY Times

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates. Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals

Modernizing Pharmaceutical Supply Chains

Speaker: Nimesh Patel, Gregory Demitrack, and Sarah Barnes Humphrey

Register for our upcoming webinar to better understand the state of the pharmaceutical supply chain. FourKites partnered with Accenture to survey supply chain executives working in pharmaceuticals, biotech, cell and gene therapy, medtech, and other related industries.

Around 250 digital health apps are launching every day, says IQVIA

Pharma Phorum

There was a dramatic increase in the launch of health-related mobile applications last year, taking the total number on offer in app stories to 350,000 – and while average quality is currently “middling” it is on the rise, according to a report from IQVIA.

Moderna founder's next big play in RNA raises $440 million

Bio Pharma Dive

Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus

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Corporate politics and eMarketing: Mismatched

World of DTC Marketing

SUMMARY: The biggest barrier to great healthcare marketing is corporate politics. As more companies merge or are bought out big bureaucratic processes run counter to what online marketing is all about.

Artificial intelligence stands to ‘revolutionize’ research: Bioclinica

Outsourcing Pharma

A leader from the clinical research tech specialist explains how the use of AI is increasing in the field and outlines the many ways it could SOMETHING. Clinical Development

Minimizing Retail Supply Chain Disruptions in 2021 and Beyond

Speaker: Izaac Moran, Customer Success Manager, FourKites; Glenn Koepke, SVP of Customer Success, FourKites; and featuring interviews with supply chain experts from Dollar Tree and Best Buy

Register for our upcoming webinar to see how savvy retailers including Dollar Tree and Best Buy are leveraging real-time visibility across their end-to-end supply chains in creative ways to drive agility and thrive in today’s unpredictable environment.

Moderna to Launch Clinical Trials for mRNA-Based HIV Vaccine

BioSpace

Moderna is expected to launch a human clinical trial as early as this week for an mRNA-based vaccine against HIV and indicated that it is looking for 56 people ages 18 to 50 who are HIV-negative

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

NY Times

The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.

SMA Awareness Month: How pharma and digital solutions can improve patient care

Pharma Phorum

Spinal Muscular Atrophy (SMA) is a rare disease affecting the motor nerve cells in the spinal cord. It’s a debilitating condition that affects 1 per 8,000 to 10,000 people worldwide , impacting their ability to walk, eat, and breathe.

Biotech M&A tracker: After hitting new heights, deals have slowed down. Here are the latest.

Bio Pharma Dive

Deals were few and far between last quarter. But the recent history of biopharma M&A suggests they'll return. Keep track of them as as they happen with BioPharma Dive's new database

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.