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?

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.

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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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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More Trending

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.

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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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.

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

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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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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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.

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.

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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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

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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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.

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.

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.

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

Although Rare, New Data Suggests Higher Rate of Myocarditis with Moderna Shot

BioSpace

As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week's report

Pfizer stocks cancer drug pipeline with $2.3B deal for Trillium

Bio Pharma Dive

The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year

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

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.

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.

Canada Gaining in the Global War for Biotech Talent

BioSpace

Toronto saw the biggest growth in technology jobs of any North American city between 2015 and 2020, while Vancouver, British Columbia also made the top five

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HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

Bio Pharma Dive

Acting FDA head Janet Woodcock asked for an investigation of the agency's decision to approve Biogen's Alzheimer's drug, but the inspector general's planned review appears to be more broadly aimed

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Small versus big digital agencies for pharma

World of DTC Marketing

SUMMARY: You should never choose an agency based on size. It should be because they are a good fit with your brand team and can take your digital marketing to the next level while ensuring that everything they do is best in class. Debra called me up in a bit of a panic.

Virtual reality technology transforming COVID-19 drug discovery

Outsourcing Pharma

Nanomeâs virtual reality tech is being put to use by Oak Ridge National Laboratory and top pharma firms to study COVID-19 and explore drug candidates. Preclinical Research

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Funding round swells digital health firm Whoop’s value to $3.6bn

Pharma Phorum

Fitness wearable company Whoop has raised another $200 million in funding that will help fund its expansion into international markets – and take on deep-pocketed rivals like Amazon, Apple and Google.

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.

A Pivotal Moment for CRISPR in the Gene Editing Journey

BioSpace

With this milestone, the field is now wide open for the next in vivo CRISPR success, and Editas is hoping that it will be in the ocular disease space

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Bio Pharma Dive

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects

The Constitution and vaccinations

World of DTC Marketing

SUMMARY : Via Marci Hamilton is a professor at the University of Pennsylvania “the Constitution is not a suicide pact guaranteeing a right to harm others.