Sat.Jul 31, 2021 - Fri.Aug 06, 2021

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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.

Drugs 348
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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. It’s more about weighing the benefit against the potential side effects. TV spots are the number one way people learn about new pharma products.

Marketing 279
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Around 250 digital health apps are launching every day, says IQVIA

pharmaphorum

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. The pandemic contributed to another 90,000 apps being introduced in 2020 – an average of 250 per day – and this coupled with rising number and functionality of wearable devices “provides evidence of digital health’s acc

Medicine 145
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Could DNA-based COVID-19 vaccine offer variant-busting booster shot?

BioPharma Reporter

With Scancell taking its DNA-based COVID-19 vaccine tech into clinical trials this year, it is already focusing its attention on the techâs potential to be used as a needle-free booster shot to address Variants of Concern.

DNA 137
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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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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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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. Only 23% of people get enough exercise and only one in ten eats enough fruit and vegetables, says the CDC.

Drugs 270

More Trending

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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.

Research 145
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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.

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Even on social media “listen to the doctor”

World of DTC Marketing

SUMMARY : People are anxious because of the resurgence of COVID. Unfortunately, there is a lot of false and bad information online. To get accurate information, follow one of the many physicians online. They can provide answers based on science and their experience. The amount of critical health information online is an enormous problem. The media still hasn’t, for example, differentiated between testing positive for COVID and getting sick from COVID.

Doctors 253
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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.

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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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Find Talent in the Pharmaceutical Industry: A Step-By-Step Guide to Xtalks Job Search

XTalks

The search to find talent in the life sciences isn’t always an easy pursuit. It requires ongoing strategies for attracting, retaining and developing the right candidates. Talent acquisition and employment practices are constantly changing in the pharma industry. This is why employers must stay up to date with the latest hiring trends. Popular online job platforms (such as Indeed, ZipRecruiter and other broader job posting websites) are optimized for unemployed job seekers.

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Startup EQRx to take drug price mission public through $1.8B SPAC deal

Bio Pharma Dive

A merger with a blank-check company backed by Casdin Capital will greatly expand the resources available to EQRx, which aims to develop competitors to existing drugs and sell them at "radically lower" prices.

Drugs 325
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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. Those people who are willing to disrupt pharma cultures will have a great career but it takes time, effort, and empathy for patients to make changes.

Marketing 269
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Evaluating methods targeting Protein-Protein Interactions

pharmaphorum

Protein-protein interactions (PPIs) are becoming increasingly relevant in the pathology of many diseases, including cancer. The issue, however, is developing an effective way of targeting them. . The latest advancements in methods targeting PPIs are designed to overcome the challenges limiting the conventional methods. Targeting PPIs offers another potential therapeutic target for diseases with complex biological profiles.

Protein 125
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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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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.

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FDA allows Novartis gene therapy trials to resume after nearly two year pause

Bio Pharma Dive

After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA.

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Pharmaceutical industry must fix broken supply chain: Phlow

Outsourcing Pharma

A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques.

Medicine 131
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UK trial to assess Sativex for the treatment of ‘aggressive’ brain tumours

Pharma Times

Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD

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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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Ophthalmology Companies See Global Opportunities for Next-Gen, Non-Invasive Therapies

BioSpace

Ophthalmology has become a focal point for private equity and venture capitalists in the past 18 months, despite being a small niche in the biopharmaceutical space.

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Gilead's Kite bets on early-stage biotech to advance allogeneic cell therapies

Bio Pharma Dive

Appia Bio, which launched with over $50 million in Series A funding earlier this year, will provide preclinical research for two CAR-iNKT candidates, which Kite will pick up should they advance past early clinical testing.

Research 294
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Psychedelics research institute launches in Australia

Outsourcing Pharma

The Psychae Institute, established by a global team of scientists, will conduct pre-clinical and clinical research around psychedelic medicine development.

Research 130
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Fresenius launches VR-based training for home dialysis patients

pharmaphorum

Fresenius has launched a virtual reality based training programme for people undergoing home dialysis in Germany, its home market, ahead of a rollout in other countries later this year. The VR system – called stay•safe MyTraining VR – is designed for use in patients undergoing peritoneal dialysis, which uses the peritoneum in a person’s abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood.

Nurses 111
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Counterproductive Career Advice That You Should Ignore

BioSpace

Getting job-hunting and career advice is hard, especially when you get it from those who have worked for decades. Some advice is still helpful today, like making a good impression, but others are considered counter-productive.

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Moderna says vaccine protective through six months, but warns boosters needed this fall

Bio Pharma Dive

Final results from the Phase 3 trial that led to the shot's authorization showed efficacy remained high, at 93%, although that data was collected before the delta variant had spread widely.

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In the absence of genetic variation, asexual invasive species find new methods of adapting to their environment

Scienmag

Research from Wellesley College shows that despite being a clonal insect species, weevils use gene regulation to adapt to new food sources and pass down epigenetic changes to future generations Without the benefits of evolutionary genetic variation that accompany meiotic reproduction, how does an asexual invasive species adapt over time to a new environment to […].

Genetics 111
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mRNA and beyond: Opportunities for US biologics

Outsourcing Pharma

The success of mRNA vaccine technology could be one of the new opportunities for US pharmaceutical manufacturing looking forward, with pandemic investments helping turbocharge the sector.

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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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Treg cell therapy showing promise in ALS trials: Coya Therapeutics

BioPharma Reporter

According to the neurodegenerative-disease-focused biotechnology firm, their research could bring hope to patients with amyotrophic lateral sclerosis.

Trials 119
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Data is becoming the healthcare ecosystem entry fee

Bio Pharma Dive

Biopharmaceutical companies have an opportunity to work alongside new healthcare ecosystem entrants for mutual benefit and better customer value.

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4 Reasons Why Employee Engagement is More Important than Ever for Companies

BioSpace

What is the culture like at your company? Are employees motivated to do their best work? Or are most people just going through the motions: clocking in, clocking out and collecting a paycheck?

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Moderna COVID-19 jab sales rocket to $4.2 billion in second quarter

pharmaphorum

Moderna made a massive $4.2 billion from sales of just under 200 million doses of its COVID-19 vaccine, taking its tally since approval to around $6 billion from 302 million shots. The tally makes the SpikeVax (mRNA-1273) vaccine the second biggest seller behind Pfizer/BioNTech’s Comirnaty, which pulled in $7.8 billion in the second quarter and $11.3 billion since the start of the year.

Sales 105
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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.