Tue.Aug 31, 2021

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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.

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Temporarily understaffed in your clinical trials?

Deltaclinical

Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, … Contact us for the right solution!

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After coronavirus success, J&J hits setback with HIV vaccine

Bio Pharma Dive

While the HIV shot is still in testing, its failure in a mid-stage study in young women may lead to yet another discontinuation of a promising project.

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Temporarily understaffed in your clinical trials?

Deltaclinical

Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, …. Contact us for the right solution!

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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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Hint of benefit in Alzheimer's drug study fuel stock surge for Swiss biotech

Bio Pharma Dive

A once-failed drug being developed by AC Immune and Roche appeared to slow cognitive decline in a small trial. But other study goals were missed, muddying the seemingly positive result.

Drugs 161
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Temporarily understaffed in your clinical trials?

Deltaclinical

Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, …. Contact us for the right solution!

More Trending

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Temporarily understaffed in your clinical trials?

Deltaclinical

Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, …. Contact us for the right solution!

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Online health seekers are having a tough time

World of DTC Marketing

SUMMARY: Online health seekers are increasing in number, but so is the prevalence of inaccurate health information. Drug side effects are among the most talked about in social media, and patients are more concerned about side effects. They may not be willing to risk potential side effects like pancreatitis. DTC marketers need to reassure their audiences that drugs have been thoroughly tested and are indeed “safe and effective.” Online health seekers are not having an easy time gettin

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

pharmaphorum

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. The sixth-round financing was led by SoftBank’s Vision Fund 2, taking the total raised by the company to date to around $400 million, and catapults Whoop’s valuation to a massive $3.6 billion.

Marketing 137
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Moderna COVID Vaccine Stimulates Twice the Antibody Response as Pfizer-BioNTech

BioSpace

Belgium researchers compared the Moderna and Pfizer-BioNTech COVID-19 vaccines and found that the Moderna jabs generated twice the antibodies than the Pfizer-BioNTech vaccine.

Antibody 113
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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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Partnership fights to amplify Black women’s voice in breast cancer research

Outsourcing Pharma

The #BlackDataMatters movement aims to improve outcomes for Black women living with breast cancer by increasing their presence in vital clinical research.

Research 111
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Chobani Has Left Plastic Packaging Behind and is Introducing Paper-Based Cups

XTalks

Chobani has been exploring and discovering new ways to package its products in a more sustainable and eco-friendly way. This is why the yogurt brand has decided to move away from plastic to paper cups for their Chobani Oat yogurt. The company’s newest products, oat milk, cold brew coffee and coffee creamers, already come in paper-based packaging that is also recyclable, so they decided to push this innovation forward and implement it on more of their products. “We all have a role to

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Merck, Ridgeback Embark on Phase III with COVID-19 Therapeutic

BioSpace

The study of Molnupiravir will assess 1,300 adult participants 18 and over who cohabitate with someone who has tested positive for the coronavirus and is symptomatic.

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The Cocaine Was Laced With Fentanyl. Now 6 Are Dead From Overdoses.

NY Times

The deaths over three days in Suffolk County reflect a dangerous shift in the street-drug marketplace, according to police and prosecutors.

Drugs 99
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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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Biotech Company Driven by Cutting Edge Science and Patients, Not Ego

BioSpace

On June 26, Intellia announced the first-ever clinical data supporting the safety and efficacy of in vivo CRISPR genome editing in human patients.

In-Vivo 98
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The Cocaine Was Laced With Fentanyl. Now Six Are Dead From Overdoses.

NY Times

The deaths over three days in Suffolk County reflect a dangerous shift in the street-drug marketplace, according to police and prosecutors.

Drugs 95
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Leading Medical Journal Validates Potential of Zentalis-discovered Cancer Therapy

BioSpace

ZN-c3 is a WEE1 inhibitor that could be used as monotherapy for uterine serous carcinoma and solid tumors, as well as combination therapy for ovarian cancer, alongside chemotherapy.

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Drones are now being used to deliver COVID-19 vaccines in US

BioPharma Reporter

The first COVID-19 vaccine drone delivery program in the US was launched last week by North Carolina-based health system, Atrium Health Wake Forest Baptist.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Money on the Move: August 25 – 31

BioSpace

The hot days of summer are nearing a close, but these life science companies aren’t cooling off their fundraising efforts. Here’s a brief overview of who’s heating up their coffers this week.

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GSK, SK to compare COVID-19 vaccine candidate to AZ’s jab

Pharma Times

Phase III trial will use AZ’s COVID-19 vaccine as an active comparator

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AstraZeneca and Thermo Fisher Partner to Match Patients to Precision Therapies

BioSpace

The duo’s mission is to identify more patients who could benefit from precision medicines by deploying more CDx tests to healthcare providers.

Medicine 110
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An Experimental H.I.V. Vaccine Fails in Africa

NY Times

Researchers ended a large trial in South Africa after finding that an experimental vaccine offered little protection.

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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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External control arms and debunking real-world data myths

pharmaphorum

For the healthcare ecosystem to drive research and care, clarity is needed about the opportunities and challenges of ECAs and their value in bringing therapies to patients faster, say COTA Viraj Narayanan and Karla Feghali from ConvergeHEALTH by Deloitte. External control arms (ECAs) – also known as synthetic control arms – are based on real world data (RWD) pulled from electronic health records, medical claims, wearable devices and other sources of patient data.

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Roche withdraws US approval for Tecentriq in mTNBC

Pharma Times

Metastatic triple-negative breast cancer treatment failed to meet PFS primary endpoint

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Mesoblast’s COVID-19 Respiratory Therapy Hits Another Snag on Route to Potential EUA

BioSpace

?Mesoblast shares dropped on the last day of August 2021 after it was told that its candidate COVID-19 treatment needs to undergo another trial to be green-lit for emergency approval by the FDA.

Trials 102
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F.D.A. Fully Approves Pfizer Vaccine

NY Times

The move was expected to kick off a round of new vaccination mandates from hospitals, schools and private companies.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Astellas Pauses Dosing of Gene Therapy After Liver-Linked Concerns

BioSpace

The company announced it paused the screening and dosing of an investigational gene therapy for patients with XLMTM following a serious adverse event report in a trial participant.

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A Video History of Pharmacies and Prescription Prices: From Soda Fountains to GoodRx

Drug Channels

Charlotte Morabito at CNBC has put together “Why Pharmacies Overcharge,” an entertaining and provocative video on the pharmacy industry and its generic prescription pricing. It’s definitely worth your time. I especially enjoyed the cool visualizations of Drug Channels Institute’s industry data. Links below. The video covers the history of pharmacy, from the “Soda Fountain Era” to “Lick, Stick, and Pour” to the rise of PBMs and GoodRx. .

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Many Cytokine Space Parallels Drawn by Asher Bio’s Series B

BioSpace

Asher Bio began two years ago and raised $55 million in a Series A financing round this March to take forward a series of engineered cytokines that aim to eliminate both the toxicities and the loss of efficacy in immunotherapy.

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Pathway To Effective Stakeholder Mapping

pharmaphorum

Before developing any stakeholder engagement plan, it is crucial to have a clear understanding of all the relevant individuals and groups your product or device could directly impact or interest in some way. Stakeholders within the pharmaceutical world encompass many diverse groups and include payers, government bodies, standard-setting bodies, physicians, key opinion leaders, patients, and advocacy groups, to name a few.

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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.