Wed.Aug 25, 2021

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UPS delivers coronavirus vaccines via temperature-controlled drone

Bio Pharma Dive

Drones have emerged as a speedy logistics option for time- and temperature-sensitive vaccine doses, potentially helping boost the availability of shots in rural areas.

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Should you change your DTC marketing buckets?

World of DTC Marketing

SUMMARY: There is a huge issue that’s challenging DTC marketers: online health misinformation. While we’re still trying to research the changes it has led to for DTC marketers, there are some observable behaviors taking place that we have examined through Google analytics. They paint a picture of people who are spending more time online looking to answer their questions and relying on HCPs to help sort out treatment choices.

Marketing 154
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Lilly puts more money into protein degradation

Bio Pharma Dive

The pharma has struck its second research pact focused on drugs that break down harmful proteins in as many years, this time with California biotech Lycia Therapeutics.

Protein 280
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Older people ‘more likely to engage with digital physiotherapy care’

pharmaphorum

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. Gen Xers, working-age baby boomers and retirees – collectively the over-41 age bracket – were more likely to start a musculoskeletal (MSK) programme delivered via digital channels than Gen Zers and millennials, according to Hinge Health, whose back and joint pain programme was used in the study.

Research 145
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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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J&J, without details, makes case for a coronavirus booster shot

Bio Pharma Dive

A second shot given six months after the first appears to provide a bigger immune response, the company said, a finding J&J aims to take to regulators in the U.S. and elsewhere.

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Merck raises pressure on Pfizer in pneumococcal vaccine tussle

pharmaphorum

Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise. The 15-valent conjugate vaccine was at least as effective as Pfizer’s 13-valent Prevnar 13 in the study, which involved infants up to 15 months old, and will form the basis of regulatory filing to extend the label for Vaxneuvance later this year, according

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COVID-19 News: Pfizer Vaccine Associated with Increased Risk of Myocarditis and More

BioSpace

As many children go back to school, new waves of COVID-19 cases continue to surge. More data keeps coming in on potential vaccine risks and how they measure up against the risk of the disease. Here’s a look.

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Study finds protection against COVID-19 ‘waning’ in fully vaccinated people

Pharma Times

The ZOE COVID Study app assessed data on positive COVID-19 PCR test results between May and July 2021

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How COVID-19 Changed Food Sampling in Retail and At Home

XTalks

In-store food sampling is a key marketing tactic that virtually disappeared during the height of the COVID-19 pandemic. There was simply no time to try new food and beverage items, nor would public safety protocols allow for it. But now that restrictions are loosening, more and more retail settings are offering food samples once again — an encouraging sign for smaller brands that rely on it to get its products into the hands of consumers. .

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Drug Candidate for Wilson Disease Meets Primary Endpoint in Phase III Trial

BioSpace

The FoCus Phase III trial by Alexion and AstraZeneca showed that ALXN1840 demonstrated around three times greater copper mobilization from tissues than SoC treatments for Wilson disease.

Trials 98
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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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Top 7 Pharma Industry Leaders in 2020 By the Numbers

Delveinsight

Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives. The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic and brand-name drugs as well as medical devices.

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Do Walnuts Reduce Death Risk and Increase Life Expectancy?

XTalks

A Harvard-led study has shown a correlation between walnut consumption and a longer life expectancy. According to the study, higher walnut consumption — whether in terms of the amount or frequency — is closely associated with a lower risk of death and increased life expectancy among adults. The study was supported by the California Walnut Commission (CWC) and was published in the journal Nutrients.

Nurses 97
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Amneal Reports Potential Therapeutic Step Forward for Parkinson’s Patients

BioSpace

In the pivotal Phase III trial, Amneal’s investigational Parkinson’s drug, IPX-203, met its primary endpoint, demonstrating superior “Good On” time in patients with motor fluctuations.

Trials 97
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UK study to test third COVID-19 vaccine for immunocompromised

Pharma Times

Participants will be given Pfizer, Moderna or Novavax vaccines

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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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Ascendis Scores First Approval with Once-Weekly Pediatric GHD Injector

BioSpace

The U.S. Food and Drug Administration (FDA) approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd) for children one year and older who have growth failure from inadequate secretion of endogenous growth hormone (GH).

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NHS to roll out same-day pre-eclampsia test for pregnant women

Pharma Times

New blood test rules out life-threatening condition

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A Clinical Stage Biotech Without a CMO? Replimune Makes Surprising Cut

BioSpace

While the biotech market sees a high demand for the chief medical officer role, one Massachusetts oncology player has deemed the role completely unnecessary.

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Does Ranitidine Cause Cancer?

Druggist

Ranitidine use was associated with a statistically significant 2.4-fold increased risk for the combined outcome of stomach/esophageal cancer, and has been linked to cancers such as bladder cancer, colon cancer and prostate cancer. The drug is contaminated with NDMA which is classified by the International Agency on Cancer Research (IARC) as “a probable human carcinogen.” The post Does Ranitidine Cause Cancer?

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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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CDC, Heat Biologics Establish New Pandemic Preparedness Initiatives

BioSpace

The CDC is taking a proactive stance and establishing a center that will use forecasting and outbreak analytics to guide public health decision-making.

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How to transfer your prescription to any pharmacy.

Druggist

There can be a number of reasons you’d want to switch pharmacies. Here’s how you can do it: Call, text, or visit your new pharmacy to request an Rx transfer. Provide the new pharmacy the list of all the medications you wish to transfer, along with the dosage and Rx numbers. Also, provide your current pharmacy’s contact information. The new pharmacy you’ve chosen will contact your previous pharmacy and take care of most of the further processes.

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Gene Variation Identified in Endometriosis, Opening New Doors for Treatment

BioSpace

Scientists from Oxford University may have found the key to treating endometriosis, a disease that affects around 176 million women worldwide.

Gene 98
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What is Private Prescription?

Druggist

Private prescriptions are medication which your private Doctor has recommended for you. They may not be available under the NHS, but if they’re necessary to help with any medical issues, it’s worth looking into these options before having surgery or buying over-the-counter medications from a pharmacy. The post What is Private Prescription?

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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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Amid Ethics Allegations, Sesen Pulls Bladder Cancer Drug Application from Europe

BioSpace

Less than 10 days after the FDA slammed Sesen bladder cancer drug with a CRL, the company has withdrawn its Marketing Application Authorization from the European Union.

Drugs 87
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Lilly taps Lycia for protein degrader tech in $1.6bn deal

pharmaphorum

Eli Lilly has bolstered its position the fast-emerging area of protein degrader drugs, agreeing a $1.6 billion-plus deal with Lycia Therapeutics spanning up to five drug targets. The drugmaker has looked close to home for its latest entry into the category, as Lycia’s founder Prof Carolyn Bertozzi has held a seat on its board of directors since 2017 – a position she has now surrendered as a result of the deal.

Protein 69
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How to Practice Leadership at Work

BioSpace

Leadership can be a very challenging skill, and you cannot learn it overnight. People take years learning how to become good leaders.

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Biden Falls Short on Pledge for U.S. to Be the World’s Vaccine ‘Arsenal,’ Experts Say

NY Times

Congress appropriated $16 billion to ramp up Covid-19 countermeasures, but a new report found that the Biden administration had spent very little of it on expanding vaccine manufacturing capacity.

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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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How to Continually Invest in Your Career

BioSpace

Think of your career as a living, breathing thing. In order to keep it alive, you need to continually feed it so it can thrive. But how do you do that?

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AbbVie’s Rinvoq is first JAK drug cleared in EU for atopic dermatitis

pharmaphorum

The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic dermatitis to AbbVie’s Rinvoq. The EU regulator has cleared Rinvoq (upadacitinib) as an oral treatment for moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older, either with or without topical corticosteroid drugs.

Drugs 59
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Pfizer Brings in Fresh Face for Chief Business Innovation Officer Spot

BioSpace

Pfizer Chief Executive Officer Albert Bourla tapped Aamir Malik to serve as the company’s chief business innovation officer.

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Why PI's Leave Research Sites and Studies

ECRG Media's Clinical Research Podcast

Why PI's Leave Research Sites and Studies Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for short is a content creati

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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.