May, 2022

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Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

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Mental health apps and services may be doing more harm than good

World of DTC Marketing

Cerebral will stop writing prescriptions for Adderall, Ritalin, and other controlled substances to new ADHD patients as concerns grow about telehealth companies’ prescribing practices. To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs.

Drugs 252
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What does good cybersecurity look like in 2022?

pharmaphorum

The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated at a rapid pace, with companies racing to integrate cloud-based platforms and telehealth services to expand the delivery of modern healthcare. Combined with the sudden arrival of COVID-19, this perfect storm of events handed cybercriminals an opportunity to exploit weaknesses in fledging systems and processes.

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Artificial intelligence stands to transform precision medicine: AiCure

Outsourcing Pharma

An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.

Medicine 138
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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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Oramed hits oral insulin clinical trial milestone

BioPharma Reporter

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.

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DrugPatentWatch named “Best of the Web” by Genetic Engineering News

Drug Patent Watch

DrugPatentWatch has been named to Genetic Engineering News‘ Best of the Web list. The review by Genetic Engineering News profile highlighted the “new training modules designed to help you find…. The post DrugPatentWatch named “Best of the Web” by Genetic Engineering News appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma’s addiction to McKinsey

World of DTC Marketing

The top executive at McKinsey & Company appeared before Congress to answer for the consulting firm’s role in fanning the opioid crisis and came under intense criticism from lawmakers. One likened the firm’s earnings from advising Purdue Pharma and other pharmaceutical companies to “blood money” from drug traffickers. Yet, pharma continues to be aligned with MBA spreadsheet consulting.

Drugs 234
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Moderna’s HIV vaccine prepped for trials in Africa

pharmaphorum

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. IAVI (the International AIDS Vaccine Initiative) has started screening subjects to be included in the study, called IAVI G003, at centres in Rwanda and South Africa, said the biotech.

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Machine learning can unlock potential of EEG data: Beacon Biosignals

Outsourcing Pharma

A leader from the neurobiomarker platform provider tells how use of ML and other advanced analytical tools can help make better use of complex information.

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Malaria parasites form vortices

Scienmag

The disease of malaria is triggered by single-celled parasites that accumulate in large groups in the salivary glands of mosquitoes before transmission to human beings. The limited space there prevents them from actually moving, unless this restriction is lifted by means of appropriate experimental preparation. In just such experiments, researchers at Heidelberg University have set […].

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Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors

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PTC Therapeutic’s Upstaza has been recommended by both the EMA and CHMP

Pharma Times

It is the first gene therapy to be directly administered into the brain to treat aromatic L-amino acid decarboxylase (AADC) deficiency

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BioMarin delays planned FDA filing for hemophilia gene therapy

Bio Pharma Dive

BioMarin now expects to resubmit its approval application to the FDA by the end of September, the latest regulatory setback for the company's closely watched treatment.

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Continuous manufacturing adoption continues to rise: Pharmatech

BioPharma Reporter

An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.

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The antimicrobial pipeline is ‘dry’ and that’s a problem

pharmaphorum

Antimicrobial resistance is a growing problem and one that is already claiming over a million lives per year. The situation is urgent but finding a sustainable solution is a difficult prospect, finds Ben Hargreaves. Alexander Fleming discovered the world’s first antibiotic, penicillin, in 1928. However, the difficulty in developing a method to adequately produce sufficient levels of the product meant that the age of the antibiotic did not truly begin until the 1940s.

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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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NeuroMetrix’s Quell Device Gets FDA Approval as First Non-Drug Treatment for Fibromyalgia

XTalks

Fibromyalgia is a chronic condition that causes widespread pain, difficulty concentrating, sleep problems, fatigue, mood disorders and other symptoms. People with fibromyalgia have abnormal pain perception processing, so they may be more sensitive to pain compared to people without the condition. Fibromyalgia affects approximately 4 million adults in the US, which is about 2 percent of the US adult population.

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“Growing end” of inflammation discovered

Scienmag

Redness, swelling, pain – these are signs of inflammation. It serves to protect the body from pathogens or foreign substances. Researchers from the Universities of Bonn and Cologne were able to show that inflammatory reactions of an important sensor protein proceed in a specific spatial direction. This finding has the potential to conceivably stop inflammation […].

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Cumulus Neuroscience begins studies of digital biomarker

Pharma Times

Technology is already being used in clinical trials of new treatments for Alzheimer’s and new studies will provide additional validation

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In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too.

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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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Lilly invests $2.1bn in new Indiana manufacturing sites

BioPharma Reporter

Eli Lilly and Company plans to expand its manufacturing footprint in Indiana by investing $2.1bn in two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.

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Why are clinical trials struggling with diversity?

pharmaphorum

In the diverse world we live in, the products we produce, the services we create and the places we work should be as equally representative. In recent years this has seen diversity, equity, and inclusion (DEI) become a big focus for industries to get right. Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening.

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Clinical Scientist Jobs: The Steps to Succeed in This Role

XTalks

Do you possess laboratory skills, an analytical mindset and a penchant for research? If you enjoy working with biological samples and are enthusiastic about healthcare, a career as a clinical scientist might be just right for you. To start applying to clinical scientist jobs today, head over to the Xtalks Job Search platform. Who is a Clinical Scientist?

Scientist 105
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Modifying the body’s immune system to help treat Type 1 diabetes

Scienmag

In a new study, a team of researchers from the University of Missouri, Georgia Tech and Harvard University has demonstrated the successful use of a novel Type 1 diabetes treatment in a large animal model. Their approach involves transplanting insulin-producing pancreas cells — called pancreatic islets — from a donor to a recipient, without the […].

Insulin 102
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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Simple blood test could save thousands from bowel cancer

Pharma Times

Comparisons with other tests available have shown that blood test has greater sensitivity for the detection of bowel cancer

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Biogen CEO to step down as company pulls back from Alzheimer's drug

Bio Pharma Dive

Michel Vounatsos, Biogen's CEO since 2017, will be replaced as the company "substantially" eliminates the commercial workforce around Aduhelm, which has generated paltry sales in the face of resistance from insurers and doctors.

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NIH awards $577m to antiviral drug developers

BioPharma Reporter

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.

Drugs 105
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How patient-on-a-chip tech could be the future of drug discovery

pharmaphorum

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. Ben Hargreaves discovers how the technology could provide more accurate safety predictions and even discover new treatments. The limits of animal models in drug discovery are well known.

Drugs 143
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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World Hunger Day 2022: History, Theme and Ways to Support the Movement

XTalks

World Hunger Day is observed each year on May 28 to raise awareness about the dramatic rise in hunger in recent years. While the day was created prior to the COVID-19 pandemic, the unprecedented global crisis has forced hundreds of millions of people into chronic hunger, escalating the need for change. Here’s everything you need to know about World Hunger Day 2022.

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Scripps Research scientists explain what makes COVID-19 antibody “J08” so potent

Scienmag

LA JOLLA, CA—Last year, scientists at Scripps Research and Toscana Life Sciences studied the blood of 14 COVID-19 survivors to find the most potent antibodies against the SARS-CoV-2 virus. One of the leading molecules that emerged—now in stage II/III trials in Italy—was an antibody dubbed J08, which seemed to be capable of both preventing and […].

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Superdrug launch comprehensive perimenopause screen service

Pharma Times

High street service has been launched to support those experiencing symptoms potentially connected to the menopause

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Pfizer to acquire Biohaven in $11.6B bet on biotech's migraine drugs

Bio Pharma Dive

The rest of Biohaven's pipeline, which includes drugs for ALS and obsessive compulsive disorder, will be spun out into a new company led by the biotech's current CEO and retaining its name.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!