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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Don’t blame mental health for mass murder

World of DTC Marketing

According to the National Institutes of Health, people with a mental health diagnosis committed less than 5 percent of gun-related homicides between 2001 and 2010. Mental health experts, including representatives from the American Psychological Association, have called it “unfounded” to blame mass shootings on mental illness in place of considering other possible factors, such as hate, bigotry, and access to assault weapons.

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MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment

Pharma Times

Authorisation of the treatment is based on results from the phase 3 trial

Marketing 145
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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.

Vaccine 145
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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 131
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?A Parent’s Story: Supporting Families Through Palliative Care

Worldwide Clinical Trials

By: Kerri Padgett, Courageous Parents Network. This year, I will celebrate the life of my son, Kai, for the 10th time since his passing from hypothalamic optic glioma at the age of two. I feel immense gratitude for the support we received during his cancer journey, but there are also moments when I wish I’d had more support. I know there are many families out there needing more, too.

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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.

Licensing 252
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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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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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Crown Bioscience and MBL Enter Joint Venture to Provide Advanced Preclinical Services for Japanese Customers

Pharma Mirror

California, Crown Bioscience and Medical & Biological Laboratories (MBL), JSR Life Sciences companies, today announced the formation of a joint venture, to further expand the provision of Crown Bioscience’s preclinical services to Japanese customers. The new entity named “Crown Bioscience & MBL”, is a long-term strategic partnership that is expected to accelerate growth for both companies.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Why I Fight | A message from Gary Fishbein, MD, MPH

Worldwide Clinical Trials

Life after cancer is about more than just survival. It’s not just the length of life that matters, but also the quality of that life. Join us as we celebrate cancer research awareness month and clinical trials awareness month. Building Bridges. Where I trained at the University of Maryland, there was literally a bridge that connected the research labs to the clinic.

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Pfizer cleared to restart hemophilia gene therapy trial

Bio Pharma Dive

While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023.

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Gun violence is a national health issue

World of DTC Marketing

Gun violence isn’t just a criminal justice issue; it’s a public health issue. There was nearly a 30 percent increase in homicides between 2019 and 2020, making it the most significant one-year increase in six decades. The number of gun deaths in 2021 climbed even higher and is approaching the previous peaks in gun death rates in the early 1970s and early 1990s. .

Nurses 46
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International Nurses Day 2022

Deltaclinical

On May 12, we celebrate Nurses Day! Sometimes it seems that we have forgotten the past 2 years. Because even after a pademic, nurses are there for us day and night. And they do this with a clear goal in mind: making other people better and taking care of those in need. It is therefore more than deserved to put all nurses in the spotlight today! THANK YOU to everyone who provides warm and professional care every day!

Nurses 130
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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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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.

Bacteria 145
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Emmes launches Advantage eClinical as a standalone cloud native clinical technology platform

Pharma Mirror

Rockville, Emmes – a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces that it will introduce to market its third generation version of Advantage eClinical at Society for Clinical Trials (SCT) in San Diego, May 15th – 18th. The cloud platform of Advantage eClinical will be available as a standalone software product after undergoing more than two years of development.

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Why I Fight | A message from Jim Eamma

Worldwide Clinical Trials

Life after cancer is about more than just survival. It’s not just the length of life that matters, but also the quality of that life. Join us as we celebrate cancer research awareness month and clinical trials awareness month. The Patient Experience. The thing that really motivates me in cancer research is seeing how, in the last couple of decades, the landscape has evolved to where we’re not only focusing on curative intent but also on improving the patient’s experience with the illness.

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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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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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Lilly has a new blockbuster

World of DTC Marketing

If You’re Short On Time: The U.S. Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. The approval for tirzepatide—which Lilly will market under the brand name Mounjaro—isn’t for weight loss but Type 2 diabetes. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks?

Drugs 218
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International Nurses Day 2022

Deltaclinical

On May 12, we celebrate Nurses Day! Sometimes it seems that we have forgotten the past 2 years. Because even after a pademic, nurses are there for us day and night. And they do this with a clear goal in mind: making other people better and taking care of those in need. It is therefore more than deserved to put all nurses in the spotlight today! THANK YOU to everyone who provides warm and professional care every day!

Nurses 130
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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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Avantor Announces Investment in Manufacturing and Distribution Hub in Singapore to Serve Rapidly Growing Asia Pacific Biopharma Industry

Pharma Mirror

Singapore, Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, today announced it will create a new manufacturing and distribution Hub in Singapore, by integrating its existing distribution facility with new manufacturing operations.

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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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?The Current State of Advanced Therapeutics

Worldwide Clinical Trials

The past few years we’ve had exciting opportunities to work on more cell and gene therapy programs for our sponsors. The industry is just at the tip of the iceberg for exploring the potential of these therapies in revolutionizing how we treat disease, and as the approvals start to trickle in, the pipeline only grows. (For a full look at the cell and gene therapy landscape, check out our webinar titled: “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapy.”)

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Scientists home in on cause of Duchenne gene therapy side effect

Bio Pharma Dive

An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.

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A new era of pharma marketing?

World of DTC Marketing

Just 13% of people trust the pharma companies they interact with. 68% say the interactions feel transactional. Only a third agree that organizations know their communication preferences. Communication and transparency are vital to building trust, which necessitates a shift away from traditional DTC marketing. If pharma is going to leap to a new era of marketing, they have to get to know their audiences.

Marketing 214
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International Nurses Day 2022

Deltaclinical

On May 12, we celebrate Nurses Day! Sometimes it seems that we have forgotten the past 2 years. Because even after a pademic, nurses are there for us day and night. And they do this with a clear goal in mind: making other people better and taking care of those in need. It is therefore more than deserved to put all nurses in the spotlight today! THANK YOU to everyone who provides warm and professional care every day!

Nurses 130
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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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Google gives ex-FDA digital health head Bakul Patel strategic role

pharmaphorum

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Bakul Patel. Patel – who is currently director for digital health at the FDA – said on social media that he is “looking forward to learning from the teams in health across Google and Alphabet and helping build a unified digital health and regulatory strategy.” He was also involved in the creation of the FDA’s Dig

Radiology 139
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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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?Sharing Passion and Purpose on International Clinical Trials Day

Worldwide Clinical Trials

At Worldwide Clinical Trials, we are passionate about the work we do every day and its impact on countless patients and their families around the world. For International Clinical Trials Day 2022, take a moment to learn more about what it means to be part of a Contract Research Organization (CRO) – and how you can join our global team of experts. We have opportunities for all types of professionals from various industries and backgrounds.

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Merck study results signal blood cancer potential for new type of immunotherapy

Bio Pharma Dive

Bristol Myers beat Merck to the first approval of a so-called LAG-3 inhibitor.

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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