pharmaphorum

JANUARY 17, 2023

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool. Already, it is operating at scale across the company, used in more than 28 countries and available in 62 languages.

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Bio Pharma Dive

JANUARY 17, 2023

In a conversation at the J.P. Morgan Healthcare conference, the longtime Biogen executive discussed his hesitance to jump back into an executive role and why an opportunity to run Voyager Therapeutics drew him in.

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Pharmaceutical Technology

JANUARY 16, 2023

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2023

To reduce the harmful health effects of sitting, take a 5-minute light walk every half-hour. That’s the key finding of a new study that my colleagues and I published in the journal Medicine & Science in Sports & Exercise. We asked 11 healthy middle-aged and older adults to sit in our lab for 8 hours […].

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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

Clinical Research

STAT News

JANUARY 18, 2023

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

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Bio Pharma Dive

JANUARY 19, 2023

“What we’re experiencing now is the aftershock of the party that went on for the last three years,” said Ovid CEO Jeremy Levin in a BioPharma Dive panel that included former Sage head Jeff Jonas and biotech entrepreneur Greg Verdine.

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NPR Health - Shots

JANUARY 16, 2023

The 3-digit suicide and crisis lifeline – 988 – fielded nearly half a million more calls, texts and chats in its first 5 months than the old 10-digit Lifeline did during the same time in 2021. (Image credit: PATRICK T.

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STAT News

JANUARY 18, 2023

With a few clicks, Daniel added the chemical to his online cart and ordered it. In less than a week, a vial containing white powder arrived at his house. He used a syringe to measure out sterile water and eject it into the vial to dissolve the powder. Then, with a different syringe, he drew up about a quarter of a milliliter of the solution and injected it into his lower abdomen.

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Bio Pharma Dive

JANUARY 18, 2023

The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.

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Pharmaceutical Technology

JANUARY 20, 2023

This week, at the World Economic Forum Annual Meeting, Moderna CEO Stéphane Bancel, said the company plans to build on its exponential growth through the pandemic by expanding its operations globally over the next few years. In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA tec

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

NPR Health - Shots

JANUARY 19, 2023

The lawsuit says Thinx underwear, long marketed as safe and sustainable, contains harmful chemical substances known as PFAS. The company denies those allegations but will pay up to $5 million.

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STAT News

JANUARY 19, 2023

Today’s teens and tweens have never known a world without social media. There are still a lot of open questions about how sites like TikTok and Instagram may shape their development — and stories focusing on the potential negative impacts of social media tend to dominate the news. But a recent study published in JAMA Pediatrics is the latest in a growing body of research that suggests the relationship that young people have with social media is too complicated to be categorized as

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Bio Pharma Dive

JANUARY 20, 2023

The drugmaker had sought an accelerated approval based on promising data from a small mid-stage trial. Results from a larger study are due in the second quarter.

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Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). AOC 1020 has been designed for the treatment of the underlying cause of FSHD, which is caused by the abnormal expression of a gene known as double homeobox 4 or DUX4. This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD pat

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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.

Clinical Trials

Medical Xpress

JANUARY 16, 2023

High levels of stigma experienced by some COVID long-haulers are associated with more intense symptoms, reduced physical function and loss of employment due to disability, according to newly published research in eClinicalMedicine.

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STAT News

JANUARY 17, 2023

Increased injection drug use has led to a spike in cases of the life-threatening heart condition endocarditis , with cases rapidly accelerating since the onset of Covid-19. The increased case count is one of the lesser-known side effects of the deadly addiction epidemic. But patients with endocarditis, an inflammation of the heart lining caused by infection, require complex, thoughtful care — care that the U.S. health system is ill-equipped to provide.

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Bio Pharma Dive

JANUARY 20, 2023

Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.

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NPR Health - Shots

JANUARY 19, 2023

At-home rapid tests have become a staple of COVID-19 precautions, but some experts worry that people are relying too much on these tests and that's creating a false sense of security.

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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.

Clinical Research

BioPharma Reporter

JANUARY 17, 2023

In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.

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STAT News

JANUARY 17, 2023

Moderna’s vaccine against the respiratory syncytial virus, or RSV, reduced the rate of lower respiratory disease in people over 60 in a Phase 3 trial, the company said Tuesday. The result will increase competition in a soon-to-be crowded market. The drug giants Pfizer and GlaxoSmithKline have already presented results for their RSV vaccines in older individuals, and have been preparing for what could be a brisk marketing battle.

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Bio Pharma Dive

JANUARY 20, 2023

The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.

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NPR Health - Shots

JANUARY 19, 2023

Some companies and researchers think smart computers might eventually help with provider shortages in mental health, and some consumers are already turning to chatbots to build "emotional resilience.

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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.

Clinical Supply

Medical Xpress

JANUARY 17, 2023

The SARS-CoV-2 delta variant that caused the third wave of COVID-19 in mid-2021 turned out to be more contagious than earlier SARS-CoV-2 variants. In addition, protein mutations in the delta variant were found to significantly reduce the effect of acquired humoral immunity to COVID-19 from prior infection or vaccination.

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STAT News

JANUARY 18, 2023

On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. This column is adapted from the new STAT Report : Targeting cancer: the new frontier of immunotherapy and precision oncology. Targeted immunotherapies like CAR-T have been remarkably successful in combating blood cancers like chronic lymphocytic leukemia.

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Bio Pharma Dive

JANUARY 17, 2023

Elicio’s combination with Angion Biomedica comes months after it abandoned a new stock offering, and is the latest example of how the IPO slowdown has shifted startups’ plans.

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NPR Health - Shots

JANUARY 14, 2023

It would make more sense to screen a plane's wastewater to look for new variants than to screen individual passenger volunteers, some researchers say. Others say any information is helpful.

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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.

Clinical Trials

Medical Xpress

JANUARY 16, 2023

Adults with high levels of attention-deficit hyperactivity disorder (ADHD) symptoms are more likely to experience anxiety and depression than adults with high levels of autistic traits, according to new research led by psychologists at the University of Bath in the UK.

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STAT News

JANUARY 18, 2023

WASHINGTON (AP) — The federal government says it will begin a targeted crackdown on nursing homes’ abuse of antipsychotic drugs and misdiagnoses of schizophrenia in patients. The Centers for Medicare and Medicaid Services is launching investigations this month into select nursing homes, aimed at verifying whether patients have been properly diagnosed with the psychiatric disorder.

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Bio Pharma Dive

JANUARY 19, 2023

Shoreline will acquire a preclinical NK cell therapy Editas has been developing, as well as a license to use the CRISPR biotech’s gene editing technology.

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NPR Health - Shots

JANUARY 18, 2023

And what about a cold or RSV? With all the illness spreading, it's virus soup out there these days. Some people feel so sick they're wondering if they're fighting more than one germ at once.

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Clinical Trials