Sat.Jan 14, 2023 - Fri.Jan 20, 2023

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Driving clinical trial innovation forward with precision medicine

pharmaphorum

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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The impact of climate change on the pharma supply chain

Pharmaceutical Technology

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution. Whether it’s soaring temperatures, extreme cold snaps, or devastating floods, pharmaceutical logistics providers must ensure that shipments reach their destination in their intended condition without defect or delay.

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Al Sandrock on his short retirement and taking on a biotech turnaround project

Bio Pharma Dive

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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There’s a Simple Way to Offset The Health Risks of Sitting All Day

AuroBlog - Aurous Healthcare Clinical Trials blog

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 […].

Medicine 216
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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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HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT News

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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AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

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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More Trending

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988 Lifeline sees boost in use and funding in first months

NPR Health - Shots

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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Mix-it-yourself Wegovy? Some are trying risky sources for weight-loss drugs

STAT News

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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CARsgen and Huadong Medicine to commercialise CT053 in mainland China

Pharmaceutical Technology

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 has been developed to treat relapsed/refractory multiple myeloma (R/R MM). It comprises autologous T cells that are modified genetically with a CAR including a complete human anti-BCMA single-chain fragment variant that has a high binding affinity.

Medicine 298
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Large study of J&J’s HIV vaccine stopped after shot found ineffective

Bio Pharma Dive

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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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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Thinx settled a lawsuit over chemicals in its period underwear. Here's what to know

NPR Health - Shots

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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A new study links social media use to changes in teen brains. Is that a bad thing?

STAT News

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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Hospital Universitario and Josep Carreras develop cell therapy for leukaemia

Pharmaceutical Technology

Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development. It could be used for T-Cell Acute Lymphoblastic Leukaemia (T-ALL) treatment in patients for whom bone marrow transplantation and chemotherapy failed to work.

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FDA rejects Lilly Alzheimer’s drug, citing insufficient data

Bio Pharma Dive

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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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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COVID long-haulers face stigma: Study

Medical Xpress

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.

Research 102
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The addiction crisis is causing a spike in endocarditis cases. Hospitals are struggling to respond

STAT News

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.

Drugs 132
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Moderna takes aim at global expansion plans with manufacturing ramp-up

Pharmaceutical Technology

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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Why Wall Street shrugged at Lilly’s Alzheimer’s setback

Bio Pharma Dive

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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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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Is it time for a reality check on rapid COVID tests?

NPR Health - Shots

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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STAT+: Moderna says RSV vaccine worked, setting stage for competition with GSK and Pfizer

STAT News

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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US FDA grants Fast Track status for Avidity’s AOC 1020 to treat FSHD

Pharmaceutical Technology

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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FDA lifts hold on Astellas gene therapy for Pompe disease

Bio Pharma Dive

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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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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Therapy by chatbot? The promise and challenges in using AI for mental health

NPR Health - Shots

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.

Research 129
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UK ATMP clinical research picture remains positive despite challenging global environment

BioPharma Reporter

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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In the search for therapies for solid tumors, companies are turning to a novel target: claudin-6

STAT News

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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With reverse merger, Elicio becomes latest biotech to bypass an IPO

Bio Pharma Dive

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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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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China's COVID surge prompts CDC to expand a hunt for new variants among air travelers

NPR Health - Shots

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.

Research 129
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Researchers reveal genetic predisposition to immunity against new variants of COVID-19

Medical Xpress

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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Mental health benefits of gender-affirming hormones for teens persist for two years in new study

STAT News

Trans and nonbinary teenagers who receive gender-affirming hormones experience less depression and anxiety and more satisfaction with life than before the treatment, according to a new study published Wednesday in the New England Journal of Medicine. Researchers followed over 300 adolescents across the U.S. for two years after initiating hormone treatment.

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Editas, in next restructuring step, to sell cell therapy work to Shoreline

Bio Pharma Dive

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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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.