Thu.Jan 12, 2023

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5 questions facing gene therapy in 2023

Bio Pharma Dive

Buoyed by recent approvals, the field faces a pivotal year that’s likely to bring new treatments as well as more challenges.

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COVID Autopsies Reveal The Virus Spreading Through The ‘Entire Body’

AuroBlog - Aurous Healthcare Clinical Trials blog

COVID-19 is defined as a respiratory infection, but the effects of the novel coronavirus are certainly not confined to any one organ. Dozens of recent autopsies show persistent evidence of SARS-CoV-2 throughout the body, including in the lungs, the heart, the spleen, the kidneys, the liver, the colon, the thorax, muscles, nerves, the reproductive tract, […].

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Sanofi tops off venture arm, bringing fund to $750M

Bio Pharma Dive

The pharma is rolling out a multi-year capital commitment to its biotech investment group, which this week backed biotech NextPoint Therapeutics.

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US FDA approves AstraZeneca-Avillion’s asthma treatment Airsupra

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. Previously known as PT027, Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication. It comprises short-acting beta2-agonist (SABA) albuterol and anti-inflammatory inhaled corticosteroid (ICS) budesonide.

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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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Indian pharma sees immense importance in US FDA guidance on aluminum content and labelling in parenteral nutrition

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products. There are also exports for the same. The global regulatory authority noted […].

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Solid Biosciences partners with Phlox for cardiac disease therapies

Pharmaceutical Technology

Solid Biosciences has entered a strategic research collaboration with Phlox Therapeutics to expedite the development of new therapies for rare cardiac diseases. Under the research partnership deal, the companies will develop new precision genetic medicines for a severe form of genetic dilated cardiomyopathy (DCM). The collaboration will use the vector biology, manufacturing capabilities and the drug development experience of Solid Biosciences and Phlox Therapeutics’ knowledge in genetic cardiomy

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NMPA of China approves Takeda’s Exkivity for NSCLC

Pharmaceutical Technology

The National Medical Products Administration (NMPA) of China has approved Takeda ’s Exkivity (mobocertinib) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients. The oral tyrosine kinase inhibitor (TKI) Exkivity has been specifically designed for targeting epidermal growth factor receptor (EGFR) Exon20 insertion mutations selectively.

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Medical schools are missing the mark on artificial intelligence

STAT News

Ready or not, health care is undergoing a massive transformation driven by artificial intelligence. But medical schools have barely started to teach about AI and machine learning — creating knowledge gaps that could compound the damage caused by flawed algorithms and biased decision-support systems. “We’re going to be at a point where we’re not going to be able to catch up and be able to call out the technology defects or flaws,” said Erkin Ötleş, a

Research 145
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The FDA no longer requires all drugs to be tested on animals before human trials

NPR Health - Shots

In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.

Trials 145
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Common brain network for psychiatric illness discovered

Medical Xpress

Psychiatric illnesses, such as schizophrenia and depression, affect nearly one in five adults in the United States and nearly half of patients diagnosed with a psychiatric illness also meet the criteria for a second. With so much overlap, researchers have begun to suspect that there may be one neurobiological explanation for a variety of psychiatric illnesses.

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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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STAT+: Medicare paves the way for CAR-T in doctors offices

STAT News

WASHINGTON — Medicare officials have taken a step toward making a cutting-edge cancer treatment called CAR T-cell therapy available in doctor offices, in anticipation of the procedure being used for increasingly common cancer types. CAR-T is a relatively new medical procedure that uses a person’s own cells to fight their cancer, and it offers hope of a cure for those who have run out of options.

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Bayer taps Google’s quantum power for drug discovery

pharmaphorum

Bayer has signed an agreement with Google aimed at using high-level processing power to handle quantum chemistry calculations used to predict the chemical and physical properties of drug molecules at the atomic scale. The deal with the tech giant’s Google Cloud unit revolves around its tensor processing units (TPUs), artificial intelligence-powered accelerators designed to run machine learning models and computationally-intensive workloads that can be customised to specific applications.

Drugs 122
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XB what? BQ huh? Do you need to keep up with Omicron’s ever-expanding offspring?

STAT News

It’s like clockwork now. Every few months, we’re warned that the Omicron variant of the SARS-CoV-2 virus has spawned yet another subvariant, this one even more transmissible than the ones it is fast overtaking. The new entity is given a name, an unwieldy string of letters and numbers separated by periods. There’s discussion — some of it breathless — on Twitter and in the media about the threat the new subvariant poses.

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Sitting all day can be deadly. 5-minute walks can offset harms

NPR Health - Shots

A new study finds that taking regular, short bouts of movement during the day can reduce the risk of developing conditions like diabetes and heart disease.

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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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#JPM23 in review, the year ahead, & the merits of Miami

STAT News

What happened at biotech’s big reunion? Will this year be better than the last? And is it time to quit San Francisco? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. With the 2023 J.P. Morgan Healthcare Conference drawing to a close, we look back on the biggest news of the meeting, what it means for the year in biotech ahead, and whether the industry’s biggest annual gathering might finally have outgrown its host city.

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Mature 'lab grown' neurons hold promise for neurodegenerative disease

Medical Xpress

Northwestern University-led researchers have created the first highly mature neurons from human induced pluripotent stem cells (iPSCs), a feat that opens new opportunities for medical research and potential transplantation therapies for neurodegenerative diseases and traumatic injuries.

Research 111
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Anti-fatness keeps fat people on the margins, says Aubrey Gordon

NPR Health - Shots

In her new book You Just Need To Lose Weight and 19 Other Myths About Fat People , Aubrey Gordon tackles the biases and myths that she says keeps fat people on the margins of society.

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Opinion: A lesson from JPM: Too many digital front doors in health care lead to nowhere

STAT News

Top health care leaders braved rain, hail, and flash flood warnings at this year’s J.P. Morgan Healthcare Conference in San Francisco. The other thing they’re navigating? The downpour of new-entrant retailers in health care. Announcements at JPM and the recent CES 2023 conference in Las Vegas have confirmed the desire of folks including Amazon, Best Buy, CVS, and even Samsung to try to make health care simpler.

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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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Ryan Shazier was seriously injured in an NFL game. He has advice for Damar Hamlin

NPR Health - Shots

The players suffered different injuries, though in similar settings. The former Steeler reflects on the memories Hamlin's collapse brought back and what he learned from his own long road to recovery. (Image credit: Justin K.

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Opinion: More nurses: The smart way to save lives, money — and nurses

STAT News

Although the 7,000 New York City nurses who went on strike this week reached a deal with their health systems on Jan. 12, nurse staffing levels will continue to be a problem in New York City and in hospitals across the country. The New York nurses are just the latest group to speak out about hospitals that have long minimized nursing staff, prioritizing profits over safety.

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New York City nurses end strike after reaching a tentative agreement

NPR Health - Shots

After three days on the picket line, more than 7,000 nurses are returning to work at the city's biggest hospitals with the promise of "concrete, enforceable safe staffing ratios," their union said. (Image credit: Michael M.

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STAT+: California is the latest state to sue drugmakers and PBMs over insulin pricing

STAT News

The California attorney general has filed a lawsuit accusing several drugmakers and pharmacy benefit managers of conspiring to set prices for insulin, joining a growing list of states that have taken such a step as more and more Americans struggle to afford the life-savings diabetes treatment. The lawsuit alleges that the companies “unconscionably, deceptively, misleadingly, and artificially” drove up the cost of insulin, making the medication unaffordable for many of the 3 million

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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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The rise of prescription drug abuse and drug diversion

pharmaphorum

As prescription drug abuse has grown in the US and Europe, the diversion of such treatments from legitimate sources has also increased. Ben Hargreaves speaks to an expert in the area to learn how drug diversion occurs, and how it can be countered. Drug diversion is the channelling of prescription drugs from a medical source into the illegal market. The problem is growing as abuse of prescription treatments, such as opioids, stimulants, and sedatives also increases , making the diversion of such

Drugs 101
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STAT+: BioNTech CEO lays out vision for how mRNA and AI can power personalized medicine

STAT News

SAN FRANCISCO — When BioNTech was founded in 2008, messenger RNA therapies and vaccines were still an unproven idea. The German company has now shipped out billions of doses of its mRNA Covid-19 vaccine worldwide — and BioNTech’s leaders say that’s just the beginning of a larger revolution in medicine. CEO Uğur Şahin sat down with STAT during this week’s J.P.

Medicine 105
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Nasal injections could treat long-term COVID-19–related smell loss

Medical Xpress

Early in the pandemic, when people with COVID-19 began reporting that they lost their sense of smell, Zara Patel, MD, figured as much. A professor of otolaryngology at Stanford Medicine, Patel has, for years, studied loss of smell as a symptom of viral infections.

Medicine 106
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STAT+: ‘We become millionaires and we retire babe’: Former Takeda worker and boyfriend accused of $2.3 million scam of drug firm

STAT News

A high-ranking former technology employee at Takeda Pharmaceutical’s US headquarters in Massachusetts and her boyfriend were arrested Wednesday on federal charges for allegedly setting up a fake consulting firm that defrauded the Japanese drug giant of about $2.3 million. Priya Bhambi, 39, who was fired in November after an internal investigation, and Samuel N.

Drugs 98
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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.

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Real-time monitoring with a wearable device reveals IBS-related changes

Medical Xpress

Irritable bowel syndrome (IBS) is a difficult disease to treat, characterized by chronic abdominal pain related to bowel movements, of which there are four types: diarrheal, constipation, mixed, and unclassifiable. Patients with IBS report a reduction in quality of life and experiences of social discomfort, as they are forced to restrict their activity, such as work or travel, because of the sudden and unpredictable need to use the bathroom.

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Merck Takes Action to Address Clinical Research Workforce Challenges

ACRP blog

New initiatives include Merck and ACRP collaborations. Taking action to increase and diversify the clinical research workforce is a high priority at Merck, known as MSD outside the U.S. and Canada. “Passively watching sites struggle to hire and retain talent is not an option for our industry,” says Kelly Clark, Head of U.S. Partnerships and Global Site Development, Merck.

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The history of Alzheimer’s disease

Antidote

Alzheimer’s disease is the most common type of dementia in the United States, impacting around 6.2 million people above the age of 65. Since it was first observed in the early 1900s, a lot of information has been uncovered through medical research.

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Link between sphingolipids and complement signaling may be key to stopping cancer metastasis

Medical Xpress

MUSC Hollings Cancer Center researchers have identified the sequence of molecular interactions that could be key to stopping the spread of cancer cells. Currently, there is no reliable therapeutic approach to prevent metastasis, the leading cause of death from solid cancerous tumors. Published in Cell Reports, this work is the first to uncover the link between two important groups of molecules that regulate cell-to-cell communication within tumors to increase cancer cell migration and metastasis

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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.