5 questions facing gene therapy in 2023
Bio Pharma Dive
JANUARY 12, 2023
Buoyed by recent approvals, the field faces a pivotal year that’s likely to bring new treatments as well as more challenges.
Bio Pharma Dive
JANUARY 12, 2023
Buoyed by recent approvals, the field faces a pivotal year that’s likely to bring new treatments as well as more challenges.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 12, 2023
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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Bio Pharma Dive
JANUARY 12, 2023
The pharma is rolling out a multi-year capital commitment to its biotech investment group, which this week backed biotech NextPoint Therapeutics.
Pharmaceutical Technology
JANUARY 12, 2023
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 12, 2023
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 […].
Pharmaceutical Technology
JANUARY 12, 2023
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
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 12, 2023
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.
STAT News
JANUARY 12, 2023
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
NPR Health - Shots
JANUARY 12, 2023
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.
Medical Xpress
JANUARY 12, 2023
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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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.
STAT News
JANUARY 12, 2023
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.
pharmaphorum
JANUARY 12, 2023
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.
STAT News
JANUARY 12, 2023
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.
NPR Health - Shots
JANUARY 12, 2023
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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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.
STAT News
JANUARY 12, 2023
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.
Medical Xpress
JANUARY 12, 2023
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.
NPR Health - Shots
JANUARY 12, 2023
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.
STAT News
JANUARY 12, 2023
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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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.
NPR Health - Shots
JANUARY 12, 2023
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.
STAT News
JANUARY 12, 2023
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.
NPR Health - Shots
JANUARY 12, 2023
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.
STAT News
JANUARY 12, 2023
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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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.
pharmaphorum
JANUARY 12, 2023
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
STAT News
JANUARY 12, 2023
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.
Medical Xpress
JANUARY 12, 2023
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.
STAT News
JANUARY 12, 2023
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.
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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.
Medical Xpress
JANUARY 12, 2023
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.
ACRP blog
JANUARY 12, 2023
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.
Antidote
JANUARY 12, 2023
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.
Medical Xpress
JANUARY 12, 2023
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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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.
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