Pharmaceutical Technology
FEBRUARY 22, 2023
Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. While some courts were previously on Sanofi’s side, it is possible that Amgen’s case could win this time, some legal experts say. However, Sanofi’s side also has significant support, highlighting the dispute’s contentious nature.
Bio Pharma Dive
FEBRUARY 22, 2023
The messenger RNA specialist said Wednesday it is teaming up with Life Edit Therapeutics to develop therapies that can modify genes “in vivo.
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Pharmaceutical Technology
FEBRUARY 22, 2023
The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). The new myostatin-targeting biologic investigational agent has been designed for specific binding to myostatin (GDF-8) to reduce overall levels of myostatin. It also works as a receptor antagonist to block myostatin signalling in skeletal muscles.
Worldwide Clinical Trials
FEBRUARY 22, 2023
Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. With so many important discussions happening this year between stakeholders, it is impossible to be a part of them all.
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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
Rethinking Clinical Trials
FEBRUARY 22, 2023
In this Friday’s PCT Grand Rounds, Dr. Konstantin Dragnev and Dr. Karen Reckamp will present “S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials.” The Grand Rounds session will be held on Friday, February 24, 2023, at 1:00 pm eastern. S2302 Pragmatica-Lung is pragmatic clinical trial testing the effect of ramucirumab and pembrolizumab vs standard treatment on overall survival among patients whose non-small-cell lung canc
Pharmaceutical Technology
FEBRUARY 22, 2023
Karyopharm Therapeutic and Menarini Group have received complete marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Nexpovio (selinexor) along with bortezomib (Velcade) and dexamethasone (SVd) to treat multiple myeloma in adult patients. The combination of Nexpovio, once-weekly bortezomib, and low-dose dexamethasone has received approval to treat adult patients who have previously received a minimum of one therapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 22, 2023
Tocilizumab biosimilar is under clinical development by Bio-Thera Solutions and currently in Pre-Registration for Rheumatoid Arthritis.
Bio Pharma Dive
FEBRUARY 22, 2023
Weeks after the first Humira copycat launched in the U.S., a survey by Cardinal Health suggests insurer mandates will drive biosimilar adoption.
NPR Health - Shots
FEBRUARY 22, 2023
Archaeologists have discovered evidence of a rare type of skull surgery dating back to the Bronze Age that's similar to a procedure still being used today. (Image credit: Kalisher et al.
STAT News
FEBRUARY 22, 2023
Moderna is aiming to build a gene editing franchise powered by some of the same technologies used in its COVID-19 vaccines. The Cambridge biotech company announced Wednesday that it will partner with Life Edit Therapeutics to develop potentially permanent treatments for rare genetic diseases and other conditions. Life Edit is the North Carolina subsidiary of ElevateBio, a cell and gene therapy manufacturing firm in Waltham.
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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
Pharmaceutical Technology
FEBRUARY 22, 2023
Olezarsen Sodium is an antisense oligonucleotide commercialized by Ionis Pharmaceuticals, with a leading Phase III program in Familial Chylomicronemia (Type I Hyperlipoproteinemia).
STAT News
FEBRUARY 22, 2023
Stroke risk prediction tools are meant to guide how doctors approach a potentially deadly condition, using factors like heart disease and high blood pressure to get a handle on which patients might benefit from a particular treatment. For years, doctors have used several different algorithms to try to capture the true risk of stroke, including newer models that use machine learning.
Pharmaceutical Technology
FEBRUARY 22, 2023
CMN-005 is under clinical development by CoImmune and currently in Phase II for B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia). According to GlobalData, Phase II drugs for B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia) have a 57% phase transition success rate (PTSR) indication benchmark for progressing into Phase III.
NPR Health - Shots
FEBRUARY 22, 2023
The U.S. faces a shortfall of about 450,000 nurses and 120,000 doctors in the coming years. The Senate's top health committee, led by Sen. Bernie Sanders, is considering bipartisan solutions. (Image credit: J.
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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.
Pharmaceutical Technology
FEBRUARY 22, 2023
Lefitolimod is under clinical development by Mologen and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Lefitolimod’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
STAT News
FEBRUARY 22, 2023
SAN DIEGO — The first time it happened, veteran real estate broker Ted Jacobs thought it was a fluke. But it didn’t take long for him to realize that the biotech industry’s demand for lab and office space, which had once seemed unquenchable, was suddenly slowing. It was the fall of 2022, and Jacobs, who represents San Diego life science tenants for CBRE, was working with a company that was planning to expand after raising around $200 million.
Pharmaceutical Technology
FEBRUARY 22, 2023
Lefitolimodis under clinical development by Mologen and currently in Phase I for Solid Tumor.
Pharma Times
FEBRUARY 22, 2023
Research will analyse how Huawei’s wearable technology detects atrial fibrillation in post-stroke patients
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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.
Pharmaceutical Technology
FEBRUARY 22, 2023
Bezuclastinib is a small molecule commercialized by Cogent Biosciences, with a leading Phase III program in Gastrointestinal Stromal Tumor (GIST).
Medical Xpress
FEBRUARY 22, 2023
Patients with Parkinson's disease achieved a significant improvement in their tremors, mobility, and other physical symptoms after having a minimally invasive procedure involving focused ultrasound, according to a new study today published in the New England Journal of Medicine.
Pharmaceutical Technology
FEBRUARY 22, 2023
Cenerimod is a small molecule commercialized by Idorsia Pharmaceutical, with a leading Phase III program in Systemic Lupus Erythematosus.
STAT News
FEBRUARY 22, 2023
Charles River Laboratories, one of the largest clinical research organizations in the U.S., is suspending shipments of non-human primates that are widely used in pharmaceutical research after receiving a subpoena from federal authorities probing a Cambodian smuggling ring. The move comes after several people — including two Cambodian wildlife officials — were indicted in November for their alleged involvement in the monkey-smuggling operation.
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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.
Medical Xpress
FEBRUARY 22, 2023
A daily dose of a strain of brewer's yeast used to produce cachaça (distilled spirit made from fermented sugarcane juice) can act as a preventive against asthma, according to a Brazilian study involving male mice. The results are reported in an article published in the journal Probiotics and Antimicrobial Proteins. The authors are researchers at the University of São Paulo (USP) and the Federal University of Minas Gerais (UFMG).
STAT News
FEBRUARY 22, 2023
This year’s flu shot generated relatively robust levels of protection, new data show, with the vaccine’s effectiveness ranging between about 45% and 55%, depending on the age group and the metric studied, such as whether there was protection against any infection or infection that was severe enough to require hospitalization. The data were presented Wednesday to the Advisory Committee on Immunization Policy, which advises the Centers for Disease Control and Prevention.
Medical Xpress
FEBRUARY 22, 2023
Over the past two decades, a great deal of attention has been given to marijuana—also known as pot or weed. As of early 2023, marijuana has been legalized for recreational use in 21 states and Washington, D.C., and the use of marijuana for medical purposes has grown significantly during the last 20 or so years.
STAT News
FEBRUARY 22, 2023
NEW YORK — Amazon said Wednesday it has closed its $3.9 billion acquisition of the primary care organization One Medical. The e-commerce giant has said the buyout, which was announced in July, is a key component of its growing health care business, which includes its online drugstore Amazon Pharmacy and a patient to doctor messaging service called Amazon Clinic.
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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.
Medical Xpress
FEBRUARY 22, 2023
Mount Sinai researchers have published a study in Alzheimer's & Dementia: The Journal of the Alzheimer's Association that sheds new light on the role of DNA methylation in Alzheimer's disease (AD). The study found that DNA methylation has a profound impact on gene and protein co-expression networks associated with AD and could lead to the discovery of new neuropathological processes and molecular mechanisms for developing novel treatments for the disease.
STAT News
FEBRUARY 22, 2023
The progress the world has made in reducing maternal mortality has stalled in recent years, with some regions — including Europe and Northern America — backsliding since 2015, according to a new report from United Nations agencies. The report estimated that there were 287,000 maternal deaths globally in 2020, a slight decrease compared to an estimated 309,000 maternal deaths in 2016.
Outsourcing Pharma
FEBRUARY 22, 2023
Father and software engineer, Vincent Keunen combined his personal experience of leukemia and his son's bone cancer with his professional skills to provide all patients with a tool to manage their health information on their smartphone.
STAT News
FEBRUARY 22, 2023
When I go to a health care provider and check “Black” for my race or ethnicity, it means that my provider — before even seeing me — knows I have dark skin and “different” hair. But the biases or stereotypes emanating from my answer could include assumptions that I have no husband, limited education, or earn a low income or none.
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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.
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