May, 2024

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Participants of pioneering CRISPR gene editing trial see vision improve

Science Daily: Pharmacology News

About 79% of clinical trial participants experienced measurable improvement after receiving experimental, CRISPR-based gene editing that is designed to fix a rare form of blindness, according to a new article.

Trials 137
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Patient dies in Pfizer study of Duchenne gene therapy

BioPharma Drive: Drug Pricing

Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.

Therapies 142
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There's a New Set of COVID Variants Called FLiRT: What You Need to Know

Drugs.com

WEDNESDAY, May 8, 2024 -- The virus behind COVID has mutated again, this time producing variants nicknamed FLiRT, the U.S. Centers for Disease Control and Prevention (CDC) has reported.The variants are appearing in wastewater sampling, the CDC.

Virus 126
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Navigating Trust and Data in Healthcare Marketing

Perficient: Drug Development

In the ever-evolving landscape of healthcare, trust reigns supreme. As consumers increasingly rely on data to inform their decisions, the healthcare industry faces a pressing need to not only meet but exceed expectations. With disruptive forces emerging from various corners, healthcare organizations find themselves in a race to create personalized experiences that foster lasting engagement and trust.

Marketing 111
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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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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.

FDA 111
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How CDISC SDTM Improves Cost & Quality in ISS/ISE in 2024

Quanticate

When investigating the efficacy and safety of a new drug/device it is sometimes necessary to combine the research from multiple clinical trials for your analysis. In such cases, it is important to consider the cost and quality of producing integrated summaries and how CDISC SDTM (Clinical Data Interchange Standards Consortium Study Data Tabulation Model) can aid in reducing costs and improving quality for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) submissions.

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Ajax, aiming for a better JAK drug, raises $95M to begin first tests

BioPharma Drive: Drug Pricing

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

Therapies 127
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FDA Approves First Self-Test Collection Kit for HPV

Drugs.com

WEDNESDAY, May 15, 2024 -- The U.S. Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could increase early detection in those at risk for cervical cancer. Women.

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Handling Not Allowed Reflection Method in Sitecore

Perficient: Drug Development

Recently, to meet project requirements, we customized and expanded the functionality of the “General Link” feature by incorporating a new “Telephone Link” feature. Everything was working correctly on our local project instance, but we got the below-listed error when the changes were deployed on the higher environment. Exception: Sitecore.Exceptions.AccessDeniedException Message: Calling Fieldtypes.ExtendedGeneralLink.ExtendedGeneralLinkForm.OnModeChange method through ref

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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

FDA Law Blog: Biosimilars

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).

FDA 105
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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.

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Antidote to be announced as Corporate Honoree at MSAA Improving Lives Benefit

Antidote

We are thrilled to be honored as the Multiple Sclerosis Association of America’s Corporate Honoree at their 10th annual Improving Lives Benefit on May 15! This inspiring event supports MSAA’s free programs and services and honors key players in the MS research space.

Research 105
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Stretchable e-skin could give robots human-level touch sensitivity

Science Daily: Pharmacology News

A stretchy electronic skin could equip robots and other devices with the same softness and touch sensitivity as human skin, opening up new possibilities to perform tasks that require a great deal of precision and control of force.

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Drug patents protect pharma profits. Track when they’ll expire here.

BioPharma Drive: Drug Pricing

Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.

Drugs 129
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Early Hints at a Gene Therapy Cure for Herpes

Drugs.com

WEDNESDAY, May 15, 2024 -- An experimental gene therapy could one day provide a first-ever cure for genital and oral herpes, researchers report.The gene therapy removed 90% or more of oral herpes infection in lab mice, and it also suppressed how.

Therapies 103
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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Women in Stem with Stefanie Flückiger-Mangual

Drug Target Review

Can you tell us about your journey in the field of STEM and the challenges you encountered along the way? My journey in STEM has been both challenging and immensely fulfilling. Early in my career, I had a bad experience in one of my first jobs, helping in the lab as a young student. My professor’s seeming support of my work quickly shifted into a more personal interest in me.

Science 105
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Cell Line Services FAQ

Crown Bioscience

This post delves into some frequently asked questions about Omni Screen and its unique capabilities in providing compliant, large-scale cell line screening solutions that are not only cutting-edge but also aligned with industry standards and regulations. Whether you're a researcher, a biotech professional, or someone keen on understanding the nuances of cell line screening, this discussion will provide valuable insights into how Crown Bioscience can support your scientific endeavors.

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Advancing Clinical Data Management into a New Era

Quanticate

Innovative strategies paving the way for enhanced data quality, integrity and streamlined data validation and cleaning. The way we clean and validate data within clinical trials is continuously evolving, more than ever now with the advancements in technology that we are seeing across this industry year on year. These technological developments are reshaping the way data is handled, leading to improvements in the accuracy and efficiency of data.

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Scientists generate heat over 1,000 degrees Celsius with solar power instead of fossil fuel

Science Daily: Pharmacology News

Instead of burning fossil fuels to smelt steel and cook cement, researchers in Switzerland want to use heat from the sun. The proof-of-concept study uses synthetic quartz to trap solar energy at temperatures over 1,000 C (1,832 F), demonstrating the method's potential role in providing clean energy for carbon-intensive industries.

Research 124
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Eisai sets new revenue target for Alzheimer’s drug Leqembi

BioPharma Drive: Drug Pricing

The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.

Drugs 114
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Getting Abortion Pill Via Mail Order Is Quick, Safe & Effective

Drugs.com

MONDAY, May 13, 2024 -- Women who get abortion pills through the mail receive care that's as good as those who are required to get them in person from a clinic or doctor’s office, a new study says. Using a mail-order pharmacy to deliver the.

Pharmacy 108
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CDD Vault Update (May 2024)

Collaborative Drug

Hooray for curve overlays!! We are excited to announce a new round of features associated with our Curve Analytics Module. If you are not yet subscribed to Curve Analytics, please contact your CDD Vault account manager or the CDD Vault Support Team to discuss enabling these features in your Vault.

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NVIDIA GTC Training Labs On Demand Available Now

Nvidia Developer: Drug Discovery

Missed GTC or want to replay your favorite training labs? Find it on demand with the NVIDIA GTC Training Labs playlist. Missed GTC or want to replay your favorite training labs? Find it on demand with the NVIDIA GTC Training Labs playlist.

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#ScienceSaturday: May 4, 2024

KIF1A

#ScienceSaturday posts share exciting scientific developments and educational resources with the KAND community. Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. KIF1A-Related Research Clinical and Genetic Characterization of a Cohort of Brazilian Patients With Congenital Ataxia KAND is a rare disorder, but each new patient makes it slightly less so.

Science 99
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Scientists work out the effects of exercise at the cellular level

Science Daily: Pharmacology News

The health benefits of exercise are well known but new research shows that the body's response to exercise is more complex and far-reaching than previously thought. In a study on rats, a team of scientists has found that physical activity causes many cellular and molecular changes in all 19 of the organs they studied in the animals.

Research 135
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Lilly’s once-weekly insulin matches daily shots in late-stage tests

BioPharma Drive: Drug Pricing

The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.

Drugs 112
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Leptospirosis: What Every Dog Owner Should Know

Drugs.com

FRIDAY, May 17, 2024 -- Mice, rats and other wildlife can pick up bacteria called leptospira from water or soil and excrete it in urine. If your dog contacts any soil or water contaminated by the germ (especially if they have an open wound) they.

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Including Patients with Borderline Personality Disorder in Clinical Trials

Conversations in Drug Development Trends

By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment. Despite these risks, there are no medications specifically approved to target the core symptoms of BPD; current treatments are limited to managing underlying affective symptoms.

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New patent for Mallinckrodt Hosp drug INOMAX

Drug Patent Watch

Annual Drug Patent Expirations for INOMAX Inomax is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from one supplier.

Drugs 97
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Perficient Awarded as HCL Software’s Gold Reseller Award

Perficient: Drug Development

We are proud to announce Perficient has been awarded HCL Software’s Gold Reseller Award! This award comes as recognition for our continued collaboration and outstanding performance in regard to sales and delivery in 2023. As an HCL Software strategic partner, we actively drive innovation into HCL’s roadmap and collaborate closely from a product innovation and support perspective.

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A simple quantum internet with significant possibilities

Science Daily: Pharmacology News

It's one thing to dream up a quantum internet that could send hacker-proof information around the world via photons superimposed in different quantum states. It's quite another to physically show it's possible. That's exactly what physicists have done, using existing Boston-area telecommunication fiber, in a demonstration of the world's longest fiber distance between two quantum memory nodes to date.

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AstraZeneca withdraws COVID-19 vaccine, citing declining demand

BioPharma Drive: Drug Pricing

The move ends a turbulent saga for AstraZeneca, which successfully developed a coronavirus shot but struggled to sell it amid competition and the emergence of rare but serious side effects.

Vaccine 117
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Major Women's Health Study Supports Hormone Replacement Therapy in Early Menopause

Drugs.com

WEDNESDAY, May 1, 2024 -- Hormone replacement therapy can safely ease middle-aged women’s symptoms during early menopause, data from a major women’s health study show. Women younger than 60 can use hormone replacement to treat symptoms.

Therapies 112
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Antibodies 101: Flow Compensation

addgene Blog

In flow cytometry, compensation is the process of correcting spillover from one fluorescent channel to another. When you label your samples with multiple antibodies, the fluorescent probes on the antibodies may have similar emission spectra, meaning they will emit fluorescent light at similar wavelengths (See this handy emission spectra chart to find your antibody's spectra ).

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Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: A May 2024 Update

Drug Channels

It's time for Drug Channels ’ annual update of vertical integration among insurers, PBMs, specialty pharmacies, and providers within U.S. drug channels. Below you’ll find our latest illustration of the major vertical business relationships among the largest companies along with some of the notable activity since our previous update. These organizations continue to exert greater control over patient access, sites of care/dispensing, and pricing, although some have started to unwind their vert