Sat.Jan 28, 2023 - Fri.Feb 03, 2023

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World Cancer Day cancer research roundup

Antidote

The statistics about the prevalence of cancer can be disheartening. Over 10 million people die each year from cancer , making it one of the leading causes of death — and unfortunately, researchers have yet to find a cure for many cancers.

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The Effectiveness of DIY Air Filtration Units

NIOSH Science Blog: Drugs

Portable air filtration units, or air cleaners, remove airborne particles (called aerosols) from the air indoors. Air filtration units were widely used during large wildfire outbreaks in the western United States,[1] and their use surged nationwide during the COVID-19 pandemic as a way to reduce exposure to aerosols containing the SARS-CoV-2 virus. Homemade or Do-It-Yourself (DIY) air filtration units are an alternative to commercially produced products that can be made from supplies available a

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Drug Channels News Roundup, January 2023: My $0.02 on Amazon & OptumRx, PBMs vs. AFPs, WSJ on 340B, Accumulators & Maximizers, and Tipping Culture

Drug Channels

Here at our worldwide headquarters in Philadelphia, Eagles Super Bowl fever has landed. The police are already getting extra Crisco for the light poles. ( Yes, really.) Before you start training to gorge at your game day party, tackle this month’s selection of notable news stories, intercepted for you from the Drug Channels gridiron: Offsides : My $0.02 on the latest moves by Amazon and OptumRx Trick play : OptumRx attacks alternative funding programs Offensive line : Shocking Wall Street Journa

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

By Mark A. Tobolowsky & Charles G. Raver — Amongst the many provisions that Congress included in the recent Food and Drug Omnibus Reform Act (“FDORA”) were two subtle changes – one change to the Federal Food, Drug, & Cosmetic Act’s (“FD&C Act”) requirements for advancing an investigational new drug into clinical trials and another change to the Public Health Service Act’s (“PHS Act”) (as amended by the Biologics Price Competition and Innovation Act of 2009) requirements for developin

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Focal Points and Monetization: New Uses of Pareto Frontiers in Clinical Development

Cytel

For clinical development and research and development teams, the Pareto Frontier can perform two functions.

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Improving access to rare disease trials by incorporating DCT elements

Labcorp Drug Development

Welcome to the February 2023 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day? … The post Improving access to rare disease trials by incorporating DCT elements appeared first on Insights From Our Labs to Yours.

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Talk of the Towne episode 06: XpertPatient

Antidote

Talk of the Towne is a podcast from Antidote focused on that special place where science and patients converge. It’s hosted by Richard Towne, PharmD, Antidote’s Senior Clinical Informatics Manager. Each episode, Talk of the Towne features a new guest from an Antidote partner organization, and takes an in-depth look at particular therapeutic areas, zeroing in on the story that our data is telling about how best to connect patients and research.

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Celebrating the Invaluable Contributions of Black Scientists to STEM

BenchSci

Diversity, equity, and inclusion are important to us at BenchSci and as a part of our DEI journey, we are committed to learning about, celebrating, and amplifying the voices and accomplishments of people from diverse backgrounds. In honor of Black History Month, we are taking this opportunity to celebrate some of the significant contributions Black scientists have made to advancing STEM fields.

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Generative Molecular Design - We Need to Raise the Bar

Practical Cheminformatics

While it's great that we're now seeing papers describing the experimental validation of generative algorithms for molecular design, we need to consider the significance of these findings and put them into the appropriate context. Over the last five years, we've seen an explosion in the number of papers describing methods for generative molecular design.

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New patent expiration for Endo Pharms drug OPANA ER

Drug Patent Watch

Annual Drug Patent Expirations for OPANA+ER Opana Er is a drug marketed by Endo Pharms and is included in two NDAs. There are eleven patents protecting this drug and six… The post New patent expiration for Endo Pharms drug OPANA ER appeared first on DrugPatentWatch - Make Better Decisions.

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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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How we randomized 75 patients into a knee osteoarthritis clinical trial [case study]

Antidote

Osteoarthritis (OA) is the most common type of arthritis that impacts the knee joint. It is a result of the knee cartilage progressively wearing away , which can lead to difficulty moving, stiffness, and weakness, all of which worsen with time. Knee OA makes up 80% of diagnosed osteoarthritis cases , impacting 19% of adults over the age of 45.

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Linked Data Studies: Improving the Way We Do Observational Research in Germany

Cytel

Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical guidelines, there continue to be high rates of uncontrolled asthma. In order to evaluate differences in healthcare resource utilization and cost among patients with controlled and uncontrolled asthma in Germany, Cytel experts applied a unique approach: a linked data study comparing insurance claims data with primary data.

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Weight-of-Evidence Assessments: Unpacking New Guidance on Carcinogenicity Testing

The Premier Consulting Blog

On November 1, 2022, the U.S. Food and Drug Administration (FDA) adopted an addendum to the guidance titled “ S1B(R1) Testing for Carcinogenicity of Pharmaceuticals ,” which had previously been finalized by the International Council for Harmonization (ICH). The guidance document and integrated addendum detail an integrative, weight-of-evidence (WoE) method of determining whether carcinogenicity testing in rats will be informative in human risk assessments for drug approvals.

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New patent for Seagen drug TUKYSA

Drug Patent Watch

Annual Drug Patent Expirations for TUKYSA Tukysa is a drug marketed by Seagen and is included in one NDA. It is available from one supplier. There are five patents protecting… The post New patent for Seagen drug TUKYSA appeared first on DrugPatentWatch - Make Better Decisions.

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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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Make a Difference with Fresh Residual Human Tissue Donation for Research – How to Get Involved!

Reprocell

Fresh human tissue residual to surgical and diagnostic procedures is often discarded as waste or processed and prepared in a fixed or frozen state for long-term storage as part of a biobank collection. Some stored tissue may be compatible with, and distributed for use in, future investigations and studies, but for many, the donated tissue can remain in storage unused for years.

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Introducing ASCEND™ by BenchSci, our innovative new AI platform with the power to transform preclinical pharmaceutical research

BenchSci

Bringing new medicines and hope to patients faster all starts with preclinical research. But on average, a staggering 98 percent of all pharmaceutical research investment fails to reach patients. There’s a reason for this: biology is incredibly complex. Choosing the right targets, designing successful experiments, and identifying safety and efficacy risks, as just a few examples, involve hundreds or even thousands of trial-error processes and require scientists to work with a seemingly endless n

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Antidote is attending SCOPE 2023

Antidote

We’re always excited to get a chance to connect with people in the clinical trial industry, and this year, we’re thrilled to share that we’ll be attending SCOPE 2023 from February 6 to 9 in Orlando, Florida.

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Which pharmaceutical drugs have the most drug patents in Philippines?

Drug Patent Watch

This chart shows the drugs with the most patents in Philippines. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Philippines? appeared first on DrugPatentWatch - Make Better Decisions.

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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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Discovery moments: TYK2 pseudokinase inhibitor

Plenge Gen

For me, the most enjoyable aspect of discovery research is exploring the unknown. It is about having a big idea; believing in that big idea based on a scientific belief framework ; coming to a crossroads in the validity of the big idea, which is usually marked by deep uncertainty and skepticism; making a data-driven scientific decision to proceed (or not) to the next inflection point of testing the big idea; and ultimately arriving at a conclusion of whether the big idea is true.

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From Coffee to Collaboration: Bringing ASCEND to Life with AMGEN

BenchSci

With the launch of ASCEND™ by BenchSci, we wanted to take the time to dive deeper into the story of how it came to be and the instrumental role one of our top customers played to help shape this revolutionary new technology platform for preclinical pharmaceutical research.

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How co-innovation can unlock cell and gene therapy market potential

Pharma Manufacturing

Collaboration in five key areas is critical to overcoming growth obstacles

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New patent expiration for Pf Prism drug CHANTIX

Drug Patent Watch

Annual Drug Patent Expirations for CHANTIX Chantix is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from three suppliers. There are two… The post New patent expiration for Pf Prism drug CHANTIX appeared first on DrugPatentWatch - Make Better Decisions.

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Embracing the New Normal: Our 2023 Hybrid Model Experiment

LifeSciVC

By Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC Biotwitter is great for healthy debates. The most recent has been on the merits of the hybrid vs.an in-person model. John Maraganore’s excellent article on the topic and the ensuing discussion articulated what’s been on the minds of most CEOs, executive teams and board members I’ve interacted with over the last few months.

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More approaches to design of covalent inhibitors of SARS-CoV-2 main protease

Molecular Design

<< previous | I’ll pick up from the previous post on design covalent inhibitors of SARS-CoV-2 main protease (structure and chart numbering follows from there). As noted previously, I really think that you need to exploit conserved structural features, such as the catalytic residues and the oxyanion hole, if you’re genuinely concerned about resistance and I do consider it a serious error to make a virtue out of non-covalency.

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Full circle: Two decades from bootstrap startup to Magazine of the Year

Pharma Manufacturing

It’s hard to believe that twenty years have passed since I penned the “From the Editor” message in the very first issue of Pharmaceutical Manufacturing magazine

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New patent for Galderma Labs drug EPSOLAY

Drug Patent Watch

Annual Drug Patent Expirations for EPSOLAY Epsolay is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are five… The post New patent for Galderma Labs drug EPSOLAY appeared first on DrugPatentWatch - Make Better Decisions.

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Emerging from Emergency – Two COVID-Related Developments This Week

Eye on FDA

Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one. Emergency Ends – First, the Biden Administration announced that it would be allowing the Public Health Emergency (PHE) declaration to lapse this coming May.

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When the Law Isn’t Really the Law – Creative Jurisprudence in Mostly Bad C.D. California Singulair Decision

Drug & Device Law

We have decided that 2023 will be a year of new adventures for us. We are dipping our toes into the world of dog shows (our gorgeous poodle puppy is now past five months old and soon to begin his show career with a top poodle handler) and we are running for local elected office. The journey is finite, more road is behind than ahead, and change – simply for change’s sake – strikes us as a good thing.

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Beyond ‘good’ practices

Pharma Manufacturing

Pharma quality regulation has evolved beyond routine CGMP compliance toward a more holistic, proactive approach

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New patent expiration for Sunovion Pharms drug KYNMOBI

Drug Patent Watch

Annual Drug Patent Expirations for KYNMOBI Kynmobi is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are nineteen… The post New patent expiration for Sunovion Pharms drug KYNMOBI appeared first on DrugPatentWatch - Make Better Decisions.

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Which pharmaceutical companies have the most drug patents in Slovakia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Slovakia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Slovakia? appeared first on DrugPatentWatch - Make Better Decisions.

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New patent expiration for Novartis drug ZYKADIA

Drug Patent Watch

Annual Drug Patent Expirations for ZYKADIA Zykadia is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eleven patents protecting… The post New patent expiration for Novartis drug ZYKADIA appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Allergan drug DALVANCE

Drug Patent Watch

Annual Drug Patent Expirations for DALVANCE Dalvance is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are four patents protecting… The post New patent for Allergan drug DALVANCE appeared first on DrugPatentWatch - Make Better Decisions.

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