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

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Podcast: The impact of synthetic biology and collaboration in pharma

Drug Discovery World

This is the latest episode of the free DDW podcast. It covers two articles written for Volume 23, Issue 1 – Winter 2021/22 of DDW. They are called “ Why synthetic biology is the next big thing for biopharma ” and “ Collaborative spirit helps drive innovation ”. ‘Can synthetic biology save us?’ and ‘Synthetic biology can benefit us all’, are just some of the headlines this emerging scientific field has recently elicited.

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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

Drugs 98
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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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Quicker time to regulatory submission through improved digital data management

Drug Discovery World

Robust digital workflows can reduce errors and time to compile data leading to greater transparency, faster reporting and help biopharmaceutical companies reach regulatory submission faster. Ken Forman , Senior Director of Product Strategy, IDBS explains. For many start-ups operating on limited investment capital, the ticking clock can be overwhelming.

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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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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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UK biotech investment drops after bumper years

Drug Discovery World

Investment in UK biotech has fallen from £4.5 billion in 2021 to just £1.8 billion in 2022, mirroring the global economic downturn impacting all sectors. However, venture capital investment in the sector was the third-best year recorded for the UK, with £1.2 billion raised, new analysis from the UK BioIndustry Association (BIA) and Clarivate shows.

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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.

Science 52
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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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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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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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Common antidepressants increase antibiotic resistance

Drug Discovery World

Researchers have found a range of commonly prescribed antidepressants can increase bacteria’s resistance to antibiotic medications. A study led by Professor Jianhua Guo from University of Queensland’s Australian Centre for Water and Environmental Biotechnology focused on prescription drugs used to treat depressive disorders, anxiety disorders, and other psychological conditions.

Science 130
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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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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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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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This week in drug discovery (30 January – 3 February)

Drug Discovery World

News round-up for 30 January – 3 February by DDW Digital Content Editor Diana Spencer. As February 4 is World Cancer Day, this week’s update focuses on developments in the field of oncology. Drugs for lung cancer, lymphoma and breast cancer have received regulatory approvals, an investment boost will allow the development of a novel approach to treating tumours, and a new global commission will seek to improve access to personalised therapies.

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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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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.

Drugs 52
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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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$2 million awarded to antibiotic resistance researcher

Drug Discovery World

A major boost of £1.76 million ($2.16 million) will fund research designed to stop antibiotics failing, to help mitigate the rising threat of antibiotic resistance. Professor Stefano Pagliara, at the University of Exeter, has received the award to advance his work on controlling the processes and biological mechanisms that cause antibiotics to fail, and can mean infectious diseases become life-threatening.

Research 130
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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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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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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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New oral option for anaemia of CKD approved in US

Drug Discovery World

The US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat) for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in the US. Tony Wood, President and Chief Scientific Officer, GSK, said: “Over the last several decades, there has been little innovation in anaemia of CKD.

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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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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.

Drugs 52
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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.

Science 52
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How to choose the most promising drug candidates from your hit list

Drug Discovery World

DDW is hosting an exclusive free event, Connected chemistry: How to choose the most promising drug candidates from your hit list. It will be supported by Torx Software. It will take place on March 8, 2023 3PM GMT. Register here for free. AI and machine learning (AI/ML) methods offer an alluring way to expedite the drug discovery process by delivering a large number of possible new candidates for any given therapeutic area.

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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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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.

Drugs 52
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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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The impact of synthetic biology and collaboration in pharma

Drug Discovery World

This is the latest episode of the free DDW podcast. It covers two articles written for Volume 23, Issue 1 – Winter 2021/22 of DDW. They are called “ Why synthetic biology is the next big thing for biopharma ” and “ Collaborative spirit helps drive innovation ”. ‘Can synthetic biology save us?’ and ‘Synthetic biology can benefit us all’, are just some of the headlines this emerging scientific field has recently elicited.

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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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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.

Drugs 52