Sat.Oct 29, 2022 - Fri.Nov 04, 2022

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This week in drug discovery (31 October – 4 November)

Drug Discovery World

News round-up for 31 October – 4 November by DDW Digital Content Editor Diana Spencer . In a week that saw magic mushrooms making the headlines in the UK, we also reported on exciting potential new therapies for geographic atrophy and malaria prevention. Meanwhile, the quest to understand Covid-19 continues, as study findings reveal how the virus affects the brain and the effectiveness of vaccines in those with compromised immunity. .

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Patient-specific cancer tumours replicated in 3D bioprinting advance

Drug Discovery Today

Bowel cancer patients could in future benefit from a new 3D bioprinting technology which would use their own cells to replicate the complex cellular environment of solid tumours in 3D models. The University of Bristol-led advance, published in Biofabrication, would allow clinicians to treat the models, known as spheroids, with chemotherapy drugs and radiation to help them understand an individual patient’s resistance to therapies.

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Innovate4Outcomes: Collaborating to Solve Antimicrobial Resistance

Drug Channels

Today’s guest post comes from Matthew Balogh, Head of Digital Marketing at Melinta Therapeutics. Matt discusses the ongoing global problem of antimicrobial resistance (AMR). He suggests that lessons learned from the COVID-19 pandemic can inform both innovation in AMR therapies and our understanding of AMR. To learn more about the global challenge of AMR and brainstorm solutions, request an invitation to Innovate4Outcomes ®.

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New patent for Exeltis Usa drug SLYND

Drug Patent Watch

Annual Drug Patent Expirations for SLYND Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. There are nine patents protecting this drug. SLYND drug…. The post New patent for Exeltis Usa drug SLYND 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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Study insights may aid TB vaccine development

Drug Discovery World

New research has furthered our understanding of the immune-related factors that drive infection and disease, which will be necessary for an effective tuberculosis (TB) vaccine to be developed. Researchers from the University of Oxford investigated whether previously identified correlates of protection associated with risk of full-blown TB disease could also be associated with risk of infection from the bacteria that causes TB.

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ROME Therapeutics and Enara Bio to Host Inaugural Dark Genome Symposium Convening Industry and Academic Leaders to Catalyze Therapeutic Application of Dark Genome Research

Drug Discovery Today

BOSTON, Mass. and Oxford, UK – November 2, 2022 – ROME Therapeutics and Enara Bio, two leading biotechnology companies focused on developing novel medicines driven by insights to the dark genome, today announced that they will host the inaugural Dark Genome Symposium on Monday, November 7, 2022 at ROME’s headquarters in Boston. This one-day event brings together leaders from academia, biotech and pharma working on the dark genome to share knowledge, opportunities, applications and challenges to

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New patent for Azurity drug KATERZIA

Drug Patent Watch

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

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Avista continues investment in pharma services with Taconic acquisition 

Drug Discovery World

Avista Capital Partners has acquired Taconic Biosciences, a provider of genetically engineered research models (GEMs), as it reaches its 70th anniversary. . Taconic specialises in genetically engineered research models and services, specifically murine models for use in drug discovery research and non-clinical safety testing. . The company has reassured customers that there will be no interruption or changes to services due to the new ownership. .

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Enhanced pacemaker developer Ceryx Medical wins prestigious Institute of Physics award

Drug Discovery Today

University of Bath spin-out hailed for revolutionary development to provide world’s first curative therapy for heart failure

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What the FDA’s guidance on diversity means for rare disease sponsors

Conversations in Drug Development Trends

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. This plan, designed to help make clinical trial enrollment more representative, stands to support diversity, equity and inclusion (DEI) initiatives in R&D — a sector that certainly needs more attention across all clinical trials.

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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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New patent for Exeltis Usa drug DROSPIRENONE

Drug Patent Watch

Annual Drug Patent Expirations for DROSPIRENONE Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs Ltd, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs,…. The post New patent for Exeltis Usa drug DROSPIRENONE appeared first on DrugPatentWatch - Make Better Decisions.

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PhoreMost enters multi-target collaboration with Arvinas

Drug Discovery World

PhoreMost and targeted protein degradation (TPD) specialists Arvinas have agreed a multi-target collaboration. Under the terms of the agreement, PhoreMost will deploy its phenotypic screening platform, SITESEEKER, toward multiple high-value therapeutic targets. The output from SITESEEKER screening campaigns will be used to drive degrader drug discovery in oncology and neurodegeneration using Arvinas’s PROTAC Discovery Engine platform.

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Antidote Technologies and Beyond Celiac Partner to Match Celiac Patients with Research Opportunities

Antidote

We’re thrilled to share that today, we announced an important collaboration with Beyond Celiac, the leading celiac disease organization working to drive diagnosis, advance research, and accelerate the discovery of new treatments and a cure. We’ve been working with this incredible organization to make our celiac disease clinical trial search even better for patients and caregivers — and we’re now unveiling this blend of our matching technology with Beyond Celiac’s deep understanding of the condit

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How PPD’s New Implementation Lead Role Streamlines Onboarding Efficiency for FSP Projects

PPD

Implementing functional service provider (FSP) partnerships is complex and requires significant resources and investments from each stakeholder in the early stages of a relationship. Partnerships involving a high volume of dedicated resources are complicated and time-intensive, requiring significant collaboration across multiple functions. To better manage these complexities, PPD created the implementation lead role to streamline the resource capacity management process and create efficiencies d

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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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New patent for Takeda Pharms drug TRINTELLIX

Drug Patent Watch

Annual Drug Patent Expirations for TRINTELLIX Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from three suppliers. There are ten…. The post New patent for Takeda Pharms drug TRINTELLIX appeared first on DrugPatentWatch - Make Better Decisions.

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Exclusive webinar: How to remove the barriers to CGT innovation

Drug Discovery World

One critical bottleneck in Cell and Gene Therapy (CGT) manufacturing is the production of high-quality plasmid DNA (pDNA), a vital building block for mRNA-based vaccines, viral vector-based cell, or gene therapies that require pDNA as a starting material. . Join this free webinar – Early phase support for plasmid DNA supply helps secure future manufacturing for advanced therapies – for an in-depth discussion of the challenges CGT innovators face and how experts resolve these barriers through

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4 ways ex vivo models offer Pharma better alternatives to animal testing

Reprocell

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. And while animal testing has progressed thousands of therapeutics that we use today, it is not without its experimental and ethical downfalls. An article published in the Financial Times described how scientists are moving away from animal experimentation toward alternatives that more closely resemble human physiology. 1 The piece, titled "How science is getting closer to a world without ani

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15 questions to ask clinical trial recruitment companies

Antidote

Clinical trial patient recruitment companies implement a range of methods, from digital advertising to community partnerships, to reach patients that might be a good fit for a study — but because there are many options for companies to work with, it is important that sites and sponsors thoroughly evaluate their options and choose the right vendor for their needs.

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New patent for Mylan Ireland drug YUPELRI

Drug Patent Watch

Annual Drug Patent Expirations for YUPELRI Yupelri is a drug marketed by Mylan Ireland Ltd and is included in one NDA. It is available from one supplier. There are sixteen…. The post New patent for Mylan Ireland drug YUPELRI appeared first on DrugPatentWatch - Make Better Decisions.

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New vodcast on Avacta’s Open Day 2022

Drug Discovery World

Clinical stage oncology company Avacta Group has moved its Therapeutics division to a new headquarters at Scale Space in Imperial College’s White City Campus, London. DDW Multimedia Editor Megan Thomas attended the open day to learn more about the company’s intentions. In this video, she speaks to Neil Bell, Chief Development Officer at Avacta and Dr Fiona McLaughlin, Chief Scientific Officer at Avacta.

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IND Data Requirements and US FDA Submission Process

ProRelix Research

A clinical trial is a culmination of the several stages of a drug or medical device development program that begins with the discovery of a candidate molecule followed by preclinical […]. The post IND Data Requirements and US FDA Submission Process appeared first on ProRelix Research.

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Playing Small Ball

LifeSciVC

By Robert Clarke, CEO and founder of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC 2022 has been a hallmark year for Kinaset Therapeutics as we’ve continued to advance our P1b trial with our lead asset. We’ve also nearly doubled the size of the team…to 5 employees from 3. A testament to our team, we’ve received a fair amount of praise (and sometimes incredulity) from investors and business development colleagues alike with regard to the amount of progress we have ma

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New patent for Genzyme Corp drug CERDELGA

Drug Patent Watch

Annual Drug Patent Expirations for CERDELGA Cerdelga is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are six patents…. The post New patent for Genzyme Corp drug CERDELGA appeared first on DrugPatentWatch - Make Better Decisions.

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Vodcast: Avacta Group Open Day 2022

Drug Discovery World

Clinical stage oncology company Avacta Group has moved its Therapeutics division to a new headquarters at Scale Space in Imperial College’s White City Campus, London. DDW Multimedia Editor Megan Thomas attended the open day to learn more about the company’s intentions. In this video, she speaks to Neil Bell, Chief Development Officer at Avacta and Dr Fiona McLaughlin, Chief Scientific Officer at Avacta.

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Quality Data Part 6: Evidence-based, data lineage, and metadata

DrugBank

This blog is part of a bigger series. Missed part one? Check out the blog post here or Download Your Guide to Quality Drug Data to get the whats, whys, and hows of quality drug data, according to our experts. Quality data will never be the result of a single metric or of executing on one dimension of quality perfectly. Rather, it is the sum of many crucial elements working together.

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Ninth Circuit Dissent from Denial of En Banc re Injunction against Prop 65 Lawsuit: Sturm und Drang und Wrong

Drug & Device Law

Like most judicial clerks (and, for that matter, judges) we found writing dissents more fun than writing majority opinions. Dissents free one from the need to articulate a consensus. Moreover, since a dissent does not establish a precedent that others must at least pretend to follow, the dissent’s author can be less precise and can let the rhetorical fireworks fly.

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New patent for Strongbridge drug RECORLEV

Drug Patent Watch

Annual Drug Patent Expirations for RECORLEV Recorlev is a drug marketed by Strongbridge and is included in one NDA. There are six patents protecting this drug. This drug has twenty-eight…. The post New patent for Strongbridge drug RECORLEV appeared first on DrugPatentWatch - Make Better Decisions.

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Hit-finding strategies for potent and specific molecules

Drug Discovery World

Download the guide for hit-finding tools that will accelerate your hit to lead and lead optimisation programs for CNS, metabolic, oncology and other therapeutic areas. Synthetic, medicinal, and computational chemistry capabilities along with in house available diversity and focused libraries. Small molecule and biologics targeted screening for GPCRs, kinases, ion channels, interleukins, checkpoints, novel targets and a few case studies.

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Latest guide: Hit-finding strategies for potent and specific molecules

Drug Discovery World

This new guide is brought to you by Eurofins Discovery. Download the guide to hit-finding tools that will accelerate your hit to lead and lead optimisation programmes for CNS, metabolic, oncology and other therapeutic areas. Synthetic, medicinal, and computational chemistry capabilities along with in house available diversity and focused libraries. Small molecule and biologics targeted screening for GPCRs, kinases, ion channels, interleukins, checkpoints, novel targets and a few case studies.

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Covid-19 triggers inflammation in the brain

Drug Discovery World

Research led by The University of Queensland has found that Covid-19 activates the same inflammatory response in the brain as Parkinson’s disease. . The discovery identified a potential future risk for neurodegenerative conditions in people who have had Covid-19, but also a possible treatment. . The UQ team was led by Professor Trent Woodruff and Dr Eduardo Albornoz Balmaceda from UQ’s School of Biomedical Sciences, and virologists from the School of Chemistry and Molecular Biosciences.

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Stem cell dry eye therapy could offer rapid and total relief

Drug Discovery World

The US Food and Drug Administration (FDA) has approved the Phase III clinical trial design for BRIM Biotechnology’s lead candidate for dry eye disease (DED), BRM421. BRIM will submit the Phase III study protocol to the FDA later this year. . BRM421 is a novel, first-in-class regenerative peptide therapy which, if successful, could offer patients full relief of symptoms plus repair the damage to the cornea. .

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Merger creates $5 billion pharma technology company 

Drug Discovery World

Norstella and Citeline (formerly Pharma Intelligence) have merged to form a $5 billion global company, one of the largest pharma intelligence solutions providers on the market. . Norstella now has more than 1,500 employees across its five brands: Evaluate , MMIT , Panalgo , The Dedham Group , and Citeline. . “We believe that patient access starts with identifying unmet needs and doesn’t end until a patient has a therapy in hand,” commented Mike Gallup, CEO of Norstella. .

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GSK reports strong Q3 results  

Drug Discovery World

GSK has announced strong quarterly results, reporting sales of £7.8 billion and growth in various sectors of the business. . Overall, the company’s adjusted operating profit for the third quarter came in at £2.6 billion, a 17% increase compared to the same period last year and reflecting a 4% year-on-growth at CER. . The quarterly results are for the first for GSK since it separated its consumer healthcare business, making GSK a pure-play therapeutics company.

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Monoclonal antibody could transform malaria prevention

Drug Discovery World

One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa. . The antibody was up to 88.2% effective at preventing infection over a 24-week period, demonstrating for the first time that a monoclonal antibody can prevent malaria infection in an endemic region. .

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