Drug Discovery World

FEBRUARY 17, 2023

Aura Biosciences has announced positive interim Phase II safety and efficacy data for belzupacap sarotalocan (bel-sar) as a first-line treatment for patients with early-stage choroidal melanoma with suprachoroidal administration. The results showed a statistically significant reduction in tumour growth rate compared to each patient’s documented growth rate at study entry, and a 100% tumour control rate.

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ProRelix Research

FEBRUARY 12, 2023

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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Drug Channels

FEBRUARY 17, 2023

Today’s guest post comes from Jim Longley, Head of Commercial, Pharma Manufacturer Solutions at GoodRx. Jim discusses GoodRx Assist , a point-of-sale (POS) rebate program designed to help cash-paying patients start and stay on brand-name medication. Click here to learn more about GoodRx Assist. Read on for Jim’s insights. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Antidote

FEBRUARY 13, 2023

When matching individuals to medical research opportunities, patient centricity is at the heart of the process for Antidote. Through our best-in-class clinical trial matching software, we provide a streamlined, user-friendly experience for any individual searching for a trial — and now, through our curated journeys, we’re able to refine this process even more.

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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.

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Drug Discovery World

FEBRUARY 17, 2023

News round-up for 13-17 February by DDW Digital Content Editor Diana Spencer. The drug discovery sector is feeling the love this Valentine’s week, with several new research collaborations bringing together a range of expertise and advanced bioinformatics, automation and artificial intelligence technologies to speed up the development of new treatments.

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NIOSH Science Blog: Drugs

FEBRUARY 15, 2023

Why Do Psychosocial Factors of Work Matter? The construction industry has considerable safety and health hazards that result in high rates of injury, illness, and fatality. Common hazards include noise, fall, electrical, and chemical hazards. Approximately 60% of all construction fatalities each year can be attributed to the ‘focus four’ hazards of falls, struck-by, caught in and between, and electrocutions.1 Construction occupational safety and health (OSH) has traditionally focused on eliminat

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Labcorp Drug Development

FEBRUARY 17, 2023

In December 2022, Labcorp and Biomakers signed an agreement that will positively impact thousands of cancer patients in Latin America through greater access to diagnostic molecular profiling and participation in clinical trials. We recently asked Nicolas Kirchuk (NK), CEO and co-founder of Biomakers, and Isagani Chico (IC), MD, VP, global … The post Innovative collaboration between Biomakers and Labcorp to provide greater access to oncology patients in Latin America appeared first on Insig

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Drug Discovery World

FEBRUARY 17, 2023

Newron Pharmaceuticals’ Evenamide could be a potential breakthrough treatment in the management of treatment-resistant schizophrenia (TRS) patients, according to new trial data. The drug is being assessed as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS who are not responding to their current antipsychotic medication.

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keypoint

FEBRUARY 17, 2023

On April 11, we celebrated the 2022 recipients of the Michelson Philanthropies & Science Prize for Immunology in this live ePanel event. This international prize focuses on transformative research in human immunology, with trans-disease applications to accelerate vaccine and immunotherapeutic discovery. The prize is intended to encourage and support young investigators from a wide range of disciplines and is awarded annually based on work done in the past three years.

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Antidote

FEBRUARY 17, 2023

The Summit for Clinical Ops Executives ( known as SCOPE ), is one of the year’s largest conferences focused on clinical research — and one the Antidote team was thrilled to attend in 2023.

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Drug Patent Watch

FEBRUARY 16, 2023

Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are nine… The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

FEBRUARY 17, 2023

A new multi-year strategic partnership between M2GEN and Zephyr AI will leverage clinicogenomic data, bioinformatics, and artificial intelligence to accelerate drug discovery and expanded use cases for oncology treatments. In this partnership, M2GEN will license its real-world data set (RWD) to Zephyr AI, while Zephyr AI will become a bioinformatics partner for M2GEN, providing the company with AI and machine learning capabilities.

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Crown Bioscience

FEBRUARY 16, 2023

Next-generation discovery proteomics in preclinical and translational research is an exciting application of this proteomic approach. By leveraging advanced technologies, the ability to identify and quantify thousands of proteins in an unbiased manner can have a significant impact on the overall development of novel therapies.

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EG Life Sciences

FEBRUARY 15, 2023

The year 2022 reflected a transformative path for the drug development industry. It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. Every year, the FDA’s Center for Drug Evaluation and Research (CDER) clarifies to drug developers required study design elements, as well as other data needed on the drug application to support a full and comprehensive assessment.

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Clinical Trials

Drug Patent Watch

FEBRUARY 16, 2023

Annual Drug Patent Expirations for LUMAKRAS Lumakras is a drug marketed by Amgen Inc and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Amgen Inc drug LUMAKRAS appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

FEBRUARY 16, 2023

Aera Therapeutics has launched with a vision to “unlock the potential of genetic medicines across a wide range of modalities and therapeutic areas”. The company’s delivery platform is based on research conducted in the laboratory of scientific founder Feng Zhang and aims to address the limitations of today’s delivery technologies to more broadly enable new genetic medicines.

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Advarra

FEBRUARY 15, 2023

Metrics in general are one of the ways we can gauge how well a program or service delivers. In the world of institutional review boards (IRBs), some measurements can be easily ascertained, such as review turnaround times and submission volumes, which help the human research protection program (HRPP) assess the IRB’s activities. Measurements such as review timelines and volumes are typically easy to obtain and can inform the speed at which the IRB assesses proposed research and provides a determi

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Cytel

FEBRUARY 14, 2023

The U.S. FDA has recently provided specific guidance [i] on the design and conduct of trials incorporating an external control group, sometimes known as a synthetic control arm. Their guidance represents the culmination of several other topics related to these trial designs and research themes, such as existing guidance on the use real-world data and real-world evidence, [ii] the use of electronic health records and medical claims to support regulatory decision-making, [iii] and guidance on demo

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Drug Patent Watch

FEBRUARY 16, 2023

Annual Drug Patent Expirations for HETLIOZ Hetlioz is a drug marketed by Vanda Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty-one… The post New patent for Vanda Pharms drug HETLIOZ appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

FEBRUARY 16, 2023

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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The Strateos Blog: Drug Discovery

FEBRUARY 13, 2023

Are you interested in discovering how AI and automation can be put to work in the drug discovery space? Then join us at the first SLAS conference of the year in beautiful San Diego, CA, from February 25th – March 1st. It's an event not to be missed! A meeting of the minds, leading industry professionals, including Benchling, GlaxoSmithKline and Strateos, will come together to discuss the technologies, laboratory automation and deep learning tools that are enabling innovative and life

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NIOSH Science Blog: Drugs

FEBRUARY 16, 2023

Social determinants of health (SDOH) are conditions in the places where people live, learn, work, and play. These conditions affect a wide range of health and quality of life risks and outcomes. CDC, the World Health Organization (WHO), and others recognize work as a social determinant of health.[1],[2],[3] Despite this recognition, this key SDOH is not fully integrated into public health data collections or assessments.

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Drug Patent Watch

FEBRUARY 15, 2023

Annual Drug Patent Expirations for TLANDO Tlando is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are eleven… The post New patent for Antares Pharma drug TLANDO appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

FEBRUARY 16, 2023

Minoryx Therapeutics has revealed the findings from the first and largest international study to enroll adult male X-linked adrenoleukodystrophy patients. The Phase II/III ADVANCE clinical trial of lead candidate, leriglitazone, published in The Lancet Neurology , did not meet the primary outcome for the six-minute walk test. However, clinical measures of body sway (assessing balance) demonstrated clinically relevant differences and favourable trends were observed for Expanded Disability St

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Elrig

FEBRUARY 16, 2023

Get recognized, propel your career: Why you can’t miss ELRIG’s Early Career Professional Impact Award The drug discovery sector consistently delivers innovation and new discoveries that have the potential to transform lives for the better. For that reason, it’s an exceptionally rewarding sector to craft a career in. But while the power and pace of drug discovery relies on a continual influx of bright, enthusiastic minds, it can be a daunting sector for early career professionals (ECPs) to get th

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LifeSciVC

FEBRUARY 16, 2023

By Bob Clarke, CEO of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC As I ride the Amtrak towards New York City for a series of meetings on Park Avenue with bankers/analysts, face-to-face (F2F) meetings are back as part of my normal routine. However, the routine certainly has some new facets spawned from our collective experience over the last 3 years.

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Drug Patent Watch

FEBRUARY 14, 2023

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

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Drug Discovery World

FEBRUARY 16, 2023

Ahead of SLAS2023 in San Diego, Jill Hronek , SLAS Director, Marketing & Communications, shares her enthusiasm for the opportunities, products, technologies and innovation that this event brings together. Data is the glue that keeps automation tools working together. We’re accelerating into another year of innovation and automation at SLAS: our events calendar is set for our conferences and symposia, and we are excited to be planning meet-ups and roadshows around the world with enthusiastic

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sptlabtech

FEBRUARY 13, 2023

SLAS San Diego 2023 has come and gone, and SPT Labtech were thrilled to be exhibiting at this premier event for life sciences and laboratory automation. This year's conference was bigger and better than ever, bringing together leading experts, innovators, and decision-makers from the industry to share insights, showcase new technologies, and network with one another.

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Molecular Design

FEBRUARY 14, 2023

I’ll be discussing promiscuity in this post and, if there’s one thing that religious leaders and drug discovery scientists agree on, it’s that promiscuity is a Bad Thing. In the drug discovery context compounds that bind to many targets or exhibit ‘activity’ in many assays are described as promiscuous. I first became aware that promiscuity was a practical (as opposed to a moral) problem when we started to use high-throughput screening (HTS) at Zeneca in the mid-1990s and we soon learned that not

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Drug Patent Watch

FEBRUARY 14, 2023

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

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Drug Discovery World

FEBRUARY 16, 2023

There have been a number of significant appointments in the drug discovery sector over the last month. So who are the latest movers and shakers? Amy Berrington and Montserrat Garcia-Closas, Institute of Cancer Research: Professors Amy Berrington and Montserrat Garcia-Closas have been appointed as Team Leaders at the Institute of Cancer Research’s Division of Genetics and Epidemiology.

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Drug & Device Law

FEBRUARY 13, 2023

One aspect of Pietrantoni v. Corcept Therapeutics Inc. , F. Supp.3d , 2022 WL 16857262 (D. Mass. Nov. 10, 2022), has troubled us ever since we first noticed the opinion. But we recently noticed that Pietrantoni had been selected for publication, so we decided the issue was important enough to examine in depth. In a lot of ways Pietrantoni is a pretty good case for the defendants.

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Drug Discovery World

FEBRUARY 15, 2023

Cerevance has expanded its Series B funding round with an additional close of $51 million, bringing the total to $116 million. The financing will support upcoming clinical trials focused on Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS), and schizophrenia. “We are thrilled to secure additional funding from world-class investors who strongly support the need for novel therapies to treat neurological diseases,” said Craig Thompson, Chief Executive Officer of Cerevance.

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