Drug Discovery World

DECEMBER 6, 2022

Dr Andrew Garrett, Executive Vice President of Scientific Operations at ICON, explores the benefits of integrating some of the validation and standardisation practices already developed for PIs into the practices around NPIs and public health data; outlines some of the practices that can be implemented in order to do this; and highlights the need for interdisciplinary collaboration between pharmaceutical and non-pharmaceutical researchers and public health centres to consider the overlap between

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

By Mark A. Tobolowsky & James E. Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Antidote

DECEMBER 9, 2022

Participating in a clinical research study can have many benefits. From offering specialized care to providing participants with potential new treatment options, finding the right clinical trial can lead to positive outcomes for today’s patients and unlock breakthroughs for those diagnosed in the future.

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Drug Channels

DECEMBER 9, 2022

Today’s guest post comes from Leslie Small, Managing Editor, and Jinghong Chen, Reporter, at Health Plan Weekly , published by AIS Health, the journalism division of Managed Markets Insight & Technology, LLC. (MMIT). Leslie and Jinghong discuss the terms of health insurance startups CEOs’ compensation packages. They explain why the reported CEO total compensation numbers are deceiving.

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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.

Clinical Trials

Drug Discovery World

DECEMBER 6, 2022

CAR-T therapy can be used to eliminate unwanted cells that cause autoimmunity, according to the results of a new study in mice with an autoimmune disease similar to multiple sclerosis (MS). . CAR-T, which uses genetically altered immune cells to destroy cancer cells, has revolutionised treatment of some blood cancers since it was introduced in 2017. .

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Cytel

DECEMBER 9, 2022

As promised in my last post prior to PHUSE-EU Connect, I’d like to now share some reflections on my “Integration Dilemma” speech, in which I discussed integrating data from different studies for supporting, for example, integrated summaries of safety and effectiveness. An Integrated Summary of Safety (ISS) is required by the U.S. Food and Drug Administration (FDA) as a critical component in any New Drug Application (NDA) or similar market approval request.

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Drug Channels

DECEMBER 7, 2022

In yesterday’s post , I highlighted the largest pharmacy chains that will participate in the 2023 Medicare Part D prescription drug plans (PDP). Today, I update our annual analyses of how smaller pharmacies will participate as preferred cost sharing pharmacies via the pharmacy services administrative organizations (PSAOs) that represent them in negotiations with plans.

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Drug Discovery World

DECEMBER 9, 2022

An initial 100 organisations have signed an agreement to support, promote and enhance innovation in the Greater Cambridge area. . Signatories to the ‘Innovate Cambridge Charter’ also hope to develop a set of ecosystem-wide initiatives that ensure Cambridge continues to compete effectively on the international stage in the future. . Cambridge Enterprise, Cambridge Innovation Capital, and the University of Cambridge launched ‘Innovate Cambridge’ in September 2022 to create an inclusive vision fo

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Drug Patent Watch

DECEMBER 8, 2022

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 expiration for Vanda Pharms drug HETLIOZ appeared first on DrugPatentWatch - Make Better Decisions.

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Nvidia Developer: Drug Discovery

DECEMBER 8, 2022

The NVIDIA BioNeMo service is now available for early access. At GTC Fall 2022, NVIDIA unveiled BioNeMo, a domain-specific framework and service for training. The NVIDIA BioNeMo service is now available for early access. At GTC Fall 2022, NVIDIA unveiled BioNeMo, a domain-specific framework and service for training and serving biomolecular large language models (LLMs) for chemistry and biology at supercomputing scale across billions of parameters.

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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.

Clinical Trials

Drug Channels

DECEMBER 6, 2022

In Preferred Pharmacy Networks in 2023’s Medicare Part D Plans: Cigna, CVS Health, Humana, UnitedHealthcare, WellCare, and More , I highlighted how those networks have taken over the world of stand-alone Medicare Part D prescription drug plans (PDP) and become a major presence in Medicare Advantage prescription drug (MA-PD) plans. Today, I examine the seven largest retail chains’ 2023 participation in the 22 major 2023 Part D preferred networks that the eight largest plan sponsors will offer.

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Drug Discovery World

DECEMBER 9, 2022

News round-up for 5-9 December by DDW Digital Content Editor Diana Spencer. ‘Teamwork makes the dream work’ this week, with the launch of new partnerships to further the development of precision drugs in neurodevelopmental disorders, lung cancer and rare paediatric diseases. The benefits of collaboration have also been seen in the announcement of positive trial data for Jardiance, a type 2 diabetes treatment created by an alliance between Boehringer Ingelheim and Eli Lilly, while various researc

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Drug Patent Watch

DECEMBER 8, 2022

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

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keypoint

DECEMBER 8, 2022

By Shannon Weiman 2022 marked an exciting return to in-person meetings after a two year hiatus due to COVID-19. Although we had to delay the beginning of the season due to the Omicron wave in January and February, audiences enthusiastically returned to in-person meetings in March. Audiences were THRILLED to reconvene in person, which made all the waiting and efforts to reschedule meetings all the more worth it.

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Clinical Trials

DrugBank

DECEMBER 8, 2022

Over the course of this data quality blog series, we tapped into the deep pool of expertise here at DrugBank and have come to a very simple conclusion, defining quality in data is difficult. Fortunately, we were up for the challenge of nailing down this somewhat slippery, amorphous problem. As we pursued a concise definition, we found that our convictions that data quality must be individualized and audience-specific only grew stronger.

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Drug Discovery World

DECEMBER 9, 2022

The 18th Annual Drug Discovery Chemistry meeting will be held on April 10-13, 2023 in San Diego, CA, US and also online. . Early bird registration closes on December 16. . Drug Discovery Chemistry is a conference for medicinal and biophysical chemists working in pharma, biotech, and academia. The event is focused on discovery and optimisation challenges of small molecule drug candidates, with various content tracks running concurrently across the three days. .

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Drug Patent Watch

DECEMBER 8, 2022

Annual Drug Patent Expirations for AUVELITY Auvelity is a drug marketed by Axsome and is included in one NDA. There are ninety-three patents protecting this drug. This drug has one…. The post New patent for Axsome drug AUVELITY appeared first on DrugPatentWatch - Make Better Decisions.

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keypoint

DECEMBER 8, 2022

The December 2022 issue of the Keypoint Newsletter features the latest news and views from Keystone Symposia, including announcement of new CSO Terry Shepard, welcome to the Fellows class of 2023, and Open Access virtual content on Reimagining Scientific Conferences and Climate Health.

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Tecan

DECEMBER 8, 2022

By Joe Guterl Bring the test to the patient, not the patient to the test. When diagnostic test instruments are available at the point of care (POC), healthcare providers and patients will have faster and easier access to reliable results. Risks can be assessed earlier when diagnosis and treatment are most effective. High-performance liquid handling technologies are enabling advancements in POC instruments that deliver more accurate and reliable results faster.

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Drug Discovery World

DECEMBER 9, 2022

The ‘Rare Disease Moonshot’, a new initiative to boost research and development into rare and paediatric diseases, has launched at the European Health Summit. . The initiative is a commitment and collaboration between seven organisations to break down the barriers to finding new treatments and cures for the world’s rarest and severe conditions. It aims to speed up research into more than 7000 identified rare diseases, of which a staggering 95% have no approved treatment or cure. .

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Drug Patent Watch

DECEMBER 7, 2022

Annual Drug Patent Expirations for ELCYS Elcys is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Exela Pharma drug ELCYS appeared first on DrugPatentWatch - Make Better Decisions.

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Cytel

DECEMBER 6, 2022

In this edition of the Career Perspectives series, I spoke with Veronica Chan, Principal Clinical Data Manager at Cytel. Veronica is based in Singapore and is a critical part of Cytel’s Data Management global group. In this interview, we learn about her professional journey, her insights on the data management function and its challenges, and the necessary qualifications to work at Cytel.

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Tecan

DECEMBER 7, 2022

By Joe Guterl More than $72 billion – that is what some researchers estimate will be the global point-of-care (POC) biochemical diagnostic testing market size in 2027, up from $36 billion in 2021. 1,2 The POC molecular diagnostics market is expected to reach $4-$5 billion in the same timeframe, up from about $3 billion in the 2020/2021 timeframe. 2,3 The COVID-19 pandemic has dramatically changed the way we engage with healthcare, but other trends in disease, technology innovation, and healthcar

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Drug Discovery World

DECEMBER 9, 2022

A new type of targeted medicine has shown ‘remarkable’ benefits for patients with advanced breast cancer in a major Phase III clinical trial. . The drug capivasertib combined with hormone therapy doubled the time it took for cancer to progress in people with advanced forms of the most common type of breast cancer. . The findings establish capivasertib as a potential new treatment for people with oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER-2) negative breast

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Drug Patent Watch

DECEMBER 7, 2022

Annual Drug Patent Expirations for NYMALIZE Nymalize 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 NYMALIZE appeared first on DrugPatentWatch - Make Better Decisions.

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Antidote

DECEMBER 6, 2022

At Antidote, we understand that successfully engaging patients for a clinical trial starts with a deep understanding of the patient population. Knowing who patients are, what motivates them, and what messages will resonate with them can all be beneficial when finding individuals who may be eligible to take part in specific studies.

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Tecan

DECEMBER 5, 2022

By Hannah van Schijndel (Artemis) and Dajana Domik (Tecan) It is estimated that up to 20% of the world’s population may have some degree of food intolerance, which can manifest itself in pathologies such as celiac disease, dermatitis, atopic eczema, inflammatory bowel disease (IBD) and irritable bowel syndrome IBS. 1 We established in our previous article that IgG and IgG4-based ELISA testing can be used to reduce the guesswork in identifying food sensitivities, and is indeed the most widely use

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Drug Discovery World

DECEMBER 8, 2022

Evonik has launched a non-animal-derived squalene suitable for vaccines and other pharmaceutical applications. PhytoSquene is the first known amaranth oil-derived squalene on the market for use in adjuvants in parenteral dosage forms. It is an alternative to animal-derived squalene, which for pharmaceutical applications is typically sourced from shark liver oil. .

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Drug Patent Watch

DECEMBER 7, 2022

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

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The Strateos Blog: Drug Discovery

DECEMBER 5, 2022

What is the Pistoia Alliance? The Pistoia Alliance is a global, not-for-profit organization that strives to lower barriers and overcome obstacles to innovation to transform life sciences R&D with a focus on collaboration across all levels from academia, biotech companies big and small to technology providers. The Alliance fosters pre-competitive collaboration with members working together as equals on projects that will benefit the industry as a whole—whether it is identifying the roo

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New Drug Approvals

DECEMBER 3, 2022

ABT-737 Molecular Weight 813.43 Formula C 42 H 45 ClN 6 O 5 S 2 CAS No. 852808-04-9 ABT-737 is a small molecule drug that inhibits Bcl-2 and Bcl-xL , two members of the Bcl-2 family of evolutionarily-conserved proteins that share B cl-2 H omology (BH) domains. First developed as a potential cancer chemotherapy , [1] it was subsequently identified as a senolytic (a drug that selectively induces cell death in senescent cells ). [2] The Bcl-2 family is most notable for their regulation of apoptosis

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Drug Discovery World

DECEMBER 8, 2022

Thousands of US lawsuits claiming that the heartburn drug Zantac caused cancer have been dismissed on the basis that they are not backed by sound science. The ruling against around 50,000 claims was made by US District Judge Robin Rosenberg in West Palm Beach, Florida. The manufacturers have repeatedly asserted that Zantac does not cause [.]. To read this content in full, you need to login.

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Drug Patent Watch

DECEMBER 6, 2022

Annual Drug Patent Expirations for IGALMI Igalmi is a drug marketed by Bioxcel and is included in one NDA. There is one patent protecting this drug. This drug has twenty…. The post New patent for Bioxcel drug IGALMI appeared first on DrugPatentWatch - Make Better Decisions.

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keypoint

DECEMBER 8, 2022

Keystone Symposia is pleased to introduce the Keystone Symposia Fellows Class of 2023! This year we welcome 10 early-career investigators who represent an exciting line-up of rising talent in biological and biomedical research. Keystone Symposia’s leadership and Fellows Alumni Network are deeply committed to supporting their careers and development as leaders in the biomedical research community.

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