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 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 Patent Watch

DECEMBER 3, 2022

This chart shows the drugs with the most patents in Sweden. 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 Sweden? appeared first on DrugPatentWatch - Make Better Decisions.

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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

Treatment

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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Antidote

DECEMBER 5, 2022

Though kidney disease is estimated to affect 31 million people across the U.S., the different terms surrounding this common condition still remain a source of confusion. Chronic kidney disease (CKD), Stage 3 kidney disease, and C3G all share similarities, both in name and impact, but understanding how they relate to one another can help to make things more clear.

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Drug Patent Watch

DECEMBER 7, 2022

This chart shows the companies which have received the most New Patient Population exclusivities in the past five years. New Patient Populations are one of the categories for which the…. The post Pharmaceutical companies with the most ‘New Patient Population’ drugs 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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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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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 Patent Watch

DECEMBER 9, 2022

This chart shows the pharmaceutical companies with the most concentrate dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most concentrate dosed drugs…. The post Which pharmaceutical companies have the most concentrate dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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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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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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Clinical Trials

Drug Patent Watch

DECEMBER 8, 2022

This chart shows the drugs with the most patents in Ecuador. 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 Ecuador? 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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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 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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Clinical Trials

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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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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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 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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Practical Cheminformatics

DECEMBER 4, 2022

I've been a longtime fan of Peter Ertl's work on identifying and classifying the ring systems in molecules. I wanted a Python implementation for some of my work, so I coded something similar in spirit to what Peter has published. In this post, I begin by highlighting some of Peter's papers and showing some interesting analyses that can be performed with a tool for extracting ring systems.

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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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The ChEMBL-og

DECEMBER 6, 2022

Recently, the ChEMBL team participated in the " School of Chemoinformatics in Latin America " which was kindly organized by José Medina-Franco and Karina Martinez-Mayorga (both at the National Autonomous University of Mexico). The event was very well attended with 1,181 registrants from 79 different countries. 57% of the participants attended from Latin America, 23% from Asia, and around 8% from Africa and Europe, respectively. 52% of the participants were students (undergraduate and graduate st

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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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LifeSciVC

DECEMBER 6, 2022

By Gerry Harriman and Jonathan Montagu, CSO and CEO, respectively, and co-founders of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC. HotSpot Therapeutics today announced a strategic collaboration with Abbvie to develop IRF5 transcription factor inhibitors for autoimmune diseases. The following blog post provides some valuable real-world perspective on why this initiative is such an important breakthrough in immunology therapeutics.

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Drug & Device Law

DECEMBER 6, 2022

In a 341-page opinion, In re Zantac (Ranitidine) Products Liability Litigation , 9:20-md-02924-RLR, slip op. (S.D. Fla. Dec. 6, 2022), the MDL court held that all of the Zantac plaintiffs’ general causation experts (concerning five cancer types) failed to meet the admissibility standards of Fed. R. Evid. 702. Consequently the court granted the defendants’ motions for summary judgment.

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The ChEMBL-og

DECEMBER 5, 2022

As part of the EMBL-EBI online courses, on the 7th of December we will participate in a Q&A session on the theme of Chemical Biology. We will be explaining where the different data sources that ChEMBL integrates come from, how we curate them and how you can access them programmatically. But it also gives you the opportunity to ask everything you always wanted to know about ChEMBL.

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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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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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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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