January, 2022

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Avacta Selects Second pre|CISION™ Pro-drug Candidate for Development

Drug Discovery Today

Cambridge and Wetherby, UK, 18 January 2022: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms announces that the next pre|CISION™ drug candidate, AVA3996, has been selected for pre-clinical development with a view to a first-in-human Phase I clinical trial beginning in the second half of 2023.

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OPDP Issues First Regulatory Action Letter of 2022

Eye on FDA

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent enforcement actions over the past several years is that smaller, less well-known companies have mostly been the recipients of letters from OPDP.

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Five Takeaways from the Big Three PBMs’ 2022 Formulary Exclusions

Drug Channels

For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. Each exclusion list contains 400 to 500 products. Growth in the number of excluded drugs slowed, due partly to the fact that so many drugs have already been dropped from PBMs’ formularies.

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New patent expiration for Genentech Inc drug ESBRIET

Drug Patent Watch

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

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Homepage

Broad Institute

Homepage By admin January 31, 2022 Watch now Broad is accelerating discovery Broad Institute is a multidisciplinary community of researchers on a mission to improve human health. About us Latest Our community Join Broad We are a research organization dedicated to better understanding the roots of disease and narrowing the gap between new biological insights and impact for patients.

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State Boards of Pharmacy Missing in Action During Opioid Crisis

Policy Prescription

This post should serve as the beginning of a serious inquiry into the failure of U.S. state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. Sociologist Elizabeth Chiarello writes , “Boards have a duty to protect the public, but because they are mostly comprised of professionals whose common interests may conflict with those of the public, their ability to do so is questionable.

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FDA Advisory Committee Review of 2021

Eye on FDA

FDA has scheduled the first advisory committee meetings of 2022. One meeting of the Oncologic Drugs Advisory Committee is set for February 10 to discuss a new application for the proposed treatment of Non-Small Cell Lung Cancer (NSCLC. And a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee is meeting jointly with the Drug Safety and Risk Management Advisory Committee on February 15 to consider an NDA in the pain category.

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PCMA Business Forum

Drug Channels

PCMA Business Forum. February 28 – March 1, 2022 JW Marriott Grande Lakes | Orlando, FL Register Today! www.pcma.com/businessforum. The PCMA Business Forum is PCMA's largest business networking and educational conference. PCMA’s PBM Members send a large number of executives from relevant business units including pharma and trade relations, specialty pharmacy, clinical and patient care services, and the c-suite.

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Which pharmaceutical companies have the most drug patents in Mexico?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Mexico. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Mexico? appeared first on DrugPatentWatch - Make Better Decisions.

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Biomarkers: A Novel Approach to Understanding Dementia

PerkinElmer

A Global Scourge Around 50 million people worldwide currently suffer from one or more forms of dementia. Of these, around 850,000 live in the United Kingdom (UK) at an annual care cost of £26 billion (US$38 billion). Unless something is done, experts predict these numbers will likely double within the next 20 years. 1 To address the urgent need for new therapies, the UK’s Medical Research Council (MRC), a national public agency supporting health science and research, established the Dementias

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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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The Solubility Forecast Index

Practical Cheminformatics

Introduction Recently, I've seen a number of deep learning models designed to predict the aqueous solubility of drug-like molecules. Despite the advantages brought about by techniques like graph neural networks, I have yet to see a commercial or open-source method that outperforms the venerable Solubility Forecast Index (SFI). I've written about the challenges associated with predicting aqueous solubility before , so I won't revisit that discussion.

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Iceni Glycoscience to spearhead ‘glycorevolution’ as it broadens scope of operations within the field of glycoscience

Drug Discovery Today

Award-winning platform company, Iceni Glycoscience (formerly Iceni Diagnostics) is to broaden the scope of its operations within the field of glycoscience (carbohydrate chemistry and biology) as the role of carbohydrates in human disease becomes increasingly apparent.

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What They Said 2021 – An Overview of FDA Press Statements

Eye on FDA

Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is a good deal of change that occurs. When Dr. Scott Gottlieb took the reins of FDA as Commissioner, the amount of communications material put out jumped enormously.

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NEW: The Drug Channels 2022 Video Webinar Series

Drug Channels

Join Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI), for three live video webinars during 2022. These live, interactive events will be broadcast via Zoom from the Drug Channels Video studio in beautiful downtown Philadelphia. Click here to order the Drug Channels 2022 Video Webinar Series. During these events, Dr. Fein will address the latest issues confronting the U.S. drug channel.

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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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Which drugs have the most supplementary protection certificates?

Drug Patent Watch

This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long…. The post Which drugs have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.

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Our new Chairman: Dr Charles Woler

Sygnature Discovery

We’ve appointed the highly experienced pharmaceutical executive Dr Charles Woler as Chairman. In a broad career, Charles has held multiple key roles in the sector, including CEO at Roche France, Executive Chairman for Europe at SmithKline Beecham PLC, and CEO at Cadus Pharmaceutical in the US. He has also worked in numerous biotech-focused venture capital firms, chairing the advisory committee of the public-private Inserm-Transfert Initiative Investment Committee fund and serving as Vice C

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FDA CDER & CBER Global Data Standards

Pharmaceutical Development Group

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting,

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The Current issue of “The view from here” is concerned with Therapeutics

Drug Discovery Today

The topic of this month’s newsletter from Drug Discovery Today is “Therapeutics”.

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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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FDA OPDP Look Back at 2021 – The Yawning Gap

Eye on FDA

Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

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Four Big Implications for Patients and the Prescription Journey in 2022

Drug Channels

Today’s guest post comes from Chris Dowd, Senior Vice President of Market Development at ConnectiveRx. Chris discusses how COVID-19 is impacting stakeholders across the healthcare system, including patients, providers, pharmacies, and manufacturers. On February 22nd at 1:00 pm ET, ConnectiveRx will host Four Big Implications for Patients and the Prescription Journey in 2022 , a free webinar about the pandemic’s impact on key healthcare stakeholders.

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Which pharmaceutical drugs have the most patents?

Drug Patent Watch

This chart shows the pharmaceutical drugs with the greatest number of patents still in force. The number of patents covering a drug can be indicative of the value of a…. The post Which pharmaceutical drugs have the most patents? appeared first on DrugPatentWatch - Make Better Decisions.

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Sygnature strengthens with MedChemica software solution

Sygnature Discovery

We’ve strengthened our drug discovery offering even further – by licensing industry-leading software for lead optimisation. We’ve deployed the MCPairs platform from MedChemica , which uses anonymised data from major pharmaceuticals to extract rules that can then guide the medicinal chemistry process. Our scientists are now using the tool to help automate directed idea generation.

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The AI Challenge in drug discovery and development: What is “truth”? 

Plenge Gen

[ I am an employee of Bristol Myers Squibb. The views expressed here are my own, assuming I am real and not a humanoid. ] In the original Blade Runner (1982), Harrison Ford’s character, Deckard, implements a fictitious Voight-Kampff test to measure bodily functions such as heart rate and pupillary dilation in response to emotionally provocative questions.

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Improving Drug Safety Through Cardiotoxicity Assessment

PerkinElmer

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity.

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How to Cope with a Loved One’s Alzheimer’s Diagnosis

Olympian Clinical Research

When a loved one is diagnosed with Alzheimer’s disease , it can be challenging to know what to do or how to cope. You may first want to understand this degenerative disease so that you can best support your loved one after their Alzheimer’s diagnosis. What is Alzheimer’s Disease? . Alzheimer’s disease is a progressive brain disorder that causes a gradual decline of a person’s mental functions, resulting in memory loss and an inability to think clearly.

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Betting Big on Biosimilars: How Evolving Market Dynamics Will Impact Patient Access

Drug Channels

Today’s guest post comes from Fiza Bari, Senior Solutions Consultant and GTM Liaison at MMIT. Fiza discusses the impending influx of biosimilars and its effect on manufacturers, specifically in the immunology space. To learn more, sign up for MMIT’s Immunology Biosimilars webcast. It's a moderated discussion with payers on how the changing market might impact their management strategies in immunology.

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Which pharmaceutical companies have the most cream dosed drugs?

Drug Patent Watch

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

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Directory

Broad Institute

Directory By admin January 31, 2022 Breadcrumb Home Directory Type the name of the person you're searching for.

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Latest news on drug repurposing in oncology #13

The Anticancer Fund

13 January 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. It is one of the focus areas of the Anticancer Fund. Below, we have listed recent findings about the repurposing of generic drugs in oncology. Our intention is to help bring these findings to the attention of the broader cancer research community.

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Visible Particles within Injectable Products

Pharmaceutical Development Group

The FDA expects and requires that Sterile Injectable Products adhere to strict FDA standards pertaining to quality, purity, safety, and efficacy. As a result, Patients and Physicians rely upon and trust that the Injectable Products they administer adhere to the same high standards. The cGMP Injectable Product Manufacturing process is generally the primary place where fibers, dust, rubber, shards, metallic flakes, and silicone may enter into Injectable and other Drug Products.

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Useful RDKit Utilities

Practical Cheminformatics

There's a lot of useful functionality in the RDKit. My problem is remembering where all of the most useful bits are, and how to use them. In order to make my life, and perhaps yours, a little easier, I put together a Python package called " useful_rdkit_utils ". Some of what's in there is simply a repackaging of existing functionality to make it easier to use (at least for me).

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The 340B Rebate Model: A Solution to the Contract Pharmacy Controversy

Drug Channels

Today’s guest post comes from Jeremy Docken, Founder and Chief Strategy Officer at Kalderos. Jeremy describes Kalderos’ 340B rebate model. He discusses an independent research organization’s study of the 340B rebate model’s impact on covered entities’ cash flow. To learn more, download the whitepaper: The Kalderos 340B Rebate Model In Action: Ensuring a Thriving and Sustainable 340B Program.

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Which pharmaceutical drugs have the most drug patents in Slovenia?

Drug Patent Watch

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