Drug Discovery Today

JANUARY 20, 2022

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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Eye on FDA

JANUARY 26, 2022

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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Drug Channels

JANUARY 19, 2022

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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Drug Patent Watch

JANUARY 24, 2022

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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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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Broad Institute

JANUARY 31, 2022

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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Policy Prescription

JANUARY 31, 2022

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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Eye on FDA

JANUARY 5, 2022

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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Drug Channels

JANUARY 21, 2022

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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Drug Patent Watch

JANUARY 21, 2022

Annual Drug Patent Expirations for NAPROXEN+SODIUM Naproxen Sodium is a drug marketed by Bionpharma Inc, Catalent, Puracap Pharm Llc, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd,…. The post New patent for Bionpharma Inc drug NAPROXEN SODIUM appeared first on DrugPatentWatch - Make Better Decisions.

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PerkinElmer

JANUARY 21, 2022

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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Practical Cheminformatics

JANUARY 17, 2022

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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Drug Discovery Today

JANUARY 6, 2022

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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Eye on FDA

JANUARY 12, 2022

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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Drug Channels

JANUARY 18, 2022

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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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

Clinical Trials

Drug Patent Watch

JANUARY 30, 2022

Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Zydus Pharms, and Pfizer and, and is included…. The post New tentative approval for Amneal Pharms drug fesoterodine fumarate appeared first on DrugPatentWatch - Make Better Decisions.

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Sygnature Discovery

JANUARY 13, 2022

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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Pharmaceutical Development Group

JANUARY 7, 2022

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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Drug Discovery Today

JANUARY 6, 2022

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

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Eye on FDA

JANUARY 9, 2022

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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Drug Channels

JANUARY 10, 2022

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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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for BRAFTOVI Braftovi is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Array Biopharma drug BRAFTOVI appeared first on DrugPatentWatch - Make Better Decisions.

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Sygnature Discovery

JANUARY 7, 2022

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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Plenge Gen

JANUARY 6, 2022

[ 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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PerkinElmer

JANUARY 7, 2022

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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Olympian Clinical Research

JANUARY 5, 2022

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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Drug Channels

JANUARY 28, 2022

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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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for XARELTO Xarelto is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. There are four patents…. The post New patent for Janssen Pharms drug XARELTO appeared first on DrugPatentWatch - Make Better Decisions.

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Broad Institute

JANUARY 31, 2022

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

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Pharmaceutical Development Group

JANUARY 5, 2022

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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Practical Cheminformatics

JANUARY 3, 2022

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 Anticancer Fund

JANUARY 12, 2022

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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Drug Channels

JANUARY 14, 2022

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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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for VALTOCO Valtoco is a drug marketed by Neurelis Inc and is included in one NDA. There are five patents protecting this drug. VALTOCO drug price…. The post New patent for Neurelis Inc drug VALTOCO appeared first on DrugPatentWatch - Make Better Decisions.

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Broad Institute

JANUARY 31, 2022

Careers By admin January 31, 2022 Breadcrumb Home Careers Become a Broadie: Join us in propelling the understanding and treatment of disease. Search open positions [link] About the Broad Institute The Broad is an experiment in a new way of doing science. Broad brings together people with diverse expertise, backgrounds, and talents to explore big, bold ideas that drive scientific discovery and impact patients' lives.

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