Sat.Nov 05, 2022 - Fri.Nov 11, 2022

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Publication in Nature Chemistry Demonstrates the Benefits of Native Mass Spectrometry in the Interrogation of Target Ecosystems and Drug Discovery

Drug Discovery Today

Joint publication in Nature Chemistry between OMass Therapeutics’ scientists and co-founder Professor Dame Carol Robinson’s team at Oxford University. Data demonstrates the ability of native mass spectrometry (MS) to interrogate the pharmacology of the beta-1 adrenergic receptor (ß1AR), a G protein-coupled receptor (GPCR).

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Family caregivers month: How caregivers can be partners in research

Antidote

November is designated as National Family Caregivers Month , which is a way to honor over 50 million Americans that provide care and assistance to loved ones. Caregivers play a vital role in the medical journeys of many patients , and they often dedicate their entire lives to maintaining a person’s health and dignity throughout the process.

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From U.S. Air Force Captain to CRO Leader: Karl D. Kendall Shares His Story

Conversations in Drug Development Trends

At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?

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Cell and Gene Therapy Roundup: What the Road to Success Looks Like

Drug Channels

Today’s guest post comes from Lung-I Cheng, Vice President of Cell & Gene Therapy at AmerisourceBergen. Lung-I discusses advancements in cell and gene therapy and explains how to tackle the challenges facing manufacturers, providers, and patients. Click here to learn about AmerisourceBergen’s Cell and Gene Therapy solutions for biopharma companies, providers, and patients.

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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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North West chemical manufacturer secures £2.2m to supercharge growth

Drug Discovery Today

Chemical manufacturer LCC has raised £2.2m of investment from a panel of regional investors, to expand its team and continue its global operation from the UK.

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Alzheimer's vs. dementia: An overview for National Alzheimer's Disease Awareness Month

Antidote

While there are many conditions that can cause memory loss , dementia and Alzheimer’s disease are probably two of the most well-known terms associated with cognitive decline. However, while these two terms are often used interchangeably, they actually refer to different kinds of memory loss diseases. In honor of November being National Alzheimer’s Disease Awareness Month , we wanted to take a few moments to address some important considerations when comparing Alzheimer’s and dementia.

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The Consolidated Drug Channel and Cash-Pay Drugs: My Podcast with a16z's Julie Yoo

Drug Channels

I recently joined Julie Yoo on Bio Eats World , a podcast from legendary venture capital firm Andreessen Horowitz (also known as "a16z"). Julie is a General Partner at Andreessen Horowitz. We chatted about the current state of the U.S. drug channel, the roles and controversies around pharmacy benefit managers (PBMs), GoodRx, Mark Cuban’s cost-plus pharmacy, the 340B Drug Pricing Program, and much more.

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The collaboration combines Salipro Biotech’s unique expertise and its Salipro® platform technology to stabilize a challenging drug target with Sanofi’s drug discovery programs to move forward the generation of biologics.

Drug Discovery Today

Stockholm, Sweden, November 8, 2022 – Swedish biotech company Salipro Biotech AB today announced that it has entered into a research collaboration and license agreement with Sanofi on the discovery of therapeutic biologics against a challenging drug target.

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3 ways Antidote serves sites

Antidote

Successful clinical trial patient recruitment is about more than just finding potential participants. In fact, clinical trial matching is just one part of the equation — which is why we offer tailored solutions for sponsors, including trial site support.

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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.

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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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Drug Channels Outlook 2023 (NEW Live Video Webinar)

Drug Channels

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2023. Friday, December 16, 2022 12:00 p.m. to 1:30 p.m. ET. This page describes the event and explains how to purchase a registration to the live event. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

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

Drug Discovery Today

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

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How 3D In Vitro Organoids Can Enhance the Predictivity of Cancer Drug Discovery

Crown Bioscience

Drug development is a lengthy, risky, and costly endeavor with high candidate attrition. Attrition rates for anticancer agents are much higher than in other therapeutic categories. Only 5% of them are estimated to reach the clinical stage. This very high rate has been attributed in part to the poor translatability of current preclinical data.

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Which pharmaceutical companies have the most elixir dosed drugs?

Drug Patent Watch

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

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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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FDA’s September 2022 NPRMs: What They Mean for Academia and Industry

Advarra

On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed harmonization with the Health and Human Services (HHS) 2018 Common Rule (also referred to as the revised Common Rule ).?This blog highlights some of the major proposed changes and how they may impact the clinical research community. .

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Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

The Premier Consulting Blog

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. Working to bring these valuable new therapies to patients, sponsors engaged in strategic development often approach Premier Consulting for regulatory clarification: “Is this actually a combination product?

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Leverage the Clinical API: Categories

DrugBank

DrugBank’s Clinical API is a powerful tool that can be used across an array of use cases, including everything from EMR/EHR to hospice and precision medicine. We’ve intentionally built our Clinical API to connect multiple data points across unique modules as a means of delivering specific and empowering insights to the full range of our users.

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New patent for Exelixis Inc drug CABOMETYX

Drug Patent Watch

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

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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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Researchers Identify Novel Immunotherapeutic Compound Targeting Key Cancer Pathway

PerkinElmer

Immunotherapy has revolutionized cancer treatment and proved to be pivotal in the field of oncological research. Among several immunotherapeutic approaches that have been pursued, inhibiting the PD-1 (programmed cell death protein-1)/PD-L1 pathway has gained increased attention in recent years and shown exciting clinical success in a range of human cancers.

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Bullous Pemphigoid: Causes, Symptoms and Potential Treatments

Olympian Clinical Research

Bullous pemphigoid is a rare, autoimmune skin condition that forms large, fluid-filled blisters. The blisters typically form on the outermost layer of skin (the epidermis) and may occur anywhere on the body. However, they most commonly appear on the belly, chest, legs, arms, groin, or armpits. Although this disease is estimated to affect less than 50,000 Americans, it may be life-threatening, especially for people who are already in poor health.

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Antidote’s insights from 7,000+ type 2 diabetes patients [one-pager]

Antidote

Having a deep understanding of the patient population is key to successful recruiting for clinical trials — which is why Antidote takes discovering patient insights seriously.

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Most prolific drug patent challengers

Drug Patent Watch

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2017 to 2022. Companies that successfully challenge patents on branded drugs are granted six…. The post Most prolific drug patent challengers appeared first on DrugPatentWatch - Make Better Decisions.

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Upcoming 20/15 Visioneers Virtual Conference

The Strateos Blog: Drug Discovery

Lab automation solutions for addressing the reproducibility crisis Strateos is excited to, once again, take part in the 20/15 Visioneers Cloud Lab, High Throughput Experimentation (HTE), & Lab Automation Virtual Conference between November 8-10th. The conference will bring together experts in these fields to demonstrate cutting-edge technologies and their impact on the advancement of high-quality science.

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Atlas Venture 2022 Year In Review

LifeSciVC

We just held our 2022 Annual General Meeting for our investors, and a few weeks ago convened our Atlas Venture Retreat – both in person for the first time in 3 years. Kicking off each of these meetings is our “Year In Review” presentation, which covers a broad range of macro themes, the biotech ecosystem, and our firm. This year, given the 2+ year rollercoaster in the markets, we start with a deep dive into both the public and private capital markets, as well as the recent M&#

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OneStudyTeam and Antidote are partnering to maximize clinical trial recruitment and enrollment

Antidote

We are excited to announce our new partnership with OneStudyTeam , a company that provides the cloud-based platform StudyTeamTM to connect site and sponsor workflows. By combining our complementary technology, this partnership will provide sites and sponsors with a connected, end-to-end patient referral management experience.

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New patent for Acacia drug BARHEMSYS

Drug Patent Watch

Annual Drug Patent Expirations for BARHEMSYS Barhemsys is a drug marketed by Acacia and is included in one NDA. There are five patents protecting this drug. This drug has forty-nine…. The post New patent for Acacia drug BARHEMSYS appeared first on DrugPatentWatch - Make Better Decisions.

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The Year Ahead: Six Predictions for the Biopharma and Biotech Industries in 2023

PPD

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. The U.S. Food and Drug Administration (FDA) has granted 26 novel drug approvals to date in 2022, moving at a remarkably slower pace than 2020 and 2021, which yielded 53 and 50 approvals, respectively.

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International research coalition verifies safe surgical access to the central core of the human cochlea for the very first time

Drug Discovery Today

A team of surgeons and scientists from the UK, Sweden and Canada, funded by Rinri Therapeutics, has confirmed secure surgical access to the central core of the human cochlea The research, published in Scientific Reports, is critical to the first in-human trials of new cell, gene and drug therapies for the inner ear, and will assist with treatment for improving hearing loss and deafness over the long-term

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FUFRA Enacted; HP&M Issues Detailed Summary and Analysis

FDA Law Blog: Drug Discovery

On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 , Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”). In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—sever

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New patent for Daiichi Sankyo drug TURALIO

Drug Patent Watch

Annual Drug Patent Expirations for TURALIO Turalio is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There are twelve…. The post New patent for Daiichi Sankyo drug TURALIO appeared first on DrugPatentWatch - Make Better Decisions.

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California Appellate Court Reaffirms Federal Preemption, Learned Intermediary Doctrine in Amiodarone Cases

Drug & Device Law

A potential top-ten case came across our desks the other day, and even better, it comes out of our home state of California. In Amiodarone Cases , No. A161023, 2022 WL 16646728 (Cal. Ct. App. Nov. 3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine.

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Which pharmaceutical companies have the most SPCs in Luxembourg?

Drug Patent Watch

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

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New patent for Incyte Corp drug PEMAZYRE

Drug Patent Watch

Annual Drug Patent Expirations for PEMAZYRE Pemazyre is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Incyte Corp drug PEMAZYRE appeared first on DrugPatentWatch - Make Better Decisions.

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