Tue.Apr 02, 2024

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New DDW Highlights podcast: 2 April 2024

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. In another busy week for drug discovery and development, we have seen the FDA approval of a monoclonal antibody for emergency use in Covid-19, the launch of trials into innovative new treatments for urea cycle disorders and alcohol use disorder, and a significant acquisition for Novo No

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Scientists link certain gut bacteria to lower heart disease risk

Broad Institute

Scientists link certain gut bacteria to lower heart disease risk By Allessandra DiCorato April 2, 2024 Breadcrumb Home Scientists link certain gut bacteria to lower heart disease risk Study finds several species of cholesterol-metabolizing bacteria in people with lower cholesterol levels. By Allessandra DiCorato April 2, 2024 Credit: Ahmed Mohamed Rod-shaped Oscillibacter sp. bacteria take up fluorescently labeled cholesterol (here shown in green).

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Case Study: Streamline preclinical drug discovery

Drug Discovery World

A new Case Study is now available to download for free: ‘In Vivo Evaluation Of Bispecific-Cell Engager Efficacy & Safety ‘ Discover a clinically predictive and reproducible platform developed by The Jackson Laboratory for simultaneous efficacy and safety assessment. This platform identifies patient-therapy combinations at risk of developing severe inflammatory syndrome, a potentially fatal complication.

Drugs 148
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Australia on track for unprecedented, decades-long megadroughts

Science Daily: Pharmacology News

Australia could soon see megadroughts that last for more than 20 years, according to new modelling. The researchers' bleak findings are before factoring in human impact on the climate since the Industrial Revolution. According to the scientists, the findings paint a worrying picture of future droughts in Australia that are far worse than anything in recent experience.

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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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R&D partnership to jointly develop new ALS drugs

Drug Discovery World

PrecisionLife and the Nucleic Acid Therapy Accelerator (NATA) have announced a collaboration to co-develop novel oligonucleotide therapies for sporadic motor neurone disease/ALS. The collaboration combines NATA’s expertise in NAT design and optimisation with PrecisionLife’s understanding of complex disease biology and the mechanisms, drug targets and treatments that are relevant to specific ALS patient subgroups.

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The FDA’s New Draft Guidance on DMCs: What to Know

Cytel

Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct based on risk-benefit. DMCs are an essential component to ensuring the integrity and safety of clinical trials. New draft guidance published by the U.S. FDA on the use of DMCs in clinical trials provides six major updates to the FDA’s expectations regarding DMC structure and practice.

More Trending

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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

By Sara W. Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. This year is no different , and in fact some of the requests on this year’s list are repeat offenders from last year’s. And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides im

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Streamline preclinical drug discovery: PBMC-humanised mouse models

Drug Discovery World

Discover a clinically predictive and reproducible platform developed by The Jackson Laboratory for simultaneous efficacy and safety assessment. This platform identifies patient-therapy combinations at risk of developing severe inflammatory syndrome, a potentially fatal complication. Optimise the safety profiles of your immunomodulatory therapeutics before first-in-human trials by leveraging this platform.

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Acorda files for bankruptcy, reveals asset sale plan

BioPharma Drive: Drug Pricing

Stalking horse bidder Merz Therapeutics could get rights to Acorda’s three marketed drugs if its $185 million proposal holds.

Marketing 120
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Webinar: Enhancing collaboration in drug discovery

Drug Discovery World

Join DDW and Revvity Signals for this free event ‘ Enhancing collaboration between sponsors and contract partners in drug discovery ’. The event will take place on 23 April at 4pm BST / 5pm CEST / 11am EDT / 8am PDT. Most contemporary drug discovery companies (sponsors) outsource some (or all) drug development to external contract partners, e.g. Contract Research Organisations (CROs) and/or Contract Development and Manufacturing Organisations (CDMOs).

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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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100 kilometers of quantum-encrypted transfer

Science Daily: Pharmacology News

Researchers have taken a big step towards securing information against hacking. They have succeeded in using quantum encryption to securely transfer information 100 kilometers via fiber optic cable -- roughly equivalent to the distance between Oxford and London.

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Verve pauses base editing study after treatment side effect

BioPharma Drive: Drug Pricing

Lab test abnormalities in one study participant led the company to halt enrollment and prioritize a different version of its gene editing therapy for heart disease.

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First results from BREAD experiment demonstrate a new approach to searching for dark matter

Science Daily: Pharmacology News

One of the great mysteries of modern science is dark matter. We know dark matter exists thanks to its effects on other objects in the cosmos, but we have never been able to directly see it. And it s no minor thing currently, scientists think it makes up about 85% of all the mass in the universe.

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Ginkgo, in search of more cell therapy tools, buys another startup

BioPharma Drive: Drug Pricing

An acquisition of Modulus Therapeutics is the latest move by Ginkgo to accumulate technologies that can help other companies develop cellular medicines.

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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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What CVS Pharmacy’s New Cost-Plus Reimbursement Approach Means for PBMs, Pharmacies, Plan Sponsors, and Prescription Prices (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. For more on acquisition cost reimbursement for pharmacies, see Sections 8.4. and 12.3.4. of our new 2024 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. Click here to see the original post from December 2023.

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Roivant reveals positive immune drug data, share buyback plans

BioPharma Drive: Drug Pricing

A Pfizer drug licensed to a Roivant subsidiary surpassed expectations in a type of uveitis, while a stock purchase plan will see Roivant buy out shares owned by Sumitomo Pharma.

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Chemical Biology and Drug Design

Cover Image © molekuul_be/Shutterstock.

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Lessons From A Private Funding Round: Science, Relationships, And Experience

LifeSciVC

By Mike Cloonan, CEO of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC An insightful piece on this blog following the JPM healthcare conference noted the “ refreshing burst of enthusiasm ” in the biotech sector. It’s true that venture funds raised significant capital despite numerous challenges over the past two years. And many are looking for the right investments now.

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Gritstone shares fall on shaky study results for colorectal cancer vaccine

BioPharma Drive: Drug Pricing

While the company claimed its shot showed signs of working in a Phase 2 trial, the data weren’t strong enough to prove a treatment benefit.

Vaccine 70
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Biotech strategies for an uncertain world

SugarCone Biotech

Contributed by Paul Rennert There is a lot to worry about as your biotech moves from discovery work to IND filings to clinical development. Time, money and execution are daily critical issues that color every decision. Steering a steady course is the job description for every management team but so is the ability to shift course mid-stream. “This is the business we have chosen” says Hyman Roth in The Godfather, and many days that’s a familiar sentiment: “I didn’t ask who gave the order”.

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A dementia-focused VC digs past amyloid for new kinds of brain drugs

BioPharma Drive: Drug Pricing

The Dementia Discovery Fund set out to spark research into new approaches for diseases like Alzheimer’s, even as anti-amyloid therapies reach patients.

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New tentative approval for MYLAN drug efavirenz, emtricitabine and tenofovir alafenamide

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

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How to reach the right patients in clinical trial advertising

Antidote

Digital advertising, which encompasses social media, online channels, streaming content, and more can be a powerful way to reach patients. One of the biggest avenues of reaching potential clinical trial participants through digital advertising is social media — and from the statistics, it is clear why. Not only does Facebook boast more than 3 billion users every month, but 80% of social media users are searching for health information.

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New patent expiration for Sumitomo Pharma drug KYNMOBI

Drug Patent Watch

Annual Drug Patent Expirations for KYNMOBI Kynmobi is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are fourteen patents protecting this drug.

Drugs 59
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Harmony in Colour and Collaboration:A Sankranti Spectacle of Pookolam, Kite Crafting, and Team Unity

Perficient: Drug Development

Introduction: Our organisation celebrated Sankranti, an auspicious occasion that marks the sun’s entry into the northern hemisphere, with a joyful celebration that united staff members in a colourful extravaganza. We made the decision to incorporate teamwork, creativity, and traditions into this year’s celebrations in order to provide everyone an unforgettable time.

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New patent expiration for Merck Sharp drug DUTREBIS

Drug Patent Watch

Annual Drug Patent Expirations for DUTREBIS Dutrebis is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.

Drugs 59
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React reusable API call using Custom React Hooks

Perficient: Drug Development

Introduction Custom Hooks are reusable functions that let a React JS developer tailor and adjust a React application’s functionality. React JS version 16.8 includes them. A special JavaScript function with the prefix “use” is referred to as a “ Custom Hooks.” Using a customized Hook, retrieve information from an API. This hook will return an object with the data and an optional error message given a URL.

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New patent expiration for Msd Sub drug ISENTRESS HD

Drug Patent Watch

Annual Drug Patent Expirations for ISENTRESS+HD Isentress Hd is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from nine suppliers.

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Bromodomain and Extra-Terminal Domain Protein 2 in Multiple Human Diseases [Minireview]

ASPET

Bromine domain protein 2 (BRD2), a member of the Bromodomain and extraterminal domain (BET) protein family, is a crucial epigenetic regulator with significant function in various diseases and cellular processes. The central function of BRD2 is modulating gene transcription by binding to acetylated lysine residues on histones and transcription factors.

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New patent expiration for Msd Sub drug ISENTRESS

Drug Patent Watch

Annual Drug Patent Expirations for ISENTRESS Isentress is a drug marketed by Msd Sub Merck and is included in three NDAs. It is available from nine suppliers.

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Synthetic Origins

Codon

In 1997, as Michael Elowitz was studying for a Ph.D. in physics at Princeton University, he had a remarkable idea: What if it were possible to build a circuit out of DNA, rather than electronics, and use it to “program” a living cell? For the next three years, working with advisor Stanislas Leibler, Elowitz labored over this synthetic gene circuit and achieved precisely that.

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New patent expiration for Otter Pharms drug SYMPAZAN

Drug Patent Watch

Annual Drug Patent Expirations for SYMPAZAN Sympazan is a drug marketed by Otter Pharms and is included in one NDA. It is available from one supplier.

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Therapeutic approaches for UCPPS management: research advances, experimental targets, and future directions [Minireview]

ASPET

Urologic Chronic Pelvic Pain Syndrome (UCPPS) is a painful chronic condition with persistent pain originating from the pelvis that often leads to detrimental lifestyle changes in the affected patients. The syndrome develops in both sexes, with an estimated prevalence of 5.7% to 26.6% worldwide. This narrative review summarizes currently recommended therapies for UCPPS, followed by the latest animal and clinical research advances in the field.

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New patent expiration for Aquestive drug EXSERVAN

Drug Patent Watch

Annual Drug Patent Expirations for EXSERVAN Exservan is a drug marketed by Aquestive and is included in one NDA. It is available from one supplier.

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