June, 2024

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DDW Summer issue out now

Drug Discovery World

The DDW Summer issue is out now and looks at where the global biotech hubs are for drug discovery and development, asks how 3D genomics can accelerate personalised medicine, and looks at the technological advances in mass spectrometry. It also includes an exclusive global cancer research guide examining the innovation happening in this sector. Read the digital version here.

Therapies 272
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Simple test for flu could improve diagnosis and surveillance

Broad Institute

Simple test for flu could improve diagnosis and surveillance By Allessandra DiCorato June 18, 2024 Breadcrumb Home Simple test for flu could improve diagnosis and surveillance A low-cost CRISPR-based paper strip test distinguishes between influenza types and can be reprogrammed to recognize different viruses including the H5N1 bird flu virus. By Allessandra DiCorato June 18, 2024 Credit: Jon Arizti-Sanz SHINE, a rapid diagnostic test developed by Pardis Sabeti's lab in 2020, uses paper strips an

Virus 144
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These microscopic tunnels are a goldmine for new medicines

BioPharma Drive: Drug Pricing

A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.

Research 137
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Using AI to decode dog vocalizations

Science Daily: Pharmacology News

Have you ever wished you could understand what your dog is trying to say to you? Researchers are exploring the possibilities of AI, developing tools that can identify whether a dog's bark conveys playfulness or aggression.

Research 136
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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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CDC Advises Updated COVID Vaccine for Everyone Over 6 Months of Age

Drugs.com

FRIDAY, June 28, 2024 -- As a summer wave of COVID infections rolls across the country, U.S. health officials have recommended that all Americans over the age of 6 months get one of the updated COVID vaccines when they become available this.

Vaccine 124
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What to know about endometrial cancer

Antidote

Also known as endometrial carcinoma or uterine cancer, endometrial cancer occurs when the cells that line the uterus begin growing uncontrollably. Though the mortality rates are relatively low due to the high rate of early detection, it is a cancer that impacts nearly 70,000 people every year.

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Some CRISPR screens may be missing cancer drug targets

Broad Institute

Some CRISPR screens may be missing cancer drug targets By Allessandra DiCorato June 14, 2024 Breadcrumb Home Some CRISPR screens may be missing cancer drug targets Current CRISPR guides don’t work equally well in cells from people of all ancestries, which could lead to false negative results. By Allessandra DiCorato June 14, 2024 Credit: Ricardo Job-Reese, Broad Communications CRISPR/Cas9 gene editing has made possible a multitude of biomedical experiments including studies that systematically t

Drugs 145
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New data showcase promise, growing pains of CAR-T in autoimmune disease

BioPharma Drive: Drug Pricing

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

Disease 139
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Walking brings huge benefits for low back pain

Science Daily: Pharmacology News

Adults with a history of low back pain went nearly twice as long without a recurrence of their back pain if they walked regularly, a world-first study has found.

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Statins, Metformin Can Cut Odds for Brain Aneurysms

Drugs.com

THURSDAY, June 6, 2024 -- Common drugs used to control cholesterol, blood sugar and high blood pressure might also lower a person’s risk of stroke, a new study finds.The researchers evaluated the risk of brain aneurysms that cause bleeding strokes i.

Research 124
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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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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog: Biosimilars

By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.

FDA 116
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The Intricate Journey of Drug Patents: From Filing to Expiry

Drug Patent Watch

In the high-stakes world of pharmaceuticals, patents play a pivotal role in safeguarding intellectual property and ensuring a return on investment for drug developers. The journey of a drug patent is a complex and intricate one, spanning from the initial filing to its eventual expiry.

Drugs 111
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National Safety Month 2024

NIOSH Science Blog: Drugs

Each June, we bring a little extra attention to safety issues by highlighting National Safety Month®. For each week of the month, the National Safety Council (NSC) identifies a theme to focus on. This blog highlights select research and prevention efforts from the National Institute for Occupational Safety and Health (NIOSH) and NSC in this year’s focus areas of safety engagement; roadway safety; risk reduction; and slips, trips and falls.

Research 113
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Duchenne approval exposes FDA rift over Sarepta gene therapy

BioPharma Drive: Drug Pricing

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

FDA 133
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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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Scientists preserve DNA in an amber-like polymer

Science Daily: Pharmacology News

With their 'T-REX' method, researchers developed a glassy, amber-like polymer that can be used for long-term storage of DNA, such as entire human genomes or digital files such as photos.

DNA 130
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Moderna Announces Good Results From Trial of Combo COVID/Flu Vaccine

Drugs.com

MONDAY, June 10, 2024 -- An experimental vaccine that could offer one-stop prevention for both COVID-19 and influenza is showing positive results among older adults in trials, maker Moderna announced Monday.The shot — for now called mRNA-1083 — "ha.

Vaccine 119
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OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog: Biosimilars

By Sara W. Koblitz & Jeffrey N. Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact.

FDA 111
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Uncovering Lucrative Low-Competition Generic Drug Opportunities

Drug Patent Watch

In the ever-evolving pharmaceutical landscape, savvy businesses are constantly on the lookout for untapped markets and lucrative opportunities. One area that has garnered significant attention is the realm of low-competition generic drugs.

Drugs 110
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Hero, Villain, or Victim? Stories that Sabotage

Perficient: Drug Development

In 1968, psychiatrist Stephen Karpman modeled what he called the Drama Triangle. With this, he illustrated dysfunctional mindsets that can derail social interactions. The three roles defined in this model are the rescuer (hero), persecutor (villain), and victim. This is another view of the lies we tell ourselves. Since the dawn of history, we’ve loved stories.

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In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

BioPharma Drive: Drug Pricing

The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.

FDA 133
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Studies uncover the critical role of sleep in the formation of memories

Science Daily: Pharmacology News

A lack of sleep can make it extraordinarily difficult to retain information. Two new studies uncover why this is and what is happening inside the brain during sleep and sleep deprivation to help or harm the formation of memories.

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Microplastics Found in Human Penises

Drugs.com

THURSDAY, June 20, 2024 -- Seven different kinds of microplastics have been discovered in human penises for the first time.The tiny fragments, formed when plastic products break down in the environment, were found in four of five samples of penis.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog: Biosimilars

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

FDA 111
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Divisional Patent Minefields: Navigating Big Pharma’s Patent Extension Strategies

Drug Patent Watch

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

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How to Configure ServiceNow Catalog Items for Microsoft Search

Perficient: Drug Development

If you are using ServiceNow as your IT service management platform, you might want to make your catalog items searchable in Microsoft Search. Microsoft Search is a unified search experience that helps you find what you need across your organization, including files, sites, people, and more. By connecting your ServiceNow catalog items to Microsoft Search, you can enable your users to find and request them directly from the Microsoft 365 apps.

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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

BioPharma Drive: Drug Pricing

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

FDA 130
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Father's diet before conception influences children's health

Science Daily: Pharmacology News

A recent study provides new insights into how fathers' diets and overweight can affect their children's health even before conception. The findings of the study can help develop preventive health measures for men wishing to become fathers: The healthier the father's diet, the lower the risk for their children to develop obesity or diseases such as diabetes later in life.

Disease 130
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Colombian Family's Genes Could Hold Key to Delaying Alzheimer's

Drugs.com

THURSDAY, June 20, 2024 -- A Colombian family’s genetics are shining a spotlight on a gene that might help protect people from the ravages of Alzheimer’s disease.About 1,200 out of 6,000 family members carry a genetic variant called the “Paisa mutat.

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Innovation, Partnerships & Progress: How Life Sciences Is Booming in Maryland’s Montgomery County

Fierce BioTech

Drive or take the metro in any direction within Montgomery County, Maryland, and you'll come across a life science company responsible for a major innovation. | Drive or take the metro in any direction within Montgomery County, Maryland, and you'll come across a life science company responsible for a major innovation.

Science 106
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How long does a patent last for drugs?

Drug Patent Watch

Sure, here’s a more detailed explanation with examples: Drug Patent Duration Drug patents are granted by the United States Patent and Trademark Office (USPTO) for a period of 20 years… Source

Drugs 111
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FDA Approved Oncology Drugs 2023

Crown Bioscience

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

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FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

BioPharma Drive: Drug Pricing

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

FDA 130
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A high-fat diet may fuel anxiety

Science Daily: Pharmacology News

New research shows when animals are fed a diet high in saturated fat for nine weeks, their gut bacteria change in ways that influence brain chemicals and fuel anxiety.

Research 129
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High Out-of-Pocket Costs Keep Some From Lifesaving Opioid Antidote

Drugs.com

TUESDAY, June 18, 2024 -- Patients are less likely to fill prescriptions for the overdose-reversing drug naloxone when they have to shell out more at the pharmacy, a new study finds.Naloxone (also known by the brand name Narcan) is a critical.

Pharmacy 115