June, 2024

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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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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 140
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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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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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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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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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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 138
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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 135
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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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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 114
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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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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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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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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.

Therapies 135
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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 135
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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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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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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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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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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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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 134
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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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A Malaria Drug, Tafenoquine, May Combat Tick-Borne Babesiosis

Drugs.com

WEDNESDAY, June 5, 2024 -- A malaria drug could help immune-compromised people who can’t shake off babesiosis, a tick-borne parasitic infection, a new study says. The drug tafenoquine helped cure four New England patients whose babesiosis.

Drugs 119
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GitHub – On-Prem Server Connectivity Using Self-Hosted Runners

Perficient: Drug Development

Various deployment methods, including cloud-based (e.g., CloudHub) and on-premises, are available to meet diverse infrastructure needs. GitHub, among other tools, supports versioning and code backup, while CI/CD practices automate integration and deployment processes, enhancing code quality and speeding up software delivery. GitHub Actions, an automation platform by GitHub, streamlines building, testing, and deploying software workflows directly from repositories.

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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 100
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CRISPR to Reveal How “Water Bears” (Tardigrades) Survive Extreme Environments

PLOS: DNA Science

Tardigrades are among the weirdest of animals. Also known as “water bears” or “moss piglets,” the 1,300 recognized species are the only members of phylum Tardigrada, a term that means “slow stepper” for their somewhat waddling gait. German zoologist Johann August Ephraim Goeze first described the tardigrades in 1773.

DNA 98
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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 131
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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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CDC Supports Use of Antibiotic, Doxycycline, as 'Morning After Pill' to Stop STDs

Drugs.com

WEDNESDAY, June 5, 2024 -- In new guidelines released Tuesday, U.S. health officials now recommend that certain people take the antibiotic doxycycline as a morning-after pill to lower the risk of some sexually transmitted diseases (STDs). The.

Disease 116
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Perficient Launches PRISM Employee Resource Group

Perficient: Drug Development

New ERG Will Further Perficient’s Progress in Supporting and Empowering the LGBTQ+ Community and its Allies At Perficient, we believe in developing a workforce that is as diverse and inclusive as the clients we work with. We are committed to fostering an environment where we celebrate all colleagues because our people make us unique, their perspectives make us stronger, and the label we all share is talent.

Marketing 105
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RAS: Targeting the Impossible

Crown Bioscience

Explore the ‘undruggable’ oncology target RAS, inhibitory techniques used on downstream pathways, and the preclinical models available to test up-and-coming RAS targeted agents.

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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog: Biosimilars

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.

FDA 98
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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 131
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Poor quality diet makes our brains sad

Science Daily: Pharmacology News

Eating a poor quality diet might lead to brain changes that are associated with depression and anxiety. This is according to a first-of-its-kind study into the brain chemistry and structure, and diet quality of 30 volunteers.

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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.

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Perficient Achieves AWS DevOps Competency

Perficient: Drug Development

Perficient is excited to announce our achievement in Amazon Web Services (AWS) DevOps Competency for AWS partners. This designation recognizes Perficient as an AWS partner that has demonstrated expertise in delivering Dev Sec Ops solutions. This competency highlights Perficient’s ability to drive innovation, meet business objectives , and get the most out of your AWS services.