Sat.Jun 08, 2024 - Fri.Jun 14, 2024

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Removing the needle: the unmet need for oral GLP-1 drugs 

Drug Discovery World

The hormone GLP-1 (glucagon-like peptide-1) and its receptor agonists (GLP-1RAs) have emerged as a compelling class of drugs to tackle diabetes, particularly due to their remarkable efficacy in lowering obesity levels, a fundamental contributing factor of type 2 diabetes. But there is much more to come from this drug class, argues Jeremy Skillington, CEO of Poolbeg Pharma.

Drugs 219
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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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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.

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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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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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New lab space for early-stage life science businesses

Drug Discovery World

Discovery Park has opened CoLab, a new shared lab facility in the UK. In partnership with Canterbury Christ Church University, CoLab has been designed for early-stage life science businesses, providing flexible bench space in a coworking environment. Dr Cornelia Wilson, Senior Lecturer and Academic Laboratory Director at Canterbury Christ Church University, said: “Finding lab space is too often a blocker for promising life science spin outs and start-ups, and CoLab exists to solve this.

Science 147
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Improved prime editing system makes gene-sized edits in human cells at therapeutic levels

Broad Institute

Improved prime editing system makes gene-sized edits in human cells at therapeutic levels By Allessandra DiCorato June 10, 2024 Breadcrumb Home Improved prime editing system makes gene-sized edits in human cells at therapeutic levels The gene-editing approach uses prime editors and evolved enzymes called recombinases, and could pave the way to effective one-size-fits-all gene therapies for diseases such as cystic fibrosis.

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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.

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Breakthrough drug discovery research collaboration in obesity

Drug Discovery World

Flagship Pioneering and ProFound Therapeutics have announced a collaboration to conduct foundational research to identify potential next-generation first-in-class therapies for the treatment of obesity. The collaboration is the first initiated under Flagship’s Pioneering Medicines strategic partnership with Pfizer announced in July 2023. Pioneering Medicines, Flagship’s in-house drug discovery and development unit, is responsible for leading the partnership with Pfizer, including driving the exp

Research 147
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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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Would astronauts' kidneys survive a roundtrip to Mars?

Science Daily: Pharmacology News

The structure and function of the kidneys is altered by space flight, with galactic radiation causing permanent damage that would jeopardise any mission to Mars, according to a new study led by researchers from UCL.

Research 118
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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.

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CAR-T therapy successfully targets advanced prostate cancer

Drug Discovery World

A team of investigators at City of Hope in the US funded by the Prostate Cancer Foundation (PCF) reports that patients with advanced prostate cancer can be safely treated with chimeric antigen receptor (CAR)-T cell therapy. The results of their first-in-human Phase I clinical trial, which also showed promising therapeutic activity, were published in Nature Medicine.

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FDA Tells Vaccine Makers to Target New COVID Variant for Fall

Drugs.com

FRIDAY, June 14, 2024 -- COVID vaccine makers will be advised to update their shots to target the KP.2 variant, an offshoot of the JN.1 variant that spread widely last winter, the U.S. Food and Drug Administration announced Thursday. It's a.

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AI-powered simulation training improves human performance in robotic exoskeletons

Science Daily: Pharmacology News

Researchers have demonstrated a new method that leverages artificial intelligence (AI) and computer simulations to train robotic exoskeletons to autonomously help users save energy while walking, running and climbing stairs.

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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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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

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Combination vaccine better than separate flu and Covid-19 jabs

Drug Discovery World

In clinical trials, Moderna’s combination vaccine elicited higher immune responses against influenza (flu) virus and SARS-CoV-2 than licensed flu and Covid-19 vaccines in adults 50 years and older. The Phase III trial investigated mRNA-1083, an investigational combination vaccine against influenza and Covid-19. mRNA-1083 comprises components of mRNA-1010, Moderna’s vaccine candidate for seasonal influenza, and mRNA-1283, Moderna’s Covid-19 vaccine candidate.

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ADHD Patients Could Face Disrupted Access to Meds Following Fraud Case

Drugs.com

FRIDAY, June 14, 2024 -- The two top officers of a telehealth company that began to distribute ADHD drugs widely during the pandemic have been charged with health care fraud, the U.S. Department of Justice announced Thursday. The arrests will.

Drugs 111
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Swimming microrobots deliver cancer-fighting drugs to metastatic lung tumors in mice

Science Daily: Pharmacology News

Engineers have developed microscopic robots, known as microrobots, capable of swimming through the lungs to deliver cancer-fighting medication directly to metastatic tumors. This approach has shown promise in mice, where it inhibited the growth and spread of tumors that had metastasized to the lungs, thereby boosting survival rates compared to control treatments.

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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.

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New DDW Highlights podcast: 11 June 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. With the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting concluding this week, the headline news has all focused on breakthrough cancer research shared at the event.

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Avidity drug for muscular dystrophy shows promise; Syntis takes new approach to weight loss

BioPharma Drive: Drug Pricing

Study results indicated Avidity’s medicine muted target genes. Elsewhere, Syntis revealed obesity drug plans and Nodthera chalked up more positive data for its NLRP3 inhibitor.

Drugs 109
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Are mixed emotions real? New research says yes

Science Daily: Pharmacology News

Neuroscientists found that brains display distinct neural activity when experiencing emotions such as bitter-sweetness. The advance could help solve a longstanding scientific debate: whether 'mixed emotions' arise from unique activity in the brain, or if we're just flip-flopping back and forth between positive and negative feelings.

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J&J Settles Talcum Powder Lawsuits From States for $700 Million

Drugs.com

THURSDAY, June 13, 2024 -- Johnson & Johnson will pay $700 million to settle claims from 42 states and the District of Columbia that the company continued to market its talcum powder products even as evidence tied them to a heightened risk for.

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Researchers discover genetic cause of inflammatory bowel diseases

Drug Discovery World

Researchers have discovered a new biological pathway in inflammatory bowel disease (IBD) and related conditions that can be targeted using existing drugs. About 5% of the world’s population are currently affected by an autoimmune disease, such as IBD, the umbrella term for Crohn’s disease and ulcerative colitis. These diseases are also becoming more common, with over half a million people living with IBD in the UK as of 2022, nearly double the 300,000 previously estimated.

Disease 147
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Ipsen drug for rare liver disease approved by FDA

BioPharma Drive: Drug Pricing

The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

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Tiny New Zealand bird delivers a lesson in birdsong evolution

Science Daily: Pharmacology News

Scientists are rethinking the evolution of vocal learning in birds. New Zealand's smallest bird, the rifleman or titipounamu, may have a rudimentary version of the talent possessed by parrots, hummingbirds and songbirds.

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Two-Drug Treatment Could Curb Meth Addiction

Drugs.com

MONDAY, June 10, 2024 — Though overdose deaths continue to surge, there is no approved medication to treat methamphetamine use disorder.Now, an experimental two-drug therapy has yielded promising results, UCLA researchers report."These findings h.

Treatment 108
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Gene therapy restores hearing in both ears

Drug Discovery World

Five children who were born with congenital hearing loss can hear in both ears after taking part in a gene therapy trial at Fudan University in Shanghai, China. Within weeks of receiving the therapy, the children could locate the sources of sounds, and recognised speech in noisy environments. Two of the children were recorded dancing to music, the researchers reported in Nature Medicine.

Therapies 147
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Pfizer gene therapy for Duchenne fails to meet goals of key trial

BioPharma Drive: Drug Pricing

The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.

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Pair plasmas found in deep space can now be generated in the lab

Science Daily: Pharmacology News

Researchers have experimentally generated high-density relativistic electron-positron pair-plasma beams by producing two to three orders of magnitude more pairs than previously reported.

Research 104
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Secondary Tumors After CAR-T Cancer Therapies Are Rare: Study

Drugs.com

THURSDAY, June 13, 2024 -- CAR-T cell therapy to treat blood cancers is safer than previously thought, with little risk that the immunotherapy will create secondary cancers, a new study finds.The U.S. Food and Drug Administration issued a warning.

Therapies 105
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New Cardiff facility to manufacture organoids for drug discovery

Drug Discovery World

A new facility has opened in Cardiff, UK designed to manufacture patient-derived organoids (PDOs) at scale for use in drug discovery and development. The multi-million-pound facility was custom-built by Molecular Devices to house its bioprocess workflow and bioreactor technology Mary Duseau, President of Molecular Devices said: “With our new facility, we now have the capacity to manufacture 300 million PDOs annually.

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Driving Toward Nanopores

Codon

An organism’s entire genome can be sequenced today using little more than a laptop and a $1,000 device, slightly larger than a smartphone, called a nanopore sequencer. The smallest of these measures just four by one-and-a-half inches across and one inch thick. Such a device seems implausible. But these little machines, small enough to fit inside a pocket, have become commonplace.

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The rotation of Earth's inner core has slowed, new study confirms

Science Daily: Pharmacology News

The new study provides unambiguous evidence that the inner core began to decrease its speed around 2010, moving slower than the Earth's surface.

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