Drug Discovery World

JUNE 7, 2024

Charles River Laboratories has announced the launch of its Virtual Control Groups (VCG) initiative with Sanofi. The companies are working together to reduce animal usage by replacing selected control group animals with selected matched virtual control animals developed using retrospective datasets. The VCG collaboration is a project guided by Charles River’s Alternative Methods Advancement Project (AMAP), focused on reducing the use of animals in research.

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BioPharma Drive: Drug Pricing

JUNE 7, 2024

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.

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Drug Discovery World

JUNE 7, 2024

News round-up for 3-7 June by DDW Senior Digital Content Editor Diana Spencer. 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. The top stories: New drug represents a ‘remarkable advancement’ in lung cancer New data show that an unprecedented 60% of patients with advanced lung cancer given Lorbrena (lorlatinib) remain alive without disease progression after fiv

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Vaccine Drugs Trials Research 130

Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- Roughly 1 in 6 people who stop taking an antidepressant will experience symptoms caused by discontinuing the drug, a new review finds.However, only 1 in 35 will experience severe symptoms after dropping their medication.

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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.

Clinical Trials

Drug Discovery World

JUNE 7, 2024

The biopharmaceutical industry is revealing increasing optimism regarding its growth prospects over the next 12 months. While the upward trend is a positive sign, it remains below the levels of confidence seen in 2022, finds data and analytics company GlobalData. In a recent survey, ‘The State of the Biopharmaceutical Industry 2024 (mid-year update)’, 73% of surveyed healthcare industry professionals felt optimistic or very optimistic about the industry’s growth during the next 12 months.

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Science Daily: Pharmacology News

JUNE 7, 2024

Scientists used CRISPR/Cas9 to increase gene expression in rice by changing its upstream regulatory DNA. While other studies have used the technology to knock out or decrease the expression of genes, this study, is an unbiased gene-editing approach to increase gene expression and downstream photosynthetic activity. The approach is more difficult than transgenic breeding, but could potentially preempt regulatory issues by changing DNA already within the plant, allowing the plants to get in the ha

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DNA 101

Reprocell

JUNE 7, 2024

In his opening remarks during a welcome reception at the 27 th annual meeting of the American Society of Gene & Cell Therapy , Maryland Secretary of Commerce Kevin Anderson touted the most recent accomplishments of biotech companies including Regenexbio, MaxCyte, and AstraZeneca. What these companies have in common is that they are all in the heart of Maryland’s biotech corridor in Montgomery County and their successes contribute to Maryland’s mission to make the state a biotech hub.

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Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- The U.S. Food and Drug Administration on Thursday asked states to work harder to protect the public from the risks of raw milk as a bird flu outbreak continues to spread among dairy cows.In an open letter to state and local.

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FDA Drugs 104

Science Daily: Pharmacology News

JUNE 7, 2024

Ancient apes in Germany co-existed by partitioning resources in their environment, according to a new study.

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Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- Severe forms of autism could be linked to overgrowth of the brain’s outer layer that starts while a baby is in the womb, a new study finds.Toddlers with autism have cerebral cortexes -- often referred to as “gray matter” -- t.

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Clinical Trials

Drug Target Review

JUNE 7, 2024

How does Immunocore’s TCR technology differentiate itself from other approaches to targeted cancer therapy? Our proprietary ImmTAC (Immune Mobilizing Monoclonal TCRs Against Cancer) technology is comprised of a bispecific molecule where the effector end (anti-CD3) is designed to specifically activate the immune system (ie, T cells) against tumour cells to destroy them.

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Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- New research shows that a set of healthy lifestyle habits can help preserve brain function in folks with mild cognitive impairment or early dementia.About 71% of patients who ate healthy, exercised regularly and engaged in.

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BioPharma Drive: Drug Pricing

JUNE 7, 2024

After 34 years, Geron finally has an approved medicine in Rytelo. Elsewhere, Shionogi disclosed disappointing obesity drug data and AbbVie got some good trial news.

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Drugs Trials 64

Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- Anthrax disease in humans is rare and when it does occur, it's usually during hot, dry summers.That's why the case of a Texas rancher who developed anthrax in January of this year piqued the interest of investigators at the.

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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

Clinical Trials

Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD Since the passage of the Dietary Supplement Health and Education Act (DSHEA) 30 years ago, the U.S. dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Over the years, the retroactive structure of DSHEA has encouraged the influx of bad actors who have identified the dietary supplement sector as a venue for the introduction of unapproved drugs into the U.S. market.

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Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- Vigorous exercise more than once a week can lower the risk of dementia for people with high blood pressure, a new clinical trial shows.People who engaged each week in vigorous physical activity had lower rates of mild.

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Clinical Trials Trials 98

Agency IQ

JUNE 7, 2024

BY WALKER LIVINGSTON, ESQ The Environmental Protection Agency (EPA) has proposed a suite of actions for n-methylpyrrolidone (NMP), including capping concentrations at 45% and implementing a series of bans for consumer, commercial, and industrial uses. Under the Toxic Substances Control Act (TSCA), the EPA is required to conduct risk evaluations of chemicals.

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Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- An extended course of the antiviral drug Paxlovid won’t ease a person’s Long COVID symptoms, a new study finds. People who took Paxlovid for 15 days -- three times as long as it’s prescribed for an initial.

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Agency IQ

JUNE 7, 2024

BY LAURA DIANGELO, MPH Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. After a Congressional directive, the agency has now released new draft guidance on the processes and practices on BIMO inspections. The new draft guidance comes as there is a major overhaul of the Office of Regulatory Affairs (ORA) in the works, and new authorities on Remote Regulatory Assessments (RRAs) are being implemented.

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Regulations Research 59

Drugs.com

JUNE 7, 2024

FRIDAY, June 7, 2024 -- If your child is among the youngest in their school grade, it's more likely they'll be mistakenly identified by teachers as having ADHD or autism, a new study confirms."Adults involved in identifying or raising concerns over.

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Cytel

JUNE 7, 2024

In this latest edition of the Career Perspectives series, we are excited to introduce our readers to Karl Karu, Senior Statistical Programmer in Functional Service Provider (FSP) at Cytel. Karl is based in Estonia and joined Cytel in September 2023. Join us as we delve into his refreshing and enthusiastic perspective on statistical programming and the skills it requires, the importance of communication with sponsors, and a work-life balance when working from home.

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Agency IQ

JUNE 7, 2024

BY COREY JASEPH, MS, RAC While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations. While designation numbers are up, there are still concerns that manufacturers need to be aware of.

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Regulations 59

Quanticate

JUNE 7, 2024

Discover how Risk-Based Quality Management (RBQM) optimizes clinical data management for improved safety, efficiency, and regulatory compliance in clinical trials

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Compliance Clinical Trials Trials 59

Agency IQ

JUNE 7, 2024

BY SCOTT STEPHENS, MPA The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU. Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances.

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Common Sense for Drug Policy Blog

JUNE 7, 2024

Community Pharmacies and Harm Reduction "Community pharmacies are essential healthcare destinations that serve as an optimal resource for addressing non-urgent inquiries, such as safe injecting practices, management of adverse drug reactions, and medication provision, thus reducing the burden on general practitioners (GPs) [ 1 , 2 ]. Pharmacists also have a role in addressing social determinants of health and promoting health equity, including the support of primary prevention strategies such as

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Antidote

JUNE 7, 2024

Recruiting and retaining patients are two of the most challenging aspects of clinical trials. The average clinical trial must extend its recruitment timeline by 71%, and up to 30% of patients will eventually drop out. While patients can leave a trial if it is not a good fit for them, there are patient-centric approaches that can make enrolling and participating in a study a more enjoyable experience.

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Clinical Trials Trials 52

Common Sense for Drug Policy Blog

JUNE 7, 2024

Community Pharmacies and Anabolic-Androgenic Steroid Consumers "With the growing availability of AAS [Anabolic-Androgenic Steroids] through online platforms [ 71 , 72 ] the traditional reliance on social networks and healthcare providers for access to injecting equipment and safer use information has diminished [ 73 – 76 ]. This unregulated supply of AAS and other PIEDs from online sources is accompanied by misleading information regarding the benefits and risks associated with their use [ 13 ,

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Drug Channels

JUNE 7, 2024

Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir highlights manufacturers' top objectives and vendor metrics from CareMetx’s recent survey of leaders and decision makers in the specialty pharmaceutical industry. He then outlines key questions to help manufacturers evaluate their potential hub partners. You can donwload CareMetx’s full 2024 Patient Services Report here: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

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Drug Patent Watch

JUNE 7, 2024

Annual Drug Patent Expirations for ILEVRO Ilevro is a drug marketed by Harrow Eye and is included in one NDA. It is available from two suppliers.

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Reprocell

JUNE 7, 2024

Discover how functional genomics is transforming IBD treatment with groundbreaking research on ETS2's role in inflammation.

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Treatment Disease Research Drugs 59

ASPET

JUNE 7, 2024

While acute inflammation serves essential functions in maintaining tissue homeostasis, chronic inflammation is causally linked to many diseases. Macrophages are a major cell-type that orchestrates inflammatory processes. During inflammation, macrophages undergo polarization and activation, thereby mobilizing pro-inflammatory and anti-inflammatory transcriptional programs that regulate ensuing macrophage functions.

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Regulations Disease Production 40

Agency IQ

JUNE 7, 2024

The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked. Since the passage of the Dietary Supplement Health and Education Act (DSHEA) 30 years ago, the U.S. dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Over the years, the retroactive structure of DSHEA has encouraged the influx of bad actors who have identified the dietary supplement sector as a venue for the introduction of unapproved drugs i

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ASPET

JUNE 7, 2024

Beta-adrenergic receptors (β-AR) are expressed on the membranes of various cell types and their activation affects body water balance by modulating renal sodium and water excretion, cardiovascular function and metabolic processes. However, β-AR-associated body fluid imbalance has not been well characterised. In the present study, we hypothesized that chronic β-AR stimulation increases electrolyte and water content at the tissue level.

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Agency IQ

JUNE 7, 2024

FDA’s new guidance explains what to do during a BIMO inspection Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. After a Congressional directive, the agency has now released new draft guidance on the processes and practices on BIMO inspections. The new draft guidance comes as there is a major overhaul of the Office of Regulatory Affairs (ORA) in the works, and new authorities on Remote Regulatory Assessments (RRAs) are being implemen

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