Drug Discovery World

JUNE 21, 2024

Leriglitazone has been shown to halt disease progression in adult patients with early cerebral adrenoleukodystrophy (cALD) in a compassionate-use study. cALD is a fatal neurodegenerative disorder that is characterised by growing, demyelinating brain lesions, with death occurring typically within three to four years of onset. The study was led by Fanny Mochel, Professor at the Hôspital Universitaire La Pitié-Salpêtrière (Paris, France), as part of an early-access programme through the French nati

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BioPharma Drive: Drug Pricing

JUNE 21, 2024

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.

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Drug Discovery World

JUNE 21, 2024

Allogene Therapeutics and Foresight Diagnostics have announced the initiation of a Phase II trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line treatment regimen for newly diagnosed large B-cell lymphoma (LBCL) patients who are likely to relapse. The ALPHA3 trial will screen patients who are likely to relapse after first line treatment for enrolment in the trial by using the Foresight Clarity Investigational Use Only (IUO) measurable residual disease (MRD

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Drugs.com

JUNE 21, 2024

FRIDAY, JUNE 21, 2024 -- Both the World Health Organization and Eli Lilly Co. warned Thursday that consumers should avoid fake versions of weight-loss drugs that are circulating in numerous countries.The WHO warning said that the international.

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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 21, 2024

A preclinical study in cystic fibrosis sheep models has demonstrated that low doses of the ENaC blocker ETD001 can enhance airway mucus clearance with a long duration of action. The study indicates that ETD001, at a dose level that was well tolerated in healthy volunteers, provides an opportunity to test whether a long-acting ENaC blocker can deliver benefit to people with cystic fibrosis (pwCF).

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Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 -- A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key.

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Science Daily: Pharmacology News

JUNE 21, 2024

Meet SQUID, a new computational tool. Compared with other genomic AI models, SQUID is more consistent, reduces background noise, and can yield better predictions regarding critical mutations. The new system aims to bring scientists closer to their findings' true medical implications.

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Drug Discovery World

JUNE 21, 2024

A new machine learning (ML) software platform has been launched to facilitate wider adoption of advanced and adaptive clinical trials. The latest version of AdaptV includes an advanced mode to support more in-depth modifications of relevant algorithmic and statistical parameters that go into trial design, accounting for the unique characteristics of a specific trial.

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Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 -- They aren't exactly ready to open a jungle clinic, but new research suggests wild chimpanzees are practicing a kind of medicine.Fifty-one chimps living in two communities in Uganda appear to select edible plants.

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Science Daily: Pharmacology News

JUNE 21, 2024

Some 1,000 years ago, a small band of Polynesians sailed thousands of miles across the Pacific to settle one of the world's most isolated places -- a small, previously uninhabited island they named Rapa Nui. Eventually, their numbers ballooned to unsustainable levels, they wrecked the environment, and their civilization collapsed. At least that is the longtime story, told in academic studies and popular books.

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Clinical Trials

Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 -- For the fourth year in a row, rates of gun injuries stayed above levels seen before the pandemic, a new government report shows.Race played a key role in who saw those higher rates of gun violence in 2023, the researchers.

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Drug Channels

JUNE 21, 2024

This week, I’m rerunning some popular posts while I prepare for today's live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook. The webinar begins at 12:00 PM ET. Click here to see the original post from March 2024. Today’s guest post comes from Mark Cuban, co-founder of the Mark Cuban Cost Plus Drug Company A few weeks ago, Mark participated in the White House Roundtable on Lowering Healthcare Costs and Bringing Transparency to Prescription Drug Middlemen.

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Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 -- Everyday tasks like taking a shower or navigating stairs can be risky business for folks in the aftermath of a stroke.But grab bars, shower seats, ramps and other safety interventions allow many to live independently and.

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Drug Patent Watch

JUNE 21, 2024

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs. There are three patents protecting this compound. Drug patent litigation for DABIGATRAN ETEXILATE MESYLATE. Nine suppliers are listed for this compound.

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Clinical Trials

Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 -- A surgery that helps 7- to 10-year-olds with cerebral palsy walk also helps older kids and teens with the condition, a groundbreaking study shows."We had thought that the older kids would not do as well, but there was.

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Science Daily: Pharmacology News

JUNE 21, 2024

Fewer than one percent of people who get the flu every year get tested, in part because most tests require trained personnel and expensive equipment. Now researchers have developed a low-cost paper strip test that could allow more patients to find out which type of flu they have and get the right treatment. The test uses CRISPR to distinguish between the two main types of seasonal flu, influenza A and B, as well as seasonal flu subtypes H1N1 and H3N2.

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Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 — Can you trust your gut?UCLA researchers have shown that people who rank high in resilience -- meaning they accept change positively and follow their instincts -- have the bacteria living in their bellies in part to thank for.

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BioPharma Drive: Drug Pricing

JUNE 21, 2024

A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study. Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead.

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Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 -- The bacteria colonizing your bowels play a key part in your risk for infection, new research shows.A study of more than 600 people hospitalized with infections found their microbiomes had fewer bacteria that were able to.

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Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments.

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Science Daily: Pharmacology News

JUNE 21, 2024

Menthol sensing appeared long before cold sensing, suggesting distinct activation modes that can be disentangled, paving the way for new pain therapies without adverse thermal side effects.

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Agency IQ

JUNE 21, 2024

BY ALEXANDER GAFFNEY, MS, RAC This week, PETER MARKS, director of FDA’s Center for Biologics Evaluation and Research (CBER), spoke at several sessions of the Drug Information Association (DIA) annual meeting. AgencyIQ has the highlights, with new information on a “Rare Disease Hub” modeled as a sort of Center of Excellence for rare diseases. Fill out the form to read the full article.

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Drugs.com

JUNE 21, 2024

FRIDAY, June 21, 2024 -- Men looking to limit their odds for fatherhood probably have questions about vasectomy. They should steer clear of TikTok for answers, however.A new study examining the quality of the top 100 most liked videos on TikTok.

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Agency IQ

JUNE 21, 2024

BY WALKER LIVINGSTON, ESQ The Office of Information and Regulatory Affairs (OIRA) has just begun review of a proposed EPA rule that will likely add new effluent limitations guidelines, pretreatment standards and new source performance standards for PFAS to the Organic Chemicals, Plastics and Synthetic Fibers (OCPSF) point source category. The rule will likely be published in September.

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Collaborative Drug

JUNE 21, 2024

Burlingame, CA, June 21, 2024 — Collaborative Drug Discovery (CDD), a leading provider of data management solutions for the pharmaceutical and biotechnology industries, is pleased to announce the integration of iChemLabs' industry-leading IUPAC naming technologies into CDD Vault. This integration is facilitated through the licensing of the ChemDoodle Java Application Programming Interface (API), enhancing CDD Vault’s capabilities in cheminformatics and chemical structure analysis.

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Agency IQ

JUNE 21, 2024

BY LAURA DIANGELO, MPH Under the Federal Food, Drug and Cosmetic Act, facilities may not deny, delay or limit FDA inspections of facilities, or else the products they make may be considered adulterated. While this policy has been in place since 2012 for drug facilities, the same authority was only extended to FDA’s oversight of medical devices in 2017.

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Alta Sciences

JUNE 21, 2024

Simpler Clinical Development From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. At Altasciences, we connect the dots, so you don’t have to. With you in mind, we establish a clear and consistent path from drug discovery to delivery—one solution seamlessly connecting to the next.

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Agency IQ

JUNE 21, 2024

BY KIRSTEN MESSMER, PHD, RAC This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. This regulation provides the framework for implementing post-authorization changes, or “variations,” to a medicinal product, and the updates implement efficiencies and incorporate current regulatory practice used by the EMA and national regulators.

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Drug Patent Watch

JUNE 21, 2024

Annual Drug Patent Expirations for PEDMARK Pedmark is a drug marketed by Fennec Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. This drug has thirty-six patent family members in thirteen countries. The generic ingredient in PEDMARK is sodium thiosulfate.

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Agency IQ

JUNE 21, 2024

BY SCOTT STEPHENS, MPA ECHA’s committees for risk assessment (RAC) and socio-economic analysis (SEAC) met last week to continue work on developing opinions on the universal PFAS restriction proposal submitted in early 2023. New developments include the committees’ provisional evaluations on consumer uses of cosmetics and other mixtures, as well as industrial uses of metal plating and metal product manufacturing.

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Drug Patent Watch

JUNE 21, 2024

Annual Drug Patent Expirations for EPSOLAY Epsolay is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. This drug has twenty-eight patent family members in eleven countries. The generic ingredient in EPSOLAY is benzoyl peroxide.

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Perficient: Drug Development

JUNE 21, 2024

The saying “one size fits all,” absolutely does not apply to the healthcare industry. Consumers are flat out demanding a more tailored approach to their health care. To provide this type of more personalized and effective care and services, healthcare organizations (HCOs) need to take concentrated efforts to understand the diverse needs and preferences of their consumers.

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Drug Patent Watch

JUNE 21, 2024

Annual Drug Patent Expirations for BORTEZOMIB Bortezomib is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Mylan Labs Ltd, Pharmascience Inc, Qilu Pharm Hainan, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Waverley Pharma Inc, Zydus Pharms, and […] Source

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Perficient: Drug Development

JUNE 21, 2024

Six months ago, the Perficient team in Mexico contacted Tec Racing, the Formula SAE team at Monterrey Tec, to discuss a potential partnership as part of Perficient’s Electrifying the Future of Automotive Program. While the team was excited to partner, they were in the middle of a generational change. Their leaders were heading through their final semester and needed to focus on their assignments and graduation.

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