Drug Discovery World

JUNE 28, 2024

A new Phase II trial, REGENERATE-PD, will study AB-1005, an adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy for the treatment of moderate-stage Parkinson’s disease. The trial will include an estimated 87 subjects with study sites located in the US, UK and Europe. In January, AskBio announced that the Phase Ib trial of AB-1005 met its primary endpoint, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putam

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Drugs.com

JUNE 28, 2024

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.

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Drug Discovery World

JUNE 28, 2024

News round-up for 24-28 June by DDW Senior Digital Content Editor Diana Spencer. This week has seen some exciting advances in neuroscience drug discovery, including Phase II clinical trials for two potentially game-changing treatments, a synapse-regenerating drug for Alzheimer’s and a gene therapy for Parkinson’s, as well as the launch of DDW’s latest In Focus report.

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Science Daily: Pharmacology News

JUNE 28, 2024

A recent discovery by NASA's James Webb Space Telescope (JWST) confirmed that luminous, very red objects previously detected in the early universe upend conventional thinking about the origins and evolution of galaxies and their supermassive black holes.

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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 28, 2024

Download this In Focus eReport to learn more about the drug discovery innovation and advancement taking place in this field. The eReport includes: A global market overview including prevalence, value and future outlook A scientific article on developing therapeutics targeting biomolecular condensates An interview with ApconiX’s Director and Co-founder, Professor Ruth Roberts, and Scientific Lead, Kimberly Rockley An exploration of the new frontiers in neuroscience The post Neuroscience: Advances

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Research Marketing Drugs 130

Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 20204 (HealthDay news) -- An immunotherapy/chemotherapy combo drug can help early-stage breast cancer patients remain cancer-free following treatment, a new trial shows. The combo drug, Kadcyla, is already approved to treat.

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Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- The U.S. Supreme Court on Thursday struck down a controversial settlement that drug maker Purdue Pharma had reached with victims of the opioid epidemic.The ruling threatens a massive bankruptcy plan that would have.

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Drugs 106

Perficient: Drug Development

JUNE 28, 2024

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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Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- A new "microrobot" pill may help tame inflammatory bowel disease (IBD), a new study in mice suggests.The pill significantly reduced IBD symptoms in mice and promoted the healing of damaged colon tissue without toxic side.

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Disease 101

Science Daily: Pharmacology News

JUNE 28, 2024

A new study has produced supranormal hearing in mice, while also supporting a hypothesis on the cause of hidden hearing loss in people.

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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.

Clinical Trials

Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- The U.S. Food and Drug Administration has sent a warning letter to one of America's biggest bakeries, asking the company to stop claiming there are allergens such as sesame or nuts in products when in fact they are not.

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Production FDA Drugs 101

Science Daily: Pharmacology News

JUNE 28, 2024

An international team of researchers combine orbital imagery with seismological data from NASA's Mars InSight lander to derive a new impact rate for meteorite strikes on Mars. Seismology also offers a new tool for determining the density of Mars' craters and the age of different regions of a planet.

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Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- Scientists have documented the first case of Down syndrome in Neanderthals, a finding which also supports the notion that these cousins of modern man were capable of providing care and support to a vulnerable member of.

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Science Daily: Pharmacology News

JUNE 28, 2024

The Coral Triangle, also known as the Indo-Australian Archipelago, is renowned for having the greatest marine biodiversity on our planet. Despite its importance, the detailed evolutionary history of this biodiversity hotspot has remained largely a mystery. An international research team has now shed light on this history, reconstructing how biodiversity in the region has developed over the past 40 million years.

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International Research 90

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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

Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 20204 (HealthDay news) -- An immunotherapy/chemotherapy combo drug can help early-stage breast cancer patients remain cancer-free following treatment, a new trial shows.The combo drug, Kadcyla, is already approved to treat patients.

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Drugs Trials Treatment 97

Science Daily: Pharmacology News

JUNE 28, 2024

Researchers developed a new wireless receiver that can block strong interference signals at the earliest opportunity, which could improve the performance of a mobile device.

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Research 81

Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- Specific types of gut bacteria appear to be linked to compulsive eating, a new study reports.Researchers found that one type of gut bacteria -- the Proteobacteria family -- is abundant in people and mice with an addiction.

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BioPharma Drive: Drug Pricing

JUNE 28, 2024

Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

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Regulations FDA 80

Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- The spread of H5N1 avian flu to dairy cows has health experts and many Americans on edge, and now a new study finds the virus stays viable on milking equipment for at least an hour.“Dairy cows have to be milked even if they.

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Virus 95

Science Daily: Pharmacology News

JUNE 28, 2024

A team of researchers has developed a soft, stretchy electronic device capable of simulating the feeling of pressure or vibration when worn on the skin. This device represents a step towards creating haptic technologies that can reproduce a more varied and realistic range of touch sensations for applications such as virtual reality, medical prosthetics and wearable technology.

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Research 78

Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- Heart valve disease is much more common in aging adults that has been thought, a new study warns.More than a quarter of healthy and symptom-free people aged 60 and older had previously undetected heart valve disease.

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Disease 95

Science Daily: Pharmacology News

JUNE 28, 2024

Atmospheric scientists predict that unchecked carbon emissions will force tropical rains to shift northward in the coming decades, which would profoundly impact agriculture and economies near the Earth's equator. The northward rain shift would be spurred by carbon emissions that influence the formation of the intertropical convergence zones that are essentially atmospheric engines that drive about a third of the world's precipitation.

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Engineering 70

Chemical Biology and Drug Design

JUNE 28, 2024

Cover Image © molekuul_be/Shutterstock.

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Science Daily: Pharmacology News

JUNE 28, 2024

Hydrothermal vents can be found around the world at the junctions of drifting tectonic plates. But there are many hydrothermal fields still to be discovered. During a 2022 expedition of the MARIA S. MERIAN, the first field of hydrothermal vents on the 500-kilometer-long Knipovich Ridge off the coast of Svalbard was discovered.

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BioPharma Drive: Drug Pricing

JUNE 28, 2024

Advisers to the agency unanimously recommended use of Capvaxive in older adults and in certain younger ones, putting it in the same tier as Pfizer's competing Prevnar shot.

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Vaccine 64

Science Daily: Pharmacology News

JUNE 28, 2024

Bringing us one step closer to solving the 'missing satellites problem,' researchers have discovered two new satellite galaxies.

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Research 81

BioPharma Drive: Drug Pricing

JUNE 28, 2024

European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.

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Biosimilars Regulations Drugs Disease 64

Drug Patent Watch

JUNE 28, 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.

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Drugs Marketing 59

BioPharma Drive: Drug Pricing

JUNE 28, 2024

The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.

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Therapies FDA 70

Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for RINVOQ Rinvoq is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. There are thirty-three patents protecting this drug.

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Drugs Marketing 59

Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 20204 (HealthDay news) -- An immunotherapy/chemotherapy combo drug can help early-stage breast cancer patients remain cancer-free following treatment, a new trial shows. The combo drug, Kadcyla, is already approved to treat.

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Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for XYWAV Xywav is a drug marketed by Jazz and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug.

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Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH The FDA has just unveiled its long-awaited draft guidance on diversity action plans. The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for MOVANTIK Movantik is a drug marketed by Valinor and is included in one NDA. It is available from three suppliers.

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