Sun.Sep 17, 2023

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Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

BioSpace

After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.

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Ophthalmology disorders and current developments of novel treatments under clinical trials

ProRelix Research

The rising prevalence of ophthalmology disorders such as dry eye disease (DED) and vision-related issues is largely related to the increasing use of mobile phones, tablet screens, and laptops. Since […] The post Ophthalmology disorders and current developments of novel treatments under clinical trials appeared first on ProRelix Research.

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The First Annual BioTechX USA: Blending Science and Technology

BioSpace

The first annual BioTechX USA, held in Santa Clara in September, bridged the communication gap by bringing together life sciences leaders in all areas of the industry.

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Hidden Fatal ECG Manifestations

JAMA Internal Medicine

This case report presents the electrocardiogram findings of a patient in their 50s with syncope and palpitation and amaurosis followed by loss of consciousness for several minutes without preceding position change, cough, chest pain, or shortness of breath.

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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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Despite Early Success, Karyopharm’s Selinexor Faces Uncertain Path to Expansion

BioSpace

While achieving FDA approvals in rare cancers such as multiple myeloma and diffuse large B-cell lymphoma, Karyopharm's cancer drug has a variety of scientific and market hurdles to clear.

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Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats

FDA Law Blog

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform. Now, in addition to engaging with FDA via Zoom, medical device sponsors can once again engage in in-person meetings with the Agency.

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Which pharma companies have the most supplementary protection certificates?

Drug Patent Watch

This chart shows the drug companies with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the… The post Which pharma companies have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.

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DOJ, Chamber of Commerce Tussle in Court Over IRA’s Drug Price Negotiations

BioSpace

The legal battle over the Inflation Reduction Act’s price negotiation program moved to federal court in Ohio with the Department of Justice and U.S. Chamber of Commerce sparring about the law.

Drugs 101
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Samsung Biologics Strikes $242M Manufacturing Deal with BMS for Cancer Antibody

BioSpace

The deal is an expansion of an existing production agreement between the companies and just one of several deals with large pharma companies that the Korean biotech has scooped up this year.

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FDA Action Alert: ARS Pharma, Appili, Ocuphire and BrainStorm

BioSpace

The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.

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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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As Impact of Substance Use Disorders Rise, so Do Innovative Solutions

BioSpace

From reversing overdose to blocking cravings, the biopharma industry is looking at a range of possible solutions to addiction.

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