Mon.Sep 04, 2023

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How Will Generative AI Change the Role of Clinicians In the Next 10 Years?

MedCity News

A new report predicted that generative AI tools will increasingly streamline many aspects of a clinician’s day in the next five to 10 years — and that this is particularly true for tools that can automate diagnoses and respond to patients’ questions.

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NICE recommends new Fabry disease treatment

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) has recommended Chiesi’s Elfabrio ® (pegunigalsidase alfa) for Fabry disease (alpha-galactosidase deficiency) in adults. A new Fabry disease treatment The agreement made in the NICE’s Final Draft Guidance means there is now a “new treatment option for people living with Fabry disease across England,” according to Dr Kamran Iqbal, Head of Medical Affairs for Global Rare Diseases at Chiesi UK&I. “Fabry disease brings a mu

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5 Foundational Capabilities Needed for Implementing a Value-Based Care Program

MedCity News

Apprehension among practices and providers is understandable, given the complexity and variance of VBC contracts. However, instead of feeling overwhelmed and burdened by VBC, practices can slowly embrace these concepts by leveraging the many tools they already have in place or that exist in the healthcare ecosystem.

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FTC order could ease biopharma competition

European Pharmaceutical Review

According to the US Federal Trade Commission (FTC), Amgen is to be barred from leveraging its drug portfolio to disadvantage its industry competitors. The biopharma company will be required to seek prior approval before acquiring related products. The FTC has settled on a proposed consent order with Amgen Inc. to address the potential competitive harm Amgen’s $27.8 billion acquisition of Horizon Therapeutics plc could bring.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Taming the Healthcare Data Beast: Conquering Complexity for Better Care

MedCity News

By following these foundational data best practices, healthcare organizations will harness the power of their data to provide superior patient care while safeguarding patient privacy and compliance.

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European Pharmaceutical Review Issue 4 2023

European Pharmaceutical Review

Included in Issue 4 of European Pharmaceutical Review : FOREWORD Dissolution testing – a dual role David Elder, David P Elder Consultancy REGULATORY INSIGHT EU packaging reform: a prescription for change? Maciej Adamczyk and Monika Pyzio-Michalik, DBS Law Firm EVENT PREVIEW Modern methods in microbiology and analytics PharmaLab Congress DRUG DELIVERY Dry powder delivery to the lungs Jnanadeva Bhat, ACG EVENT PREVIEW CPHI Barcelona 2023: what to expect Featuring company profiles from BioSpectra,

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iNtRON wins US Army contract to develop bacteriophages for E.coli infections

Pharmaceutical Technology

iNtRON's contract is part of the US Army’s DEVCOM strategy to develop drugs to treat antibiotic-resistant UTIs.

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US Prescription Drug Costs More Than Double Those in Canada [Sponsored]

MedCity News

Increasingly, patients in the U.S. look to Canada for more affordable prescription options since the Canadian government regulates drug costs. Some companies have noticed and are beginning to capitalize on the demand.

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Chiesi’s Elfabrio receives NICE recommendation

PharmaTimes

The therapy has been developed for the treatment of Fabry disease among adult patients - News - PharmaTimes

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Report: About Half of MA Beneficiaries Leave Their Plan After 5 Years

MedCity News

After five years of enrolling in a Medicare Advantage plan, 48.3% of non-dually enrolled beneficiaries left their contract and 53.4% of dually enrolled beneficiaries did, a new study found.

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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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Marketing authorisation for AbbVie’s Aquipta

PharmaTimes

The therapy has been developed for the treatment of migraine among adults - News - PharmaTimes

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Twice Rejected Diabetes Drug/Device Product Gets New Chance at Startup i2O

MedCity News

Intarcia Therapeutics’ GLP-1 agonist product candidate for type 2 diabetes now belongs to i2O Therapeutics, which will make the treatment’s case for approval at an upcoming FDA advisory committee meeting. The startup’s $46 million Series A financing is one of several recently announced funding rounds.

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Japan accepts GSK’s Nucala application to treat rhinosinusitis for review

Pharmaceutical Technology

The Japanese MHLW has accepted GSK’s supplementary new drug application (sJNDA) for Nucala (mepolizumab) to treat chronic rhinosinusitis

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CCC and GO FAIR Foundation Plan FAIR Forum in September

Copyright Clearance Center

CCC, a leader in advancing copyright, accelerating knowledge, and powering innovation, in partnership with the GO FAIR Foundation, will host its inaugural FAIR Forum on ‘The Evolving Role of Data in the AI Era' on 18 September at Poortgebouw, the University of Leiden, the Netherlands.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Advanced Methodology of PLGA Parenteral Formulations

PharmaTech

This executive summary highlights strategies that can be used to maximize long-acting parenteral formulations using nanoparticles, microspheres and in-situ forming gels.

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Best of VOC: And The Oscar Goes To… ChatGPT?

Copyright Clearance Center

Writers in Hollywood are the latest to declare concerns that technology based in powerful artificial intelligence tools may jeopardize their livelihoods.

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Centogene finds diagnostic and predictive biomarker for Gaucher disease

Pharmaceutical Technology

The company published a study showing lyso-Gb1 (glucosylsphingosine) as a diagnostic and predictive biomarker for the rare metabolic disease.

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Adapting to Demand: The Importance of Flexibility in HPAPI Small-Batch Manufacturing

PharmaTech

Webinar Date/Time: Thursday, October 12, 2023 at 11am EDT | 4pm BST | 5pm CEST

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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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Bidco to acquire biopharmaceutical services company Ergomed

Pharmaceutical Technology

Bidco has signed an agreement to acquire British biopharmaceutical services company Ergomed in a deal valued at about GBP703.1m ($884.79m).

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A bioanalytical discovery strategy for fast and flexible decision making

PharmaTech

Webinar Date/Time: Wed, Oct 11, 2023 11:00 AM EDT

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Biocon Generics purchases Eywa’s manufacturing facility in US

Pharmaceutical Technology

Biocon Generics has purchased the US-based oral solid dosage manufacturing facility of Eywa Pharma for a total consideration of $7.7m.

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Amgen and Horizon Therapeutics settle FTC lawsuit

Pharmaceutical Technology

Amgen and Horizon Therapeutics have reached a consent order agreement with the FTC to resolve the ongoing administrative lawsuit.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Signal: UK clinical research provider Ergomed bought out in $888m deal

Pharmaceutical Technology

Private Equity firm Permira has announced that it is taking the company private, following many other UK firms.

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Minimal impact expected for first ten drugs released for Medicare price negotiation

Pharmaceutical Technology

The Biden Administration has released the anticipated list of ten drugs selected for Medicare price negotiations under the IRA.