November, 2024

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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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Wearable Health Tech: Innovations and Impacts on Chronic Disease Management

MedCity News

Wearable devices, such as a glucose meter device or a defibrillator and pacemaker, can provide valuable and real-time information to a healthcare provider so that decisions can be made to protect the patient. The post Wearable Health Tech: Innovations and Impacts on Chronic Disease Management appeared first on MedCity News.

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Eisai dials back forecasts for Alzheimer's drug Leqembi

pharmaphorum

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

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Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals

PharmaVoice

A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Digital transformation expected to shorten drug development timelines

Pharmaceutical Technology

Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.

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Accelerating Discovery and Development with Advances in High-Throughput Screening

PharmaTech

Automation, miniaturization, and new software algorithms are improving throughput and accuracy.

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More Trending

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This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths

MedCity News

Endoscopy, the standard for detecting esophageal precancer, is quite an invasive procedure — so a lot of people who should be screened end up never being tested. Lucid Diagnostics is trying to solve this problem by selling a quick, office-based diagnostic. The post This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths appeared first on MedCity News.

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XRHealth buys NeuroReality in health XR marriage

pharmaphorum

Two players in medical extended reality (XR) – XRHealth and NeuroReality – have come together in a quest to build the biggest company in the sector.Boston, US-based XRHealth is leading the deal, acquiring NeuroReality of the Netherlands for an undisclosed sum, combining their products and expertise in the use of XR and virtual reality software for healthcare applications.

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CEO with type 1 diabetes works to deliver ‘world’s first’ functional cure

PharmaVoice

Sernova’s technology helped type 1 diabetes patients achieve insulin independence in early- and mid-stage trials.

Patients 124
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Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat

Pharmaceutical Technology

The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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IVIG Demonstrates Effectiveness in Several Neuroimmune Conditions, Indicating Potential for Long COVID Treatment

Pharmacy Times

Intravenous immunoglobulin (IVIG) has proven efficacy in autoimmune neuropathies, with mixed but promising outcomes in severe COVID-19 cases and post-acute sequelae of SARS-CoV-2 infection trials.

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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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Synapticure Secures $25M To Scale Virtual Care for Neurodegenerative Diseases

MedCity News

Synapticure’s Series A round was led by B Capital and included participation from CommonSpirit Health, CVS Health Ventures and RA Capital. The post Synapticure Secures $25M To Scale Virtual Care for Neurodegenerative Diseases appeared first on MedCity News.

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AZ shares weaken as China investigation rumours swirl

pharmaphorum

AstraZeneca's shares have fallen more than 8% on speculation about an anti-corruption probe in China, its second-largest market, wiping around $14 billion off its value.The sell-off appears to have been prompted by an article in Chinese financial media outlet Yicai which suggested that "dozens of senior executives" at AZ's Chinese subsidiary have been implicated in an ongoing insurance fraud case.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Spravato is just the beginning in a new wave of depression meds

PharmaVoice

Psychiatry is getting more targeted as drugmakers develop a new range of treatments for depression.

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UK Government to launch first ever men’s health strategy

Pharmaceutical Technology

The government said that men are less likely than women to seek medical help, particularly for mental health issues.

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Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years

Pharmacy Times

ASHP investigators determined the severity and impact of ongoing drug shortages, with approximately 99% of respondents reporting that they experienced a shortage.

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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

Safety 328
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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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AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges? 

MedCity News

Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise. The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges? appeared first on MedCity News.

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Aignostics leads latest crop of digital health financings

pharmaphorum

Recent funding rounds in the digital health arena feature digital pathology startup Aignostics, remote care specialists TCC, Yazen Health, and Nema Health, wearables developer Alimetry, and clinical trial automation startup Research Grid.Digital pathology specialist Aignostics, which develops artificial intelligence algorithms to glean information from medical images and combine it with epidemiological, clinical, and genomic data, has completed a $34 million Series B financing.

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

Medicine 104
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EMA launches ESMP for better management of drug shortages in EU

Pharmaceutical Technology

The ESMP platform enables marketing authorisation holders to report shortages and will be mandatory from 2025.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Clinical Safety Data Show Switching Between Rituximab Biosimilars Does Not Increase Adverse Events

Pharmacy Times

There were 2 main types of switches, including switching to rituximab subcutaneous and switching among different intravenous rituximab treatments.

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Novavax coughs up $123.8M to settle COVID vaccine supply dispute with UK

Fierce Pharma

Novavax has inked another settlement for a past COVID-19 vaccine supply deal. | Novavax has inked another settlement for a past COVID-19 vaccine supply deal. The Maryland biotech has agreed to pay $123.8 million to end a COVID vaccine supply pact with the U.K.

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How 3 Health Systems Are Scaling Hybrid & Home-Based Models

MedCity News

Leaders from three health systems — Providence, OSF HealthCare and UMass Memorial Health — detailed how their organizations are maximizing hybrid and home-based care models during a recent panel. The post How 3 Health Systems Are Scaling Hybrid & Home-Based Models appeared first on MedCity News.

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Journey slips on FDA approval of rosacea therapy

pharmaphorum

Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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What RFK Jr.’s influence could mean for pharma

PharmaVoice

Past comments hint at the changes Robert F. Kennedy Jr. could make across the various sectors of healthcare.

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GSK CEO addresses declining trust in vaccines following Trump re-election

Pharmaceutical Technology

GSK CEO Emma Walmsley said the sector would need to wait to see who is appointed in key roles in the Trump administration to gauge impact.

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Semaglutide Improves Liver Fibrosis in Patients with Metabolic Dysfunction-Associated Steatohepatitis

Pharmacy Times

Glucagon-like peptide-1 agonists have increasingly showed potential for treating liver fibrosis in patients, which disproportionately affects those who are overweight or have obesity.

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Jazz's HER2 bispecific snags FDA nod, teeing up showdown with AZ and Daiichi's Enhertu

Fierce Pharma

A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate Enhertu | A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star ADC Enhertu.

FDA 321
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten