Sat.Aug 31, 2024 - Fri.Sep 06, 2024

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Digital Transformation in Healthcare: Mastering Efficiency and Innovation

Pharma IQ

Explore how digital transformation, particularly cloud technology and AI enhances efficiency and patient outcomes.

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AstraZeneca staffers detained in China over patient data collection, drug imports: Bloomberg

Fierce Pharma

AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.

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The Life Sciences Generative AI Council and a sustainable technological future

pharmaphorum

Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.

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With Direct-to-Patient Zepbound, Eli Lilly Takes a Stand Against Compounders and PBMs

MedCity News

Eli Lilly now offers vials of obesity medication Zepbound directly to self-pay patients at a nearly 50% discount off the drug’s list price. But more than offering patients a lower-cost alternative, this move represents a strategic stance against certain pharmaceutical industry players. The post With Direct-to-Patient Zepbound, Eli Lilly Takes a Stand Against Compounders and PBMs appeared first on MedCity News.

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

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HDA 2024 Traceability Seminar: Best Practices Amid the Forthcoming Stabilization Period

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.

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In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

Fierce Pharma

Late last year, Novo Nordisk responded to a growing shortage of popular Ozempic with a plan to cut down on production of its older diabetes med Victoza to make room for more Ozempic. | The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.

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Can AI Help Fix Our Demographic Time Bomb?

MedCity News

By 2030, the U.S. expects shortages of 200,000 nurses and 124,000 physicians snd similar shortages are already being felt in the U.K. and elsewhere. Here’s how to build and train a modern healthcare workforce in the age of AI The post Can AI Help Fix Our Demographic Time Bomb? appeared first on MedCity News.

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HDA 2024 Traceability Seminar: Legal Advice for DSCSA Compliance Teams

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

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J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysis

Fierce Pharma

Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better chall | Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better challenge AstraZeneca’s Tagrisso.

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China detains AstraZeneca workers in data, imports probe

pharmaphorum

A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches

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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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What Challenges Do Implementing New Tech at a Hospital Pose?

MedCity News

Cyril Philip, vice president of digital health ventures with Bon Secours Mercy Health and digital ventures lead for Accrete Health Partners, is taking part in a panel discussion at INVEST Digital Health in Dallas on September 18. In response to emailed questions, he addressed some of these challenges. The post What Challenges Do Implementing New Tech at a Hospital Pose?

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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.

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GSK posts COPD win for Nucala as Sanofi-Regeneron rival Dupixent nears delayed FDA decision

Fierce Pharma

GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. | On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.

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Lykos CEO steps down after MDMA is rejected by FDA

pharmaphorum

The fallout from the FDA's recent decision not to approve Lykos Therapeutics' psychedelic treatment has spread to its senior management, with chief executive Amy Emerson stepping down.

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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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What Do Consumers and AI Think Of Omada Health?

MedCity News

Omada Health is a respected health tech company but what do customers see it? A flesh and blood and an AI analysis follows. The post What Do Consumers and AI Think Of Omada Health? appeared first on MedCity News.

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Web of Science Research Assistant elevates discovery with responsible AI

Clarivate

The Web of Science Research Assistant, a generative AI-powered tool built with and for researchers, is now available to the global research community. After extensive collaboration and testing with the research community that began in December 2023, we are pleased to announce the global launch of the Web of Science Research Assistant. The research assistant combines the power of generative artificial intelligence (AI), the Web of Science knowledge graph and an all-new chat interface to provide r

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Biogen to seek approval for high-dose version of SMA stalwart Spinraza after trial win

Fierce Pharma

Over the last decade, three blockbuster drugs—Biogen’s Spinraza, Roche’s Evrysdi and Novartis’ gene therapy Zolgensma—have transformed the treatment landscape for spinal muscular atrophy (SMA). | Biogen revealed that a portion of its phase 2/3 DEVOTE study met its primary endpoint, as a higher dose of Spinraza improved the motor function of treatment-naive infants with spinal muscular atrophy.

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Alnylam hails vutrisiran data, but investors seem sceptical

pharmaphorum

Alnylam Pharma has been riding high since revealing top-line results from its HELIOS-B trial of vutrisiran in transthyretin-mediated amyloidosis (ATTR) – but a look at the full data seems to have disappointed investors.Shares in the company retreated after the presentation of the results at the European Society of Cardiology (ESC) conference, which confirmed a 28% reduction in the primary endpoint of deaths from any cause and recurrent cardiovascular events after at least 33 months of follow-up.

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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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Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

MedCity News

The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The full approval comes nearly a year after the Travere drug narrowly missed the main goal of its confirmatory study. The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News.

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How to optimize efficiencies at site-centric clinical trials

Pharmaceutical Technology

By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.

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Astellas Gene Therapies to turn out the lights at South San Francisco production plant

Fierce Pharma

Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a Californ | Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a California production plant.

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Roche trumpets new fenebrutinib data in relapsing MS

pharmaphorum

Data from a phase 2 trial of Roche's oral BTK inhibitor fenebrutinib have shown "near-complete suppression" of disease activity and disability progression in relapsing multiple sclerosis (MS).The full results of the FENopta open-label extension study are due to be reported in full at the ECTRIMS congress in Copenhagen later this month, but top-line findings include that 99% of patients treated with fenebrutinib were free of T1 gadolinium-enhancing lesions, markers of active inflammation, at 48 w

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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MedCity FemFwd: Inside WHAM & KPMG’s Women’s Health Partnership

MedCity News

In this episode, we’re joined by Carolee Lee, CEO and founder of Women’s Health Access Matters (WHAM), and Ash Shehata, KPMG U.S. sector leader for healthcare. The two discuss WHAM and KPMG’s new partnership that aims to advance women’s health research and investment. The post MedCity FemFwd: Inside WHAM & KPMG’s Women’s Health Partnership appeared first on MedCity News.

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Novavax wins FDA emergency approval for updated Covid-19 vaccine

Pharmaceutical Technology

The US regulatory agency has also approved updated versions of Covid-19 vaccines from Moderna and Pfizer / BioNTech’s in the past two weeks.

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Cash-crunched ImmunityBio, on heels of FDA nod for Anktiva, lays off staffers

Fierce Pharma

With dwindling funds after a prior snub from the FDA, ImmunityBio’s journey to bag approval for its Merck-rivaling bladder cancer drug Anktiva wasn’t easy. | The drugmaker laid off 20 employees as it attempts to recoup from dwindling funds during its Anktiva launch in bladder cancer.

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Illumina avoids hefty EU fine over Grail merger

pharmaphorum

EU had no grounds to probe Illumina's takeover of Grail, says ECJ, but while spinoff has already taken place Illumina can now avoid a €432m fine

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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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Samsung Acquires AI-Powered Prenatal Ultrasound Startup

MedCity News

Samsung announced its plans to acquire French medtech startup Sonio. The startup’s AI platform, which was cleared by the FDA last year, automates ultrasound reporting so that healthcare providers can conduct these exams with greater accuracy and efficiency. The post Samsung Acquires AI-Powered Prenatal Ultrasound Startup appeared first on MedCity News.

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UAE MoHAP and Novo Nordisk partner for obesity management

Pharmaceutical Technology

The UAE has partnered with Novo Nordisk Pharma Gulf to develop a national scientific guide for obesity management and weight control.

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Glenmark joins growing list of drugmakers to settle long-running US price-fixing claims

Fierce Pharma

After handing over $30 million in criminal penalties last summer, Glenmark Pharmaceuticals has agreed to settle with the U.S. | Glenmark will pay the U.S. Department of Justice $25 million to resolve claims that it worked with other drugmakers to rig prices of the cholesterol med pravastatin. The case forms part of a larger antitrust probe implicating numerous manufacturers.

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Trial of Click's DTx for migraine sets up FDA filing

pharmaphorum

Click Therapeutics' digital therapeutic for migraine clears late-stage study using an endpoint used to test drugs, clearing the way for regulatory filing.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.