Trending Articles

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Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request'

Fierce Pharma

Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. | Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. Federal Trade Commission has teed up a further extension on the deal’s review period.

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Healthcare Is a Frontier Not Even Walmart Could Conquer  — And It’s Not Looking Great For Others Either

MedCity News

Walmart’s decision to shutter its healthcare division reflects just how difficult it is to achieve profitability in the primary care and telehealth markets. Experts think retailers simply aren’t prepared to handle the bevy of challenges that come along with delivering healthcare — but could this news also be a sign of the system being broken? The post Healthcare Is a Frontier Not Even Walmart Could Conquer — And It’s Not Looking Great For Others Either appeared first on MedCity News.

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Bristol Myers, Johnson & Johnson plot appeal after US judge dismisses IRA lawsuits

Fierce Pharma

Biopharma companies and industry lobbying groups are striking out in their legal efforts to challenge price-cutting measures in the Inflation Reduction Act. | A federal judge tossed lawsuits by Bristol Myers Squibb and Johnson & Johnson, which questioned the constitutionality of the U.S. government requiring drugmakers to negotiate with Medicare on drug pricing.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Beyond discovery: AI and the future of the Web of Science

Clarivate

Learn about our generative AI-powered Web of Science Research Assistant, which will be available from September 2024. Last year, we announced our collaboration with the research community to bring a new generative-AI-powered capability to the Web of Science — the Web of Science Research Assistant. Since we released the beta to our development partners around the world, we have identified innovative ways to ensure the quality, strength and suitability of generative AI for academic researchers.

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MHRA publishes strategy on AI regulation

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI). It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023. Following publication of this white paper, the government requested that the MHRA outline the steps the agency is working on in relation to its expectations.

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J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer

MedCity News

Enlaza Therapeutics’ drugs form covalent bonds that lock the therapy onto its target. With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. The post J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer appeared first on MedCity News.

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Angle signs AstraZeneca deal to develop prostate cancer assay

Pharmaceutical Technology

UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.

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CCC Wins Five Top Workplaces Culture Excellence Awards

Copyright Clearance Center

May 2, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announced today that it has earned five 2023 Top Workplaces Culture Excellence Awards from Energage LLC for Compensation & Benefits; Leadership; Work-Life Flexibility; Innovation; and Purpose & Values for the second consecutive year.

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What is the future of biologic medicines?

European Pharmaceutical Review

Recent developments in the biologic therapies sector include the authorisation of Pyzchiva ® (biosimilar ustekinumab) by the European Commission, and promising 12-month data for Roche’s subcutaneous injection of OCREVUS ® (ocrelizumab) for relapsing or primary progressive multiple sclerosis. The biologics market is expected to continue its fast growth despite the slowdown in funding observed in the past year.

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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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Emergent BioSolutions to cut 300 employees, shutter 2 facilities in restructuring launched under new CEO

Fierce Pharma

Just about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. | Merely about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. And it involves a major organizational restructuring.

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How ACOs Can Harness AI’s Transformative Potential

MedCity News

Strategies for building the datasets needed for ACOs to take advantage of artificial intelligence, manage costs and improve outcomes for all The post How ACOs Can Harness AI’s Transformative Potential appeared first on MedCity News.

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ESCMID 2024: Using AI in infection prevention and control

Pharmaceutical Technology

Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.

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The Relationship Between Cold Chain Logistics and Cell & Gene Therapies

Pharmaceutical Commerce

A one-on-one with Thermo Fisher’s Wilfredo Marin, who dives into the value of ultra-low temperature storage, the need for flexibility in the cold chain logistics space, and more.

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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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Walmart retreats from healthcare, closing clinics across US

pharmaphorum

For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and telehealth services. Now, it is reining back on those plans.

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Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run

Fierce Pharma

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

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Navigating the Transition to Value-Based Care: Addressing Fears and Embracing Risk in ACO REACH

MedCity News

Offering blended options, individual risk pools, and net neutral capitation payments providers can embark on their journey toward value-based care at a pace aligned with their tolerance and readiness. The post Navigating the Transition to Value-Based Care: Addressing Fears and Embracing Risk in ACO REACH appeared first on MedCity News.

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The top pharmaceutical companies by R&D expenditure

Pharmaceutical Technology

From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.

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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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Enhancing medicine manufacturing through digitalisation

European Pharmaceutical Review

By providing pharma companies with a real-life replicable model of a cloud-first manufacturing facility, we will drive forward the digital capability of pharma manufacturers” A new digital collaboration is set to take advantage of a manufacturing facility model featuring innovative technologies, accelerating how fast new medicines are made. The Centre for Process Innovation (CPI), academia, and the pharma industry will work together to develop the model which will harness artificial intell

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Boehringer will use Walgreens trials unit for obesity trial

pharmaphorum

Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim

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Facing pricing pressure from Lilly's Zepbound, Novo Nordisk scales Wegovy supply

Fierce Pharma

Novo Nordisk is facing fierce competition from Eli Lilly’s obesity rival Zepbound, which has shaken up U.S. pricing dynamics for the Danish company's popular GLP-1 drug. | Novo Nordisk is facing fierce competition from Eli Lilly’s obesity rival Zepbound, which has shaken up U.S. pricing dynamics for the Danish company's popular GLP-1 drug.

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An Ohio Pharmacy Was Fined $250K. It Represents Everything Wrong With the Prescription Drug Industry.

MedCity News

We must realign the financial incentives and democratize access through data sharing. Pharma needs to lead the charge, but employers and pharmacies must also be agents of change. Here’s how we can do it. The post An Ohio Pharmacy Was Fined $250K. It Represents Everything Wrong With the Prescription Drug Industry. appeared first on MedCity News.

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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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FDA grants RMAT designation to Taysha’s Rett syndrome gene therapy 

Pharmaceutical Technology

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

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AbbVie breaks ground on new R&D centre

European Pharmaceutical Review

A new state-of-the-art research and laboratory building is being built on AbbVie’s main campus at its Rhineland-Palatinate site, the company ’s second largest research and development ( R&D ) location globally. The central research building LUdwighafens neue Arbeitswelt (LUnA) will benefit from an investment of approximately €150 million. Currently, the Rhineland-Palatinate site has over 2,000 employees, and LUnA will house over 300 researchers and scientists, according to AbbVie.

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Merck, Huma alliance bears fruit with UK bladder cancer app

pharmaphorum

A partnership between Huma Therapeutics and Merck KGaA to develop digital support tools for cancer patients has borne fruit with the launch of a bladder cancer app in the UK

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Moderna gears up for potential RSV vaccine launch this fall after better-than-expected first quarter

Fierce Pharma

With Moderna’s COVID-19 sales on the backfoot following the switch to an endemic vaccine market, the Massachusetts-based biopharma is busy laying the groundwork for its next potential mRNA shot in | Moderna currently expects initial approvals of its RSV vaccine to start rolling in during the first half of 2024, the company said Thursday. In turn, the company is eyeing a potential U.S. launch in the fall, which would capitalize on its established commercial efforts in the seasonal COVID-19 immuni

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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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Experts Aren’t Surprised About Optum Closing Its Virtual Care Business

MedCity News

Optum is shutting down its virtual care unit after a three-year run. Industry experts agree that the closure reflects broader trends in the telehealth market, in which saturation and differentiation challenges are leading some providers to struggle. The post Experts Aren’t Surprised About Optum Closing Its Virtual Care Business appeared first on MedCity News.

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ESCMID 2024: The infectious consequences of climate change

Pharmaceutical Technology

Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.

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CHMP meeting highlights: April 2024

European Pharmaceutical Review

The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines. A positive opinion of a marketing authorisation was granted for Altuvoct (efanesoctocog alfa), as a treatment and prophylaxis of bleeding in patients with the rare blood disorder haemophilia A. Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B.

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Apple gets FDA okay to use AFib tool in clinical trials

pharmaphorum

Apple gets FDA okay to use the atrial fibrillation history tool incorporated in some of its Apple Watch devices in clinical trials

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.