Fierce Pharma
MAY 6, 2024
As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.
MedCity News
MAY 5, 2024
Mass General Brigham researchers conducted a study to learn more about the efficacy of large language models when used to draft responses to patient messages in the EHR. The results showed that these AI tools can do a good job at reducing physicians’ workloads and improving patient education — but also that these tools have limitations that require human oversight.
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MedCity News
MAY 1, 2024
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.
Pharmaceutical Technology
MAY 1, 2024
AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.
Clarivate
MAY 1, 2024
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.
PharmaVoice
MAY 1, 2024
The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 3, 2024
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.
pharmaphorum
MAY 3, 2024
Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim
European Pharmaceutical Review
MAY 2, 2024
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.
Fierce Pharma
MAY 6, 2024
“Our next question will come from Andrew Baum with Citi.” | Citi analyst Andrew Baum, after covering Pfizer for more than a decade, will join the Big Pharma company as chief strategy and innovation officer. In the role, he'll oversee the drugmaker's portfolio management and business development activities.
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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.
MedCity News
MAY 2, 2024
Mariana Oncology brings Novartis a lead radiopharmaceutical program in development for small cell lung cancer. The deal is the latest in a string of big pharma M&A moves in the red-hot radiopharmaceuticals space. The post Novartis Extends Its Reach in Radiopharmaceuticals With $1B Mariana Oncology Acquisition appeared first on MedCity News.
Copyright Clearance Center
MAY 2, 2024
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.
pharmaphorum
MAY 6, 2024
The Novo Nordisk Foundation, the Bill & Melinda Gates Foundation, and Wellcome have joined forces to tackle some of the most pressing threats to human health and wellbeing. The new initiative gets underway with $300 million in funding over three years earmarked for handling infectious diseases and antimicrobial resistance (AMR), addressing climate change, and raising our understanding of how nutrition can impact immunity, disease, and the development of children.
European Pharmaceutical Review
MAY 2, 2024
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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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
Fierce Pharma
MAY 1, 2024
Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. | Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. The company plans to sell products such as its COVID treatment Paxlovid and a migraine nasal spray in this way, it told the Financial Times.
MedCity News
MAY 6, 2024
Is a widened enforcement net squeezing physicians unfairly? That’s the belief of one high-profile author and health policy expert. The post Stark Law Crackdown Jacks Up Fines, Settlements and Physician Pressures appeared first on MedCity News.
Pharmaceutical Technology
MAY 2, 2024
From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.
pharmaphorum
MAY 3, 2024
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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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.
PharmaVoice
MAY 6, 2024
With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.
Fierce Pharma
MAY 1, 2024
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.
MedCity News
MAY 2, 2024
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.
European Pharmaceutical Review
MAY 6, 2024
New results from a Phase I/II clinical trial of a CRISPR/Cas9 gene editing therapy show that around 79 percent of patients with a rare form of inherited blindness experienced “measurable improvement”. The BRILLIANCE trial included 14 participants (12 adults and two children) who received an injection of EDIT-101 in one eye. These individuals had a form of Leber Congenital Amaurosis (LCA) caused by mutations in the centrosomal protein 290 (CEP290) gene.
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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.
pharmaphorum
MAY 6, 2024
Shah Capital has stepped up its campaign for change at vaccine producer Novavax, lobbying against the re-election of three directors and executive pay packages in a letter to fellow stockholders. The hedge fund says it wants to send a “strong and clear message” to the board at Novavax, reiterating the claim – first made a few weeks ago – that the company is “being hindered by an overly conservative board and management that clings to failed strategies.
Pharmaceutical Technology
MAY 3, 2024
The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.
Fierce Pharma
MAY 2, 2024
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
MedCity News
MAY 5, 2024
As we enter the digital era of healthcare at scale, we must redefine how we care for people … and how we evaluate that care. The post Opinion: Why PHTI’s Recent Assessment of Digital Diabetes Management Tools is Inadequate appeared first on MedCity News.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
European Pharmaceutical Review
MAY 1, 2024
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
pharmaphorum
MAY 1, 2024
The MHRA's regulatory sandbox for artificial intelligence as medical device technologies, AI-Airlock, will go live this spring, according to a new strategy document
Pharmaceutical Technology
MAY 3, 2024
Moderna reported a net loss of $1.2bn in the first quarter (Q1) of 2024, a stark contrast to its net income of $79m in Q1 2023.
Fierce Pharma
MAY 2, 2024
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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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.
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