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Twelve people with type 1 diabetes who received an investigational off-the-shelf stem cell therapy were able to produce their own insulin and keep healthy blood glucose levels for at least one year, Vertex Pharmaceuticals said Friday. After three months, none of them suffered severe bouts of low blood sugar. After 12 months, out of the 12 participants, 10 no longer needed to inject insulin.
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Now that Gilead Sciences has won U.S. regulatory approval for its groundbreaking HIV prevention drug , the company has another hurdle to clear — ensuring the medicine can be accessed in low-income countries where the disease remains a stubborn problem. As far as Gilead is concerned, the groundwork exists to meet that goal. Last October, the drugmaker reached voluntary licensing agreements to eventually make lenacapavir available in 120 mostly low- and lower-middle-income countries.
A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.
Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.
The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.
NEC Corporation, in collaboration with Chugai Pharmaceutical, has conducted an experiment using artificial intelligence (AI) to predict drug combinations that may improve the effectiveness of certain cancer treatments. According to the companies, the AI system may reduce the time required to produce these predictions by approximately 50 per cent when compared to Chugai’s conventional methods.
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NEC Corporation, in collaboration with Chugai Pharmaceutical, has conducted an experiment using artificial intelligence (AI) to predict drug combinations that may improve the effectiveness of certain cancer treatments. According to the companies, the AI system may reduce the time required to produce these predictions by approximately 50 per cent when compared to Chugai’s conventional methods.
Subscribe Advertise About us Follow Follow Follow Follow GO Magazine PharmaTimes Magazine Archive Web Exclusives News Competitions Appointments Business Insights Webinars Thought Leadership Jobs eXmoor and Signadori Bio enter cell therapy partnership by Emily Kimber | 19th Jun 2025 | News Signadori is advancing a platform designed to overcome the challenges of treating solid cancers eXmoor Pharma and Signadori Bio have entered into a partnership aimed at advancing a gene-modified monocyte-derive
The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.
Most in a small group of patients receiving a stem cell-based infusion no longer needed insulin, but the drug may not suit those with more manageable type 1 diabetes.
As regulator prepares to approve lenacapavir in the US, campaigners are urging the manufacturer, Gilead, to make it ‘available and affordable for all who need it’ A drug with the potential to “end the HIV pandemic” will launch in the US this week – as a new study reveals it could be sold for 1,000 times less than its possible price tag. Lenacapavir, given as a twice-yearly injection, can prevent someone from being infected with HIV, according to clinical trial results.
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
As former chairs of the CDC’s Advisory Committee on Immunization Practices ( ACIP ), we are deeply alarmed by the growing politicization of vaccines — a public health innovation that has saved 154 million lives globally. While politicization of science is not new, the escalating distrust in science across the political spectrum, and its intrusion into the vaccine ecosystem, now threatens the very infrastructure that has long protected Americans from infectious diseases.
In a study published in Nature Machine Intelligence , researchers from the University of Sheffield, in collaboration with AstraZeneca and the University of Southampton, have developed a machine learning framework that demonstrates improved accuracy in inverse protein folding compared to existing methods. Inverse protein folding involves identifying amino acid sequences that form a desired 3D protein structure.
Prothena will cut 63% of its workforce and evaluate a “range of business options.” Elsewhere, Zealand revealed data for a dual-acting obesity drug and Biogen kicked off a new late-stage trial.
Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.
This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: What’s Next for Retail Pharmacy: Data, Debate, and Disruption. I’ll be joined by special guest Antonio Ciaccia, CEO of 46brooklyn Research, and President of 3 Axis Advisors. Click here to see the original post from April 2025. Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs.
LONDON — A U.K. health agency reiterated on Thursday that the limited benefits of a pair of new Alzheimer’s drugs do not justify their high prices, meaning the medicines won’t be made available through the National Health Service. The decision by the U.K.’s cost-effectiveness watchdog reflects how health authorities in different parts of the world have taken different approaches with the drugs, which are the first to have shown they can slow the progression of the dis
New medicines can transform the treatment and prevention of disease, improving – and in many cases saving – lives. But no health system has unlimited resources. This creates a political and technical challenge for governments and health systems which must decide which drugs to make available and to whom. Few areas of health policy are […] The post How new medicines become available on the NHS appeared first on The Pharmacist.
Supply chains for a new generation of therapies are complex, costly, and require meticulous management to ensure patient safety and regulatory compliance. AI can transform cell and gene therapy (CGT) orchestration by automating manual processes, improving productivity, enhancing supply chain visibility and improving scalability.
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.
This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here , and sign up for our morning biotech news roundup newsletter here. Hello all, I have a fresh double shot of espresso in hand, which I’m sure would please my colleague Ed Silverman , aka Pharmalot. BIO has been busy this year.
Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Whether it’s the hold time between filtration and filling, the location of EM plates, the frequency of visual inspection, or the number of media fill runs – decisions must be supported by documented rationale based on QRM (Quality Risk Management) princip
Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.
Subscribe Advertise About us Follow Follow Follow Follow GO Magazine PharmaTimes Magazine Archive Web Exclusives News Competitions Appointments Business Insights Webinars Thought Leadership Jobs FDA approves UroGen’s Zusduri to treat recurrent bladder cancer by Emily Kimber | 17th Jun 2025 | News Approximately 59,000 LG-IR-NMIBC patients experience recurrent disease every year in the US The US Food and Drug Administration (FDA) has approved UroGen Pharma’s Zusduri (mitomycin intravesical solutio
The intersection of artificial intelligence and pharmaceutical marketing is creating new waves of innovation. In 2025, AI generated marketing campaigns are no longer experimental. They are being deployed to personalize content, predict engagement, and automate outreach. But is the pharma industry truly ready to embrace these capabilities? Table of Contents What Are AI Generated Marketing Campaigns?
CHICAGO — Late-stage results of Novo Nordisk’s obesity candidate CagriSema suggest the drug is comparable to Eli Lilly’s Zepbound on safety and efficacy, further data indicating that CagriSema may not be the standout treatment that investors had hoped for. Novo previously reported that patients on CagriSema lost 20% of their weight in a 68-week Phase 3 trial when looking at all participants, a similar level of weight loss seen in Zepbound studies.
Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.
Gerresheimer, a systems and solutions provider for the pharmaceutical and biotech industry, has introduced a web-based product database designed to streamline the selection and registration of primary plastic packaging for medicinal products. By offering comprehensive and audit-proof documentation, the platform aims to simplify regulatory approvals and reduce time-to-market for pharmaceutical companies.
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