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It’s easy to feel as though you’re doing something wrong these days if you don’t know your VO 2 -Max and how many hours of REM sleep you get each night, or if you’re not taking a dozen different supplements and scrutinizing every morsel of food that makes its way into your mouth. “Biohackers” and other longevity seekers — with their many podcasts, YouTube channels, and X accounts — would have you believe that if you diligently measure your
By Dr. Naomi Lowy, Principal Drug Regulatory Expert FDA recently announced, CEO Forums: An FDA Listening Tour to Engage Pharma CEOs. These are scheduled to take place in several cities on both coasts in June and July (Link here). This tour to engage with pharmaceutical and biotech CEOs is unprecedented. According to the announcement, Commissioner Makary will be holding these along with Principal Deputy Commissioner Sara Brenner, M.D., M.P.H and Director of FDAs Center for Biologics Evaluation a
This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here. We’re back on this Tuesday — hope you had a good Memorial Day weekend! This Friday at 10:55 a.m. ET, I’ll be participating (virtually) on a panel run by the National Academies of Sciences, Engineering, and Medicine. We’ll be talking about all things Medicare Advantage.
Cadila Pharmaceuticals has launched Empadon (Empagliflozin), marking its foray into the transformative SGLT2 inhibitor therapy space. The SGLT2 inhibitor class, with Empagliflozin at its forefront, has emerged as a cornerstone in the management of Type 2 Diabetes Mellitus (T2DM), Cardiovascular Disease (CVD), and Chronic Kidney Disease (CKD). With the recent expiry of Empagliflozins patent, the landscape is ripe for expanding access to this game-changing therapy.
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 Royal Marsden, a world-leading cancer research centre, has launched a large-scale, AI-powered radiology platform designed to accelerate cancer detection and treatment using medical imaging. This marks a major milestone in the application of AI for cancer research. The technology will develop and evaluate AI algorithms to improve the accuracy of cancer evaluation, including sarcoma, […] The post The Royal Marsden launches AI radiology platform to revolutionise cancer care appeared first
The Committee for Medicinal Products for Human Use (CHMP) has recommended ten medicines for approval in its latest meeting. The committee recommended authorisation of three cancer medicines. The first, aconditional approval of Aucatzyl (obecabtagene autoleucel), to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia. Blenrep (belantamab mafodotin), a treatment for relapsed or refractory multiple myeloma was also granted a positive opinion.
"The Patent Paradox: How Paragraph IV Challenges Are Disrupting the Pharmaceutical Industry As the pharmaceutical landscape continues to evolve, one thing is clear: the rules of the game have changed. Paragraph IV challenges, once a rare occurrence, have become a staple of the industry, with 2022 seeing a record number of filings. But what do these challenges mean for pharma executives, and how can they navigate this complex landscape to protect their intellectual property and stay ahead of
"The Dark Side of Prescription Prices: Uncovering the Hidden Costs of Pharma Procurement As the cost of prescription medications continues to skyrocket, patients and payers are left wondering: where's the money going? A closer look at the pharma procurement process reveals a complex web of hidden fees, opaque pricing, and inefficient practices that are driving up costs and hurting those who need care the most.
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
MC2 Therapeutics, a Danish pharma company focused on topical therapies for inflammatory skin conditions, has appointed Trine Ahlgreen as CEO. This intends to support the MC2s goal to globally commercialise its PAD Technology and lead asset, Wynzora Cream. Ahlgreen brings a rich background in pharma leadership to MC2, having led teams and business developments across […] The post MC2 Therapeutics appoints Trine Ahlgreen as new CEO appeared first on Pharmafile.
As this medical approach continues to become more widely adopted, the industry must adapt to help provide precise, compliant, temperature-controlled, delivery of highly individualized treatments.
HLX22 is the first anti-HER2 targeted treatment to receive ODD from both the US Food and Drug Administration (FDA) in March 2025 and from the EU. An international multicentre Phase III clinical study (HLX22-GC-301) investigated HLX22 combined with trastuzumab and chemotherapy as a first-line therapy for HER2-positive advanced gastric cancer. The study has obtained new drug clinical trial (IND) approval from regulatory agencies across multiple regions including the US, China, Germany, Japan, Aust
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.
Following a meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA announced their recommendation of COVID-19 vaccines targeting LP.8.1, a strain of the JN.1 variant that has become dominant in the US.
In this roundtable, 3 pharmacy faculty members reflect on how shifting federal priorities and the defunding of research initiatives have impacted their work, communities, and careerswhile highlighting the power of resilience, solidarity, and reimagined academic impact in advancing public health equity.
Despite the FDA first approvingPfizersantibody-drug conjugate (ADCs) Mylotarg (gemtuzumab ozogamicin) in 2000, it was not until 2022 for non-small-cell lung cancer (NSCLC) to see its first ADC approval,AstraZenecasandDaiichi Sankyos Enhertu (trastuzumab deruxtecan), for human epidermal growth factor receptor (HER) 2-mutated patients. Following this approval, the ADC market in NSCLC is projected to grow at a CAGR of 6.8 per cent across the seven major markets (7MM*) and exceed $3.9 billion in 203
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.
Worldwide, more than 55 million people suffer from dementia caused by Alzheimer's Disease (AD) and other conditions that destroy cells in the brain and nervous system. While there is no treatment to control or manage these neurodegenerative conditions, investigators at Case Western Reserve University, University Hospitals and the Louis Stokes Cleveland VA Medical Center have identified a new and promising drug to treat AD.
Former director of external affairs at Asthma + Lung UK Henry Gregg has today started in post as the new chief executive of the National Pharmacy Association (NPA). When he was appointed in March, Mr Gregg vowed to build strong links with the government and fight for pharmacies to ensure they had the right support […] The post New NPA chief executive begins in post appeared first on The Pharmacist.
We need to broaden access to advanced technologies so that, ultimately, every patient can benefit from them. Its a goal otherwise known as the hyperscaling of healthcare.
When a South Korean patient needed a life-changing gene therapy, Marken orchestrated an international distribution strategy under the strictest regulatory and temperature specifications. With precise temperature-control required at -80C with dry ice, Markens teams navigated weekend scheduling, specialized package handling and final-mile complexities to ensure the vital treatment remained on schedule with white glove service from pick up to final mile delivery.
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.
Pharmacies across the UK are embracing the digital revolution but until now, a critical link has been missing. While many have moved their services online, bridging the gap between clinical services, private prescribing, and e-commerce has been a challenge. Thats where The WooPW, an emerging e-commerce prescribing solution for pharmacies. This GPhC-compliant, secure platform isnt just another online store.
Tasked with the delivery of two ultra-sensitive gene therapies to Japan treatments targeting vision loss that required continuous -80C temperature control and dry ice replenishment throughout an 80-hour transit Marken activated a customized, precision-driven supply chain strategy. Navigating one of the worlds most complex regulatory landscapes for advanced therapies, success depended on flawless execution, specialized handling protocols, and seamless cross-functional collaboration.
Pharmacy owners must register to deliver the Pharmacy Contraception Service, Hypertension Case Finding Service and Pharmacy First before Sunday 1 June to ensure they are entitled to a monthly fixed payment. From 1 June, the Pharmacy First bundling requirements come into force, meaning pharmacies must be registered to deliver all three services in addition […] The post Deadline for Pharmacy First, contraception and hypertension bundle this week appeared first on The Pharmacist.
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.
Rocket Pharmaceuticals said Tuesday that a patient had died in a trial studying its experimental gene therapy for a rare heart condition called Danon disease. Rocket did not disclose the patient’s age, although the Phase 2 study aimed to enroll boys and young men. The company said it was still investigating the cause of the death.
On the long list of ways that leading thinkers warn AI could end humanity is one that feels very comic-book villain: helping a rogue actor use modern biology tools to synthesize a lethal pathogen that would “cause more than a billion deaths in a matter of months.” While I am deeply concerned about the long-term existential threat of AI and synthetic biology to create new or modified pathogens, my extensive experience detecting and controlling outbreaks around the world makes me fea
The approval is based on findings from the INSPIRE trial, where treprostinil demonstrated efficacy in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
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