Skip to content

First Malaria Drug Approved for Newborns and Infants: Novartis Celebrates Breakthrough in Global Health

  • News

Basel, July 8, 2025 – In a historic step for global healthcare, the Swiss Agency for Therapeutic Products Swissmedic has granted pharmaceutical company Novartis approval for Coartem Baby (known in some countries as Riamet Baby) – the first malaria drug specifically developed for newborns and infants weighing between 2 and under 5 kilograms. This groundbreaking development closes a long-standing supply gap for the youngest and most vulnerable patients in malaria-endemic regions, particularly in Sub-Saharan Africa, where the disease claims hundreds of thousands of lives annually. Eight African countries involved in the evaluation are close to granting approval as well, which could make the drug available in affected regions in the coming weeks. The new formulation of Coartem Baby, a combination of artemether and lumefantrine, was developed in collaboration with the non-profit organization Medicines for Malaria Venture (MMV). To date, there have been…

US Sanctioning Malicious North Korean Cyber Actors

  • News

The United States is imposing sanctions on Song Kum Hyok, a North Korean cyber actor associated with the U.S.-designated North Korea hacking group Andariel.  Song was involved in malicious cyber-enabled activities, which included an illicit information technology (IT) worker scheme.  He is also linked to an attempted hack of the U.S. Department of the Treasury.  We are also imposing sanctions on Russia-based facilitator Gayk Asatryan and four entities – two Russian and two North Korean – all involved in deploying IT workers internationally to generate revenue for the North Korean government. The Democratic People’s Republic of Korea deploys IT workers who obfuscate their identities, often through identity theft of U.S. persons, to fraudulently obtain employment at unwitting foreign firms.  The North Korea regime uses revenue generated by these workers to support its unlawful weapons of mass destruction and ballistic… 

GSK Revolutionizes Drug Development: New Webinar Shows Risk Minimization Strategies

  • News

Newton, Massachusetts, July 8, 2025 – PharmaVoice, in collaboration with its award-winning content studio studioID, has released a new on-demand webinar highlighting GlaxoSmithKline’s (GSK) innovative approaches to minimizing risks in drug development. Titled “Unlocking Drug Success: How GSK De-risks Drug Development,” the webinar offers insights into GSK’s strategies that enhance the efficiency and safety of drug development through early investment in claims data. The webinar demonstrates how GSK gains crucial insights into treatment dynamics in the early stages of development through novel analysis of claims data. This approach differs significantly from traditional workflows, enabling early identification and minimization of risks. Key content includes: “The webinar offers valuable insights into how GSK is transforming drug development through data-driven approaches,” explained a spokesperson for studioID. “The strategies presented are not only relevant for large pharmaceutical companies, but…

MediView Launches Multicenter Study to Validate XR90 System for Soft Tissue Biopsies

  • News

Cleveland, Ohio, July 8, 2025 – MediView XR, Inc., a leader in medical imaging technology, announced the enrollment of the first patient in a clinical trial investigating the efficacy of its XR90 Holographic Surgical Navigation System for percutaneous tumor biopsies. The study, titled “Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Performing Percutaneous Soft Tissue Tumor Biopsy as an Adjunct to Standard Image Guidance,” is being conducted in collaboration with renowned institutions including NewYork-Presbyterian/Weill Cornell Medical Center, MedStar Georgetown University Hospital, and MedStar Washington Hospital Center. The multicenter study, which has received IRB approval, plans to enroll 104 patients over the next 24 months. The objective is to evaluate the procedural efficiency of the XR90 system as an adjunct to standard imaging techniques such as ultrasound and CT, compared to standard imaging alone. The investigation aims to… 

Great Britain launches six projects against food inequality: Innovative approaches for healthy nutrition

London, July 8, 2025 – Six new projects to tackle food inequality in the UK were unveiled today by UK Research and Innovation (UKRI). The initiatives aim to improve the availability and affordability of nutritious food and reduce food insecurity in communities most affected. The projects, funded under UKRI’s ‘Create, Grow, Innovate’ theme, are implementing innovative approaches including: The projects respond to alarming figures: Between 2023 and 2024, 7.5 million people lived in food insecure households per month – an increase of 300,000 from 2022 and 2.5 million since 2019. Low-income households and people with disabilities are disproportionately affected. “These innovative projects from Wales to Dundee and Nottingham to the Isle of Wight will be crucial in tackling food inequalities,” said Professor Alison Park, UKRI’s Create, Grow, Innovate theme lead. Science and Technology Minister Peter Kyle added, “No one should be without access… 

NIH Introduces Cap on Publication Fees: Measure Against Exorbitant Costs for Publicly Funded Research

  • News

Bethesda, Maryland, July 8, 2025 – The National Institutes of Health (NIH) today announced a new policy that will cap the fees publishers can charge NIH-funded scientists for publishing their research findings, starting in fiscal year 2026. This measure aims to curb exorbitant publication costs, promote scientific transparency, and strengthen public trust in public health. “An open, honest, and transparent research environment is crucial for restoring public trust,” stated NIH Director Dr. Jay Bhattacharya. “This reform not only makes science accessible to the general public but also removes financial incentives that harm taxpayers.” Currently, some publishers charge up to $13,000 per article for immediate open access and additionally collect high subscription fees from agencies. For example, the NIH pays over two million dollars annually in subscriptions and an additional ten million dollars in...

ETC Model Participant Data Sharing Agreement (DSA) Signing in 4innovation (4i) Platform Now Open

CMS has extended a final opportunity for ETC model participants to complete their Data Sharing Agreement (DSA). The final ETC Model DSA signing window for Measurement Year 7 (MY 7) is now open until July 24 at 11:59pm. ETC Participants or their designees must sign their relevant DSAs by 7/24/25 to gain access to beneficiary-level reports available in the 4i Data Hub. Background Under ETC Model’s regulations at § 512.390, CMS makes certain beneficiary-identifiable data available to ETC Participants under the condition that an ETC Participant completes and submits, on at least an annual basis, a signed data sharing agreement. Beneficiary-identifiable data include the ETC Participant’s attributed beneficiaries‘ names, Medicare Beneficiary Identifiers, dates of birth, dual eligible status, and LIS recipient status. Beneficiary-identifiable data may be retrieved by ETC Participants no later than one month before the start of each PPA Period. For the purposes of this notice, beneficiary-identifiable data…

New Hope for Children with High-Risk Neuroblastoma: Swissmedic Approves IFINWIL®

The Swissmedic, Switzerland’s drug regulatory authority, has approved the drug IFINWIL® (eflornithine) for the treatment of children aged one year and older with high-risk neuroblastoma (HRNB). This decision marks a significant advancement in pediatric oncology, as the drug can be used as a monotherapy for patients who no longer have active disease after intensive first-line treatment. High-risk neuroblastoma is a rare but aggressive form of cancer that primarily affects children under the age of five. Annually, approximately 10.2 out of every million children under 15 are diagnosed worldwide, with half of the cases considered high-risk. Despite intensive therapies, the five-year survival rate is below 50 percent, and the disease accounts for about 15 percent of cancer-related deaths in children. The drug works by inhibiting an enzyme crucial for tumor development, aiming to prevent relapses – a critical factor for long-term survival. The approval was granted in...

Child Abuse Impairs Body Awareness: New Findings from Dresden and Berlin

A research team from TU Dresden and FU Berlin has investigated the connection between child abuse and internal body awareness, also known as interoception, in a meta-analysis. The findings, published in the journal Nature Mental Health, show that emotional abuse and neglect in childhood significantly reduce trust in one's own body awareness, which can have far-reaching consequences for mental health. Interoception describes the ability to perceive and interpret internal signals such as heartbeat, breathing, or stomach activity. It is crucial for emotion regulation, stress management, and physical well-being, yet its development and significance are still poorly understood scientifically. The analysis included 17 studies with 3,705 participants and found no consistent link between child abuse and altered interoception. However, it did show that affected individuals, particularly those who experienced emotional abuse and neglect, have less trust in their body awareness. This can affect emotion regulation, the perception of one's own needs, and stress processing...

MAGA is Dead: Trump Protects Pedophile Criminality by Covering Up Epstein Files (COMMENTARY)

Donald Trump's "Make America Great Again" is a lie, shredded by his refusal to release the full Epstein files. This cover-up is not bureaucratic failure, but an ice-cold act that shields pedophile crime, mocks victims, and destroys the foundations of justice. With every day the files remain sealed, Trump not only protects his own past but a network of powerful criminals who have destroyed the lives of minors. This is not an attack on one man – it is an outcry against the shame he brings upon the American people and humanity. Jeffrey Epstein was not an isolated perpetrator, but the head of a criminal system that systematically abused minors and involved elites from politics, business, and media. His files – thousands of pages of court documents, testimonies, and evidence – could expose this network. Yet, under Trump's presidency, they remain locked away. In February 2025…