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ECJ strengthens data protection in online drug trade

The European Court of Justice (ECJ) ruled in case C-21/23 (Lindenapotheke) that Member States can allow competitors of a company to judicially challenge violations of the General Data Protection Regulation (GDPR) as unfair commercial practices. The ruling concerns the online sale of prescription-only medicines, where explicit consent from customers for the processing of their personal data is required – even for over-the-counter medicines. In its decision, the ECJ clarifies that the GDPR allows competitors to take action against suspected data protection violations. This strengthens the rights of affected individuals and ensures greater data protection. Furthermore, it can help to prevent further violations of the GDPR.

Groundbreaking Study on Antimicrobial Stewardship in Wound Care

MolecuLight Inc., the global leader in fluorescence imaging technology for real-time detection of harmful bacteria in wound care, is excited to announce the publication of a new study that addresses a critical challenge in wound care: the need for standardized and evidence-based antibiotic and antimicrobial prescribing. Published in Diagnostics, this groundbreaking research underscores the urgent need for widespread adoption of antimicrobial stewardship programs (ASPs) and reveals the significant potential to improve prescribing practices with MolecuLight. The study, led by Dr. Thomas Serena and titled „Audit of Antimicrobial Prescribing Trends in 1447 Outpatient Wound Assessments: Baseline Rates and Impact of Bacterial Fluorescence Imaging“, examined antimicrobial prescribing practices in 2022 across eight U.S. outpatient wound clinics. By comparing trends between clinics with and without MolecuLight, the research provides valuable insights into current prescribing practices and the impact of MolecuLight on antimicrobial use.… 

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Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test

Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA’s De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes. Validation of Healgen’s at-home test data was supported through the Independent Test Assessment Program (ITAP), part of National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program. ITAP assessed Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test’s quality, accuracy and reliability, and found it demonstrated sensitivity and specificity of greater than 90% and 99%, respectively.

Judo Bio debuts with $100 million

The Cambridge, Massachusetts-based biotech company uses so-called ligand-siRNA conjugates to reach drug target molecules in the kidney, which have been difficult to reach with RNA therapies until now. Biopharma Dive reports: “A new biotechnology company called ‘Judo Bio’ aims to combat kidney diseases. Equipped with $100 million and an RNA drug platform, the company is set to reach targets that have been difficult for researchers to reach until now. Judo was founded three years ago and is supported by a handful of investors, including Atlas Venture, which incubated the startup and co-led its Series A, as well as The Column Group and Droia Ventures.With its technology, Judo is following in the footsteps of Alnylam Pharmaceuticals, which was the first manufacturer to use a biological process called RNA interference to produce a new class of drugs. Unlike Alnylam’s first drugs, which target the liver, Judo claims it can reliably smuggle its RNA drugs into the kidneys… 

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Pet Health: Elanco Receives FDA Approval for Credelio Quattro™

Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Food and Drug Administration (FDA) has approved Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), becoming the broadest approved canine oral parasiticide with its protection against six types of parasites—fleas, ticks, heartworms, and the three risky intestinal parasites—roundworms, hookwormsii and tapeworms. Credelio Quattro is a single, monthly chewable tablet for dogs eight weeks of age or older. "Zoonotic disease is more common than many might think. One of our own Elanco veterinarians recently found echinococcus tapeworm lurking in her back yard," said Dr. David Gosche, veterinarian and U.S. Pet Health Medical Director at Elanco. "Zoonotic disease affects millions of people and animals worldwide each year. Our pets can easily serve as the 'bridge hosts,' bringing these parasites into our homes when they cuddle with us on couches or in ...

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MediLink Announces Global Clinical Trial Collaboration

MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”), a clinical-stage biotech company, today announced a global clinical trial collaboration and supply agreement with Amgen Inc. Amgen will lead a global clinical study to evaluate the therapeutic potential of the combination of MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 and Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE®) IMDELLTRA™ in extensive-stage small cell lung cancer (ES-SCLC) under the clinical trial collaboration and supply agreement. MediLink will provide the investigational drug YL201 for the combination study. This open-label, global, multi-center Phase Ib clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of this combination regimen in ES-SCLC patients. Both YL201 and IMDELLTRA™ have shown potential in ES-SCLC. In May of this year, IMDELLTRA™ received accelerated approval from the FDA and is currently marketed in the US for the treatment of adult patients… 

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Nobel Prize in Medicine for Gene Researchers

This year’s Nobel Prize in Physiology or Medicine goes to Victor Ambros and Gary Ruvkun. The Karolinska Institute announced this on Monday in Stockholm. The two scientists were honored for their discovery of microRNA and its role in post-transcriptional gene regulation. The prize is endowed with eleven million Swedish kronor, equivalent to approximately 970,000 euros. […] Nobel Prize in Medicine for Gene Researchers

BMG: “Long-term care insurance is not bankrupt”

The Federal Ministry of Health has contradicted the assertion that long-term care insurance is facing immediate insolvency. “Long-term care insurance is not bankrupt,” said a ministry spokeswoman on Monday in Berlin. Provisions will be made accordingly. Federal Minister of Health Karl Lauterbach (SPD) is therefore expected to present a “financial concept” shortly to support long-term care insurance. This will be effective “both in the short term and […] Ministry of Health: “Long-term care insurance is not bankrupt”

Promising Results from MRX-5 Study for Treating Mycobacterium abscessus Infections

MicuRx Pharmaceuticals announced the publication of groundbreaking research on MRX-5, a novel oral oxaborole prodrug, demonstrating significant potential in the treatment of pulmonary infections caused by Mycobacterium abscessus (Mab), a severe nontuberculous mycobacterium (NTM) infection. The research was led by Dr. Gyanu Lamichhane, Associate Professor at Johns Hopkins University School of Medicine. Mab infections are notoriously difficult to treat, often requiring prolonged, complex, and poorly tolerated courses of multiple antibiotics. With no FDA-approved treatment for Mab, the results of this study are a promising step towards addressing the growing unmet clinical need for effective and convenient treatment options. Importantly, MRX-5 offers an oral alternative to current treatment regimens that are primarily intravenous and highly toxic, with failure rates exceeding 50%. MRX-5 could vastly improve patient compliance and quality of life compared to the current standard intravenous therapies

Increase in suicides following FDA warnings on antidepressants for adolescents

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A new systematic review led by the Harvard Pilgrim Health Care Institute examined a broad body of evidence documenting the impact on children's mental health following the FDA's black box warnings linking antidepressants to suicidal thoughts and behaviors in adolescents. The data show that these warnings, intended to bring about increased monitoring of suicidal thoughts and behaviors, led to a decrease in the use of important medications and less psychiatric treatment for depression in children, as well as an increase in suicide attempts and deaths. The findings support a re-evaluation of the black box warning. Since 2003, the FDA has warned that antidepressants may be linked to suicidal thoughts and behaviors in young people. These warnings, upgraded to a black box warning (the most severe warning level) in 2005 for those under 18 and extended in 2007 to young adults up to age 24 ...

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