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MolecuLight Announces Groundbreaking Study on Antimicrobial Use in Wound Care

MolecuLight, the global leader in fluorescence imaging technology for real-time detection of harmful bacteria in wound care, is pleased to announce the publication of a new study addressing a critical challenge in wound care: the need for standardized and evidence-based prescribing of antibiotics and antimicrobials. This groundbreaking study, published in the journal Diagnostics, underscores the urgent need for widespread adoption of antimicrobial stewardship programs (ASPs) and demonstrates the significant potential for improving prescribing practices with MolecuLight. https://www.mdpi.com/2075-4418/14/18/2034

Discovery of microRNA leads to Nobel Prize

The groundbreaking discovery of microRNA originated from the research of Ambros and Ruvkun on a small roundworm, Caenorhabditis elegans, in the late 1980s and early 1990s. Their work focused on two genes, lin-4 and lin-14, which were crucial for the worm's developmental timing. In 1993, they published their findings in two seminal papers in the journal Cell, demonstrating that lin-4 produced a short RNA sequence that could bind to complementary sequences in the lin-14 mRNA, effectively blocking protein production. This discovery initially met with little resonance in the scientific community, as it was considered a peculiarity of worm biology. However, subsequent research revealed that microRNAs are widespread in nature and play essential roles in gene regulation across various species, including humans. The identification of microRNAs as a new class of regulatory molecules has since transformed our understanding…

Telekom goes Lab Medicine

In recent years, Deutsche Telekom has developed into a significant player in the field of laboratory medicine by providing innovative IT solutions and digitalization concepts for the healthcare sector. Although Telekom is traditionally known as a telecommunications company, it has greatly expanded its portfolio in the healthcare sector and now offers comprehensive solutions for clinics, laboratories, and other medical facilities[1]. In the field of laboratory medicine, Telekom plays an increasingly important role in networking and digitalizing processes. The company provides platforms and infrastructures that enable laboratories to efficiently process, store, and exchange data. A specific example of this is Telekom's collaboration with vitagroup, offering an open platform in the Open Telekom Cloud[3]. This platform, the HIP Clinical Data Repository (HIP CDR), enables clinics and laboratories to use, centrally store, and… 

Clinical Development of Lutetium (177Lu) rhPSMA-10.1 Injection

Blue Earth Therapeutics Ltd, an emerging leader in the development of therapeutic radiopharmaceuticals, today announced further positive developments for its novel investigational radioligand therapies. Enrolment of patients in the Phase 1 trial of Lutetium (177Lu) rhPSMA-10.1 Injection was completed in July. Early data from the trial suggests an encouraging safety profile. Radiation dosimetry performed for up to three cycles showed delivery of high tumor absorbed radiation doses relative to the dose delivered to the key normal organs, such as kidney and salivary glands. While final analysis is ongoing, the ratio between radiation dose to tumors vs. dose to the kidneys and salivary glands was compelling vs. published data1 for first generation radioligand therapies. This data opens the way for the Phase 2 portion of the Phase 1/2 trial to start later this year. The company has shared the intended Phase…

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.… 

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… 

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… 

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…