News Digest Edition 12

Clinical Research Focus. 12th Edition

Cromos Pharma’s Guide to the EU Legal Representation Requirements

Any biopharmaceutical company that plans to conduct clinical trials in the EU and doesn’t have a registered office in the European Economic Area (EEA), needs to use the services of a Legal Representative. First established in 2001, this provision aims to ensure that the EU offers an attractive and favorable atmosphere for carrying out clinical research on a large scale, with high public transparency and safety standards for the clinical trial participants.

If your company plans to conduct clinical trials in the EU, then according to the EU Clinical Trials Regulation No 536/2014 (CTR), it should appoint a Legal Representative with an established office in the EEA.

Please read our article here.

EU Regulators Publish New Recommendations on Decentralized Trials

EU Regulators Publish New Recommendations on Decentralized TrialsThe European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA), have published new recommendations aiming to protect the rights and well-being of patients who participate in clinical trials, and to ensure reliability of the collected data. The recommendations include an overview of national provisions for specific decentralized clinical trial elements to be used in clinical research.

Please follow the link to learn more.

 

FDA Approves First Capsid Inhibitor for HIV

FDA Approves First Capsid Inhibitor for HIVGilead’s Sunlenca has become the first capsid inhibitor to be approved by the US Food and Drug Administration (FDA) for treating human immunodeficiency virus type 1 (HIV-1). In August 2022, the European Commission (EC) granted marketing authorization for the use of Sunlenca® (lenacapavir) injection and tablets in adults with multi-drug resistant HIV infection. The safety and efficacy of Sunlenca were established through the multicentre Phase II/III CAPELLA clinical trial.

Please follow the link to learn more.

 

Moderna Vaccine Succeeds in Early-Stage Skin Cancer Trial with Merck’s Keytruda

Moderna Vaccine Succeeds in Early-Stage Skin Cancer Trial with Merck’s KeytrudaA Moderna personalized cancer vaccine, combined with Merck & Co.’s immunotherapy Keytruda, kept people with melanoma alive and disease free after surgery significantly longer than Keytruda alone in a mid-stage trial, KEYNOTE-942. The companies said they hope to get a Phase III trial underway in 2023 and will begin testing the combination in other types of cancer. 

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Promising First-In-Human Study Results for Orally Inhaled Antibiotiс

Promising First-In-Human Study Results for Orally Inhaled AntibiotiсSpexis AG has announced positive safety data from the first-in-human clinical trial of its orally inhaled antibiotic, murepavadin (iMPV). The novel macrocyclic compound achieved high inhibiting concentrations against Pseudomonas aeruginosa in the lung airways of participants. The results from the first-in-human study showed that murepavadin was well tolerated at all dose levels.

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Stem Cell Transplants May Slow Disability Progression in Multiple Sclerosis

Stem Cell Transplants May Slow Disability Progression in Multiple SclerosisA study funded by the Italian Multiple Sclerosis Foundation suggests stem cell transplants may delay disability longer than some other medications in patients with active secondary progressive multiple sclerosis. Five years into the study, researchers found 62 percent of the participants who had stem cell transplants experienced no worsening of their MS disability, compared to 46 percent of those who took medications.

Please review the article here.

 

Chronic Exposure to Synthetic Food Colorant Allura Red AC Promotes Susceptibility to Experimental Colitis via Intestinal Serotonin in Mice

Chronic Exposure to Synthetic Food Colorant Allura Red AC Promotes Susceptibility to Experimental Colitis via Intestinal Serotonin in MiceA recent study published in the journal Nature Communications has shown that chronic exposure of Allura Red AC (AR) at a dose found in commonly consumed dietary products exacerbates susceptibility to experimental models of colitis in mice. The researchers discovered that exposure to AR during early life primes mice to heightened susceptibility to colitis. The study reveals that chronic long-term exposure to this very common synthetic colorant promotes experimental colitis via colonic 5-HT in gut microbiota-dependent and independent pathways.

Please review the article here.

 

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