Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.

PARIS – Researchers from the department of radiation oncology at the European Hospital Georges Pompidou (HEGP) and Stanford University School of Medicine have together developed a new artificial intelligence (AI) prediction tool for patients diagnosed with prostate cancer. These researchers have just published a validation of this interpretable AI model in Cancers. “It’s a question of distinguishing patients at risk of mortality from aggressive cancer that is spreading rapidly, from patients who might have far less aggressive cancer and who are not likely to die from it in under 10, 15 or even 20 years,” Jean-Emmanuel Bibault, radiotherapy oncologist at HEGP, told BioWorld.

PARIS – A consortium led by French clinical and scientific experts has just published results in the Journal of Experimental Medicine of a study showing the contribution of a new simplified diagnostic test in better identifying the level of contagiousness of subjects infected with SARS-CoV-2.

LONDON – Endomag Ltd. has received endorsement from the U.K. health technology assessment body NICE, opening the way to broader adoption of its Magtrace non-radioactive cancer staging technology in the National Health Service, and providing backing for commercialization of the system in other markets.

Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.

Less than two weeks after Fibrogen Inc. received an FDA complete response letter for its hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, Evrenzo (roxadustat), Astellas Pharma Inc. and Fibrogen have won European Commission approval for the drug to treat symptomatic anemia associated with chronic kidney disease (CKD) in adults. The approval, which followed a positive CHMP opinion in June, triggered a $120 million milestone payment from Astellas to Fibrogen. In addition, Fibrogen will receive royalties on EU sales of the drug.

PARIS – The High Authority for Health (HAS) in France recently published a 165-page report on use over 10 years of long term mechanical circulatory assist devices (MCS). HAS conducted this wide-ranging study to review the conditions for the management of MCS devices, technology that has been constantly evolving over the past decade.

Lightpoint Medical Ltd. is stepping up commercialization activities and collaborating with Telix Pharmaceuticals Ltd. on radio-guided cancer surgery. The companies plan to initiate prostate cancer clinical trials evaluating Lightpoint’s Sensei with Telix’s investigational prostate cancer single photon emission computed tomography (SPECT) imaging agent TLX599-CDx.

For most people, neither polyglutamine disorders nor neuromuscular disorders are likely to be among the things they associate with androgen receptor (AR) dysfunction. But the three are indeed linked. And researchers have reported new insights into the nature of those links that could lead to a treatment for spinal and bulbar muscular atrophy, and possibly other disorders linked to AR signaling dysfunction.