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NEWS

Belenos Biosciences Reports P-II Trial Results on BEL512 for CRSwNP
Shots: P-II trial, conducted by Belenos’partner Keymed Biosciences, assessed BEL512 (SC; 300mg, Q12W/Q24W or 600mg, Q24W) vs PBO, both on top of intranasal corticosteroid (QD), in 120 Chinese pts with CRSwNP with NPS of ≥5 (≥2 polyps/nostril) & a NCS of 2-3 Trial met its 1 & 2EPs, with the BEL512 showing statistically significant improvements…
Mereo BioPharma and Sentynl Therapeutics Ink ~$475M Pact for Alvelestat
Shots: Sentynl, a subsidiary of Zydus, has entered into an option & license agreement with Mereo for the US commercial & global manufacturing rights to alvelestat for Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD) Sentynl will have an exclusive option to license alvelestat in the US, while Mereo retains ex-US commercial rights; Sentynl will also hold…
Bracco
Bracco Imaging Secures FDA and Health Canada Clearances for VueJect
Shots: Bracco Imaging has received the US FDA 510(k) clearance & Health Canada authorization for VueJect, its dedicated ultrasound contrast delivery system designed specifically for cardiology imaging VueJect is designed to improve workflow efficiency, reduce operator variability & enable continuous administration of ultrasound contrast agents for more consistent enhancement during cardiac imaging VueJect will initially…
Alfasigma to Acquire Nordic Pharma, Expanding Rheumatology and Global Reach
Shots: Alfasigma has entered into an agreement with SEVER Life Sciences to acquire 100% of Nordic Pharma & its subsidiaries, adding the Nordimet methotrexate franchise to Alfasigma’s rheumatology portfolio alongside Jyseleca Deal will expand Alfasigma’s commercial footprint through Nordic Pharma’s direct operations across 18 EU countries, while adding platforms in Canada & Japan. The portfolio…
Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements
Shots: The US FDA has granted 510(k) clearance to two AI algorithm enhancements, Epileptiform Abnormality Detection & Artifact Reduction, which are integrated into its cloud-based Neurology Portal The Artifact Reduction algorithm identifies interference from patient movement, medical equipment, and physiological signals, while Epileptiform Abnormality Detection flags abnormal patterns across lengthy EEG recordings, helping neurologists navigate…
Mabwell Reports ASEAN Partnerships for Its Aflibercept Biosimilar (Biosimilar, Eylea) 
 Shots:  Mabwell has signed licensing and commercialization agreements with local partners in the Philippines, Vietnam, and Malaysia for its aflibercept biosimilar, a biosimilar version of Eylea  As per the deal, Mabwell and its partners jointly advance the product’s registration and commercialization in these markets  Aflibercept is a VEGF inhibitor approved for the treatment of Neovascular (wet) age-related macular…
Revvity Debuts SuperFlex Prenatal Screening System
Shots: Revvity has launched SuperFlex, a compact immunoassay platform for rapid, reliable prenatal screening in lower-volume laboratories & clinics, incl. preeclampsia testing SuperFlex offers an affordable, low-waste setup with annual maintenance, simplified operation and minimal training, plus flexible throughput with continuous loading and results in as little as 14min SuperFlex supports first & second-trimester biochemical…