NEWS

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots: Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024 Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…

March 17, 2025

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Shots: The US FDA has granted 510(k) clearance to MONARCH QUEST, an AI-powered navigation tech for improved robotic-assisted bronchoscopy MONARCH QUEST features a scope-in-sheath design & continuous vision, utilizing NVIDIA RTX platform to boost its computational power by 260% for enhanced accuracy. It also allows integration with GE HealthCare’s OEC 3D CBCT Imaging System to…

March 17, 2025

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

Shots: Kemin Industries has launched Prosidium to improve biosecurity in animal feed and global food supply Prosidium is based on peroxy acids, which disrupts pathogen cell membranes to reduce Salmonella risk & viral transmission in animal feed, while the residual acids offer continuous feed protection Additionally, Prosidium’s ingredients are approved by various regulatory bodies incl.…

March 17, 2025

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Shots: The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL In pts treated in 3L+ setting, study met…

March 17, 2025

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots: The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

March 13, 2025

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

Shots: Kemin Industries has launched Prosidium to improve biosecurity in animal feed and global food supply Prosidium is based on peroxy acids, which disrupts pathogen cell membranes to reduce Salmonella risk & viral transmission in animal feed, while the residual acids offer continuous feed protection Additionally, Prosidium’s ingredients are approved by various regulatory…

March 13, 2025

China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

Shots: China’s NMPA has accepted BLA of Tivdak for the treatment of recurrent or metastatic cervical cancer in pts who had disease progression on or after systemic therapy The BLA was supported by P-III (innovaTV 301) trial data, incl. clinical evidence from Chinese cohort, evaluating Tivdak vs CT in adults. Chinese pts had prior standard…

March 13, 2025

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025 MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…

March 13, 2025

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025 MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…

March 13, 2025

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Shots: The US FDA has granted 510(k) clearance to MONARCH QUEST, an AI-powered navigation tech for improved robotic-assisted bronchoscopy MONARCH QUEST features a scope-in-sheath design & continuous vision, utilizing NVIDIA RTX platform to boost its computational power by 260% for enhanced accuracy. It also allows integration with GE HealthCare’s OEC 3D CBCT Imaging System…

March 13, 2025

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

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