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…

ByRidhi RastogiMarch 17, 2025

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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…

ByRidhi RastogiMarch 13, 2025

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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…

ByRidhi RastogiMarch 13, 2025

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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…

ByRidhi RastogiMarch 13, 2025

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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…

ByRidhi RastogiMarch 13, 2025

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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…

ByRidhi RastogiMarch 13, 2025

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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…

ByRidhi RastogiMarch 13, 2025

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Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Shots: Zealand Pharma & Roche will develop & market petrelintide & its products incl. petrelintide + CT-388 (Roche’s asset) in the US & EU for weight loss, with Roche obtaining exclusive marketing rights in the rest of the world Zealand will handle ~50% marketing in the US & EU with opt-in/out rights under specific…

ByRidhi RastogiMarch 12, 2025

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Pierre Fabre Laboratories and RedRidge Bio Enter R&D Collaboration & License Agreement for Biparatopic Antibody (BPA) Candidates

Shots: Pierre Fabre has partnered with RedRidge for BPA drugs against various targets in oncology, dermatology & rare diseases, where the latter will engineer, screen, & characterize BPAs for jointly selected targets, while Pierre will advance 2 co-development programs As per the deal, RedRidge will hold marketing rights in the US, Canada, & Japan…

ByRidhi RastogiMarch 12, 2025

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Nosis Biosciences Partners with Janssen Biotech for Cell-Targeted RNA Drugs

Shots: Nosis Biosciences has entered into a strategic collaboration with Janssen Biotech (subsidiary of J&J) to design & develop cell-targeted RNA medicines The collaboration leverages J&J’s drug discovery & clinical expertise as well as Nosis’ Connexa platform to design drugs with extra-hepatic access to multiple & hard-to-target cell types involved in chronic diseases …

ByRidhi RastogiMarch 12, 2025

Ridhi Rastogi

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

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Pierre Fabre Laboratories and RedRidge Bio Enter R&D Collaboration & License Agreement for Biparatopic Antibody (BPA) Candidates

Nosis Biosciences Partners with Janssen Biotech for Cell-Targeted RNA Drugs

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