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

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Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Shots: Arvinas & Pfizer have reported topline data from ongoing P-III (VERITAC-2) trial of vepdegestrant in ER+/HER2- advanced or metastatic breast cancer pts who had progression with CDK 4/6 inhibitors & endocrine therapy Pts received either vepdegestrant (PO, QD) for 28 days or fulvestrant (intramuscular) on Day 1 & 15 of first 28-day cycle,…

ByRidhi RastogiMarch 12, 2025

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Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

Shots: The EC has approved Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy in 30 EEA states; commercialization to begin in select EU states by 2026 pending country-by-country reimbursement Approval was based on P-III (IMerge) study of Rytelo vs PBO…

ByRidhi RastogiMarch 12, 2025

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Ono Pharma and Ionis Enter into License Agreement for Sapablursen to Treat Polycythemia Vera

Shots: Ionis has granted Ono Pharma an exclusive global license to develop & commercialize sapablursen for the treatment of polycythemia vera (PV) As per the deal, Ionis will get $280M upfront & ~$660M in development, regulatory & sales milestones, plus mid-teens net sales-based royalties as well as Ionis will be responsible to complete ongoing…

ByRidhi RastogiMarch 12, 2025

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China’s NMPA Approves Kelun-Biotech’s Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC

Shots: China’s NMPA has approved label expansion of sacituzumab tirumotecan (SKB264/MK-2870) to locally advanced or metastatic (LA/M) EGFRm NSCLC following disease progression on EGFR-TKI therapy or Pt-based Ct Approval was based on OptiTROP-Lung03 trial assessing sac-TMT alone (5mg/kg, IV, Q2W) vs docetaxel in mentioned pts, where it demonstrated improved ORR, PFS & OS sac-TMT is…

ByRidhi RastogiMarch 11, 2025

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Beckman Coulter Receives the US FDA 510(k) Clearance For DxC 500i Clinical Analyzer

Shots: The US FDA granted 510(k) Clearance to the DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer capable of processing up to 800 clinical chemistry and 100 immunoassay tests per hour The DxC 500i analyzer leverages Beckman’s previous model DxC 500 AU technology within its clinical chemistry capabilities, including its Six…

ByRidhi RastogiMarch 11, 2025

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Antech Launches trūRapid FOUR For Canine Vector-Borne Disease Screening

Shots: Antech has launched trūRapid FOUR test for screening canine vector-borne disease trūRapid FOUR is an in-house lateral flow test that detects canine antibodies for Anaplasma spp., Ehrlichia spp., and Lyme C6 (Borrelia burgdorferi), as well as heartworm (Dirofilaria immitis) antigen, using whole blood, serum, or plasma Test offers streamlined workflow, using only…

ByRidhi RastogiMarch 11, 2025

Ridhi Rastogi

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

Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

Ono Pharma and Ionis Enter into License Agreement for Sapablursen to Treat Polycythemia Vera

China’s NMPA Approves Kelun-Biotech’s Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC

Beckman Coulter Receives the US FDA 510(k) Clearance For DxC 500i Clinical Analyzer

Antech Launches trūRapid FOUR For Canine Vector-Borne Disease Screening

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