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

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Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Shots: Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks. Trial met its co-1EPs demonstrated 15.7% superior weight loss…

ByRidhi RastogiMarch 11, 2025

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AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the EC’s Approval to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Shots: The EC has approved Wainzua to treat ATTRv-PN (stage 1/2 polyneuropathy) in adults pts based on P-III (NEURO-TTRansform) trial assessing eplontersen vs external PBO over 66wks., with follow-up to Wk. 85 & an end-of-trial evaluation. Eligible pts could then enter an ongoing OLE study Trial showed sustained benefits in co-1EPs of serum transthyretin…

ByRidhi RastogiMarch 11, 2025

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Eli Lilly and Incyte Highlight P-III (BRAVE-AA-PEDS) Trial Data of Baricitinib for Alopecia Areata at AAD 2025

Shots: The P-III (BRAVE-AA-PEDS) trial assessed baricitinib (2 or 4mg, QD, PO) vs PBO in 257 pts (12 to <18yrs.) with severe AA, where 89% had significant scalp hair loss, 65% had minimal/no eyebrow hair, & 57% had minimal/no eyelash hair with ClinRO of 2/3; next cohort (6 to <12yrs) enrollment to start in 2026…

ByRidhi RastogiMarch 11, 2025

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The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

Shots: The US FDA has granted 510(k) clearance to Persona Revision SoluTion Femur as an alternative for knee implant in pts with metal sensitivities; commercially available in the US in Q3’25 SoluTion Femur, part of the Persona Revision Knee System, utilizes surface-hardening treatment for enhanced wear performance & provides surgeons with anatomic components, incl.…

ByRidhi RastogiMarch 10, 2025

Ridhi Rastogi

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

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the EC’s Approval to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Eli Lilly and Incyte Highlight P-III (BRAVE-AA-PEDS) Trial Data of Baricitinib for Alopecia Areata at AAD 2025

The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

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