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NextCure Signs a ~$745M Licensing Agreement with Simcere Zaiming for SIM0505

Shots: Simcere has granted NextCure exclusive global rights to develop, manufacture, & commercialize SIM0505 to treat solid tumors, excl. Greater China, where Simcere will retain its rights As per the deal, Simcere will receive ~$745M in upfront, development, regulatory & sales milestones, along with net sales-based royalties up to double-digits outside of Greater China. NextCure…
4 days ago0Comments

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CSL Receives the US FDA Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots:   The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 end Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean, as well as attacks requiring…
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VIEWPOINTS

Standardizing DLBCL Treatment: Dr. John Burke in a Riveting Conversation with PharmaShots  

Shots:   In the five-year follow-up data from the randomized POLARIX study, where participants received R-CHOP with a placebo for polatuzumab (control arm) and Pola-R-CHP with a placebo for vincristine   The primary endpoint of the study was progression free survival, and the secondary endpoint was overall survival  PharmaShots welcomes Dr. John Burke from Rocky Mountain Cancer…
June 16, 20250Comments

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Johnson& Johnson
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Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Shots:  J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposure Trial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…
June 16, 20250Comments

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Bracco Imaging & Subtle Medical’s AiMIFY Receives the European CE Mark Approval for Enhanced Brain MRI 

Shots: Bracco Imaging & Subtle Medical have received the European MDR CE Mark approval for their AI-powered AiMIFY software for brain MRI; phased commercial availability expected from late 2025 to early 2026 AiMIFY has depicted consistent efficacy across extensive validation data, incl. diverse pts demographics, pathologies, lesion sizes, MRI sequences, scanner vendors, & acquisition orientations…
June 16, 20250Comments

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THOUGHTSPOT

The Expanding Role of Pharmacists in Holistic Patient Treatment Plans

Modern healthcare continues to evolve, embracing a more patient-centered approach where collaboration and comprehensive care stand at the forefront. Among the most transformative shifts has been the redefinition of the pharmacist's role within this broader framework. Traditionally viewed as dispensers of medications, pharmacists are now increasingly recognized as integral members of multidisciplinary healthcare teams. Their…
June 16, 20250Comments

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Merck-3
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Merck Receives the US FDA’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The US FDA has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC based on P-III (KEYNOTE-689) trial Trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ± cisplatin vs…
June 16, 20250Comments

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