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Takeda
News

Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Shots: The EC has approved Adcetris (brentuximab vedotin) + ECADD (etoposide, cyclophosphamide, doxorubicin, dacarbazine & dexamethasone) to treat adults with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma following CHMP’s positive opinion in Apr 2025 Approval was based on P-III (HD21) trial assessing Adcetris + ECADD vs escalated doses of BEACOPP in above pts,…
June 4, 20250Comments

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Amber implants
News

Amber Implants Reports Trial Data of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots: Amber Implants has reported 1yr. follow-up data from its trial assessing VCFix Spinal System in Germany for the treatment of vertebral compression fractures Trial showed immediate & sustained improvements in pain, with ≥8-point decrease in NPRS along with 84-point reduction in disability scores (per ODI) at 6mos., which were sustained through 1yr. in pts with…
June 4, 20250Comments

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J&J
News

J&J Presents P-III (AMPLITUDE) Trial Data of Akeega for Metastatic Castration-Sensitive Prostate Cancer (mCSPC) at ASCO 2025

Shots: The P-III (AMPLITUDE) trial assessed Akeega (niraparib & abiraterone acetate tablet) + prednisone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mCSPC, meeting its 1EP of improved rPFS In BRCA-altered pts (n=191), trial showed a 48% & 56% reduction in rPFS & symptomatic progression risk, respectively,…
June 4, 20250Comments

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Bayer
News

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoing Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP),…
June 4, 20250Comments

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Biosimilar (May 2025)
INSIGHTS+

Key Biosimilars Events of May 2025 

Shots:        Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency         Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   Fresenius Kabi Secured the CHMP’s Positive Opinion for Bomyntra & Conexxence. Our…
June 3, 20250Comments

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Roche
News

Roche Reports P-III (IMforte) Trial Findings on Tecentriq Regimen as a 1L Maintenance Therapy for ES-SCLC

Shots: Roche has reported P-III (IMforte) trial data of Tecentriq + lurbinectedin as 1L maintenance therapy for ES-SCLC pts (≥18yrs) Trial assessed the regimen vs Tecentriq monotx. in ES-SCLC pts, where 660 pts received induction therapy with Tecentriq + CT (4 x 21-day cycles) & 483 pts without progression were then randomized to maintenance with…
June 3, 20250Comments

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Bayer
News

Bayer Presents P-III (OASIS 4) Study Data of Elinzanetant for Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies at ASCO 2025

Shots: The P-III (OASIS-4) study evaluated elinzanetant (120mg, PO, QD) vs PBO for 52wks. to treat mod. to sev. VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer, with an optional 2yr. extension; regulatory filings are ongoing in the US, EU & other regions Trial showed reduced VMS frequency (1EP), with…
June 3, 20250Comments

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